Orthopedics

Over the past several decades, an increasing number of orthopedic surgery residents have pursued fellowship training.¹ This inclination parallels market trends toward subspecialization.^2-5 In 1984, 83% of orthopedics job announcements were for general orthopedists. Twenty-five years later, almost 70% of orthopedic opportunities were for fellowship-trained surgeons.⁶ Further, between 1990 and 2006, the proportion of practicing orthopedic generalists decreased from 44% to 29%.³ In 2007, the American Academy of Orthopaedic Surgery (AAOS) reported 90% of graduating residents were planning to pursue fellowship training.⁷ Reasons for the explosion in subspecialty training are plentiful and well documented.^2-5 Subspecialty positions now dominate the job market, further reinforcing incentives for residents to pursue fellowship training.

The past several decades have seen numerous changes in the orthopedic fellowship interview process. Early on, it was largely unregulated, dependent on personal and professional connections, and flush with the classic “exploding offer” (residents were given a fellowship offer that expired within hours or days). In the 1980s, as the number of fellowship applications surged, the Accreditation Council for Graduate Medical Education (ACGME) pushed for a more regulated process.⁸ To further standardize the system, the American Orthopaedic Association (AOA), the AAOS, and several other specialty organizations created the Orthopaedic Fellowship Match Program Initiative in 2008.⁹ Currently, all orthopedic specialties are represented in either the San Francisco Match Program or National Residency Match Program.

As the system currently stands, postgraduate year 4 (PGY-4) residents are required to interview across the country to secure postgraduate training. This process necessitates residents’ absence from their program, reducing educational opportunities and placing potential continuity-of-care constraints on the residency program. Despite the growing competitiveness for fellowship positions, the increasing number of fellowships available, the rising educational debt of residents, and the limitations of the 80-hour work week, the impact of the interview process on both residents and residency programs has received minimal attention.

We conducted a study to elucidate the impact of the fellowship interview process on residents and residency programs. We hypothesized the time and financial costs for fellowship interviews would be substantial.

Materials and Methods

We obtained institutional review board (IRB) approval for this study. Then, in April 2014, we sent 2 mixed-response questionnaires to orthopedic surgery residency directors and residents. There were 8 items on the director questionnaire and 11 on the resident questionnaire. The surveys were designed to determine the impact of the fellowship interview process on residents and residency programs with respect to finances, time, education, and continuity of care. Each survey had at least 1 free-response question, providing the opportunity to recommend changes to the interview process. The surveys were reviewed and approved by our IRB.

An email was sent to 155 orthopedic surgery program directors or their secretaries. The email asked that the director complete the director questionnaire and that the resident questionnaire be forwarded to senior-level residents, PGY-4s and PGY-5s, who had completed the fellowship interview process. Forty-five (29%) of the 155 directors responded, as did 129 (estimated 9.5%) of an estimated 1354 potential PGY-4s and PGY-5s.¹⁰

The Survey Monkey surveys could be completed over a 3-week period. All responses were anonymous. Using Survey Monkey, we aggregated individual responses into predefined clusters before performing statistical analysis. Descriptive statistics were generated with Microsoft Excel.

Results

Survey respondents represented all the orthopedic subspecialties (Table). Seventy-eight percent of residents applied to at least 13 programs (average, 19) (Figure 1). Ninety-two percent received at least 8 interview offers (average, 14). Eighty-three percent attended 8 or more interviews (average, 11). Seventy-one percent of all interviews were granted when requested, and 79% of all interviews were attended when offered.

Residents spent an average of $5875 (range, $500-$12,000+) on the fellowship interview process (Figure 2). The highest percentage of respondents, 39.5%, selected an average expense between $4000 and $6000. Forty-nine percent of residents borrowed money (from credit cards, additional loans, family members) to pay their expenses.

Average number of days away from residency programs was 11, with 86% of residents missing more than 8 days (Figure 1). About one-third of residents reported being away from their home program for almost 2 weeks during the interview season. Further, 74% of residents wanted changes made to the fellowship application process.

Thirty-seven (82%) of the 45 program directors were from academic programs, the other 8 from community-based programs. Average number of residents in programs per year was 4 (73% of the programs had 4-6 residents per year). Respondents rated the disruption caused by residents’ interview absences from 1 (least disruptive) to 10 (most disruptive) (Figure 3); the average rating was over 7 (high level of disruption). Although 9% of directors thought the process caused little or no disruption (rating, 1-3), 62% thought it extremely disruptive (rating, 8-10).

Thirty-one (69%) of the 45 directors agreed that the fellowship interview process should undergo fundamental change. Asked about possible solutions to current complaints, 60% of the directors agreed that interviews should be conducted in a central location. Of the directors who thought fundamental change was needed, 59% indicated AAOS and other specialty societies together should lead the change in the fellowship interview process.

Both residents and program directors were given the opportunity to write in suggestions regarding how to improve the fellowship interview process. Suggestions were made by 85 (66%) of the 129 residents and 24 (53%) of the 45 directors (Appendix).        

Discussion

Graduating residents are entering a health care environment in which they must be financially conscious because of increasing education debt and decreasing reimbursement prospects.³ Nevertheless, an overwhelming majority of residents delay entering practice to pursue fellowship training—an estimated opportunity cost of $350,000.³ Minimal attention has been given to the potential costs of the fellowship interview process.

Our study results highlight that time away from residency training, financial costs associated with the fellowship interview process, and disruption of the residency program are substantial. On average, residents applied to 19 programs, received 14 interview offers, attended 11 interviews, were away from residency training 11 days, and spent $5875 on travel. The great majority of both residents and program directors wanted changes in the current paradigm governing the orthopedic fellowship interview process.

It is reasonable to think that the number of days residents spend away on interviews would reduce the time available for education and patient care. Although unknown, it is plausible that residents of programs outside major metropolitan centers and residents who apply to more competitive fellowships may be forced to spend even more time away from training. Outside the focus of this study are the impact that residents’ absence might have on their education and the impact of this absence on the people who do the residents’ work while they are away.

Mean fellowship expense was similar to that reported by residents pursuing a pediatric general surgery fellowship ($6974) or a plastic surgery fellowship ($6100).^11,12 Unfortunately, we were unable to determine if average cost is influenced by choice of fellowship specialty or location of residency program. Regardless, fellowship cost may impose an additional financial burden on residents. According to the Association of American Medical Colleges (AAMC), the median salary for PGY-4 residents was $56,380 in 2013. Therefore, on average, the fellowship process consumes more than 10% of a resident’s pretax salary. For perspective, this equates to more than $40,000 for a practicing orthopedic surgeon with a median salary of $413,000.¹³ With an average medical student graduate debt of $175,000 and continuing decreases in reimbursement, further financial hardships to newly graduating residents cannot be understated.^5,11,12

Almost 70% of program directors thought the fellowship process significantly disrupted their program. Reasons given for this disruption mainly involved residents’ time away from the program and the resulting strains placed on maintaining adequate coverage for patient care. The overall disruption score of 7.4 out of 10 was consistent with the great majority thinking that the fellowship process negatively affects their residency program. Altering the fellowship interview process may provide unintended benefits to programs and program directors.

Both program directors and residents communicated that change is needed, but there was little consensus regarding how to effect change and who should lead. This lack of consensus highlights how important it is for the various orthopedic leadership committees to actively and collectively participate in discussions about redefining the system. It has been proposed that it would be ideal for the AOA to lead the change, as the AOA consists of a representative cohort of academic orthopedists and leaders across the spectrum of all fellowship specialties.¹⁴ Given the abundant concern of both residents and program directors, we find it prudent to issue a call to arms of sorts to the AAOS and the individual orthopedic subspecialty societies to work together on a common goal that would benefit residents, programs, and subspecialties within orthopedics.

In trying to understand the challenges that residents, program directors, and programs face, as well as the inherent complexity of the current system, we incorporated respondents’ write-in comments into suggested ways of improving the fellowship interview process. These comments had broad perspectives but overall were consistent with the survey results (Appendix).

Technology

Health care is continually finding new ways to take advantage of technological advances. This is occurring with the fellowship interview schema. Numerous disciplines are using videoconferencing platforms (eg, Skype) to conduct interviews. This practice is becoming more commonplace in the business sector. In a recent survey, more than 60% of human resource managers reported conducting video interviews.¹⁵ Two independent residency programs have used video interviews with mixed success.^16,17

Another technological change requested by residents is the creation and updating of fellowship web pages with standardized information. Such a service may prove useful to residents researching a program and may even lead to limiting the number of programs residents apply to, as they may be able to dial in on exactly what distinguishes one program from another before traveling for an interview. A recent study of orthopedic sports medicine fellowship programs found that most of these programs lacked pertinent information on their websites.¹⁸ Important information regarding case logs from current and former fellows; number of faculty, residents, and fellows; and schedules and facilities of interview sites are a few of the online data points that may help residents differentiate particular programs.^19,20 Questions like these are often asked at interviews and site visits. Having accurate information easily available online may reduce or eliminate the need to travel to a site for such information. Standardizing information would also increase transparency among available fellowships. Although not specifically mentioned, organizational software that improves the productivity of the process may help limit the large number of programs applied to, the interviews offered and attended, the days away, and the financial costs without reducing the match rate.

Timing and Location

The issue of timing—with respect to geographical or meteorological concerns—was another recurring theme among respondents. Numerous respondents indicated that certain programs located in geographic proximity tried to minimize travel by offering interviews around the same time. This coordination potentially minimizes travel expenses and time away from the residency program by allowing residents to interview at multiple locations during a single trip per region. The sports medicine fellowship process was identified as a good example of aligning interviews based on geography. Several respondents suggested an option that also reflects the practice of nonsurgical fellowships—delaying the interview season to bypass potential weather concerns. Winter 2013–2014 saw the most flight delays or cancellations in more than a decade; about 50% of all flights scheduled between December and February were delayed or canceled.²¹ Beyond the additional factor of more time away or missing an interview because of the weather are safety concerns related to the weather. One resident reported having a motor vehicle accident while traveling to an interview in poor weather conditions (Appendix).

National Meetings

Each orthopedic subspecialty has numerous national meetings. Many programs offer applicants the opportunity to interview at these meetings. One respondent mentioned that the annual meeting of the Orthopaedic Trauma Association offers trauma applicants the opportunity to interview with multiple programs. It might be beneficial to endorse this practice on a larger scale to help reduce travel and time away. We recognize that visiting individual programs is an important aspect of the match process, but doing so on a targeted level may make more sense, increasing financial efficiency and reducing time away from programs.

Proposed Solution

A combined proposed solution that can be implemented without a radical overhaul or significant investments might involve moving the interview season to early spring, switching to a 2-tiered system with a centralized first round of interview screening coinciding with subspecialty national meetings or the AAOS annual meeting, and standardizing online information for all orthopedic fellowship programs. A 2-tiered interview process would allow programs and candidates to obtain exposure to a significant number of programs in the first round without incurring significant costs and then would impose a cap on the number of programs to visit. This would level the playing field between candidates with more time and money and candidates who are more constrained in their training environment and finances. A stopgap or adjunct to residents or fellowship programs unable to attend a centralized meeting would be to combine technological tools, such as Internet-based videoconferencing (Skype), before site visits by residents. After this first round of introductions and interviews, residents could then decide on a limited number of programs to formally visit, attend, and ultimately rank. This proposed system would still be able to function within the confines of the match, and it would benefit from the protections offered to residents and programs. Although capping the number of interviews attended by residents clearly can lower costs across the board, we recognize the difficulty of enforcing such a requirement. These potential changes to the system are not exhaustive, and we hope this work will serve as a springboard to further discussion.

Our study had several inherent weaknesses. Our data came from survey responses, which reflect the perspectives only of the responding residents and program directors. Unfortunately, a small number of orthopedic residents responded to this survey, so there was a potential for bias. However, we think the central themes discovered in this survey are only echoes of the concerns of the larger population of residents and program directors. Our hope in designing such a study was to bring to light some of the discrepancies in the fellowship interview process, the goal being to stimulate interest among the orthopedic leadership representing future orthopedic surgeons. More study is needed to clarify if these issues are reflective of a larger segment of residents and program directors. In addition, action may be needed to fully elucidate the intricate interworking of the fellowship process in order to maximize the interest of the orthopedic surgeons who are seeking fellowship training. Another study limitation was the potential for recall bias in the more senior PGY-5 residents, who were further from the interview process than PGY-4 respondents were. Because of the need for anonymity with the surveys, we could not link some findings (eg, program impact, cost, time away) to individual programs or different specialty fellowships. Although it appears there is a desire for a more cost-effective system, given the financial pressures on medical students and residents, the desire to match increases costs because students are likely to attend more interviews than actually needed. Our proposed solution does not take into account residents’ behavior with respect to the current match system. For example, the prevailing thought is that interviewing at more programs increases the likelihood of matching into a desired subspecialty. Despite these study limitations, we think our results identified important points for discussion, investigation, and potential action by orthopedic leadership.

Conclusion

The challenge of critiquing and improving the orthopedic fellowship process requires the same courageous leadership that was recommended almost a decade ago.¹⁴ In this study, we tried to elucidate the impact of the PGY-4 fellowship interview process with respect to residents and residency programs. Our results highlight that time away from residency training, financial costs associated with the fellowship interview process, and disruption of the residency program are substantial and that both residents and program directors want changes made. Leadership needs to further investigate alternatives to the current process to lessen the impact on all parties in this important process.

Over the past several decades, an increasing number of orthopedic surgery residents have pursued fellowship training.¹ This inclination parallels market trends toward subspecialization.^2-5 In 1984, 83% of orthopedics job announcements were for general orthopedists. Twenty-five years later, almost 70% of orthopedic opportunities were for fellowship-trained surgeons.⁶ Further, between 1990 and 2006, the proportion of practicing orthopedic generalists decreased from 44% to 29%.³ In 2007, the American Academy of Orthopaedic Surgery (AAOS) reported 90% of graduating residents were planning to pursue fellowship training.⁷ Reasons for the explosion in subspecialty training are plentiful and well documented.^2-5 Subspecialty positions now dominate the job market, further reinforcing incentives for residents to pursue fellowship training.

The past several decades have seen numerous changes in the orthopedic fellowship interview process. Early on, it was largely unregulated, dependent on personal and professional connections, and flush with the classic “exploding offer” (residents were given a fellowship offer that expired within hours or days). In the 1980s, as the number of fellowship applications surged, the Accreditation Council for Graduate Medical Education (ACGME) pushed for a more regulated process.⁸ To further standardize the system, the American Orthopaedic Association (AOA), the AAOS, and several other specialty organizations created the Orthopaedic Fellowship Match Program Initiative in 2008.⁹ Currently, all orthopedic specialties are represented in either the San Francisco Match Program or National Residency Match Program.

As the system currently stands, postgraduate year 4 (PGY-4) residents are required to interview across the country to secure postgraduate training. This process necessitates residents’ absence from their program, reducing educational opportunities and placing potential continuity-of-care constraints on the residency program. Despite the growing competitiveness for fellowship positions, the increasing number of fellowships available, the rising educational debt of residents, and the limitations of the 80-hour work week, the impact of the interview process on both residents and residency programs has received minimal attention.

We conducted a study to elucidate the impact of the fellowship interview process on residents and residency programs. We hypothesized the time and financial costs for fellowship interviews would be substantial.

Materials and Methods

We obtained institutional review board (IRB) approval for this study. Then, in April 2014, we sent 2 mixed-response questionnaires to orthopedic surgery residency directors and residents. There were 8 items on the director questionnaire and 11 on the resident questionnaire. The surveys were designed to determine the impact of the fellowship interview process on residents and residency programs with respect to finances, time, education, and continuity of care. Each survey had at least 1 free-response question, providing the opportunity to recommend changes to the interview process. The surveys were reviewed and approved by our IRB.

An email was sent to 155 orthopedic surgery program directors or their secretaries. The email asked that the director complete the director questionnaire and that the resident questionnaire be forwarded to senior-level residents, PGY-4s and PGY-5s, who had completed the fellowship interview process. Forty-five (29%) of the 155 directors responded, as did 129 (estimated 9.5%) of an estimated 1354 potential PGY-4s and PGY-5s.¹⁰

The Survey Monkey surveys could be completed over a 3-week period. All responses were anonymous. Using Survey Monkey, we aggregated individual responses into predefined clusters before performing statistical analysis. Descriptive statistics were generated with Microsoft Excel.

Results

Survey respondents represented all the orthopedic subspecialties (Table). Seventy-eight percent of residents applied to at least 13 programs (average, 19) (Figure 1). Ninety-two percent received at least 8 interview offers (average, 14). Eighty-three percent attended 8 or more interviews (average, 11). Seventy-one percent of all interviews were granted when requested, and 79% of all interviews were attended when offered.

Residents spent an average of $5875 (range, $500-$12,000+) on the fellowship interview process (Figure 2). The highest percentage of respondents, 39.5%, selected an average expense between $4000 and $6000. Forty-nine percent of residents borrowed money (from credit cards, additional loans, family members) to pay their expenses.

Average number of days away from residency programs was 11, with 86% of residents missing more than 8 days (Figure 1). About one-third of residents reported being away from their home program for almost 2 weeks during the interview season. Further, 74% of residents wanted changes made to the fellowship application process.

Thirty-seven (82%) of the 45 program directors were from academic programs, the other 8 from community-based programs. Average number of residents in programs per year was 4 (73% of the programs had 4-6 residents per year). Respondents rated the disruption caused by residents’ interview absences from 1 (least disruptive) to 10 (most disruptive) (Figure 3); the average rating was over 7 (high level of disruption). Although 9% of directors thought the process caused little or no disruption (rating, 1-3), 62% thought it extremely disruptive (rating, 8-10).

Thirty-one (69%) of the 45 directors agreed that the fellowship interview process should undergo fundamental change. Asked about possible solutions to current complaints, 60% of the directors agreed that interviews should be conducted in a central location. Of the directors who thought fundamental change was needed, 59% indicated AAOS and other specialty societies together should lead the change in the fellowship interview process.

Both residents and program directors were given the opportunity to write in suggestions regarding how to improve the fellowship interview process. Suggestions were made by 85 (66%) of the 129 residents and 24 (53%) of the 45 directors (Appendix).        

Discussion

Graduating residents are entering a health care environment in which they must be financially conscious because of increasing education debt and decreasing reimbursement prospects.³ Nevertheless, an overwhelming majority of residents delay entering practice to pursue fellowship training—an estimated opportunity cost of $350,000.³ Minimal attention has been given to the potential costs of the fellowship interview process.

Our study results highlight that time away from residency training, financial costs associated with the fellowship interview process, and disruption of the residency program are substantial. On average, residents applied to 19 programs, received 14 interview offers, attended 11 interviews, were away from residency training 11 days, and spent $5875 on travel. The great majority of both residents and program directors wanted changes in the current paradigm governing the orthopedic fellowship interview process.

It is reasonable to think that the number of days residents spend away on interviews would reduce the time available for education and patient care. Although unknown, it is plausible that residents of programs outside major metropolitan centers and residents who apply to more competitive fellowships may be forced to spend even more time away from training. Outside the focus of this study are the impact that residents’ absence might have on their education and the impact of this absence on the people who do the residents’ work while they are away.

Mean fellowship expense was similar to that reported by residents pursuing a pediatric general surgery fellowship ($6974) or a plastic surgery fellowship ($6100).^11,12 Unfortunately, we were unable to determine if average cost is influenced by choice of fellowship specialty or location of residency program. Regardless, fellowship cost may impose an additional financial burden on residents. According to the Association of American Medical Colleges (AAMC), the median salary for PGY-4 residents was $56,380 in 2013. Therefore, on average, the fellowship process consumes more than 10% of a resident’s pretax salary. For perspective, this equates to more than $40,000 for a practicing orthopedic surgeon with a median salary of $413,000.¹³ With an average medical student graduate debt of $175,000 and continuing decreases in reimbursement, further financial hardships to newly graduating residents cannot be understated.^5,11,12

Almost 70% of program directors thought the fellowship process significantly disrupted their program. Reasons given for this disruption mainly involved residents’ time away from the program and the resulting strains placed on maintaining adequate coverage for patient care. The overall disruption score of 7.4 out of 10 was consistent with the great majority thinking that the fellowship process negatively affects their residency program. Altering the fellowship interview process may provide unintended benefits to programs and program directors.

Both program directors and residents communicated that change is needed, but there was little consensus regarding how to effect change and who should lead. This lack of consensus highlights how important it is for the various orthopedic leadership committees to actively and collectively participate in discussions about redefining the system. It has been proposed that it would be ideal for the AOA to lead the change, as the AOA consists of a representative cohort of academic orthopedists and leaders across the spectrum of all fellowship specialties.¹⁴ Given the abundant concern of both residents and program directors, we find it prudent to issue a call to arms of sorts to the AAOS and the individual orthopedic subspecialty societies to work together on a common goal that would benefit residents, programs, and subspecialties within orthopedics.

In trying to understand the challenges that residents, program directors, and programs face, as well as the inherent complexity of the current system, we incorporated respondents’ write-in comments into suggested ways of improving the fellowship interview process. These comments had broad perspectives but overall were consistent with the survey results (Appendix).

Technology

Health care is continually finding new ways to take advantage of technological advances. This is occurring with the fellowship interview schema. Numerous disciplines are using videoconferencing platforms (eg, Skype) to conduct interviews. This practice is becoming more commonplace in the business sector. In a recent survey, more than 60% of human resource managers reported conducting video interviews.¹⁵ Two independent residency programs have used video interviews with mixed success.^16,17

Another technological change requested by residents is the creation and updating of fellowship web pages with standardized information. Such a service may prove useful to residents researching a program and may even lead to limiting the number of programs residents apply to, as they may be able to dial in on exactly what distinguishes one program from another before traveling for an interview. A recent study of orthopedic sports medicine fellowship programs found that most of these programs lacked pertinent information on their websites.¹⁸ Important information regarding case logs from current and former fellows; number of faculty, residents, and fellows; and schedules and facilities of interview sites are a few of the online data points that may help residents differentiate particular programs.^19,20 Questions like these are often asked at interviews and site visits. Having accurate information easily available online may reduce or eliminate the need to travel to a site for such information. Standardizing information would also increase transparency among available fellowships. Although not specifically mentioned, organizational software that improves the productivity of the process may help limit the large number of programs applied to, the interviews offered and attended, the days away, and the financial costs without reducing the match rate.

Timing and Location

The issue of timing—with respect to geographical or meteorological concerns—was another recurring theme among respondents. Numerous respondents indicated that certain programs located in geographic proximity tried to minimize travel by offering interviews around the same time. This coordination potentially minimizes travel expenses and time away from the residency program by allowing residents to interview at multiple locations during a single trip per region. The sports medicine fellowship process was identified as a good example of aligning interviews based on geography. Several respondents suggested an option that also reflects the practice of nonsurgical fellowships—delaying the interview season to bypass potential weather concerns. Winter 2013–2014 saw the most flight delays or cancellations in more than a decade; about 50% of all flights scheduled between December and February were delayed or canceled.²¹ Beyond the additional factor of more time away or missing an interview because of the weather are safety concerns related to the weather. One resident reported having a motor vehicle accident while traveling to an interview in poor weather conditions (Appendix).

National Meetings

Each orthopedic subspecialty has numerous national meetings. Many programs offer applicants the opportunity to interview at these meetings. One respondent mentioned that the annual meeting of the Orthopaedic Trauma Association offers trauma applicants the opportunity to interview with multiple programs. It might be beneficial to endorse this practice on a larger scale to help reduce travel and time away. We recognize that visiting individual programs is an important aspect of the match process, but doing so on a targeted level may make more sense, increasing financial efficiency and reducing time away from programs.

Proposed Solution

A combined proposed solution that can be implemented without a radical overhaul or significant investments might involve moving the interview season to early spring, switching to a 2-tiered system with a centralized first round of interview screening coinciding with subspecialty national meetings or the AAOS annual meeting, and standardizing online information for all orthopedic fellowship programs. A 2-tiered interview process would allow programs and candidates to obtain exposure to a significant number of programs in the first round without incurring significant costs and then would impose a cap on the number of programs to visit. This would level the playing field between candidates with more time and money and candidates who are more constrained in their training environment and finances. A stopgap or adjunct to residents or fellowship programs unable to attend a centralized meeting would be to combine technological tools, such as Internet-based videoconferencing (Skype), before site visits by residents. After this first round of introductions and interviews, residents could then decide on a limited number of programs to formally visit, attend, and ultimately rank. This proposed system would still be able to function within the confines of the match, and it would benefit from the protections offered to residents and programs. Although capping the number of interviews attended by residents clearly can lower costs across the board, we recognize the difficulty of enforcing such a requirement. These potential changes to the system are not exhaustive, and we hope this work will serve as a springboard to further discussion.

Our study had several inherent weaknesses. Our data came from survey responses, which reflect the perspectives only of the responding residents and program directors. Unfortunately, a small number of orthopedic residents responded to this survey, so there was a potential for bias. However, we think the central themes discovered in this survey are only echoes of the concerns of the larger population of residents and program directors. Our hope in designing such a study was to bring to light some of the discrepancies in the fellowship interview process, the goal being to stimulate interest among the orthopedic leadership representing future orthopedic surgeons. More study is needed to clarify if these issues are reflective of a larger segment of residents and program directors. In addition, action may be needed to fully elucidate the intricate interworking of the fellowship process in order to maximize the interest of the orthopedic surgeons who are seeking fellowship training. Another study limitation was the potential for recall bias in the more senior PGY-5 residents, who were further from the interview process than PGY-4 respondents were. Because of the need for anonymity with the surveys, we could not link some findings (eg, program impact, cost, time away) to individual programs or different specialty fellowships. Although it appears there is a desire for a more cost-effective system, given the financial pressures on medical students and residents, the desire to match increases costs because students are likely to attend more interviews than actually needed. Our proposed solution does not take into account residents’ behavior with respect to the current match system. For example, the prevailing thought is that interviewing at more programs increases the likelihood of matching into a desired subspecialty. Despite these study limitations, we think our results identified important points for discussion, investigation, and potential action by orthopedic leadership.

Conclusion

The challenge of critiquing and improving the orthopedic fellowship process requires the same courageous leadership that was recommended almost a decade ago.¹⁴ In this study, we tried to elucidate the impact of the PGY-4 fellowship interview process with respect to residents and residency programs. Our results highlight that time away from residency training, financial costs associated with the fellowship interview process, and disruption of the residency program are substantial and that both residents and program directors want changes made. Leadership needs to further investigate alternatives to the current process to lessen the impact on all parties in this important process.

Over the past several decades, an increasing number of orthopedic surgery residents have pursued fellowship training.¹ This inclination parallels market trends toward subspecialization.^2-5 In 1984, 83% of orthopedics job announcements were for general orthopedists. Twenty-five years later, almost 70% of orthopedic opportunities were for fellowship-trained surgeons.⁶ Further, between 1990 and 2006, the proportion of practicing orthopedic generalists decreased from 44% to 29%.³ In 2007, the American Academy of Orthopaedic Surgery (AAOS) reported 90% of graduating residents were planning to pursue fellowship training.⁷ Reasons for the explosion in subspecialty training are plentiful and well documented.^2-5 Subspecialty positions now dominate the job market, further reinforcing incentives for residents to pursue fellowship training.

The past several decades have seen numerous changes in the orthopedic fellowship interview process. Early on, it was largely unregulated, dependent on personal and professional connections, and flush with the classic “exploding offer” (residents were given a fellowship offer that expired within hours or days). In the 1980s, as the number of fellowship applications surged, the Accreditation Council for Graduate Medical Education (ACGME) pushed for a more regulated process.⁸ To further standardize the system, the American Orthopaedic Association (AOA), the AAOS, and several other specialty organizations created the Orthopaedic Fellowship Match Program Initiative in 2008.⁹ Currently, all orthopedic specialties are represented in either the San Francisco Match Program or National Residency Match Program.

As the system currently stands, postgraduate year 4 (PGY-4) residents are required to interview across the country to secure postgraduate training. This process necessitates residents’ absence from their program, reducing educational opportunities and placing potential continuity-of-care constraints on the residency program. Despite the growing competitiveness for fellowship positions, the increasing number of fellowships available, the rising educational debt of residents, and the limitations of the 80-hour work week, the impact of the interview process on both residents and residency programs has received minimal attention.

We conducted a study to elucidate the impact of the fellowship interview process on residents and residency programs. We hypothesized the time and financial costs for fellowship interviews would be substantial.

Materials and Methods

We obtained institutional review board (IRB) approval for this study. Then, in April 2014, we sent 2 mixed-response questionnaires to orthopedic surgery residency directors and residents. There were 8 items on the director questionnaire and 11 on the resident questionnaire. The surveys were designed to determine the impact of the fellowship interview process on residents and residency programs with respect to finances, time, education, and continuity of care. Each survey had at least 1 free-response question, providing the opportunity to recommend changes to the interview process. The surveys were reviewed and approved by our IRB.

An email was sent to 155 orthopedic surgery program directors or their secretaries. The email asked that the director complete the director questionnaire and that the resident questionnaire be forwarded to senior-level residents, PGY-4s and PGY-5s, who had completed the fellowship interview process. Forty-five (29%) of the 155 directors responded, as did 129 (estimated 9.5%) of an estimated 1354 potential PGY-4s and PGY-5s.¹⁰

The Survey Monkey surveys could be completed over a 3-week period. All responses were anonymous. Using Survey Monkey, we aggregated individual responses into predefined clusters before performing statistical analysis. Descriptive statistics were generated with Microsoft Excel.

Results

Survey respondents represented all the orthopedic subspecialties (Table). Seventy-eight percent of residents applied to at least 13 programs (average, 19) (Figure 1). Ninety-two percent received at least 8 interview offers (average, 14). Eighty-three percent attended 8 or more interviews (average, 11). Seventy-one percent of all interviews were granted when requested, and 79% of all interviews were attended when offered.

Residents spent an average of $5875 (range, $500-$12,000+) on the fellowship interview process (Figure 2). The highest percentage of respondents, 39.5%, selected an average expense between $4000 and $6000. Forty-nine percent of residents borrowed money (from credit cards, additional loans, family members) to pay their expenses.

Average number of days away from residency programs was 11, with 86% of residents missing more than 8 days (Figure 1). About one-third of residents reported being away from their home program for almost 2 weeks during the interview season. Further, 74% of residents wanted changes made to the fellowship application process.

Thirty-seven (82%) of the 45 program directors were from academic programs, the other 8 from community-based programs. Average number of residents in programs per year was 4 (73% of the programs had 4-6 residents per year). Respondents rated the disruption caused by residents’ interview absences from 1 (least disruptive) to 10 (most disruptive) (Figure 3); the average rating was over 7 (high level of disruption). Although 9% of directors thought the process caused little or no disruption (rating, 1-3), 62% thought it extremely disruptive (rating, 8-10).

Thirty-one (69%) of the 45 directors agreed that the fellowship interview process should undergo fundamental change. Asked about possible solutions to current complaints, 60% of the directors agreed that interviews should be conducted in a central location. Of the directors who thought fundamental change was needed, 59% indicated AAOS and other specialty societies together should lead the change in the fellowship interview process.

Both residents and program directors were given the opportunity to write in suggestions regarding how to improve the fellowship interview process. Suggestions were made by 85 (66%) of the 129 residents and 24 (53%) of the 45 directors (Appendix).        

Discussion

Graduating residents are entering a health care environment in which they must be financially conscious because of increasing education debt and decreasing reimbursement prospects.³ Nevertheless, an overwhelming majority of residents delay entering practice to pursue fellowship training—an estimated opportunity cost of $350,000.³ Minimal attention has been given to the potential costs of the fellowship interview process.

Our study results highlight that time away from residency training, financial costs associated with the fellowship interview process, and disruption of the residency program are substantial. On average, residents applied to 19 programs, received 14 interview offers, attended 11 interviews, were away from residency training 11 days, and spent $5875 on travel. The great majority of both residents and program directors wanted changes in the current paradigm governing the orthopedic fellowship interview process.

It is reasonable to think that the number of days residents spend away on interviews would reduce the time available for education and patient care. Although unknown, it is plausible that residents of programs outside major metropolitan centers and residents who apply to more competitive fellowships may be forced to spend even more time away from training. Outside the focus of this study are the impact that residents’ absence might have on their education and the impact of this absence on the people who do the residents’ work while they are away.

Mean fellowship expense was similar to that reported by residents pursuing a pediatric general surgery fellowship ($6974) or a plastic surgery fellowship ($6100).^11,12 Unfortunately, we were unable to determine if average cost is influenced by choice of fellowship specialty or location of residency program. Regardless, fellowship cost may impose an additional financial burden on residents. According to the Association of American Medical Colleges (AAMC), the median salary for PGY-4 residents was $56,380 in 2013. Therefore, on average, the fellowship process consumes more than 10% of a resident’s pretax salary. For perspective, this equates to more than $40,000 for a practicing orthopedic surgeon with a median salary of $413,000.¹³ With an average medical student graduate debt of $175,000 and continuing decreases in reimbursement, further financial hardships to newly graduating residents cannot be understated.^5,11,12

Almost 70% of program directors thought the fellowship process significantly disrupted their program. Reasons given for this disruption mainly involved residents’ time away from the program and the resulting strains placed on maintaining adequate coverage for patient care. The overall disruption score of 7.4 out of 10 was consistent with the great majority thinking that the fellowship process negatively affects their residency program. Altering the fellowship interview process may provide unintended benefits to programs and program directors.

Both program directors and residents communicated that change is needed, but there was little consensus regarding how to effect change and who should lead. This lack of consensus highlights how important it is for the various orthopedic leadership committees to actively and collectively participate in discussions about redefining the system. It has been proposed that it would be ideal for the AOA to lead the change, as the AOA consists of a representative cohort of academic orthopedists and leaders across the spectrum of all fellowship specialties.¹⁴ Given the abundant concern of both residents and program directors, we find it prudent to issue a call to arms of sorts to the AAOS and the individual orthopedic subspecialty societies to work together on a common goal that would benefit residents, programs, and subspecialties within orthopedics.

In trying to understand the challenges that residents, program directors, and programs face, as well as the inherent complexity of the current system, we incorporated respondents’ write-in comments into suggested ways of improving the fellowship interview process. These comments had broad perspectives but overall were consistent with the survey results (Appendix).

Technology

Health care is continually finding new ways to take advantage of technological advances. This is occurring with the fellowship interview schema. Numerous disciplines are using videoconferencing platforms (eg, Skype) to conduct interviews. This practice is becoming more commonplace in the business sector. In a recent survey, more than 60% of human resource managers reported conducting video interviews.¹⁵ Two independent residency programs have used video interviews with mixed success.^16,17

Another technological change requested by residents is the creation and updating of fellowship web pages with standardized information. Such a service may prove useful to residents researching a program and may even lead to limiting the number of programs residents apply to, as they may be able to dial in on exactly what distinguishes one program from another before traveling for an interview. A recent study of orthopedic sports medicine fellowship programs found that most of these programs lacked pertinent information on their websites.¹⁸ Important information regarding case logs from current and former fellows; number of faculty, residents, and fellows; and schedules and facilities of interview sites are a few of the online data points that may help residents differentiate particular programs.^19,20 Questions like these are often asked at interviews and site visits. Having accurate information easily available online may reduce or eliminate the need to travel to a site for such information. Standardizing information would also increase transparency among available fellowships. Although not specifically mentioned, organizational software that improves the productivity of the process may help limit the large number of programs applied to, the interviews offered and attended, the days away, and the financial costs without reducing the match rate.

Timing and Location

The issue of timing—with respect to geographical or meteorological concerns—was another recurring theme among respondents. Numerous respondents indicated that certain programs located in geographic proximity tried to minimize travel by offering interviews around the same time. This coordination potentially minimizes travel expenses and time away from the residency program by allowing residents to interview at multiple locations during a single trip per region. The sports medicine fellowship process was identified as a good example of aligning interviews based on geography. Several respondents suggested an option that also reflects the practice of nonsurgical fellowships—delaying the interview season to bypass potential weather concerns. Winter 2013–2014 saw the most flight delays or cancellations in more than a decade; about 50% of all flights scheduled between December and February were delayed or canceled.²¹ Beyond the additional factor of more time away or missing an interview because of the weather are safety concerns related to the weather. One resident reported having a motor vehicle accident while traveling to an interview in poor weather conditions (Appendix).

National Meetings

Each orthopedic subspecialty has numerous national meetings. Many programs offer applicants the opportunity to interview at these meetings. One respondent mentioned that the annual meeting of the Orthopaedic Trauma Association offers trauma applicants the opportunity to interview with multiple programs. It might be beneficial to endorse this practice on a larger scale to help reduce travel and time away. We recognize that visiting individual programs is an important aspect of the match process, but doing so on a targeted level may make more sense, increasing financial efficiency and reducing time away from programs.

Proposed Solution

A combined proposed solution that can be implemented without a radical overhaul or significant investments might involve moving the interview season to early spring, switching to a 2-tiered system with a centralized first round of interview screening coinciding with subspecialty national meetings or the AAOS annual meeting, and standardizing online information for all orthopedic fellowship programs. A 2-tiered interview process would allow programs and candidates to obtain exposure to a significant number of programs in the first round without incurring significant costs and then would impose a cap on the number of programs to visit. This would level the playing field between candidates with more time and money and candidates who are more constrained in their training environment and finances. A stopgap or adjunct to residents or fellowship programs unable to attend a centralized meeting would be to combine technological tools, such as Internet-based videoconferencing (Skype), before site visits by residents. After this first round of introductions and interviews, residents could then decide on a limited number of programs to formally visit, attend, and ultimately rank. This proposed system would still be able to function within the confines of the match, and it would benefit from the protections offered to residents and programs. Although capping the number of interviews attended by residents clearly can lower costs across the board, we recognize the difficulty of enforcing such a requirement. These potential changes to the system are not exhaustive, and we hope this work will serve as a springboard to further discussion.

Our study had several inherent weaknesses. Our data came from survey responses, which reflect the perspectives only of the responding residents and program directors. Unfortunately, a small number of orthopedic residents responded to this survey, so there was a potential for bias. However, we think the central themes discovered in this survey are only echoes of the concerns of the larger population of residents and program directors. Our hope in designing such a study was to bring to light some of the discrepancies in the fellowship interview process, the goal being to stimulate interest among the orthopedic leadership representing future orthopedic surgeons. More study is needed to clarify if these issues are reflective of a larger segment of residents and program directors. In addition, action may be needed to fully elucidate the intricate interworking of the fellowship process in order to maximize the interest of the orthopedic surgeons who are seeking fellowship training. Another study limitation was the potential for recall bias in the more senior PGY-5 residents, who were further from the interview process than PGY-4 respondents were. Because of the need for anonymity with the surveys, we could not link some findings (eg, program impact, cost, time away) to individual programs or different specialty fellowships. Although it appears there is a desire for a more cost-effective system, given the financial pressures on medical students and residents, the desire to match increases costs because students are likely to attend more interviews than actually needed. Our proposed solution does not take into account residents’ behavior with respect to the current match system. For example, the prevailing thought is that interviewing at more programs increases the likelihood of matching into a desired subspecialty. Despite these study limitations, we think our results identified important points for discussion, investigation, and potential action by orthopedic leadership.

Conclusion

The challenge of critiquing and improving the orthopedic fellowship process requires the same courageous leadership that was recommended almost a decade ago.¹⁴ In this study, we tried to elucidate the impact of the PGY-4 fellowship interview process with respect to residents and residency programs. Our results highlight that time away from residency training, financial costs associated with the fellowship interview process, and disruption of the residency program are substantial and that both residents and program directors want changes made. Leadership needs to further investigate alternatives to the current process to lessen the impact on all parties in this important process.

Humeral shaft fractures account for about 1% of all fractures.¹ With the exception of the few absolute indications for surgical intervention, such as the presence of an open fracture, the current teaching on treatment of these fractures is that the majority can be successfully managed nonoperatively.^1-3 These conservative measures consist of bandages, abduction splints, U-casts, hanging arm casts, and, most commonly, functional bracing, which is considered the gold standard for treatment of humeral shaft fractures by many authors.^1-3 One of the most often cited disadvantages of nonoperative management over surgical treatment is the higher incidence of residual deformity, the most common of which is varus angulation.⁴

The incidence of malunion (>20° of angulation in any plane or shortening of ≥2.5 cm) after nonoperative treatment varies in the literature from 0% to 13%,^2,4-9 with a recent literature review documenting a mean incidence of 4.4% within the frontal plane and 2% within the sagittal plane across all studies.² As reported initially by Sarmiento and colleagues^3,9 and echoed by other authors,^2,5,8 angular deformity of less than 20° is thought to be both cosmetically and functionally acceptable. Whether angular deformities or malunion of more than 20° actually leads to functional limitations is unknown. Although some observational reports suggest that the degree of radiographic malalignment does not necessarily correlate with functional outcome,⁸ no studies have specifically evaluated patient outcomes of humeral shaft fracture malunions.

We conducted a study to determine the overall incidence and long-term clinical and functional outcomes of patients with malunion after nonoperative management of humeral shaft fractures. Long-term outcomes were assessed with current symptoms, physical examination findings, need for subsequent operative intervention, DASH (Disabilities of the Arm, Shoulder, and Hand) scores, and a self-reported questionnaire. We hypothesized that patients who develop a malunion after nonoperative treatment of a closed humeral shaft fracture will have satisfactory functional outcomes based on subjective reports, physical examination findings, and DASH scores.

Methods

After obtaining institutional review board approval for the study, we selected patients from a retrospective medical record review of all those 18 years or older with a humeral shaft fracture managed nonoperatively at our institution between January 1, 2001, and June 30, 2012, with a minimum 1-year follow-up. We identified 156 patients with nonoperatively managed midshaft humerus fractures. Study exclusion criteria included fracture associated with a tumor (3 patients), ipsilateral upper extremity injury (9), open/ballistic injury (18), nonunion (9), underlying cognitive disability or psychiatric illness (4), and insufficient follow-up to clinical or radiographic healing (22). Ninety-one patients were eligible for study inclusion. Radiographs at time of final clinical visit were reviewed to assess for evidence of malunion at the fracture site, as defined by previously reported criteria³ (>20° angulation in anterior/posterior or varus/valgus plane of motion or shortening of ≥2.5 cm). Fifteen patients met all the inclusion criteria for further evaluation.

Medical records were retrospectively reviewed for information on age at injury, sex, comorbidities (eg, diabetes, osteoporosis, smoking), body mass index, type and duration of immobilization, complications, return to work, cosmetic perception, time to final clinical follow-up, and symptoms at final clinical follow-up. Incidence of potential risk factors associated with malunion—obesity, noncompliance, and comorbidities such as smoking and diabetes—was compared between the 15 patients with malunion and the other study patients, who healed without malunion.

For long-term postoperative follow-up, patients were contacted to be seen in clinic to complete an updated physical examination, self-reported questionnaire, and the DASH form. Physical examination included measurements of range of motion (ROM) and strength involving the shoulder, elbow, and forearm, with ROM reported as the difference between the injured and contralateral upper extremities. Neurovascular status and focal tenderness to palpation were also assessed on examination. When in-person examination was not possible, the questionnaire and DASH form were completed over the telephone. The self-reported questionnaire asked for information on smoking status, pain, functional limitations, cosmetic perception, satisfaction, and whether or not the patient would still opt for nonoperative management if presented with the same injury again. Pain and satisfaction were measured on numerical scales: Pain scores ranged from 0 (no pain) to 10 (worst possible pain), and satisfaction scores ranged from 1 (not satisfied) to 5 (very satisfied). Data are presented as mean values.

Results

Of the 91 study-eligible patients, 15 (16%) met the radiographic criteria for the diagnosis of malunion. Retrospective data were available for all 15 patients from time of injury to final clinical follow-up (mean, 19 weeks; range, 7-53 weeks). Mean age at injury was 39 years (range, 20-79 years). Additional demographics are listed in Table 1. Incidence of potential risk factors, such as body mass index (26.5 vs 25.4), smoking (33% vs 33%), and diabetes (0% vs 8%), was not significantly different between the malunion and healed-without-malunion groups, respectively. Furthermore, all malunion patients were compliant with their treatment protocol.

Radiographs were assessed at time of final follow-up to confirm healing and to document malunion. Varus malunion was found in 13 patients (mean, 24°; range, 20.5°-35.5°), and shortening was documented in the other 2 patients (mean, 4 cm; range, 3-5 cm). Patients were immobilized a mean of 10 weeks (range, 6-13 weeks). Initial fracture management consisted of coaptation splinting for 1 to 2 weeks (12 patients), hanging arm cast for 1 week (1 patient), and posterior splint for 1 week (1 patient). Patients were then transitioned to Sarmiento fracture bracing for the duration of their treatment (range, 5-12 months). One patient, followed initially at an outside institution, was managed in a sling throughout the duration of treatment (12 weeks) (Table 1). All 15 patients were neurovascularly intact at time of final clinical examination, with return of full upper extremity ROM in all but 3 patients. Only 1 of these 3 patients reported residual pain and functional limitations 4 months after injury (Table 2). Twelve patients were evaluated for return to work, with all successfully returning to work without restrictions at time of final follow-up. The 1 minor complication noted during the treatment period involved medial-sided elbow skin breakdown from brace wear, which resolved with local wound care. No patient required or requested surgical intervention for their residual malunion.

Of the 15 patients, 8 (53%) were reached for in-person examination (6 patients) or telephone interview (2 patients) for follow-up assessment by means of DASH form and self-reported questionnaire a mean of 47 months (range, 12-99 months) after initial injury. The 6 patients who had a physical examination were neurovascularly intact, lacked focal tenderness to palpation, and demonstrated full (5/5) strength within the deltoid, biceps, triceps, pronator, and supinator musculature. Each patient had equal ROM compared with the contralateral uninjured extremity on shoulder forward flexion and abduction, elbow flexion and extension, and forearm pronation and supination. Three patients (50%) had mild residual loss of ROM, with 2 demonstrating decreased shoulder external rotation of 10° and 15°, respectively, and 1 demonstrating decreased shoulder internal rotation of 10°.

Mean DASH score was 10.4 (range, 0-49.2). Evaluation of the self-reported questionnaire revealed a mean pain score of 1.1 (range, 0-7), with only 2 patients reporting any ongoing pain. In addition, 2 patients reported functional limitations, both related to overhead activities. However, 6 (75%) of the 8 patients reported noticeable cosmetic deformity, most commonly varus angulation (4 patients), as well as palpable bony prominence (2) and muscle atrophy (1). The majority of patients were satisfied with the outcome of their treatment (mean, 4; range, 2-5), with 6 patients reporting being satisfied or very satisfied, and all 6 indicating they would undergo nonoperative management again if presented with the same injury. Two patients reported being dissatisfied with their outcome, 1 because of cosmetic appearance and 1 because of cosmetic appearance and functional limitations. Both patients indicated they would choose operative management if presented with the same injury. There was no apparent relationship between outcome and degree of residual deformity, as both patients with varus angulation of more than 30° reported no residual pain or functional limitation and were very satisfied with the outcome of their treatment (Table 2).

Of the 7 patients who could not be reached for final follow-up, 2 on initial contact expressed overall satisfaction with their outcome and denied functional limitations. However, both asked to complete the study at a later date. Subsequently, these 2 patients could not be reached to complete the formal follow-up.

Discussion

Humeral shaft fractures are usually managed nonoperatively. One of the most commonly cited disadvantages of nonoperative management is its higher incidence of residual angular deformity, up to 13% in previous studies.⁴ Our study found a slightly higher incidence, 16%, on review of 91 nonoperatively managed humeral shaft fractures treated over an 11.5 year period. Although previous studies have reported acceptable functional and cosmetic outcomes with residual angular deformity of less than 20°,^2,3,5,8,9 only observational reports have suggested acceptable function in patients with a documented malunion.⁸

To our knowledge, ours is the first study to correlate malunion with functional parameters and subjective patient-reported outcomes. We found that malunion was not associated with significant pain or functional limitation after nonoperative management of humeral shaft fractures. Furthermore, 75% of patients were satisfied or very satisfied with the outcome of their treatment and indicated they would undergo nonoperative management if presented with the same injury again. However, 75% of patients reported a noticeable cosmetic deformity, and one-third of these patients cited it as a major reason for dissatisfaction with their overall outcome. Regarding function, all patients returned to full strength and ROM of the affected extremity, aside from small losses of internal or external shoulder rotation on the magnitude of 10° to 15° in 50% of those patients tested. In addition, 75% of patients returned to regular activity without functional limitations; the other 25% reported trouble with overhead activities. There were no significant complications during the treatment or follow-up period, once the fracture had healed.

The major limitation of this study was its small patient population. (Obtaining a larger series of patients with malunion after nonoperative treatment of humeral shaft fractures likely would require a multicenter study.) Some of our study findings, such as lack of correlation between degree of malunion and subsequent functional or subjective outcomes, would require a larger sample size for verification and more definitive conclusions. Another limitation is that the study was not designed to evaluate the cause of malunion. Therefore, we cannot draw any definitive conclusions regarding what may have contributed to the development of malunion in our study population. However, all our malunion patients were compliant with their treatment protocol, and they showed no significant difference in incidence of potential risk factors (eg, obesity, comorbidities) compared with the patients who healed without malunion.

Conclusion

Malunion after nonoperative management of humeral shaft fractures does not appear to result in significant pain, dissatisfaction, or functional limitation as measured on physical examination and with validated objective outcome measures in the majority of patients. Furthermore, no patients in this study required surgical intervention for any residual limitations or complications after malunion. The majority of patients reported a noticeable cosmetic deformity, which left a small subset of patients dissatisfied. Overall, our study findings can be used to help counsel patients before and during nonoperative management—particularly patients who appear to be healing with some malunion. Our findings suggest that operative intervention to prevent malunion is not necessary, as it likely would not result in any overall improvement in patient function or satisfaction, but patients should be counseled regarding the high likelihood of cosmetic deformity, which may or may not be bothersome.

Humeral shaft fractures account for about 1% of all fractures.¹ With the exception of the few absolute indications for surgical intervention, such as the presence of an open fracture, the current teaching on treatment of these fractures is that the majority can be successfully managed nonoperatively.^1-3 These conservative measures consist of bandages, abduction splints, U-casts, hanging arm casts, and, most commonly, functional bracing, which is considered the gold standard for treatment of humeral shaft fractures by many authors.^1-3 One of the most often cited disadvantages of nonoperative management over surgical treatment is the higher incidence of residual deformity, the most common of which is varus angulation.⁴

The incidence of malunion (>20° of angulation in any plane or shortening of ≥2.5 cm) after nonoperative treatment varies in the literature from 0% to 13%,^2,4-9 with a recent literature review documenting a mean incidence of 4.4% within the frontal plane and 2% within the sagittal plane across all studies.² As reported initially by Sarmiento and colleagues^3,9 and echoed by other authors,^2,5,8 angular deformity of less than 20° is thought to be both cosmetically and functionally acceptable. Whether angular deformities or malunion of more than 20° actually leads to functional limitations is unknown. Although some observational reports suggest that the degree of radiographic malalignment does not necessarily correlate with functional outcome,⁸ no studies have specifically evaluated patient outcomes of humeral shaft fracture malunions.

We conducted a study to determine the overall incidence and long-term clinical and functional outcomes of patients with malunion after nonoperative management of humeral shaft fractures. Long-term outcomes were assessed with current symptoms, physical examination findings, need for subsequent operative intervention, DASH (Disabilities of the Arm, Shoulder, and Hand) scores, and a self-reported questionnaire. We hypothesized that patients who develop a malunion after nonoperative treatment of a closed humeral shaft fracture will have satisfactory functional outcomes based on subjective reports, physical examination findings, and DASH scores.

Methods

After obtaining institutional review board approval for the study, we selected patients from a retrospective medical record review of all those 18 years or older with a humeral shaft fracture managed nonoperatively at our institution between January 1, 2001, and June 30, 2012, with a minimum 1-year follow-up. We identified 156 patients with nonoperatively managed midshaft humerus fractures. Study exclusion criteria included fracture associated with a tumor (3 patients), ipsilateral upper extremity injury (9), open/ballistic injury (18), nonunion (9), underlying cognitive disability or psychiatric illness (4), and insufficient follow-up to clinical or radiographic healing (22). Ninety-one patients were eligible for study inclusion. Radiographs at time of final clinical visit were reviewed to assess for evidence of malunion at the fracture site, as defined by previously reported criteria³ (>20° angulation in anterior/posterior or varus/valgus plane of motion or shortening of ≥2.5 cm). Fifteen patients met all the inclusion criteria for further evaluation.

Medical records were retrospectively reviewed for information on age at injury, sex, comorbidities (eg, diabetes, osteoporosis, smoking), body mass index, type and duration of immobilization, complications, return to work, cosmetic perception, time to final clinical follow-up, and symptoms at final clinical follow-up. Incidence of potential risk factors associated with malunion—obesity, noncompliance, and comorbidities such as smoking and diabetes—was compared between the 15 patients with malunion and the other study patients, who healed without malunion.

For long-term postoperative follow-up, patients were contacted to be seen in clinic to complete an updated physical examination, self-reported questionnaire, and the DASH form. Physical examination included measurements of range of motion (ROM) and strength involving the shoulder, elbow, and forearm, with ROM reported as the difference between the injured and contralateral upper extremities. Neurovascular status and focal tenderness to palpation were also assessed on examination. When in-person examination was not possible, the questionnaire and DASH form were completed over the telephone. The self-reported questionnaire asked for information on smoking status, pain, functional limitations, cosmetic perception, satisfaction, and whether or not the patient would still opt for nonoperative management if presented with the same injury again. Pain and satisfaction were measured on numerical scales: Pain scores ranged from 0 (no pain) to 10 (worst possible pain), and satisfaction scores ranged from 1 (not satisfied) to 5 (very satisfied). Data are presented as mean values.

Results

Of the 91 study-eligible patients, 15 (16%) met the radiographic criteria for the diagnosis of malunion. Retrospective data were available for all 15 patients from time of injury to final clinical follow-up (mean, 19 weeks; range, 7-53 weeks). Mean age at injury was 39 years (range, 20-79 years). Additional demographics are listed in Table 1. Incidence of potential risk factors, such as body mass index (26.5 vs 25.4), smoking (33% vs 33%), and diabetes (0% vs 8%), was not significantly different between the malunion and healed-without-malunion groups, respectively. Furthermore, all malunion patients were compliant with their treatment protocol.

Radiographs were assessed at time of final follow-up to confirm healing and to document malunion. Varus malunion was found in 13 patients (mean, 24°; range, 20.5°-35.5°), and shortening was documented in the other 2 patients (mean, 4 cm; range, 3-5 cm). Patients were immobilized a mean of 10 weeks (range, 6-13 weeks). Initial fracture management consisted of coaptation splinting for 1 to 2 weeks (12 patients), hanging arm cast for 1 week (1 patient), and posterior splint for 1 week (1 patient). Patients were then transitioned to Sarmiento fracture bracing for the duration of their treatment (range, 5-12 months). One patient, followed initially at an outside institution, was managed in a sling throughout the duration of treatment (12 weeks) (Table 1). All 15 patients were neurovascularly intact at time of final clinical examination, with return of full upper extremity ROM in all but 3 patients. Only 1 of these 3 patients reported residual pain and functional limitations 4 months after injury (Table 2). Twelve patients were evaluated for return to work, with all successfully returning to work without restrictions at time of final follow-up. The 1 minor complication noted during the treatment period involved medial-sided elbow skin breakdown from brace wear, which resolved with local wound care. No patient required or requested surgical intervention for their residual malunion.

Of the 15 patients, 8 (53%) were reached for in-person examination (6 patients) or telephone interview (2 patients) for follow-up assessment by means of DASH form and self-reported questionnaire a mean of 47 months (range, 12-99 months) after initial injury. The 6 patients who had a physical examination were neurovascularly intact, lacked focal tenderness to palpation, and demonstrated full (5/5) strength within the deltoid, biceps, triceps, pronator, and supinator musculature. Each patient had equal ROM compared with the contralateral uninjured extremity on shoulder forward flexion and abduction, elbow flexion and extension, and forearm pronation and supination. Three patients (50%) had mild residual loss of ROM, with 2 demonstrating decreased shoulder external rotation of 10° and 15°, respectively, and 1 demonstrating decreased shoulder internal rotation of 10°.

Mean DASH score was 10.4 (range, 0-49.2). Evaluation of the self-reported questionnaire revealed a mean pain score of 1.1 (range, 0-7), with only 2 patients reporting any ongoing pain. In addition, 2 patients reported functional limitations, both related to overhead activities. However, 6 (75%) of the 8 patients reported noticeable cosmetic deformity, most commonly varus angulation (4 patients), as well as palpable bony prominence (2) and muscle atrophy (1). The majority of patients were satisfied with the outcome of their treatment (mean, 4; range, 2-5), with 6 patients reporting being satisfied or very satisfied, and all 6 indicating they would undergo nonoperative management again if presented with the same injury. Two patients reported being dissatisfied with their outcome, 1 because of cosmetic appearance and 1 because of cosmetic appearance and functional limitations. Both patients indicated they would choose operative management if presented with the same injury. There was no apparent relationship between outcome and degree of residual deformity, as both patients with varus angulation of more than 30° reported no residual pain or functional limitation and were very satisfied with the outcome of their treatment (Table 2).

Of the 7 patients who could not be reached for final follow-up, 2 on initial contact expressed overall satisfaction with their outcome and denied functional limitations. However, both asked to complete the study at a later date. Subsequently, these 2 patients could not be reached to complete the formal follow-up.

Discussion

Humeral shaft fractures are usually managed nonoperatively. One of the most commonly cited disadvantages of nonoperative management is its higher incidence of residual angular deformity, up to 13% in previous studies.⁴ Our study found a slightly higher incidence, 16%, on review of 91 nonoperatively managed humeral shaft fractures treated over an 11.5 year period. Although previous studies have reported acceptable functional and cosmetic outcomes with residual angular deformity of less than 20°,^2,3,5,8,9 only observational reports have suggested acceptable function in patients with a documented malunion.⁸

To our knowledge, ours is the first study to correlate malunion with functional parameters and subjective patient-reported outcomes. We found that malunion was not associated with significant pain or functional limitation after nonoperative management of humeral shaft fractures. Furthermore, 75% of patients were satisfied or very satisfied with the outcome of their treatment and indicated they would undergo nonoperative management if presented with the same injury again. However, 75% of patients reported a noticeable cosmetic deformity, and one-third of these patients cited it as a major reason for dissatisfaction with their overall outcome. Regarding function, all patients returned to full strength and ROM of the affected extremity, aside from small losses of internal or external shoulder rotation on the magnitude of 10° to 15° in 50% of those patients tested. In addition, 75% of patients returned to regular activity without functional limitations; the other 25% reported trouble with overhead activities. There were no significant complications during the treatment or follow-up period, once the fracture had healed.

The major limitation of this study was its small patient population. (Obtaining a larger series of patients with malunion after nonoperative treatment of humeral shaft fractures likely would require a multicenter study.) Some of our study findings, such as lack of correlation between degree of malunion and subsequent functional or subjective outcomes, would require a larger sample size for verification and more definitive conclusions. Another limitation is that the study was not designed to evaluate the cause of malunion. Therefore, we cannot draw any definitive conclusions regarding what may have contributed to the development of malunion in our study population. However, all our malunion patients were compliant with their treatment protocol, and they showed no significant difference in incidence of potential risk factors (eg, obesity, comorbidities) compared with the patients who healed without malunion.

Conclusion

Malunion after nonoperative management of humeral shaft fractures does not appear to result in significant pain, dissatisfaction, or functional limitation as measured on physical examination and with validated objective outcome measures in the majority of patients. Furthermore, no patients in this study required surgical intervention for any residual limitations or complications after malunion. The majority of patients reported a noticeable cosmetic deformity, which left a small subset of patients dissatisfied. Overall, our study findings can be used to help counsel patients before and during nonoperative management—particularly patients who appear to be healing with some malunion. Our findings suggest that operative intervention to prevent malunion is not necessary, as it likely would not result in any overall improvement in patient function or satisfaction, but patients should be counseled regarding the high likelihood of cosmetic deformity, which may or may not be bothersome.

Humeral shaft fractures account for about 1% of all fractures.¹ With the exception of the few absolute indications for surgical intervention, such as the presence of an open fracture, the current teaching on treatment of these fractures is that the majority can be successfully managed nonoperatively.^1-3 These conservative measures consist of bandages, abduction splints, U-casts, hanging arm casts, and, most commonly, functional bracing, which is considered the gold standard for treatment of humeral shaft fractures by many authors.^1-3 One of the most often cited disadvantages of nonoperative management over surgical treatment is the higher incidence of residual deformity, the most common of which is varus angulation.⁴

The incidence of malunion (>20° of angulation in any plane or shortening of ≥2.5 cm) after nonoperative treatment varies in the literature from 0% to 13%,^2,4-9 with a recent literature review documenting a mean incidence of 4.4% within the frontal plane and 2% within the sagittal plane across all studies.² As reported initially by Sarmiento and colleagues^3,9 and echoed by other authors,^2,5,8 angular deformity of less than 20° is thought to be both cosmetically and functionally acceptable. Whether angular deformities or malunion of more than 20° actually leads to functional limitations is unknown. Although some observational reports suggest that the degree of radiographic malalignment does not necessarily correlate with functional outcome,⁸ no studies have specifically evaluated patient outcomes of humeral shaft fracture malunions.

We conducted a study to determine the overall incidence and long-term clinical and functional outcomes of patients with malunion after nonoperative management of humeral shaft fractures. Long-term outcomes were assessed with current symptoms, physical examination findings, need for subsequent operative intervention, DASH (Disabilities of the Arm, Shoulder, and Hand) scores, and a self-reported questionnaire. We hypothesized that patients who develop a malunion after nonoperative treatment of a closed humeral shaft fracture will have satisfactory functional outcomes based on subjective reports, physical examination findings, and DASH scores.

Methods

After obtaining institutional review board approval for the study, we selected patients from a retrospective medical record review of all those 18 years or older with a humeral shaft fracture managed nonoperatively at our institution between January 1, 2001, and June 30, 2012, with a minimum 1-year follow-up. We identified 156 patients with nonoperatively managed midshaft humerus fractures. Study exclusion criteria included fracture associated with a tumor (3 patients), ipsilateral upper extremity injury (9), open/ballistic injury (18), nonunion (9), underlying cognitive disability or psychiatric illness (4), and insufficient follow-up to clinical or radiographic healing (22). Ninety-one patients were eligible for study inclusion. Radiographs at time of final clinical visit were reviewed to assess for evidence of malunion at the fracture site, as defined by previously reported criteria³ (>20° angulation in anterior/posterior or varus/valgus plane of motion or shortening of ≥2.5 cm). Fifteen patients met all the inclusion criteria for further evaluation.

Medical records were retrospectively reviewed for information on age at injury, sex, comorbidities (eg, diabetes, osteoporosis, smoking), body mass index, type and duration of immobilization, complications, return to work, cosmetic perception, time to final clinical follow-up, and symptoms at final clinical follow-up. Incidence of potential risk factors associated with malunion—obesity, noncompliance, and comorbidities such as smoking and diabetes—was compared between the 15 patients with malunion and the other study patients, who healed without malunion.

For long-term postoperative follow-up, patients were contacted to be seen in clinic to complete an updated physical examination, self-reported questionnaire, and the DASH form. Physical examination included measurements of range of motion (ROM) and strength involving the shoulder, elbow, and forearm, with ROM reported as the difference between the injured and contralateral upper extremities. Neurovascular status and focal tenderness to palpation were also assessed on examination. When in-person examination was not possible, the questionnaire and DASH form were completed over the telephone. The self-reported questionnaire asked for information on smoking status, pain, functional limitations, cosmetic perception, satisfaction, and whether or not the patient would still opt for nonoperative management if presented with the same injury again. Pain and satisfaction were measured on numerical scales: Pain scores ranged from 0 (no pain) to 10 (worst possible pain), and satisfaction scores ranged from 1 (not satisfied) to 5 (very satisfied). Data are presented as mean values.

Results

Of the 91 study-eligible patients, 15 (16%) met the radiographic criteria for the diagnosis of malunion. Retrospective data were available for all 15 patients from time of injury to final clinical follow-up (mean, 19 weeks; range, 7-53 weeks). Mean age at injury was 39 years (range, 20-79 years). Additional demographics are listed in Table 1. Incidence of potential risk factors, such as body mass index (26.5 vs 25.4), smoking (33% vs 33%), and diabetes (0% vs 8%), was not significantly different between the malunion and healed-without-malunion groups, respectively. Furthermore, all malunion patients were compliant with their treatment protocol.

Radiographs were assessed at time of final follow-up to confirm healing and to document malunion. Varus malunion was found in 13 patients (mean, 24°; range, 20.5°-35.5°), and shortening was documented in the other 2 patients (mean, 4 cm; range, 3-5 cm). Patients were immobilized a mean of 10 weeks (range, 6-13 weeks). Initial fracture management consisted of coaptation splinting for 1 to 2 weeks (12 patients), hanging arm cast for 1 week (1 patient), and posterior splint for 1 week (1 patient). Patients were then transitioned to Sarmiento fracture bracing for the duration of their treatment (range, 5-12 months). One patient, followed initially at an outside institution, was managed in a sling throughout the duration of treatment (12 weeks) (Table 1). All 15 patients were neurovascularly intact at time of final clinical examination, with return of full upper extremity ROM in all but 3 patients. Only 1 of these 3 patients reported residual pain and functional limitations 4 months after injury (Table 2). Twelve patients were evaluated for return to work, with all successfully returning to work without restrictions at time of final follow-up. The 1 minor complication noted during the treatment period involved medial-sided elbow skin breakdown from brace wear, which resolved with local wound care. No patient required or requested surgical intervention for their residual malunion.

Of the 15 patients, 8 (53%) were reached for in-person examination (6 patients) or telephone interview (2 patients) for follow-up assessment by means of DASH form and self-reported questionnaire a mean of 47 months (range, 12-99 months) after initial injury. The 6 patients who had a physical examination were neurovascularly intact, lacked focal tenderness to palpation, and demonstrated full (5/5) strength within the deltoid, biceps, triceps, pronator, and supinator musculature. Each patient had equal ROM compared with the contralateral uninjured extremity on shoulder forward flexion and abduction, elbow flexion and extension, and forearm pronation and supination. Three patients (50%) had mild residual loss of ROM, with 2 demonstrating decreased shoulder external rotation of 10° and 15°, respectively, and 1 demonstrating decreased shoulder internal rotation of 10°.

Mean DASH score was 10.4 (range, 0-49.2). Evaluation of the self-reported questionnaire revealed a mean pain score of 1.1 (range, 0-7), with only 2 patients reporting any ongoing pain. In addition, 2 patients reported functional limitations, both related to overhead activities. However, 6 (75%) of the 8 patients reported noticeable cosmetic deformity, most commonly varus angulation (4 patients), as well as palpable bony prominence (2) and muscle atrophy (1). The majority of patients were satisfied with the outcome of their treatment (mean, 4; range, 2-5), with 6 patients reporting being satisfied or very satisfied, and all 6 indicating they would undergo nonoperative management again if presented with the same injury. Two patients reported being dissatisfied with their outcome, 1 because of cosmetic appearance and 1 because of cosmetic appearance and functional limitations. Both patients indicated they would choose operative management if presented with the same injury. There was no apparent relationship between outcome and degree of residual deformity, as both patients with varus angulation of more than 30° reported no residual pain or functional limitation and were very satisfied with the outcome of their treatment (Table 2).

Of the 7 patients who could not be reached for final follow-up, 2 on initial contact expressed overall satisfaction with their outcome and denied functional limitations. However, both asked to complete the study at a later date. Subsequently, these 2 patients could not be reached to complete the formal follow-up.

Discussion

Humeral shaft fractures are usually managed nonoperatively. One of the most commonly cited disadvantages of nonoperative management is its higher incidence of residual angular deformity, up to 13% in previous studies.⁴ Our study found a slightly higher incidence, 16%, on review of 91 nonoperatively managed humeral shaft fractures treated over an 11.5 year period. Although previous studies have reported acceptable functional and cosmetic outcomes with residual angular deformity of less than 20°,^2,3,5,8,9 only observational reports have suggested acceptable function in patients with a documented malunion.⁸

To our knowledge, ours is the first study to correlate malunion with functional parameters and subjective patient-reported outcomes. We found that malunion was not associated with significant pain or functional limitation after nonoperative management of humeral shaft fractures. Furthermore, 75% of patients were satisfied or very satisfied with the outcome of their treatment and indicated they would undergo nonoperative management if presented with the same injury again. However, 75% of patients reported a noticeable cosmetic deformity, and one-third of these patients cited it as a major reason for dissatisfaction with their overall outcome. Regarding function, all patients returned to full strength and ROM of the affected extremity, aside from small losses of internal or external shoulder rotation on the magnitude of 10° to 15° in 50% of those patients tested. In addition, 75% of patients returned to regular activity without functional limitations; the other 25% reported trouble with overhead activities. There were no significant complications during the treatment or follow-up period, once the fracture had healed.

The major limitation of this study was its small patient population. (Obtaining a larger series of patients with malunion after nonoperative treatment of humeral shaft fractures likely would require a multicenter study.) Some of our study findings, such as lack of correlation between degree of malunion and subsequent functional or subjective outcomes, would require a larger sample size for verification and more definitive conclusions. Another limitation is that the study was not designed to evaluate the cause of malunion. Therefore, we cannot draw any definitive conclusions regarding what may have contributed to the development of malunion in our study population. However, all our malunion patients were compliant with their treatment protocol, and they showed no significant difference in incidence of potential risk factors (eg, obesity, comorbidities) compared with the patients who healed without malunion.

Conclusion

Malunion after nonoperative management of humeral shaft fractures does not appear to result in significant pain, dissatisfaction, or functional limitation as measured on physical examination and with validated objective outcome measures in the majority of patients. Furthermore, no patients in this study required surgical intervention for any residual limitations or complications after malunion. The majority of patients reported a noticeable cosmetic deformity, which left a small subset of patients dissatisfied. Overall, our study findings can be used to help counsel patients before and during nonoperative management—particularly patients who appear to be healing with some malunion. Our findings suggest that operative intervention to prevent malunion is not necessary, as it likely would not result in any overall improvement in patient function or satisfaction, but patients should be counseled regarding the high likelihood of cosmetic deformity, which may or may not be bothersome.

Polymer matrix composite materials have been widely promoted for orthopedic use in a variety of settings, including surgical instruments, medical devices, implants, and bone models.^1-13 These types of composites are engineered from 2 or more constituent materials with significantly different physical or chemical properties; these materials remain separate and distinct on a macroscopic level within the finished composite structure. As a result of ongoing biomaterial research, polymer matrix composite materials can be engineered with a wide range of physical, mechanical, and surface properties, tailored to their application. Given their advantages (eg, high strength-to-weight ratio, radiolucency), these polymer matrix composite materials have gained popularity over traditional metallic materials.

Sterilization is an essential day-to-day procedure in the health care sector, both for single- and multiple-use devices or instruments, and thus a composite material used in medical components should remain unaffected by the process. The type of sterilization most commonly performed is steam sterilization, which achieves microbiological death by moist heat and pressure. Steam is created in an autoclave at a temperature of 132°C (270°F) in typical hospital settings. Steam sterilization cycles last 5 to 14 minutes based on specific manufacturer recommendations. Most medical-grade plastics used in health care have been designed and formulated to withstand the required sterilization cycles without sacrificing key properties. The structure integrity and overall performance of polymer matrix composites may be strongly influenced by the stability of the fiber/polymer interfacial region in terms of physical, chemical, and mechanical characteristics of the material at different scales.¹⁴ Absorption of moisture causes dilatational expansion and induces stresses, which are associated with the moisture-induced expansion resulting in degradation of structure stability.¹⁵ Thus, steam sterilization could affect the properties of the polymer matrix composite materials by excessive absorption of moisture by the polymer.

To our knowledge, no one has studied whether polymer matrix material properties degrade from long-term, repeated steam sterilization followed by mechanical loading. We conducted a study to evaluate the structural properties (short-beam strength, SBS) of several composite materials exposed to repeated sterilization as compared with traditional metal materials: SS-316L (stainless steel 316L) and Al-7075-T6 (aluminum 7075-T6).

Materials and Methods

We evaluated 3 types of composite materials: Tepex (Tepex Dynalite 201; HiPer Technology Inc.), CFR-PPS (carbon-fiber–reinforced polyphenylene sulfide, Cetex PPS; TenCate Advanced Composites USA Inc.), and HTN-53 (Zytel HTN53G50HSLR NC010; HiPer Technology Inc.) (Figure 1). Tepex is being used for orthopedic applications (knee braces, orthoses, insoles) and sporting goods applications. The performance of this material is superior to that of unreinforced thermoplastics. CFR-PPS represented the state of the art in composite materials for aerospace applications (eg, airframe structures, engine nacelles, fan casings, floorboards, interior parts). This is a high-performance material with exceptional high temperature and aggressive chemical resistance characteristics. CFR-PPS is also used to make filter fabric for coal boilers, papermaking felts, electrical insulation, specialty membranes, gaskets, and packing. It is not solubilized by any known solvents, even in long-term exposure, at temperatures up to 200°C. In addition, it exhibits exceptional resistance to organic and inorganic solutions, acids and alkali solutions, and a wide array of miscellaneous chemicals. HTN-53 is a 50% glass-reinforced, lubricated, high-performance polyamide resin with improved flow, developed for applications requiring excellent surface appearance with water-heated molds. This material has specifically shown survivability in hot, cold, chemically aggressive, and load-bearing environments. In addition, it has shown superior moisture and temperature resistance. These 3 composite materials were compared with SS-316L and Al-7075-T6. SS-316L is commonly used for implants in orthopedics, and Al-7075-T6 is a relatively radiolucent alternative for medical applications. Two different tests were performed to evaluate and validate these composite materials: (1) radiographic density evaluation and (2) structural property tests (short-beam load-to-failure [LTF] test, short-beam cyclic compression loading [CCL] test) before and after sterilization cycling.

Radiographic Density Evaluation

The radiographic density of the 5 materials was evaluated with radiographic images of a cadaveric knee specimen (Figure 2). Radiographic image intensification is the gold standard for repeated radiographic imaging in the operating room. Six different radiographic images were obtained for each material superimposed over a cadaveric knee to recreate potential instrument positioning during surgery: posterior to subject (1 piece), posterior to subject (2 pieces), anterior to subject (1 piece), anterior to subject (2 pieces), anterior and posterior to subject in alignment (1 piece), and anterior and posterior to subject in alignment (2 pieces). Image-Pro Plus software (Media Cybernetics) was used to measure the radiographic density of the materials from the grayscale of the images.

Structural Properties Testing Before and After Sterilization Cycling

We used a standard SBS testing method to determine whether any degradation of structural properties resulted from standard repeated sterilization. The material geometries of the test specimens were 18.96×6.50×3.37 mm (length × width × thickness). Standard sterilization procedures were performed with steam sterilization using an autoclave at a temperature of 132°C (270°F) for at least 5 minutes (range, 5-14 minutes). Sample interval testing ran at 0, 200, and 400 sterilization cycles for structural properties in terms of SBS and moisture retention, with the structural properties at the 0th sterilization cycle (material before sterilization was performed) used as a baseline for comparison. Materials were subjected to 400 sterilization cycles, which is representative of the number of sterilization cycles per year an instrument or device would be subjected to.

Three structural tests were performed for each sample interval: moisture retention, LTF, and CCL. Moisture retention was investigated before and after repeated sterilization by measuring the weight of the test materials, as steam sterilization is known to affect the amount of moisture that is absorbed by a material. Twelve specimens of each proposed material were weighed at each sample interval, with the structural weight at the 0th sterilization cycle (material before sterilization is performed) serving as a baseline for comparison.

SBS testing was based on the ASTM (American Society for Testing and Materials) D2344 standard¹⁶ for LTF and CCL tests (Figure 3). Six samples of material were used for each test at every sample interval, yielding 180 samples. Seven servohydraulic material testing system instruments (1 MTS 810 and 6 MTS 858 Mini Bionix) were used to test the SBS of each material. For LTF testing, each specimen was loaded in compression from 30 N to complete structural failure at a constant displacement rate of 1.0 mm/min (0.05 in/min). Testing was initiated with 5 preconditioning loading cycles from 30 to 100 N at 1 Hz. The load was then applied continuously until failure occurred; force and displacement data were collected every 0.02 second. This procedure was performed for 6 replicates for each sample interval for each test material.

The calculation for SBS, F_sbs (MPa), for the constant loading rate until structural failure is:

                            Fsbs = 0.75 ×   Pm
                                                b × h

where P_m (N) is the maximum applied load observed during the test, b is the measured specimen width (mm), and h is the measured specimen thickness (mm).

CCL testing consisted of each test material axially loaded with 100 to 500 N at a frequency of 1 Hz for 100,000 cycles. The maximum load of 500 N was chosen as a standard based on 80% of the minimum ultimate failure load from previous LTF tests. Displacement and force data were collected every 5 cycles at the maximum compressive load. Degradation of the material was calculated using the difference between the deflection of the initial cycle and the deflection of the final cycle (50th cycle and 100,000th cycle). This procedure was performed for 6 replicates for each sample interval for each test material.

Statistical Analysis

LTF and CCL testing data were analyzed for any differences among the test materials using 1-way analysis of variance with the least significant difference multiple comparisons post hoc test method using SPSS Version 16.0, with P < .05 denoting significance. These analyses were used to determine the statistical relevance of the difference between the SBS (LTF and CCL) of each test material. Means and standard deviations were calculated for all tests.

Results

Radiographic Density Evaluation

Overall, all the tested composite materials were significantly more radiolucent than either SS-316L or Al-7075-T6. Figure 4 shows the 6 different radiographic images obtained for each material superimposed over a cadaveric knee to recreate potential instrument positioning during surgery: posterior to subject (1 piece), posterior to subject (2 pieces), anterior to subject (1 piece), anterior to subject (2 pieces), anterior and posterior to subject in alignment (1 piece), and anterior and posterior to subject in alignment (2 pieces). SS-316L can be considered radiopaque, and Al-7075-T6 has been used as a relatively radiolucent alternative. Tepex was statistically more radiolucent than the other 2 tested composite materials (Table 1). Even with 2 pieces placed anterior to the subject and 2 placed posterior, the radiodensity compared to the cortical bone was still lower than 1 piece of Al-7075-T6 either anterior or posterior to the subject.

Structural Properties Testing

Moisture Retention. Moisture retention was evaluated by weighing the test materials before and after repeated sterilization. There was no significant difference in moisture retention, as weight differences for all the tested materials were less than 0.5 weight percentage compared to the 0th sterilization cycle (Table 2). Therefore, the results of this study showed that all the tested materials exhibited good moisture/temperature resistance after 400 sterilization cycles.

Load to Failure. In the LTF test, significant differences were detected in SBS between all 5 tested materials (P < .05). Figure 5 shows the comparison of the structural properties in terms of SBS between the 5 tested materials, and Figure 6 shows the failure modes for the tested materials. There was no SBS for SS-316L, as the material did not exhibit complete structural failure even after 400 sterilization cycles; however, SS-316L was observed in inelastic deformation failure (Figure 6D). Al-7075-T6 had much higher SBS compared with the other composite materials, and it also resulted in an inelastic deformation failure mode only after 400 sterilization cycles; otherwise, flexure failure modes were observed. Tepex and CFR-PPS exhibited interlaminar shear failure, and HTN-53 exhibited complete structural failure.

Every composite material tested using the short-beam test for LTF showed a decrease in SBS with increased sterilization cycles (Figure 5). This decrease ranged from 17% to 57% compared with the 0th sterilization cycle. SBS was higher for CFR-PPS than for the other 2 composites. No statistically significant difference was found between CFR-PPS and Tepex except at the 200th sterilization cycle. HTN-53 was brittle at the 0th sterilization cycle but performed more like a ductile material at the 200th cycle. In addition, HTN-53 had the lowest SBS in terms of LTF testing when compared with the other 2 composites.

During the complete structural failure test, the failure modes for Tepex and CFR-PPS were visually identified as interlaminar shear failure (Figures 6A, 6B), whereas HTN-53 visually exhibited pure flexure failure (Figure 6C). As for the metals, SS-316L exhibited plastic deformation, and Al-7075-T6 exhibited flexure failure (Figures 6D, 6E).

Cyclic Compression Loading. Tepex was the only material to pass the 100,000 loading cycle without failure (Table 3). HTN-53 had the poorest performance of all: Its failure rates were 33% (2/6 samples) before sterilization (average cycle, 22,213; range, 21,500-22,925), 83% (5/6 samples) at the 200th sterilization cycle (average cycle, 4,210; range, 0-14,360), and 100% after 400 sterilization cycles (average cycle, 12,725; range, 1,190-21,900). CFR-PPS had no failures before the 400th sterilization cycle, and its failure rate after 400 sterilization cycles (average cycle, 50,735; range, 50,270-51,200) was 33% (2/6 samples).

Discussion

The success of a reusable composite material for use in orthopedic surgery depends not only on radiographic density, fabrication methods, and design but also on the ability to withstand repeated sterilization. Over the past 3 decades, investigators have explored several high-performance polymer matrix composite materials for use in orthopedics, especially in trauma, hip stems, and spinal implants.^1,3,4,17-34 According to Evans and Gregson,³⁵ composite materials have been widely promoted as possible orthopedic biomaterials but to date have found few successful commercial applications, because of the many challenging problems encountered in fabrication and testing. One of the most important factors in the mechanical properties of many composite materials is the influence of the cooling and loading rates on fiber-matrix interface adhesion.^36-38 Our results tended to agree with the findings of Evans and Gregson,³⁵ as some of these composite materials did not withstand repeated sterilizations well.

Guan and colleagues³⁹ evaluated the influence of sterilization treatment on continuous carbon-fiber–reinforced polyolefin composite. Their 3-point bending test results showed that the levels of maximum load of all the specimens undergoing sterilization by autoclave were lower than those of the control group. For these composites, they concluded that autoclave sterilization and Co-60 gamma ray irradiation sterilization should be avoided and that ethylene oxide is the best method. Our results support their findings with a different set of composites.

Although HTN-53 has shown promise in other orthopedic applications because of its superior moisture and temperature resistance, we found that its performance after repeated sterilization was relatively poor. Tepex showed the greatest potential for durability after repeated sterilization; its mechanical properties were stable after 200 steam sterilization cycles.

Clinical Applications

The composite materials investigated in the present study have potential for use in either instrumentation or long-term implantation applications because of their versatility, mechanical strength, fatigue resistance, and biocompatibility. Akay and Aslan⁴⁰ stated that carbon-fiber–filled composite implants can be designed with more appropriate modulus, strength, toughness, or stiffness by the arrangement of reinforcing fiber volume and orientation, and can provide better fatigue resistance. A notable advantage of using a composite plate with metal screws is that the potential for corrosion of metallic components is eliminated. Another major advantage of composite medical implants (eg, DiPhos-RM) is radiolucency, which allows direct visualization of osseous callus formation as well as monitoring of fracture healing, thereby improving clinical assessment and accuracy.

Numerous studies have documented the successful clinical performance of composite materials in orthopedic, trauma, and spinal surgery applications.^41-45 Bagheri and colleagues⁴¹ developed a new carbon fiber–flax–epoxy composite plate and biomechanically compared it with a standard clinical metal plate. Their results confirmed that the carbon fiber–flax–epoxy material represents a potential candidate for bone fracture plate applications, as it can simultaneously provide similar mechanical stiffness and lower stress shielding (higher bone stress) compared with a standard clinical metal bone plate. Tarallo and colleagues⁴⁵ evaluated the clinical results of 40 cases at 12-month follow-up using a new plate made of carbon-fiber–reinforced polyetheretherketon (DiPhos-RM, Lima Corporate) for the treatment of distal radius fractures. They reported good clinical results for this device at early follow-up, and its use allowed maintenance of reduction in complex AO (Arbeitsgemeinschaft für Osteosynthesefragen) fractures.

The main advantage in using composites for surgical instruments is their radiolucency. These materials do not obscure images or radiographs during fluoroscopic visualization. Surgery often requires fluoroscopic visualization of internal organs or bones, which may require temporary removal of radiopaque devices (eg, retractors, clamps, forceps, hooks, distractors). Aside from being inconvenient, removal and subsequent reinsertion consume valuable time and interfere with the smooth flow of an operation.

The shortcomings of using composite materials for surgical instruments involve detectability and sterilization. A significant issue in surgery is the accidental leaving behind of instruments in patients, which can cause serious problems ranging from organ perforation and blood infection to death. Although instrument counting and other safety protocols can reduce the risk of overlooking an instrument, mistakes are bound to happen. The other shortcoming is the influence of repeated sterilization on the mechanical properties of the composite materials, as sterilization is mandatory for surgical instruments used in the operation room. The structural integrity and overall performance of the polymer composite materials—especially the stability of the interface and the interphase zones—are strongly influenced by repeated sterilization.

On the other hand, composite materials have potential advantages that may support their introduction into long-term medical implant applications, as sterilization commonly is performed only once, during packaging. The effects of sterilization by radiation or steam are much less pronounced on composite implants than on composite surgical instruments. However, composite implants require careful consideration with respect to the bioactivity of wear particles that may be produced from articulation. Further, carbon-fiber–reinforced polymer implants are still substantially more difficult to manufacture and more costly than their metallic counterparts.⁴⁶

Limitations

This study has some limitations. Most important, studies of this nature do not account for biological factors such as corrosion, biological wear, and the soft-tissue attachment effects on structural properties for potential in vivo use. Another limitation was that the study tested only the mechanical properties in terms of SBS and provided no information about other mechanical properties, such as tensile, compression, and torsion strengths. We think SBS testing adequately evaluates challenging scenarios like thin and narrow instruments/devices that are anticipated in application, and information regarding other modes of failure and mechanical properties (compression, tension, torsion) would be a further area of research. An additional limitation was that our model used a relatively small number of samples. A larger study with more samples and varying layout patterns and layers of the carbon fibers may more clearly demonstrate the effect of steam sterilization on composite materials.

Conclusion

This study provided new information on 3 selected composite materials and their structural properties after repeated steam sterilization. We discovered that these composites were similar in radiographic density and water retention but behaved very differently in terms of mechanical durability after repeated steam sterilization. All selected composites demonstrated deterioration of mechanical properties after repeated steam sterilization. Knowing these results could aid in making decisions about the design and manufacturing of operative instruments and orthopedic biomaterials. Although our preliminary findings are intriguing, further study is warranted to seek specific applications for these composite materials in orthopedic surgery.

Polymer matrix composite materials have been widely promoted for orthopedic use in a variety of settings, including surgical instruments, medical devices, implants, and bone models.^1-13 These types of composites are engineered from 2 or more constituent materials with significantly different physical or chemical properties; these materials remain separate and distinct on a macroscopic level within the finished composite structure. As a result of ongoing biomaterial research, polymer matrix composite materials can be engineered with a wide range of physical, mechanical, and surface properties, tailored to their application. Given their advantages (eg, high strength-to-weight ratio, radiolucency), these polymer matrix composite materials have gained popularity over traditional metallic materials.

Sterilization is an essential day-to-day procedure in the health care sector, both for single- and multiple-use devices or instruments, and thus a composite material used in medical components should remain unaffected by the process. The type of sterilization most commonly performed is steam sterilization, which achieves microbiological death by moist heat and pressure. Steam is created in an autoclave at a temperature of 132°C (270°F) in typical hospital settings. Steam sterilization cycles last 5 to 14 minutes based on specific manufacturer recommendations. Most medical-grade plastics used in health care have been designed and formulated to withstand the required sterilization cycles without sacrificing key properties. The structure integrity and overall performance of polymer matrix composites may be strongly influenced by the stability of the fiber/polymer interfacial region in terms of physical, chemical, and mechanical characteristics of the material at different scales.¹⁴ Absorption of moisture causes dilatational expansion and induces stresses, which are associated with the moisture-induced expansion resulting in degradation of structure stability.¹⁵ Thus, steam sterilization could affect the properties of the polymer matrix composite materials by excessive absorption of moisture by the polymer.

To our knowledge, no one has studied whether polymer matrix material properties degrade from long-term, repeated steam sterilization followed by mechanical loading. We conducted a study to evaluate the structural properties (short-beam strength, SBS) of several composite materials exposed to repeated sterilization as compared with traditional metal materials: SS-316L (stainless steel 316L) and Al-7075-T6 (aluminum 7075-T6).

Materials and Methods

We evaluated 3 types of composite materials: Tepex (Tepex Dynalite 201; HiPer Technology Inc.), CFR-PPS (carbon-fiber–reinforced polyphenylene sulfide, Cetex PPS; TenCate Advanced Composites USA Inc.), and HTN-53 (Zytel HTN53G50HSLR NC010; HiPer Technology Inc.) (Figure 1). Tepex is being used for orthopedic applications (knee braces, orthoses, insoles) and sporting goods applications. The performance of this material is superior to that of unreinforced thermoplastics. CFR-PPS represented the state of the art in composite materials for aerospace applications (eg, airframe structures, engine nacelles, fan casings, floorboards, interior parts). This is a high-performance material with exceptional high temperature and aggressive chemical resistance characteristics. CFR-PPS is also used to make filter fabric for coal boilers, papermaking felts, electrical insulation, specialty membranes, gaskets, and packing. It is not solubilized by any known solvents, even in long-term exposure, at temperatures up to 200°C. In addition, it exhibits exceptional resistance to organic and inorganic solutions, acids and alkali solutions, and a wide array of miscellaneous chemicals. HTN-53 is a 50% glass-reinforced, lubricated, high-performance polyamide resin with improved flow, developed for applications requiring excellent surface appearance with water-heated molds. This material has specifically shown survivability in hot, cold, chemically aggressive, and load-bearing environments. In addition, it has shown superior moisture and temperature resistance. These 3 composite materials were compared with SS-316L and Al-7075-T6. SS-316L is commonly used for implants in orthopedics, and Al-7075-T6 is a relatively radiolucent alternative for medical applications. Two different tests were performed to evaluate and validate these composite materials: (1) radiographic density evaluation and (2) structural property tests (short-beam load-to-failure [LTF] test, short-beam cyclic compression loading [CCL] test) before and after sterilization cycling.

Radiographic Density Evaluation

The radiographic density of the 5 materials was evaluated with radiographic images of a cadaveric knee specimen (Figure 2). Radiographic image intensification is the gold standard for repeated radiographic imaging in the operating room. Six different radiographic images were obtained for each material superimposed over a cadaveric knee to recreate potential instrument positioning during surgery: posterior to subject (1 piece), posterior to subject (2 pieces), anterior to subject (1 piece), anterior to subject (2 pieces), anterior and posterior to subject in alignment (1 piece), and anterior and posterior to subject in alignment (2 pieces). Image-Pro Plus software (Media Cybernetics) was used to measure the radiographic density of the materials from the grayscale of the images.

Structural Properties Testing Before and After Sterilization Cycling

We used a standard SBS testing method to determine whether any degradation of structural properties resulted from standard repeated sterilization. The material geometries of the test specimens were 18.96×6.50×3.37 mm (length × width × thickness). Standard sterilization procedures were performed with steam sterilization using an autoclave at a temperature of 132°C (270°F) for at least 5 minutes (range, 5-14 minutes). Sample interval testing ran at 0, 200, and 400 sterilization cycles for structural properties in terms of SBS and moisture retention, with the structural properties at the 0th sterilization cycle (material before sterilization was performed) used as a baseline for comparison. Materials were subjected to 400 sterilization cycles, which is representative of the number of sterilization cycles per year an instrument or device would be subjected to.

Three structural tests were performed for each sample interval: moisture retention, LTF, and CCL. Moisture retention was investigated before and after repeated sterilization by measuring the weight of the test materials, as steam sterilization is known to affect the amount of moisture that is absorbed by a material. Twelve specimens of each proposed material were weighed at each sample interval, with the structural weight at the 0th sterilization cycle (material before sterilization is performed) serving as a baseline for comparison.

SBS testing was based on the ASTM (American Society for Testing and Materials) D2344 standard¹⁶ for LTF and CCL tests (Figure 3). Six samples of material were used for each test at every sample interval, yielding 180 samples. Seven servohydraulic material testing system instruments (1 MTS 810 and 6 MTS 858 Mini Bionix) were used to test the SBS of each material. For LTF testing, each specimen was loaded in compression from 30 N to complete structural failure at a constant displacement rate of 1.0 mm/min (0.05 in/min). Testing was initiated with 5 preconditioning loading cycles from 30 to 100 N at 1 Hz. The load was then applied continuously until failure occurred; force and displacement data were collected every 0.02 second. This procedure was performed for 6 replicates for each sample interval for each test material.

The calculation for SBS, F_sbs (MPa), for the constant loading rate until structural failure is:

                            Fsbs = 0.75 ×   Pm
                                                b × h

where P_m (N) is the maximum applied load observed during the test, b is the measured specimen width (mm), and h is the measured specimen thickness (mm).

CCL testing consisted of each test material axially loaded with 100 to 500 N at a frequency of 1 Hz for 100,000 cycles. The maximum load of 500 N was chosen as a standard based on 80% of the minimum ultimate failure load from previous LTF tests. Displacement and force data were collected every 5 cycles at the maximum compressive load. Degradation of the material was calculated using the difference between the deflection of the initial cycle and the deflection of the final cycle (50th cycle and 100,000th cycle). This procedure was performed for 6 replicates for each sample interval for each test material.

Statistical Analysis

LTF and CCL testing data were analyzed for any differences among the test materials using 1-way analysis of variance with the least significant difference multiple comparisons post hoc test method using SPSS Version 16.0, with P < .05 denoting significance. These analyses were used to determine the statistical relevance of the difference between the SBS (LTF and CCL) of each test material. Means and standard deviations were calculated for all tests.

Results

Radiographic Density Evaluation

Overall, all the tested composite materials were significantly more radiolucent than either SS-316L or Al-7075-T6. Figure 4 shows the 6 different radiographic images obtained for each material superimposed over a cadaveric knee to recreate potential instrument positioning during surgery: posterior to subject (1 piece), posterior to subject (2 pieces), anterior to subject (1 piece), anterior to subject (2 pieces), anterior and posterior to subject in alignment (1 piece), and anterior and posterior to subject in alignment (2 pieces). SS-316L can be considered radiopaque, and Al-7075-T6 has been used as a relatively radiolucent alternative. Tepex was statistically more radiolucent than the other 2 tested composite materials (Table 1). Even with 2 pieces placed anterior to the subject and 2 placed posterior, the radiodensity compared to the cortical bone was still lower than 1 piece of Al-7075-T6 either anterior or posterior to the subject.

Structural Properties Testing

Moisture Retention. Moisture retention was evaluated by weighing the test materials before and after repeated sterilization. There was no significant difference in moisture retention, as weight differences for all the tested materials were less than 0.5 weight percentage compared to the 0th sterilization cycle (Table 2). Therefore, the results of this study showed that all the tested materials exhibited good moisture/temperature resistance after 400 sterilization cycles.

Load to Failure. In the LTF test, significant differences were detected in SBS between all 5 tested materials (P < .05). Figure 5 shows the comparison of the structural properties in terms of SBS between the 5 tested materials, and Figure 6 shows the failure modes for the tested materials. There was no SBS for SS-316L, as the material did not exhibit complete structural failure even after 400 sterilization cycles; however, SS-316L was observed in inelastic deformation failure (Figure 6D). Al-7075-T6 had much higher SBS compared with the other composite materials, and it also resulted in an inelastic deformation failure mode only after 400 sterilization cycles; otherwise, flexure failure modes were observed. Tepex and CFR-PPS exhibited interlaminar shear failure, and HTN-53 exhibited complete structural failure.

Every composite material tested using the short-beam test for LTF showed a decrease in SBS with increased sterilization cycles (Figure 5). This decrease ranged from 17% to 57% compared with the 0th sterilization cycle. SBS was higher for CFR-PPS than for the other 2 composites. No statistically significant difference was found between CFR-PPS and Tepex except at the 200th sterilization cycle. HTN-53 was brittle at the 0th sterilization cycle but performed more like a ductile material at the 200th cycle. In addition, HTN-53 had the lowest SBS in terms of LTF testing when compared with the other 2 composites.

During the complete structural failure test, the failure modes for Tepex and CFR-PPS were visually identified as interlaminar shear failure (Figures 6A, 6B), whereas HTN-53 visually exhibited pure flexure failure (Figure 6C). As for the metals, SS-316L exhibited plastic deformation, and Al-7075-T6 exhibited flexure failure (Figures 6D, 6E).

Cyclic Compression Loading. Tepex was the only material to pass the 100,000 loading cycle without failure (Table 3). HTN-53 had the poorest performance of all: Its failure rates were 33% (2/6 samples) before sterilization (average cycle, 22,213; range, 21,500-22,925), 83% (5/6 samples) at the 200th sterilization cycle (average cycle, 4,210; range, 0-14,360), and 100% after 400 sterilization cycles (average cycle, 12,725; range, 1,190-21,900). CFR-PPS had no failures before the 400th sterilization cycle, and its failure rate after 400 sterilization cycles (average cycle, 50,735; range, 50,270-51,200) was 33% (2/6 samples).

Discussion

The success of a reusable composite material for use in orthopedic surgery depends not only on radiographic density, fabrication methods, and design but also on the ability to withstand repeated sterilization. Over the past 3 decades, investigators have explored several high-performance polymer matrix composite materials for use in orthopedics, especially in trauma, hip stems, and spinal implants.^1,3,4,17-34 According to Evans and Gregson,³⁵ composite materials have been widely promoted as possible orthopedic biomaterials but to date have found few successful commercial applications, because of the many challenging problems encountered in fabrication and testing. One of the most important factors in the mechanical properties of many composite materials is the influence of the cooling and loading rates on fiber-matrix interface adhesion.^36-38 Our results tended to agree with the findings of Evans and Gregson,³⁵ as some of these composite materials did not withstand repeated sterilizations well.

Guan and colleagues³⁹ evaluated the influence of sterilization treatment on continuous carbon-fiber–reinforced polyolefin composite. Their 3-point bending test results showed that the levels of maximum load of all the specimens undergoing sterilization by autoclave were lower than those of the control group. For these composites, they concluded that autoclave sterilization and Co-60 gamma ray irradiation sterilization should be avoided and that ethylene oxide is the best method. Our results support their findings with a different set of composites.

Although HTN-53 has shown promise in other orthopedic applications because of its superior moisture and temperature resistance, we found that its performance after repeated sterilization was relatively poor. Tepex showed the greatest potential for durability after repeated sterilization; its mechanical properties were stable after 200 steam sterilization cycles.

Clinical Applications

The composite materials investigated in the present study have potential for use in either instrumentation or long-term implantation applications because of their versatility, mechanical strength, fatigue resistance, and biocompatibility. Akay and Aslan⁴⁰ stated that carbon-fiber–filled composite implants can be designed with more appropriate modulus, strength, toughness, or stiffness by the arrangement of reinforcing fiber volume and orientation, and can provide better fatigue resistance. A notable advantage of using a composite plate with metal screws is that the potential for corrosion of metallic components is eliminated. Another major advantage of composite medical implants (eg, DiPhos-RM) is radiolucency, which allows direct visualization of osseous callus formation as well as monitoring of fracture healing, thereby improving clinical assessment and accuracy.

Numerous studies have documented the successful clinical performance of composite materials in orthopedic, trauma, and spinal surgery applications.^41-45 Bagheri and colleagues⁴¹ developed a new carbon fiber–flax–epoxy composite plate and biomechanically compared it with a standard clinical metal plate. Their results confirmed that the carbon fiber–flax–epoxy material represents a potential candidate for bone fracture plate applications, as it can simultaneously provide similar mechanical stiffness and lower stress shielding (higher bone stress) compared with a standard clinical metal bone plate. Tarallo and colleagues⁴⁵ evaluated the clinical results of 40 cases at 12-month follow-up using a new plate made of carbon-fiber–reinforced polyetheretherketon (DiPhos-RM, Lima Corporate) for the treatment of distal radius fractures. They reported good clinical results for this device at early follow-up, and its use allowed maintenance of reduction in complex AO (Arbeitsgemeinschaft für Osteosynthesefragen) fractures.

The main advantage in using composites for surgical instruments is their radiolucency. These materials do not obscure images or radiographs during fluoroscopic visualization. Surgery often requires fluoroscopic visualization of internal organs or bones, which may require temporary removal of radiopaque devices (eg, retractors, clamps, forceps, hooks, distractors). Aside from being inconvenient, removal and subsequent reinsertion consume valuable time and interfere with the smooth flow of an operation.

The shortcomings of using composite materials for surgical instruments involve detectability and sterilization. A significant issue in surgery is the accidental leaving behind of instruments in patients, which can cause serious problems ranging from organ perforation and blood infection to death. Although instrument counting and other safety protocols can reduce the risk of overlooking an instrument, mistakes are bound to happen. The other shortcoming is the influence of repeated sterilization on the mechanical properties of the composite materials, as sterilization is mandatory for surgical instruments used in the operation room. The structural integrity and overall performance of the polymer composite materials—especially the stability of the interface and the interphase zones—are strongly influenced by repeated sterilization.

On the other hand, composite materials have potential advantages that may support their introduction into long-term medical implant applications, as sterilization commonly is performed only once, during packaging. The effects of sterilization by radiation or steam are much less pronounced on composite implants than on composite surgical instruments. However, composite implants require careful consideration with respect to the bioactivity of wear particles that may be produced from articulation. Further, carbon-fiber–reinforced polymer implants are still substantially more difficult to manufacture and more costly than their metallic counterparts.⁴⁶

Limitations

This study has some limitations. Most important, studies of this nature do not account for biological factors such as corrosion, biological wear, and the soft-tissue attachment effects on structural properties for potential in vivo use. Another limitation was that the study tested only the mechanical properties in terms of SBS and provided no information about other mechanical properties, such as tensile, compression, and torsion strengths. We think SBS testing adequately evaluates challenging scenarios like thin and narrow instruments/devices that are anticipated in application, and information regarding other modes of failure and mechanical properties (compression, tension, torsion) would be a further area of research. An additional limitation was that our model used a relatively small number of samples. A larger study with more samples and varying layout patterns and layers of the carbon fibers may more clearly demonstrate the effect of steam sterilization on composite materials.

Conclusion

This study provided new information on 3 selected composite materials and their structural properties after repeated steam sterilization. We discovered that these composites were similar in radiographic density and water retention but behaved very differently in terms of mechanical durability after repeated steam sterilization. All selected composites demonstrated deterioration of mechanical properties after repeated steam sterilization. Knowing these results could aid in making decisions about the design and manufacturing of operative instruments and orthopedic biomaterials. Although our preliminary findings are intriguing, further study is warranted to seek specific applications for these composite materials in orthopedic surgery.

Polymer matrix composite materials have been widely promoted for orthopedic use in a variety of settings, including surgical instruments, medical devices, implants, and bone models.^1-13 These types of composites are engineered from 2 or more constituent materials with significantly different physical or chemical properties; these materials remain separate and distinct on a macroscopic level within the finished composite structure. As a result of ongoing biomaterial research, polymer matrix composite materials can be engineered with a wide range of physical, mechanical, and surface properties, tailored to their application. Given their advantages (eg, high strength-to-weight ratio, radiolucency), these polymer matrix composite materials have gained popularity over traditional metallic materials.

Sterilization is an essential day-to-day procedure in the health care sector, both for single- and multiple-use devices or instruments, and thus a composite material used in medical components should remain unaffected by the process. The type of sterilization most commonly performed is steam sterilization, which achieves microbiological death by moist heat and pressure. Steam is created in an autoclave at a temperature of 132°C (270°F) in typical hospital settings. Steam sterilization cycles last 5 to 14 minutes based on specific manufacturer recommendations. Most medical-grade plastics used in health care have been designed and formulated to withstand the required sterilization cycles without sacrificing key properties. The structure integrity and overall performance of polymer matrix composites may be strongly influenced by the stability of the fiber/polymer interfacial region in terms of physical, chemical, and mechanical characteristics of the material at different scales.¹⁴ Absorption of moisture causes dilatational expansion and induces stresses, which are associated with the moisture-induced expansion resulting in degradation of structure stability.¹⁵ Thus, steam sterilization could affect the properties of the polymer matrix composite materials by excessive absorption of moisture by the polymer.

To our knowledge, no one has studied whether polymer matrix material properties degrade from long-term, repeated steam sterilization followed by mechanical loading. We conducted a study to evaluate the structural properties (short-beam strength, SBS) of several composite materials exposed to repeated sterilization as compared with traditional metal materials: SS-316L (stainless steel 316L) and Al-7075-T6 (aluminum 7075-T6).

Materials and Methods

We evaluated 3 types of composite materials: Tepex (Tepex Dynalite 201; HiPer Technology Inc.), CFR-PPS (carbon-fiber–reinforced polyphenylene sulfide, Cetex PPS; TenCate Advanced Composites USA Inc.), and HTN-53 (Zytel HTN53G50HSLR NC010; HiPer Technology Inc.) (Figure 1). Tepex is being used for orthopedic applications (knee braces, orthoses, insoles) and sporting goods applications. The performance of this material is superior to that of unreinforced thermoplastics. CFR-PPS represented the state of the art in composite materials for aerospace applications (eg, airframe structures, engine nacelles, fan casings, floorboards, interior parts). This is a high-performance material with exceptional high temperature and aggressive chemical resistance characteristics. CFR-PPS is also used to make filter fabric for coal boilers, papermaking felts, electrical insulation, specialty membranes, gaskets, and packing. It is not solubilized by any known solvents, even in long-term exposure, at temperatures up to 200°C. In addition, it exhibits exceptional resistance to organic and inorganic solutions, acids and alkali solutions, and a wide array of miscellaneous chemicals. HTN-53 is a 50% glass-reinforced, lubricated, high-performance polyamide resin with improved flow, developed for applications requiring excellent surface appearance with water-heated molds. This material has specifically shown survivability in hot, cold, chemically aggressive, and load-bearing environments. In addition, it has shown superior moisture and temperature resistance. These 3 composite materials were compared with SS-316L and Al-7075-T6. SS-316L is commonly used for implants in orthopedics, and Al-7075-T6 is a relatively radiolucent alternative for medical applications. Two different tests were performed to evaluate and validate these composite materials: (1) radiographic density evaluation and (2) structural property tests (short-beam load-to-failure [LTF] test, short-beam cyclic compression loading [CCL] test) before and after sterilization cycling.

Radiographic Density Evaluation

The radiographic density of the 5 materials was evaluated with radiographic images of a cadaveric knee specimen (Figure 2). Radiographic image intensification is the gold standard for repeated radiographic imaging in the operating room. Six different radiographic images were obtained for each material superimposed over a cadaveric knee to recreate potential instrument positioning during surgery: posterior to subject (1 piece), posterior to subject (2 pieces), anterior to subject (1 piece), anterior to subject (2 pieces), anterior and posterior to subject in alignment (1 piece), and anterior and posterior to subject in alignment (2 pieces). Image-Pro Plus software (Media Cybernetics) was used to measure the radiographic density of the materials from the grayscale of the images.

Structural Properties Testing Before and After Sterilization Cycling

We used a standard SBS testing method to determine whether any degradation of structural properties resulted from standard repeated sterilization. The material geometries of the test specimens were 18.96×6.50×3.37 mm (length × width × thickness). Standard sterilization procedures were performed with steam sterilization using an autoclave at a temperature of 132°C (270°F) for at least 5 minutes (range, 5-14 minutes). Sample interval testing ran at 0, 200, and 400 sterilization cycles for structural properties in terms of SBS and moisture retention, with the structural properties at the 0th sterilization cycle (material before sterilization was performed) used as a baseline for comparison. Materials were subjected to 400 sterilization cycles, which is representative of the number of sterilization cycles per year an instrument or device would be subjected to.

Three structural tests were performed for each sample interval: moisture retention, LTF, and CCL. Moisture retention was investigated before and after repeated sterilization by measuring the weight of the test materials, as steam sterilization is known to affect the amount of moisture that is absorbed by a material. Twelve specimens of each proposed material were weighed at each sample interval, with the structural weight at the 0th sterilization cycle (material before sterilization is performed) serving as a baseline for comparison.

SBS testing was based on the ASTM (American Society for Testing and Materials) D2344 standard¹⁶ for LTF and CCL tests (Figure 3). Six samples of material were used for each test at every sample interval, yielding 180 samples. Seven servohydraulic material testing system instruments (1 MTS 810 and 6 MTS 858 Mini Bionix) were used to test the SBS of each material. For LTF testing, each specimen was loaded in compression from 30 N to complete structural failure at a constant displacement rate of 1.0 mm/min (0.05 in/min). Testing was initiated with 5 preconditioning loading cycles from 30 to 100 N at 1 Hz. The load was then applied continuously until failure occurred; force and displacement data were collected every 0.02 second. This procedure was performed for 6 replicates for each sample interval for each test material.

The calculation for SBS, F_sbs (MPa), for the constant loading rate until structural failure is:

                            Fsbs = 0.75 ×   Pm
                                                b × h

where P_m (N) is the maximum applied load observed during the test, b is the measured specimen width (mm), and h is the measured specimen thickness (mm).

CCL testing consisted of each test material axially loaded with 100 to 500 N at a frequency of 1 Hz for 100,000 cycles. The maximum load of 500 N was chosen as a standard based on 80% of the minimum ultimate failure load from previous LTF tests. Displacement and force data were collected every 5 cycles at the maximum compressive load. Degradation of the material was calculated using the difference between the deflection of the initial cycle and the deflection of the final cycle (50th cycle and 100,000th cycle). This procedure was performed for 6 replicates for each sample interval for each test material.

Statistical Analysis

LTF and CCL testing data were analyzed for any differences among the test materials using 1-way analysis of variance with the least significant difference multiple comparisons post hoc test method using SPSS Version 16.0, with P < .05 denoting significance. These analyses were used to determine the statistical relevance of the difference between the SBS (LTF and CCL) of each test material. Means and standard deviations were calculated for all tests.

Results

Radiographic Density Evaluation

Overall, all the tested composite materials were significantly more radiolucent than either SS-316L or Al-7075-T6. Figure 4 shows the 6 different radiographic images obtained for each material superimposed over a cadaveric knee to recreate potential instrument positioning during surgery: posterior to subject (1 piece), posterior to subject (2 pieces), anterior to subject (1 piece), anterior to subject (2 pieces), anterior and posterior to subject in alignment (1 piece), and anterior and posterior to subject in alignment (2 pieces). SS-316L can be considered radiopaque, and Al-7075-T6 has been used as a relatively radiolucent alternative. Tepex was statistically more radiolucent than the other 2 tested composite materials (Table 1). Even with 2 pieces placed anterior to the subject and 2 placed posterior, the radiodensity compared to the cortical bone was still lower than 1 piece of Al-7075-T6 either anterior or posterior to the subject.

Structural Properties Testing

Moisture Retention. Moisture retention was evaluated by weighing the test materials before and after repeated sterilization. There was no significant difference in moisture retention, as weight differences for all the tested materials were less than 0.5 weight percentage compared to the 0th sterilization cycle (Table 2). Therefore, the results of this study showed that all the tested materials exhibited good moisture/temperature resistance after 400 sterilization cycles.

Load to Failure. In the LTF test, significant differences were detected in SBS between all 5 tested materials (P < .05). Figure 5 shows the comparison of the structural properties in terms of SBS between the 5 tested materials, and Figure 6 shows the failure modes for the tested materials. There was no SBS for SS-316L, as the material did not exhibit complete structural failure even after 400 sterilization cycles; however, SS-316L was observed in inelastic deformation failure (Figure 6D). Al-7075-T6 had much higher SBS compared with the other composite materials, and it also resulted in an inelastic deformation failure mode only after 400 sterilization cycles; otherwise, flexure failure modes were observed. Tepex and CFR-PPS exhibited interlaminar shear failure, and HTN-53 exhibited complete structural failure.

Every composite material tested using the short-beam test for LTF showed a decrease in SBS with increased sterilization cycles (Figure 5). This decrease ranged from 17% to 57% compared with the 0th sterilization cycle. SBS was higher for CFR-PPS than for the other 2 composites. No statistically significant difference was found between CFR-PPS and Tepex except at the 200th sterilization cycle. HTN-53 was brittle at the 0th sterilization cycle but performed more like a ductile material at the 200th cycle. In addition, HTN-53 had the lowest SBS in terms of LTF testing when compared with the other 2 composites.

During the complete structural failure test, the failure modes for Tepex and CFR-PPS were visually identified as interlaminar shear failure (Figures 6A, 6B), whereas HTN-53 visually exhibited pure flexure failure (Figure 6C). As for the metals, SS-316L exhibited plastic deformation, and Al-7075-T6 exhibited flexure failure (Figures 6D, 6E).

Cyclic Compression Loading. Tepex was the only material to pass the 100,000 loading cycle without failure (Table 3). HTN-53 had the poorest performance of all: Its failure rates were 33% (2/6 samples) before sterilization (average cycle, 22,213; range, 21,500-22,925), 83% (5/6 samples) at the 200th sterilization cycle (average cycle, 4,210; range, 0-14,360), and 100% after 400 sterilization cycles (average cycle, 12,725; range, 1,190-21,900). CFR-PPS had no failures before the 400th sterilization cycle, and its failure rate after 400 sterilization cycles (average cycle, 50,735; range, 50,270-51,200) was 33% (2/6 samples).

Discussion

The success of a reusable composite material for use in orthopedic surgery depends not only on radiographic density, fabrication methods, and design but also on the ability to withstand repeated sterilization. Over the past 3 decades, investigators have explored several high-performance polymer matrix composite materials for use in orthopedics, especially in trauma, hip stems, and spinal implants.^1,3,4,17-34 According to Evans and Gregson,³⁵ composite materials have been widely promoted as possible orthopedic biomaterials but to date have found few successful commercial applications, because of the many challenging problems encountered in fabrication and testing. One of the most important factors in the mechanical properties of many composite materials is the influence of the cooling and loading rates on fiber-matrix interface adhesion.^36-38 Our results tended to agree with the findings of Evans and Gregson,³⁵ as some of these composite materials did not withstand repeated sterilizations well.

Guan and colleagues³⁹ evaluated the influence of sterilization treatment on continuous carbon-fiber–reinforced polyolefin composite. Their 3-point bending test results showed that the levels of maximum load of all the specimens undergoing sterilization by autoclave were lower than those of the control group. For these composites, they concluded that autoclave sterilization and Co-60 gamma ray irradiation sterilization should be avoided and that ethylene oxide is the best method. Our results support their findings with a different set of composites.

Although HTN-53 has shown promise in other orthopedic applications because of its superior moisture and temperature resistance, we found that its performance after repeated sterilization was relatively poor. Tepex showed the greatest potential for durability after repeated sterilization; its mechanical properties were stable after 200 steam sterilization cycles.

Clinical Applications

The composite materials investigated in the present study have potential for use in either instrumentation or long-term implantation applications because of their versatility, mechanical strength, fatigue resistance, and biocompatibility. Akay and Aslan⁴⁰ stated that carbon-fiber–filled composite implants can be designed with more appropriate modulus, strength, toughness, or stiffness by the arrangement of reinforcing fiber volume and orientation, and can provide better fatigue resistance. A notable advantage of using a composite plate with metal screws is that the potential for corrosion of metallic components is eliminated. Another major advantage of composite medical implants (eg, DiPhos-RM) is radiolucency, which allows direct visualization of osseous callus formation as well as monitoring of fracture healing, thereby improving clinical assessment and accuracy.

Numerous studies have documented the successful clinical performance of composite materials in orthopedic, trauma, and spinal surgery applications.^41-45 Bagheri and colleagues⁴¹ developed a new carbon fiber–flax–epoxy composite plate and biomechanically compared it with a standard clinical metal plate. Their results confirmed that the carbon fiber–flax–epoxy material represents a potential candidate for bone fracture plate applications, as it can simultaneously provide similar mechanical stiffness and lower stress shielding (higher bone stress) compared with a standard clinical metal bone plate. Tarallo and colleagues⁴⁵ evaluated the clinical results of 40 cases at 12-month follow-up using a new plate made of carbon-fiber–reinforced polyetheretherketon (DiPhos-RM, Lima Corporate) for the treatment of distal radius fractures. They reported good clinical results for this device at early follow-up, and its use allowed maintenance of reduction in complex AO (Arbeitsgemeinschaft für Osteosynthesefragen) fractures.

The main advantage in using composites for surgical instruments is their radiolucency. These materials do not obscure images or radiographs during fluoroscopic visualization. Surgery often requires fluoroscopic visualization of internal organs or bones, which may require temporary removal of radiopaque devices (eg, retractors, clamps, forceps, hooks, distractors). Aside from being inconvenient, removal and subsequent reinsertion consume valuable time and interfere with the smooth flow of an operation.

The shortcomings of using composite materials for surgical instruments involve detectability and sterilization. A significant issue in surgery is the accidental leaving behind of instruments in patients, which can cause serious problems ranging from organ perforation and blood infection to death. Although instrument counting and other safety protocols can reduce the risk of overlooking an instrument, mistakes are bound to happen. The other shortcoming is the influence of repeated sterilization on the mechanical properties of the composite materials, as sterilization is mandatory for surgical instruments used in the operation room. The structural integrity and overall performance of the polymer composite materials—especially the stability of the interface and the interphase zones—are strongly influenced by repeated sterilization.

On the other hand, composite materials have potential advantages that may support their introduction into long-term medical implant applications, as sterilization commonly is performed only once, during packaging. The effects of sterilization by radiation or steam are much less pronounced on composite implants than on composite surgical instruments. However, composite implants require careful consideration with respect to the bioactivity of wear particles that may be produced from articulation. Further, carbon-fiber–reinforced polymer implants are still substantially more difficult to manufacture and more costly than their metallic counterparts.⁴⁶

Limitations

This study has some limitations. Most important, studies of this nature do not account for biological factors such as corrosion, biological wear, and the soft-tissue attachment effects on structural properties for potential in vivo use. Another limitation was that the study tested only the mechanical properties in terms of SBS and provided no information about other mechanical properties, such as tensile, compression, and torsion strengths. We think SBS testing adequately evaluates challenging scenarios like thin and narrow instruments/devices that are anticipated in application, and information regarding other modes of failure and mechanical properties (compression, tension, torsion) would be a further area of research. An additional limitation was that our model used a relatively small number of samples. A larger study with more samples and varying layout patterns and layers of the carbon fibers may more clearly demonstrate the effect of steam sterilization on composite materials.

Conclusion

This study provided new information on 3 selected composite materials and their structural properties after repeated steam sterilization. We discovered that these composites were similar in radiographic density and water retention but behaved very differently in terms of mechanical durability after repeated steam sterilization. All selected composites demonstrated deterioration of mechanical properties after repeated steam sterilization. Knowing these results could aid in making decisions about the design and manufacturing of operative instruments and orthopedic biomaterials. Although our preliminary findings are intriguing, further study is warranted to seek specific applications for these composite materials in orthopedic surgery.

Several years ago, I was on the American Academy of Orthopaedic Surgeons leadership fellow committee, reviewing fellowship applications. The committee had been poised to very favorably rule on an application until a new member spoke up, stating that he had been in the applicant’s department and that points made in the recommending letter bore little resemblance to the person’s performance. Further study confirmed the dishonesty in the letter, and a more fit candidate was selected instead.

I was puzzled. Why would a leader in the field do such a thing? The question led me to a personal investigation into the monumental topic of professionalism and, more specifically, professionalism among orthopedic surgeons.

Physicians, Especially Orthopedists, Are Not Happy

Physicians, in general, are not a happy lot. According to a 2012 survey by the Physicians Foundation,¹ 77.4% of practicing physicians were pessimistic about the future of medicine, and 82% thought they had little ability to change the health care system. Sources of pessimism included “too much regulation/paperwork, loss of clinical autonomy, physicians not compensated for quality, erosion of physician/patient relationship, and money trumps patient care.” We are now in the age of “organizational physicians,” who, subject to institutional management, are experiencing a distressing loss of autonomy.

What sustains, or does not sustain, surgeons’ career satisfaction? Commonly stated positive factors include the ability to provide quality care, time with patients, income, and financial incentives²; reported negative factors include threat of malpractice, lack of autonomy, excessive administrative tasks, and high patient volume. Early-career physicians have the lowest career satisfaction, but physicians in mid-career have the highest rate of burnout and likelihood of leaving medical practice.³ Work–home conflict is most difficult in the early career, when families have young children, and the conflict generally goes unresolved. Burnout and low satisfaction with specialty choice are most common in mid-career.

Despite all the negative factors acting on medical practices, orthopedic surgeons have fared well financially, but not as well in career satisfaction. The Medscape Physician Compensation Report 2014⁴ places orthopedics compensation first among 25 specialties listed, without a close second, but orthopedists rank 15th in thinking they are fairly compensated, and next to last in indicating they would choose medicine again as a career. A separate study of physician career satisfaction ranked orthopedics 32nd of 42 specialties studied.⁵

What is our problem, and what can we do about it? It’s hard to digest this information and not feel that orthopedists are, for lack of a better word, spoiled.

DeBotton⁶ wrote about status anxiety, which arises over and over again in daily life. Essentially, it is the envy or dissatisfaction one feels when a peer gets a better deal that does not seem just. A remarkable aspect of Medscape’s compensation report⁴ is that family medicine physicians, whose annual income was well under half that of orthopedic surgeons, were more likely to view themselves as fairly compensated. On this basis, we have to conclude that orthopedic surgeons have status anxiety. But why?

Humanism

Osler, the quintessential physician, counseled medical students: “Nothing will sustain you more potently in your humdrum routine … than the power to recognize the true poetry of life—the poetry of the commonplace, of the ordinary man, of the plain, toilworn woman, with their loves and their joys, their sorrows and their griefs.”⁷ In short, take the time to know your patients. In a study of physicians who were regarded as clinically excellent, several traits were noted: honest, nonjudgmental, genuinely caring, treating all patients equally, and constantly striving for excellence.⁸ A century after Osler, Stellato⁹ echoed the sentiment: “Listen to your patients, not just about their illness, but about their life.”

Humanism, then, is the trait underlying professionalism.^10,11 Communication skills are essential to humanism.¹² However, a study of specialty physicians in Spain “showed scarce empathic behaviours or behaviours that foster a shared decision making process.”¹³ In addition, a recent survey placed the communication skills of orthopedists last among 28 specialties.¹⁴ Assessment was based on how often a physician explains things, listens carefully, gives easy-to-understand instructions, shows respect, and spends enough time.

Could it be that orthopedists are not satisfied with their income because as a group they lack the communication skills and humanistic characteristics of lower-paid physicians?

Residency and the Academic Medical Center

The education of the orthopedic surgeon starts with the selection process. Simon¹⁵ noted that “the brightest, but not always the best” are selected largely because objective criteria are an excellent measure of cognitive achievement but not of character. Also noting that 10% of examinees pass part I of the board but fail part II, Simon opined that they “lack clinical judgment, communication skills, and, in some instances, ethics.” A 1999 team of authors found that 18% of research citations listed by orthopedic residency applicants were misrepresented, and a follow-up study by the same authors in 2007 noted a rate increase, to 20.6%.¹⁶ Both sets of authors wrote of a need for a better selection process and a better evaluative process during residency.

The residency process has been substantially altered by work-hour restrictions. The 20th-century residency, which emphasizes taking responsibility for the patient throughout a hospital stay, has now been dismissed as “nostalgic professionalism.” Residents are now advised to avoid such activities as checking laboratory results from home and coming to work when they are not feeling well.¹⁷ However, there has been considerable pushback against diminishing nostalgic professionalism, primarily from surgeons.¹⁸ “Teaching residents that they should go home to rest at the end of their shift without regard for the circumstances of their cases in progress is not an acceptable example for training.”¹⁹ Current promulgated restrictions on duty hours move concern for the “circumstances of their cases” to the back burner—the shift ends, the physician leaves. Residents are pulled one way by forces telling them to leave (Accreditation Council for Graduate Medical Education) and the other way by forces telling them to stay (their conscience).

How do residents develop their surgical identities and concepts of humanism and professionalism? There is a substantial body of evidence that the so-called hidden curriculum is the dominant factor: trainees emulate what their faculty say and do.²⁰ As Gofton and Regehr²¹ noted, “It is vital for members of the surgical academic community to recognize [that] the attitudes, beliefs, and values implicit in every action, every word, every inaction, and every silence are not only shaping the attitudes, beliefs, and values of one’s protégés, but also are shaping the decisions of students who are considering the possibility of becoming one’s protégés.” It is not easy being a surgical role model given the conflicts affecting academic surgeons. For example, should a surgeon allot extra time so a trainee can do a case properly, or should the case be finished expeditiously in order to avoid canceling the next case, or to get to a committee meeting or a kid’s ballgame on time? Monetary pressures, along with the possibility of losing operative time because the schedule was not full, can influence the decision to operate or not.²² Trainees absorb what they hear and see.

In 2003, Inui²³ published A Flag in the Wind: Educating for Professionalism in Medicine, in which he stated, “There can be little doubt that physicians in general as well as the leadership of the organization of medicine have been preoccupied with finances and the economics of medical care. … The topics and the language of academic leadership [have] shifted in the last twenty years. … Core functions of the academic medical center became ‘enterprises.’” He also noted, “The most difficult challenge of all may be the need to understand—and to be explicitly mindful of, and articulate about—medical education as a special form of personal and professional formation that is rooted in the daily activities of individuals and groups in academic medical communities.”²³ In addition, the “institutional environment we create … [is] a reflection of the values we hold as a professional community.”²³ In effect, the academic medical center is part of the hidden curriculum.

Curiously, academic institutions tend not to reward clinical excellence—a self-defeating measure for any institution that recognizes the importance of the hidden curriculum.²⁴ A peer evaluation of hospitalists revealed that the most highly regarded were highly associated with humanism and a passion for clinical medicine.²⁵ At a prominent institution, however, it was found that clinical educators were less likely than research faculty to hold a higher rank.²⁶

Of the factors affecting physician dissatisfaction, workplace stress is predominant.²⁷ In this age of organizational physicians, job satisfaction correlates with how a physician feels about his or her ability to function as a physician. In a study by Wai and colleagues,²⁸ “surgical faculty reported low satisfaction with a number of questions about communication in their medical schools and their clinical practice locations.” The authors indicated that “medical school and department governance are critical determinants of faculty satisfaction within academic surgical centers.” Pololi and colleagues²⁹ extensively studied the culture of academic medicine and summarized the sources of discontent: “competitive individualism, undervaluing of humanistic qualities, deprecation, and the erosion of trust.” In another study,³⁰ they studied the incidence (~25%) of, and reasons for, considering to leave academic medicine. Reasons included feeling isolated in the department, lack of institutional support, poor communication with administrators, and a perceived difference between the stated culture of the institution and what was observed on a daily basis.³⁰

What Can We Do?

The obvious starting point is the selection process—focusing more on finding the “best,” not necessarily the “brightest.”¹⁵ This is not easy. Recommendation letters are often based on limited contact and may or may not reflect applicants’ true character. Numerous websites advise resident applicants on what questions to expect and how to prepare and practice for them. I have found questions of current events very illuminating, as they can probe how applicants view the world. Given the high income of orthopedic surgeons, some applicants likely are attracted to that aspect of the specialty. These applicants are not the “best.”

Residents who exhibit questionable ethical reasoning or behavior must be identified and not be allowed to finish their program. It is the responsibility of the program, not the board, to ensure that those entering practice exhibit a high degree of professionalism. Faculty must seriously recognize, every day, that everything they do is part of the hidden curriculum.

As noted, the academic medical environment can be inimical. Faculty who experience dissonance must be able to effectively confront administrative leadership to express their concerns, and they need to feel their concerns are recognized. Leaders of academic medical centers must guide their institutions in such a way that the day-to-day functions are compatible with the stated mission and values.³¹

Chervenak and colleagues³² forcefully stated that “appropriate ethical values” are the core component that academic leadership needs in order to respond to the opposing forces of increasing pressures of patient satisfaction, compliance, liability, and other administrative demands on one hand and diminishing resources on the other hand. They listed 4 “professional virtues” that characterize responsible professional leadership: self-effacement, which obligates physician leaders to be unbiased; self-sacrifice, the willingness to risk individual and organizational self-interest, especially in the economic domain; compassion, or “What can I do to help?”; and integrity. The principles of effective leadership are not that complicated, but implementing them requires conviction and courage.³³

Physicians increasingly are practicing in the organization setting. They need to increase their involvement in the organization in order to promulgate the needs of physicians. Organizational executive leadership is primarily driven by budgetary and capital planning processes; physician input is essential to ensure resources are directed toward better patient care. A feeling of loss of control over one’s practice is a primary cause of physician dissatisfaction. The schism between physicians and administrators traditionally has been characterized by a lack of trust; a more trusting relationship, reinforced by frequent constructive dialogue, will result in more physician control of the practice.³⁴ This will be difficult, but it is necessary for improving professional satisfaction.

For practicing physicians, Wynia³⁵ made the compelling case that professionalism demands self-regulation, which involves identifying and reporting impaired or incompetent physicians—another task that requires conviction and courage.

But the core issue is how an orthopedist regards the day-to-day aspects of his or her practice. Shanafelt and colleagues³⁶ concluded that surgeons are not very good at assessing their own well-being and stress levels. Certainly high stress can affect well-being, which in turn can affect professionalism. West and Shanafelt³⁷ uniquely described this relationship: “The effect of distress on professionalism in medicine has become clear in recent years. The well-documented decline of crucial elements of professionalism, including empathy and humanism, during medical training appears to be related in part to personal distress experienced during medical school and residency. Unfortunately, this decline continues as physicians move into practice, where distress also is associated with decreased compassion and empathy.” This description sounds completely synchronized with the current career dissatisfaction of orthopedic surgeons.

Improving orthopedists’ status requires ethical and involved leadership, both in academia and in our professional organizations, which too often seem mired in the (not so effective) status quo. Recognizing that the resident selection process is fallible is the first step in taking action—engaging in scrupulous role modeling and insisting that residents demonstrate professionalism and communication skills in their daily work. Becoming involved in organizational management is preferable to becoming angry and dissatisfied. Getting to know one’s patients is its own reward in terms of career satisfaction. Orthopedic surgeons have a well-earned macho image—that image can be enhanced with a dose of humanism. The result would be a true professional who enjoys his or her practice and has a satisfying career.

Several years ago, I was on the American Academy of Orthopaedic Surgeons leadership fellow committee, reviewing fellowship applications. The committee had been poised to very favorably rule on an application until a new member spoke up, stating that he had been in the applicant’s department and that points made in the recommending letter bore little resemblance to the person’s performance. Further study confirmed the dishonesty in the letter, and a more fit candidate was selected instead.

I was puzzled. Why would a leader in the field do such a thing? The question led me to a personal investigation into the monumental topic of professionalism and, more specifically, professionalism among orthopedic surgeons.

Physicians, Especially Orthopedists, Are Not Happy

Physicians, in general, are not a happy lot. According to a 2012 survey by the Physicians Foundation,¹ 77.4% of practicing physicians were pessimistic about the future of medicine, and 82% thought they had little ability to change the health care system. Sources of pessimism included “too much regulation/paperwork, loss of clinical autonomy, physicians not compensated for quality, erosion of physician/patient relationship, and money trumps patient care.” We are now in the age of “organizational physicians,” who, subject to institutional management, are experiencing a distressing loss of autonomy.

What sustains, or does not sustain, surgeons’ career satisfaction? Commonly stated positive factors include the ability to provide quality care, time with patients, income, and financial incentives²; reported negative factors include threat of malpractice, lack of autonomy, excessive administrative tasks, and high patient volume. Early-career physicians have the lowest career satisfaction, but physicians in mid-career have the highest rate of burnout and likelihood of leaving medical practice.³ Work–home conflict is most difficult in the early career, when families have young children, and the conflict generally goes unresolved. Burnout and low satisfaction with specialty choice are most common in mid-career.

Despite all the negative factors acting on medical practices, orthopedic surgeons have fared well financially, but not as well in career satisfaction. The Medscape Physician Compensation Report 2014⁴ places orthopedics compensation first among 25 specialties listed, without a close second, but orthopedists rank 15th in thinking they are fairly compensated, and next to last in indicating they would choose medicine again as a career. A separate study of physician career satisfaction ranked orthopedics 32nd of 42 specialties studied.⁵

What is our problem, and what can we do about it? It’s hard to digest this information and not feel that orthopedists are, for lack of a better word, spoiled.

DeBotton⁶ wrote about status anxiety, which arises over and over again in daily life. Essentially, it is the envy or dissatisfaction one feels when a peer gets a better deal that does not seem just. A remarkable aspect of Medscape’s compensation report⁴ is that family medicine physicians, whose annual income was well under half that of orthopedic surgeons, were more likely to view themselves as fairly compensated. On this basis, we have to conclude that orthopedic surgeons have status anxiety. But why?

Humanism

Osler, the quintessential physician, counseled medical students: “Nothing will sustain you more potently in your humdrum routine … than the power to recognize the true poetry of life—the poetry of the commonplace, of the ordinary man, of the plain, toilworn woman, with their loves and their joys, their sorrows and their griefs.”⁷ In short, take the time to know your patients. In a study of physicians who were regarded as clinically excellent, several traits were noted: honest, nonjudgmental, genuinely caring, treating all patients equally, and constantly striving for excellence.⁸ A century after Osler, Stellato⁹ echoed the sentiment: “Listen to your patients, not just about their illness, but about their life.”

Humanism, then, is the trait underlying professionalism.^10,11 Communication skills are essential to humanism.¹² However, a study of specialty physicians in Spain “showed scarce empathic behaviours or behaviours that foster a shared decision making process.”¹³ In addition, a recent survey placed the communication skills of orthopedists last among 28 specialties.¹⁴ Assessment was based on how often a physician explains things, listens carefully, gives easy-to-understand instructions, shows respect, and spends enough time.

Could it be that orthopedists are not satisfied with their income because as a group they lack the communication skills and humanistic characteristics of lower-paid physicians?

Residency and the Academic Medical Center

The education of the orthopedic surgeon starts with the selection process. Simon¹⁵ noted that “the brightest, but not always the best” are selected largely because objective criteria are an excellent measure of cognitive achievement but not of character. Also noting that 10% of examinees pass part I of the board but fail part II, Simon opined that they “lack clinical judgment, communication skills, and, in some instances, ethics.” A 1999 team of authors found that 18% of research citations listed by orthopedic residency applicants were misrepresented, and a follow-up study by the same authors in 2007 noted a rate increase, to 20.6%.¹⁶ Both sets of authors wrote of a need for a better selection process and a better evaluative process during residency.

The residency process has been substantially altered by work-hour restrictions. The 20th-century residency, which emphasizes taking responsibility for the patient throughout a hospital stay, has now been dismissed as “nostalgic professionalism.” Residents are now advised to avoid such activities as checking laboratory results from home and coming to work when they are not feeling well.¹⁷ However, there has been considerable pushback against diminishing nostalgic professionalism, primarily from surgeons.¹⁸ “Teaching residents that they should go home to rest at the end of their shift without regard for the circumstances of their cases in progress is not an acceptable example for training.”¹⁹ Current promulgated restrictions on duty hours move concern for the “circumstances of their cases” to the back burner—the shift ends, the physician leaves. Residents are pulled one way by forces telling them to leave (Accreditation Council for Graduate Medical Education) and the other way by forces telling them to stay (their conscience).

How do residents develop their surgical identities and concepts of humanism and professionalism? There is a substantial body of evidence that the so-called hidden curriculum is the dominant factor: trainees emulate what their faculty say and do.²⁰ As Gofton and Regehr²¹ noted, “It is vital for members of the surgical academic community to recognize [that] the attitudes, beliefs, and values implicit in every action, every word, every inaction, and every silence are not only shaping the attitudes, beliefs, and values of one’s protégés, but also are shaping the decisions of students who are considering the possibility of becoming one’s protégés.” It is not easy being a surgical role model given the conflicts affecting academic surgeons. For example, should a surgeon allot extra time so a trainee can do a case properly, or should the case be finished expeditiously in order to avoid canceling the next case, or to get to a committee meeting or a kid’s ballgame on time? Monetary pressures, along with the possibility of losing operative time because the schedule was not full, can influence the decision to operate or not.²² Trainees absorb what they hear and see.

In 2003, Inui²³ published A Flag in the Wind: Educating for Professionalism in Medicine, in which he stated, “There can be little doubt that physicians in general as well as the leadership of the organization of medicine have been preoccupied with finances and the economics of medical care. … The topics and the language of academic leadership [have] shifted in the last twenty years. … Core functions of the academic medical center became ‘enterprises.’” He also noted, “The most difficult challenge of all may be the need to understand—and to be explicitly mindful of, and articulate about—medical education as a special form of personal and professional formation that is rooted in the daily activities of individuals and groups in academic medical communities.”²³ In addition, the “institutional environment we create … [is] a reflection of the values we hold as a professional community.”²³ In effect, the academic medical center is part of the hidden curriculum.

Curiously, academic institutions tend not to reward clinical excellence—a self-defeating measure for any institution that recognizes the importance of the hidden curriculum.²⁴ A peer evaluation of hospitalists revealed that the most highly regarded were highly associated with humanism and a passion for clinical medicine.²⁵ At a prominent institution, however, it was found that clinical educators were less likely than research faculty to hold a higher rank.²⁶

Of the factors affecting physician dissatisfaction, workplace stress is predominant.²⁷ In this age of organizational physicians, job satisfaction correlates with how a physician feels about his or her ability to function as a physician. In a study by Wai and colleagues,²⁸ “surgical faculty reported low satisfaction with a number of questions about communication in their medical schools and their clinical practice locations.” The authors indicated that “medical school and department governance are critical determinants of faculty satisfaction within academic surgical centers.” Pololi and colleagues²⁹ extensively studied the culture of academic medicine and summarized the sources of discontent: “competitive individualism, undervaluing of humanistic qualities, deprecation, and the erosion of trust.” In another study,³⁰ they studied the incidence (~25%) of, and reasons for, considering to leave academic medicine. Reasons included feeling isolated in the department, lack of institutional support, poor communication with administrators, and a perceived difference between the stated culture of the institution and what was observed on a daily basis.³⁰

What Can We Do?

The obvious starting point is the selection process—focusing more on finding the “best,” not necessarily the “brightest.”¹⁵ This is not easy. Recommendation letters are often based on limited contact and may or may not reflect applicants’ true character. Numerous websites advise resident applicants on what questions to expect and how to prepare and practice for them. I have found questions of current events very illuminating, as they can probe how applicants view the world. Given the high income of orthopedic surgeons, some applicants likely are attracted to that aspect of the specialty. These applicants are not the “best.”

Residents who exhibit questionable ethical reasoning or behavior must be identified and not be allowed to finish their program. It is the responsibility of the program, not the board, to ensure that those entering practice exhibit a high degree of professionalism. Faculty must seriously recognize, every day, that everything they do is part of the hidden curriculum.

As noted, the academic medical environment can be inimical. Faculty who experience dissonance must be able to effectively confront administrative leadership to express their concerns, and they need to feel their concerns are recognized. Leaders of academic medical centers must guide their institutions in such a way that the day-to-day functions are compatible with the stated mission and values.³¹

Chervenak and colleagues³² forcefully stated that “appropriate ethical values” are the core component that academic leadership needs in order to respond to the opposing forces of increasing pressures of patient satisfaction, compliance, liability, and other administrative demands on one hand and diminishing resources on the other hand. They listed 4 “professional virtues” that characterize responsible professional leadership: self-effacement, which obligates physician leaders to be unbiased; self-sacrifice, the willingness to risk individual and organizational self-interest, especially in the economic domain; compassion, or “What can I do to help?”; and integrity. The principles of effective leadership are not that complicated, but implementing them requires conviction and courage.³³

Physicians increasingly are practicing in the organization setting. They need to increase their involvement in the organization in order to promulgate the needs of physicians. Organizational executive leadership is primarily driven by budgetary and capital planning processes; physician input is essential to ensure resources are directed toward better patient care. A feeling of loss of control over one’s practice is a primary cause of physician dissatisfaction. The schism between physicians and administrators traditionally has been characterized by a lack of trust; a more trusting relationship, reinforced by frequent constructive dialogue, will result in more physician control of the practice.³⁴ This will be difficult, but it is necessary for improving professional satisfaction.

For practicing physicians, Wynia³⁵ made the compelling case that professionalism demands self-regulation, which involves identifying and reporting impaired or incompetent physicians—another task that requires conviction and courage.

But the core issue is how an orthopedist regards the day-to-day aspects of his or her practice. Shanafelt and colleagues³⁶ concluded that surgeons are not very good at assessing their own well-being and stress levels. Certainly high stress can affect well-being, which in turn can affect professionalism. West and Shanafelt³⁷ uniquely described this relationship: “The effect of distress on professionalism in medicine has become clear in recent years. The well-documented decline of crucial elements of professionalism, including empathy and humanism, during medical training appears to be related in part to personal distress experienced during medical school and residency. Unfortunately, this decline continues as physicians move into practice, where distress also is associated with decreased compassion and empathy.” This description sounds completely synchronized with the current career dissatisfaction of orthopedic surgeons.

Improving orthopedists’ status requires ethical and involved leadership, both in academia and in our professional organizations, which too often seem mired in the (not so effective) status quo. Recognizing that the resident selection process is fallible is the first step in taking action—engaging in scrupulous role modeling and insisting that residents demonstrate professionalism and communication skills in their daily work. Becoming involved in organizational management is preferable to becoming angry and dissatisfied. Getting to know one’s patients is its own reward in terms of career satisfaction. Orthopedic surgeons have a well-earned macho image—that image can be enhanced with a dose of humanism. The result would be a true professional who enjoys his or her practice and has a satisfying career.

Several years ago, I was on the American Academy of Orthopaedic Surgeons leadership fellow committee, reviewing fellowship applications. The committee had been poised to very favorably rule on an application until a new member spoke up, stating that he had been in the applicant’s department and that points made in the recommending letter bore little resemblance to the person’s performance. Further study confirmed the dishonesty in the letter, and a more fit candidate was selected instead.

I was puzzled. Why would a leader in the field do such a thing? The question led me to a personal investigation into the monumental topic of professionalism and, more specifically, professionalism among orthopedic surgeons.

Physicians, Especially Orthopedists, Are Not Happy

Physicians, in general, are not a happy lot. According to a 2012 survey by the Physicians Foundation,¹ 77.4% of practicing physicians were pessimistic about the future of medicine, and 82% thought they had little ability to change the health care system. Sources of pessimism included “too much regulation/paperwork, loss of clinical autonomy, physicians not compensated for quality, erosion of physician/patient relationship, and money trumps patient care.” We are now in the age of “organizational physicians,” who, subject to institutional management, are experiencing a distressing loss of autonomy.

What sustains, or does not sustain, surgeons’ career satisfaction? Commonly stated positive factors include the ability to provide quality care, time with patients, income, and financial incentives²; reported negative factors include threat of malpractice, lack of autonomy, excessive administrative tasks, and high patient volume. Early-career physicians have the lowest career satisfaction, but physicians in mid-career have the highest rate of burnout and likelihood of leaving medical practice.³ Work–home conflict is most difficult in the early career, when families have young children, and the conflict generally goes unresolved. Burnout and low satisfaction with specialty choice are most common in mid-career.

Despite all the negative factors acting on medical practices, orthopedic surgeons have fared well financially, but not as well in career satisfaction. The Medscape Physician Compensation Report 2014⁴ places orthopedics compensation first among 25 specialties listed, without a close second, but orthopedists rank 15th in thinking they are fairly compensated, and next to last in indicating they would choose medicine again as a career. A separate study of physician career satisfaction ranked orthopedics 32nd of 42 specialties studied.⁵

What is our problem, and what can we do about it? It’s hard to digest this information and not feel that orthopedists are, for lack of a better word, spoiled.

DeBotton⁶ wrote about status anxiety, which arises over and over again in daily life. Essentially, it is the envy or dissatisfaction one feels when a peer gets a better deal that does not seem just. A remarkable aspect of Medscape’s compensation report⁴ is that family medicine physicians, whose annual income was well under half that of orthopedic surgeons, were more likely to view themselves as fairly compensated. On this basis, we have to conclude that orthopedic surgeons have status anxiety. But why?

Humanism

Osler, the quintessential physician, counseled medical students: “Nothing will sustain you more potently in your humdrum routine … than the power to recognize the true poetry of life—the poetry of the commonplace, of the ordinary man, of the plain, toilworn woman, with their loves and their joys, their sorrows and their griefs.”⁷ In short, take the time to know your patients. In a study of physicians who were regarded as clinically excellent, several traits were noted: honest, nonjudgmental, genuinely caring, treating all patients equally, and constantly striving for excellence.⁸ A century after Osler, Stellato⁹ echoed the sentiment: “Listen to your patients, not just about their illness, but about their life.”

Humanism, then, is the trait underlying professionalism.^10,11 Communication skills are essential to humanism.¹² However, a study of specialty physicians in Spain “showed scarce empathic behaviours or behaviours that foster a shared decision making process.”¹³ In addition, a recent survey placed the communication skills of orthopedists last among 28 specialties.¹⁴ Assessment was based on how often a physician explains things, listens carefully, gives easy-to-understand instructions, shows respect, and spends enough time.

Could it be that orthopedists are not satisfied with their income because as a group they lack the communication skills and humanistic characteristics of lower-paid physicians?

Residency and the Academic Medical Center

The education of the orthopedic surgeon starts with the selection process. Simon¹⁵ noted that “the brightest, but not always the best” are selected largely because objective criteria are an excellent measure of cognitive achievement but not of character. Also noting that 10% of examinees pass part I of the board but fail part II, Simon opined that they “lack clinical judgment, communication skills, and, in some instances, ethics.” A 1999 team of authors found that 18% of research citations listed by orthopedic residency applicants were misrepresented, and a follow-up study by the same authors in 2007 noted a rate increase, to 20.6%.¹⁶ Both sets of authors wrote of a need for a better selection process and a better evaluative process during residency.

The residency process has been substantially altered by work-hour restrictions. The 20th-century residency, which emphasizes taking responsibility for the patient throughout a hospital stay, has now been dismissed as “nostalgic professionalism.” Residents are now advised to avoid such activities as checking laboratory results from home and coming to work when they are not feeling well.¹⁷ However, there has been considerable pushback against diminishing nostalgic professionalism, primarily from surgeons.¹⁸ “Teaching residents that they should go home to rest at the end of their shift without regard for the circumstances of their cases in progress is not an acceptable example for training.”¹⁹ Current promulgated restrictions on duty hours move concern for the “circumstances of their cases” to the back burner—the shift ends, the physician leaves. Residents are pulled one way by forces telling them to leave (Accreditation Council for Graduate Medical Education) and the other way by forces telling them to stay (their conscience).

How do residents develop their surgical identities and concepts of humanism and professionalism? There is a substantial body of evidence that the so-called hidden curriculum is the dominant factor: trainees emulate what their faculty say and do.²⁰ As Gofton and Regehr²¹ noted, “It is vital for members of the surgical academic community to recognize [that] the attitudes, beliefs, and values implicit in every action, every word, every inaction, and every silence are not only shaping the attitudes, beliefs, and values of one’s protégés, but also are shaping the decisions of students who are considering the possibility of becoming one’s protégés.” It is not easy being a surgical role model given the conflicts affecting academic surgeons. For example, should a surgeon allot extra time so a trainee can do a case properly, or should the case be finished expeditiously in order to avoid canceling the next case, or to get to a committee meeting or a kid’s ballgame on time? Monetary pressures, along with the possibility of losing operative time because the schedule was not full, can influence the decision to operate or not.²² Trainees absorb what they hear and see.

In 2003, Inui²³ published A Flag in the Wind: Educating for Professionalism in Medicine, in which he stated, “There can be little doubt that physicians in general as well as the leadership of the organization of medicine have been preoccupied with finances and the economics of medical care. … The topics and the language of academic leadership [have] shifted in the last twenty years. … Core functions of the academic medical center became ‘enterprises.’” He also noted, “The most difficult challenge of all may be the need to understand—and to be explicitly mindful of, and articulate about—medical education as a special form of personal and professional formation that is rooted in the daily activities of individuals and groups in academic medical communities.”²³ In addition, the “institutional environment we create … [is] a reflection of the values we hold as a professional community.”²³ In effect, the academic medical center is part of the hidden curriculum.

Curiously, academic institutions tend not to reward clinical excellence—a self-defeating measure for any institution that recognizes the importance of the hidden curriculum.²⁴ A peer evaluation of hospitalists revealed that the most highly regarded were highly associated with humanism and a passion for clinical medicine.²⁵ At a prominent institution, however, it was found that clinical educators were less likely than research faculty to hold a higher rank.²⁶

Of the factors affecting physician dissatisfaction, workplace stress is predominant.²⁷ In this age of organizational physicians, job satisfaction correlates with how a physician feels about his or her ability to function as a physician. In a study by Wai and colleagues,²⁸ “surgical faculty reported low satisfaction with a number of questions about communication in their medical schools and their clinical practice locations.” The authors indicated that “medical school and department governance are critical determinants of faculty satisfaction within academic surgical centers.” Pololi and colleagues²⁹ extensively studied the culture of academic medicine and summarized the sources of discontent: “competitive individualism, undervaluing of humanistic qualities, deprecation, and the erosion of trust.” In another study,³⁰ they studied the incidence (~25%) of, and reasons for, considering to leave academic medicine. Reasons included feeling isolated in the department, lack of institutional support, poor communication with administrators, and a perceived difference between the stated culture of the institution and what was observed on a daily basis.³⁰

What Can We Do?

The obvious starting point is the selection process—focusing more on finding the “best,” not necessarily the “brightest.”¹⁵ This is not easy. Recommendation letters are often based on limited contact and may or may not reflect applicants’ true character. Numerous websites advise resident applicants on what questions to expect and how to prepare and practice for them. I have found questions of current events very illuminating, as they can probe how applicants view the world. Given the high income of orthopedic surgeons, some applicants likely are attracted to that aspect of the specialty. These applicants are not the “best.”

Residents who exhibit questionable ethical reasoning or behavior must be identified and not be allowed to finish their program. It is the responsibility of the program, not the board, to ensure that those entering practice exhibit a high degree of professionalism. Faculty must seriously recognize, every day, that everything they do is part of the hidden curriculum.

As noted, the academic medical environment can be inimical. Faculty who experience dissonance must be able to effectively confront administrative leadership to express their concerns, and they need to feel their concerns are recognized. Leaders of academic medical centers must guide their institutions in such a way that the day-to-day functions are compatible with the stated mission and values.³¹

Chervenak and colleagues³² forcefully stated that “appropriate ethical values” are the core component that academic leadership needs in order to respond to the opposing forces of increasing pressures of patient satisfaction, compliance, liability, and other administrative demands on one hand and diminishing resources on the other hand. They listed 4 “professional virtues” that characterize responsible professional leadership: self-effacement, which obligates physician leaders to be unbiased; self-sacrifice, the willingness to risk individual and organizational self-interest, especially in the economic domain; compassion, or “What can I do to help?”; and integrity. The principles of effective leadership are not that complicated, but implementing them requires conviction and courage.³³

Physicians increasingly are practicing in the organization setting. They need to increase their involvement in the organization in order to promulgate the needs of physicians. Organizational executive leadership is primarily driven by budgetary and capital planning processes; physician input is essential to ensure resources are directed toward better patient care. A feeling of loss of control over one’s practice is a primary cause of physician dissatisfaction. The schism between physicians and administrators traditionally has been characterized by a lack of trust; a more trusting relationship, reinforced by frequent constructive dialogue, will result in more physician control of the practice.³⁴ This will be difficult, but it is necessary for improving professional satisfaction.

For practicing physicians, Wynia³⁵ made the compelling case that professionalism demands self-regulation, which involves identifying and reporting impaired or incompetent physicians—another task that requires conviction and courage.

But the core issue is how an orthopedist regards the day-to-day aspects of his or her practice. Shanafelt and colleagues³⁶ concluded that surgeons are not very good at assessing their own well-being and stress levels. Certainly high stress can affect well-being, which in turn can affect professionalism. West and Shanafelt³⁷ uniquely described this relationship: “The effect of distress on professionalism in medicine has become clear in recent years. The well-documented decline of crucial elements of professionalism, including empathy and humanism, during medical training appears to be related in part to personal distress experienced during medical school and residency. Unfortunately, this decline continues as physicians move into practice, where distress also is associated with decreased compassion and empathy.” This description sounds completely synchronized with the current career dissatisfaction of orthopedic surgeons.

Improving orthopedists’ status requires ethical and involved leadership, both in academia and in our professional organizations, which too often seem mired in the (not so effective) status quo. Recognizing that the resident selection process is fallible is the first step in taking action—engaging in scrupulous role modeling and insisting that residents demonstrate professionalism and communication skills in their daily work. Becoming involved in organizational management is preferable to becoming angry and dissatisfied. Getting to know one’s patients is its own reward in terms of career satisfaction. Orthopedic surgeons have a well-earned macho image—that image can be enhanced with a dose of humanism. The result would be a true professional who enjoys his or her practice and has a satisfying career.

Anatomical total shoulder arthroplasty (TSA) is an effective treatment for advanced osteoarthritis (OA) of the glenohumeral joint.^1-4 Over the past 40 years, since the early reports appeared, the implants have evolved from the early monoblock humeral component to modular components, variable neck angled components with eccentric heads, and components that can provide variable neck angles, version angles, and dual eccentricity to match the anatomy of the proximal humerus. The goal of the new implants is to replicate the individual patient’s native anatomy using a combination of modularity, multiple neck and version angles, and dual eccentricity of the neck and head. The flexibility of the implant system is made possible by a replicator plate. There are few reports on outcomes of using these new implants for OA.

In this article, we report outcomes of using a dual eccentric, variable neck angle, variable version angle implant with a replicator plate for the treatment of OA of the shoulder at 4 centers.

Materials and Methods

The Western Institutional Review Board approved this study, and consent was prospectively obtained and retrospectively reviewed.

The data banks of a 4-center consortium were queried. Only primary TSA patients treated for OA with a fourth-generation Exactech Equinoxe implant (Exactech, Inc.) were included. For the center to be included, it had to have an 80% patient follow-up rate at a minimum of 2 years. Four centers qualified for inclusion: University of Florida, Medical College of Georgia, New York University, and Bordeaux-Merignac Clinic. Data were obtained on surgeries sequentially performed between August 1, 2006, and December 31, 2010. All data were obtained prospectively using a common data collection format.

The Equinoxe anatomical TSA allows for independent adaptation of neck angle and humeral version and provides 2 variable offset times (1 on replicator plate, 1 on humeral head) for matching the native anatomy in more than 99% of cases⁵ (Figure). The replicator plate is eccentric and can be angled 7.5° in any direction and rotated 360° to provide humeral head coverage. Once its optimal position is obtained, the plate is permanently fixed to the humeral stem using a breakaway screw. Some contemporary implants have similar features.

There were 218 primary shoulder arthroplasties performed on 201 patients (98 male, 103 female). Mean age at time of surgery was 67 years (range, 31-87 years), and mean follow-up was 36 months (range, 24-72 months). The collective follow-up rate at the 3-year mean follow-up and 2-year minimal follow-up was 81%. Eleven shoulders had a cemented stem, and 207 had an uncemented stem. Forty-eight shoulders used the 1.5-mm replicator plate, and 170 used the 4.5-mm offset replicator plate. The patients in this study were typically not very healthy: mean American Society of Anesthesiologists (ASA) score was 2.57 (range, 1-3).

Five outcome scores were calculated from the prospectively obtained data: Constant normalized, Shoulder Pain and Disability Index (SPADI), Simple Shoulder Test (SST), UCLA Shoulder Rating Scale (UCLA), and American Shoulder and Elbow Surgeons Shoulder Assessment (ASES). Before initiating data collection, we developed the Metric Form⁶ so we could calculate multiple scores while asking the minimal possible number of questions. This could be done for all 5 outcome scores, as their questions have significant overlap.

Objective outcomes included active external rotation, active scaption, active abduction, and active internal rotation. Complications, including revisions, were noted and analyzed. We focus on functional outcomes and do not present radiographic outcomes.

Results

A 2-tailed unpaired t test was used to compare preoperative values with final outcome values (P < .05). Four objective outcomes were significantly improved over preoperative levels: active external rotation (preoperative, 15°; postoperative, 42°), active scaption (pre, 92°; post, 137°), active abduction (pre, 80°; post, 121°), and active internal rotation (pre, S3; post, L2). The functional outcome scores that were significantly (P < .05) improved at final follow-up were Constant normalized (pre, 39; post, 79), SPADI (pre, 86; post, 20), SST (pre, 3.3; post, 10), UCLA (pre, 13; post, 31), and ASES (pre, 33; post, 85).

The outcome improvements at latest follow-up were active external rotation (+28), active scaption (+45), active abduction (+42), active internal rotation (+6 anatomical segments), Constant normalized (+40), SPADI (–66), SST (+6.7), UCLA (+18), and ASES (+52).

There were 32 complications in 25 shoulders. There were no bilateral complications. Seven shoulders had multiple complications, of which many were not independent events. For example, rotator cuff deficiency was associated with instability, and infection was associated with glenoid loosening. One patient had 2 procedures, the first an arthroscopic release and the second a revision shoulder arthroplasty for glenoid loosening. The most common postoperative complication was rotator cuff failure (RCF) or suspected RCF (13 shoulders, including 8 treated with revision arthroplasty). RCF occurred most commonly at the rotator cuff interval, followed by the subscapularis and the supraspinatus. RCF location was based on computed tomography scan or intraoperative observation. The few subscapularis failures occurred with both subscapularis tendon repair and osteotomy. The high RCF rate may derive from scrutinizing postoperative radiographs and was not necessarily confirmed with repeat surgery. We think this represents a more realistic estimate of true postoperative rotator cuff dysfunction, rather than including only reoperated cases. The second most common complication was infection (6 shoulders, 1 with a superficial suture abscess and 5 with deep infections). Other complications were instability (4, with 2 caused by rotator cuff insufficiency), glenoid loosening (4, with 2 caused by infection), stiffness (3), nerve issue (1), and hematoma evacuation (1).

In 21 shoulders, these complications were treated with revision shoulder arthroplasty (16 shoulders), arthroscopic capsular release (3), evacuation of postoperative hematoma (1), and débridement of suture abscess (1). The 16 revision shoulder arthroplasties performed were conversion to reverse shoulder arthroplasty (11 shoulders) and placement of an antibiotic spacer for infection (5). The stem was left in place for all revisions, excluding those for infection. This is a significant advantage of the modular platform stem. Details of the complications and treatments are listed in the Table. There was no difference in health status between patients with a complication (ASA, 2.57) and those without one (ASA, 2.56).

Discussion

The implant described in this article consists of a metaphyseal press-fit stem, a replicator plate, multiple eccentric humeral heads, and a glenoid of multiple sizes with 2 radii of curvatures used to match the patient’s native anatomy and still maintain the appropriate radius of curvature mismatch between the humeral head and the glenoid. Between the eccentricity in the replicator plate and the eccentricity in the humeral head, almost any humeral head cut can be covered, more than 99% of the time.¹ However, it remains to be seen if a versatile implant that comes close to matching the patient’s native anatomy will make a difference clinically.

The objective and functional outcomes in this study compare well with those of other, large TSA studies using older prostheses.^1-4 There are few reports on contemporary implants with sufficient follow-up numbers for the single diagnosis of OA. Norris and Iannotti² reported on a multicenter study of 176 patients with a Depuy Global TSA. The design of their study comes closest to that of our clinical outcome study. Nineteen surgeons were involved in their study. The follow-up rate is not clear. Their outcomes (with ours in parentheses for comparison) were active external rotation of 45° (42°), active elevation of 138° (137°), ASES of 84 (85), and SST of 9.2 (10). Norris and Iannotti² noted an overall complication rate of 13% (12% in our series). Their most common postoperative complications were RCF and glenoid loosening; ours were RCF and infection. Another multicenter study with short-term results using a contemporary prosthesis included 268 shoulders followed for a minimum of 12 months.¹ At final follow-up, Constant score was 97, active elevation was 145°, and the complication rate was 8.6%. Godenèche and colleagues¹ also noted a glenoid lucent-line rate of 58% and reported that rotator cuff pathology adversely affected outcome.

Although the overall clinical outcome results are encouraging and the complication rate is in the reported range, we believe that a focus on the major complication categories may have a significant positive impact on our patients. The present article places significant importance on reporting complications prospectively, which is more accurate than retrospective reporting. The rates of both RCF and infection, the most common complications in our study, need to be decreased. Aldinger and colleagues⁷ reported a 12% complication rate in 485 primary shoulder arthroplasties—a rate identical to ours here. In their study, nerve injuries and humeral fractures were both more common than rotator cuff tears. We think that rotator cuff deficiency after TSA is underreported because it is often based on revision surgery alone. It is also interesting that the majority of the cuff deficiencies were through the upper subscapularis rotator interval and were not a complete failure of the subscapularis repair. Not all these patients will undergo revision surgery. In the future, the RCF rate may drop with the increasingly common use of reverse shoulder arthroplasty for substandard rotator cuffs.

Use of this contemporary variable neck angle, variable version angle, dual eccentric shoulder arthroplasty with a replicator plate provides satisfying short-term clinical outcomes. Patients with less than optimal health (mean ASA, 2.57) seem to tolerate the procedure well. Continued focus on RCF and infection will have the greatest impact on the overall complication rate.

Anatomical total shoulder arthroplasty (TSA) is an effective treatment for advanced osteoarthritis (OA) of the glenohumeral joint.^1-4 Over the past 40 years, since the early reports appeared, the implants have evolved from the early monoblock humeral component to modular components, variable neck angled components with eccentric heads, and components that can provide variable neck angles, version angles, and dual eccentricity to match the anatomy of the proximal humerus. The goal of the new implants is to replicate the individual patient’s native anatomy using a combination of modularity, multiple neck and version angles, and dual eccentricity of the neck and head. The flexibility of the implant system is made possible by a replicator plate. There are few reports on outcomes of using these new implants for OA.

In this article, we report outcomes of using a dual eccentric, variable neck angle, variable version angle implant with a replicator plate for the treatment of OA of the shoulder at 4 centers.

Materials and Methods

The Western Institutional Review Board approved this study, and consent was prospectively obtained and retrospectively reviewed.

The data banks of a 4-center consortium were queried. Only primary TSA patients treated for OA with a fourth-generation Exactech Equinoxe implant (Exactech, Inc.) were included. For the center to be included, it had to have an 80% patient follow-up rate at a minimum of 2 years. Four centers qualified for inclusion: University of Florida, Medical College of Georgia, New York University, and Bordeaux-Merignac Clinic. Data were obtained on surgeries sequentially performed between August 1, 2006, and December 31, 2010. All data were obtained prospectively using a common data collection format.

The Equinoxe anatomical TSA allows for independent adaptation of neck angle and humeral version and provides 2 variable offset times (1 on replicator plate, 1 on humeral head) for matching the native anatomy in more than 99% of cases⁵ (Figure). The replicator plate is eccentric and can be angled 7.5° in any direction and rotated 360° to provide humeral head coverage. Once its optimal position is obtained, the plate is permanently fixed to the humeral stem using a breakaway screw. Some contemporary implants have similar features.

There were 218 primary shoulder arthroplasties performed on 201 patients (98 male, 103 female). Mean age at time of surgery was 67 years (range, 31-87 years), and mean follow-up was 36 months (range, 24-72 months). The collective follow-up rate at the 3-year mean follow-up and 2-year minimal follow-up was 81%. Eleven shoulders had a cemented stem, and 207 had an uncemented stem. Forty-eight shoulders used the 1.5-mm replicator plate, and 170 used the 4.5-mm offset replicator plate. The patients in this study were typically not very healthy: mean American Society of Anesthesiologists (ASA) score was 2.57 (range, 1-3).

Five outcome scores were calculated from the prospectively obtained data: Constant normalized, Shoulder Pain and Disability Index (SPADI), Simple Shoulder Test (SST), UCLA Shoulder Rating Scale (UCLA), and American Shoulder and Elbow Surgeons Shoulder Assessment (ASES). Before initiating data collection, we developed the Metric Form⁶ so we could calculate multiple scores while asking the minimal possible number of questions. This could be done for all 5 outcome scores, as their questions have significant overlap.

Objective outcomes included active external rotation, active scaption, active abduction, and active internal rotation. Complications, including revisions, were noted and analyzed. We focus on functional outcomes and do not present radiographic outcomes.

Results

A 2-tailed unpaired t test was used to compare preoperative values with final outcome values (P < .05). Four objective outcomes were significantly improved over preoperative levels: active external rotation (preoperative, 15°; postoperative, 42°), active scaption (pre, 92°; post, 137°), active abduction (pre, 80°; post, 121°), and active internal rotation (pre, S3; post, L2). The functional outcome scores that were significantly (P < .05) improved at final follow-up were Constant normalized (pre, 39; post, 79), SPADI (pre, 86; post, 20), SST (pre, 3.3; post, 10), UCLA (pre, 13; post, 31), and ASES (pre, 33; post, 85).

The outcome improvements at latest follow-up were active external rotation (+28), active scaption (+45), active abduction (+42), active internal rotation (+6 anatomical segments), Constant normalized (+40), SPADI (–66), SST (+6.7), UCLA (+18), and ASES (+52).

There were 32 complications in 25 shoulders. There were no bilateral complications. Seven shoulders had multiple complications, of which many were not independent events. For example, rotator cuff deficiency was associated with instability, and infection was associated with glenoid loosening. One patient had 2 procedures, the first an arthroscopic release and the second a revision shoulder arthroplasty for glenoid loosening. The most common postoperative complication was rotator cuff failure (RCF) or suspected RCF (13 shoulders, including 8 treated with revision arthroplasty). RCF occurred most commonly at the rotator cuff interval, followed by the subscapularis and the supraspinatus. RCF location was based on computed tomography scan or intraoperative observation. The few subscapularis failures occurred with both subscapularis tendon repair and osteotomy. The high RCF rate may derive from scrutinizing postoperative radiographs and was not necessarily confirmed with repeat surgery. We think this represents a more realistic estimate of true postoperative rotator cuff dysfunction, rather than including only reoperated cases. The second most common complication was infection (6 shoulders, 1 with a superficial suture abscess and 5 with deep infections). Other complications were instability (4, with 2 caused by rotator cuff insufficiency), glenoid loosening (4, with 2 caused by infection), stiffness (3), nerve issue (1), and hematoma evacuation (1).

In 21 shoulders, these complications were treated with revision shoulder arthroplasty (16 shoulders), arthroscopic capsular release (3), evacuation of postoperative hematoma (1), and débridement of suture abscess (1). The 16 revision shoulder arthroplasties performed were conversion to reverse shoulder arthroplasty (11 shoulders) and placement of an antibiotic spacer for infection (5). The stem was left in place for all revisions, excluding those for infection. This is a significant advantage of the modular platform stem. Details of the complications and treatments are listed in the Table. There was no difference in health status between patients with a complication (ASA, 2.57) and those without one (ASA, 2.56).

Discussion

The implant described in this article consists of a metaphyseal press-fit stem, a replicator plate, multiple eccentric humeral heads, and a glenoid of multiple sizes with 2 radii of curvatures used to match the patient’s native anatomy and still maintain the appropriate radius of curvature mismatch between the humeral head and the glenoid. Between the eccentricity in the replicator plate and the eccentricity in the humeral head, almost any humeral head cut can be covered, more than 99% of the time.¹ However, it remains to be seen if a versatile implant that comes close to matching the patient’s native anatomy will make a difference clinically.

The objective and functional outcomes in this study compare well with those of other, large TSA studies using older prostheses.^1-4 There are few reports on contemporary implants with sufficient follow-up numbers for the single diagnosis of OA. Norris and Iannotti² reported on a multicenter study of 176 patients with a Depuy Global TSA. The design of their study comes closest to that of our clinical outcome study. Nineteen surgeons were involved in their study. The follow-up rate is not clear. Their outcomes (with ours in parentheses for comparison) were active external rotation of 45° (42°), active elevation of 138° (137°), ASES of 84 (85), and SST of 9.2 (10). Norris and Iannotti² noted an overall complication rate of 13% (12% in our series). Their most common postoperative complications were RCF and glenoid loosening; ours were RCF and infection. Another multicenter study with short-term results using a contemporary prosthesis included 268 shoulders followed for a minimum of 12 months.¹ At final follow-up, Constant score was 97, active elevation was 145°, and the complication rate was 8.6%. Godenèche and colleagues¹ also noted a glenoid lucent-line rate of 58% and reported that rotator cuff pathology adversely affected outcome.

Although the overall clinical outcome results are encouraging and the complication rate is in the reported range, we believe that a focus on the major complication categories may have a significant positive impact on our patients. The present article places significant importance on reporting complications prospectively, which is more accurate than retrospective reporting. The rates of both RCF and infection, the most common complications in our study, need to be decreased. Aldinger and colleagues⁷ reported a 12% complication rate in 485 primary shoulder arthroplasties—a rate identical to ours here. In their study, nerve injuries and humeral fractures were both more common than rotator cuff tears. We think that rotator cuff deficiency after TSA is underreported because it is often based on revision surgery alone. It is also interesting that the majority of the cuff deficiencies were through the upper subscapularis rotator interval and were not a complete failure of the subscapularis repair. Not all these patients will undergo revision surgery. In the future, the RCF rate may drop with the increasingly common use of reverse shoulder arthroplasty for substandard rotator cuffs.

Use of this contemporary variable neck angle, variable version angle, dual eccentric shoulder arthroplasty with a replicator plate provides satisfying short-term clinical outcomes. Patients with less than optimal health (mean ASA, 2.57) seem to tolerate the procedure well. Continued focus on RCF and infection will have the greatest impact on the overall complication rate.

Anatomical total shoulder arthroplasty (TSA) is an effective treatment for advanced osteoarthritis (OA) of the glenohumeral joint.^1-4 Over the past 40 years, since the early reports appeared, the implants have evolved from the early monoblock humeral component to modular components, variable neck angled components with eccentric heads, and components that can provide variable neck angles, version angles, and dual eccentricity to match the anatomy of the proximal humerus. The goal of the new implants is to replicate the individual patient’s native anatomy using a combination of modularity, multiple neck and version angles, and dual eccentricity of the neck and head. The flexibility of the implant system is made possible by a replicator plate. There are few reports on outcomes of using these new implants for OA.

In this article, we report outcomes of using a dual eccentric, variable neck angle, variable version angle implant with a replicator plate for the treatment of OA of the shoulder at 4 centers.

Materials and Methods

The Western Institutional Review Board approved this study, and consent was prospectively obtained and retrospectively reviewed.

The data banks of a 4-center consortium were queried. Only primary TSA patients treated for OA with a fourth-generation Exactech Equinoxe implant (Exactech, Inc.) were included. For the center to be included, it had to have an 80% patient follow-up rate at a minimum of 2 years. Four centers qualified for inclusion: University of Florida, Medical College of Georgia, New York University, and Bordeaux-Merignac Clinic. Data were obtained on surgeries sequentially performed between August 1, 2006, and December 31, 2010. All data were obtained prospectively using a common data collection format.

The Equinoxe anatomical TSA allows for independent adaptation of neck angle and humeral version and provides 2 variable offset times (1 on replicator plate, 1 on humeral head) for matching the native anatomy in more than 99% of cases⁵ (Figure). The replicator plate is eccentric and can be angled 7.5° in any direction and rotated 360° to provide humeral head coverage. Once its optimal position is obtained, the plate is permanently fixed to the humeral stem using a breakaway screw. Some contemporary implants have similar features.

There were 218 primary shoulder arthroplasties performed on 201 patients (98 male, 103 female). Mean age at time of surgery was 67 years (range, 31-87 years), and mean follow-up was 36 months (range, 24-72 months). The collective follow-up rate at the 3-year mean follow-up and 2-year minimal follow-up was 81%. Eleven shoulders had a cemented stem, and 207 had an uncemented stem. Forty-eight shoulders used the 1.5-mm replicator plate, and 170 used the 4.5-mm offset replicator plate. The patients in this study were typically not very healthy: mean American Society of Anesthesiologists (ASA) score was 2.57 (range, 1-3).

Five outcome scores were calculated from the prospectively obtained data: Constant normalized, Shoulder Pain and Disability Index (SPADI), Simple Shoulder Test (SST), UCLA Shoulder Rating Scale (UCLA), and American Shoulder and Elbow Surgeons Shoulder Assessment (ASES). Before initiating data collection, we developed the Metric Form⁶ so we could calculate multiple scores while asking the minimal possible number of questions. This could be done for all 5 outcome scores, as their questions have significant overlap.

Objective outcomes included active external rotation, active scaption, active abduction, and active internal rotation. Complications, including revisions, were noted and analyzed. We focus on functional outcomes and do not present radiographic outcomes.

Results

A 2-tailed unpaired t test was used to compare preoperative values with final outcome values (P < .05). Four objective outcomes were significantly improved over preoperative levels: active external rotation (preoperative, 15°; postoperative, 42°), active scaption (pre, 92°; post, 137°), active abduction (pre, 80°; post, 121°), and active internal rotation (pre, S3; post, L2). The functional outcome scores that were significantly (P < .05) improved at final follow-up were Constant normalized (pre, 39; post, 79), SPADI (pre, 86; post, 20), SST (pre, 3.3; post, 10), UCLA (pre, 13; post, 31), and ASES (pre, 33; post, 85).

The outcome improvements at latest follow-up were active external rotation (+28), active scaption (+45), active abduction (+42), active internal rotation (+6 anatomical segments), Constant normalized (+40), SPADI (–66), SST (+6.7), UCLA (+18), and ASES (+52).

There were 32 complications in 25 shoulders. There were no bilateral complications. Seven shoulders had multiple complications, of which many were not independent events. For example, rotator cuff deficiency was associated with instability, and infection was associated with glenoid loosening. One patient had 2 procedures, the first an arthroscopic release and the second a revision shoulder arthroplasty for glenoid loosening. The most common postoperative complication was rotator cuff failure (RCF) or suspected RCF (13 shoulders, including 8 treated with revision arthroplasty). RCF occurred most commonly at the rotator cuff interval, followed by the subscapularis and the supraspinatus. RCF location was based on computed tomography scan or intraoperative observation. The few subscapularis failures occurred with both subscapularis tendon repair and osteotomy. The high RCF rate may derive from scrutinizing postoperative radiographs and was not necessarily confirmed with repeat surgery. We think this represents a more realistic estimate of true postoperative rotator cuff dysfunction, rather than including only reoperated cases. The second most common complication was infection (6 shoulders, 1 with a superficial suture abscess and 5 with deep infections). Other complications were instability (4, with 2 caused by rotator cuff insufficiency), glenoid loosening (4, with 2 caused by infection), stiffness (3), nerve issue (1), and hematoma evacuation (1).

In 21 shoulders, these complications were treated with revision shoulder arthroplasty (16 shoulders), arthroscopic capsular release (3), evacuation of postoperative hematoma (1), and débridement of suture abscess (1). The 16 revision shoulder arthroplasties performed were conversion to reverse shoulder arthroplasty (11 shoulders) and placement of an antibiotic spacer for infection (5). The stem was left in place for all revisions, excluding those for infection. This is a significant advantage of the modular platform stem. Details of the complications and treatments are listed in the Table. There was no difference in health status between patients with a complication (ASA, 2.57) and those without one (ASA, 2.56).

Discussion

The implant described in this article consists of a metaphyseal press-fit stem, a replicator plate, multiple eccentric humeral heads, and a glenoid of multiple sizes with 2 radii of curvatures used to match the patient’s native anatomy and still maintain the appropriate radius of curvature mismatch between the humeral head and the glenoid. Between the eccentricity in the replicator plate and the eccentricity in the humeral head, almost any humeral head cut can be covered, more than 99% of the time.¹ However, it remains to be seen if a versatile implant that comes close to matching the patient’s native anatomy will make a difference clinically.

The objective and functional outcomes in this study compare well with those of other, large TSA studies using older prostheses.^1-4 There are few reports on contemporary implants with sufficient follow-up numbers for the single diagnosis of OA. Norris and Iannotti² reported on a multicenter study of 176 patients with a Depuy Global TSA. The design of their study comes closest to that of our clinical outcome study. Nineteen surgeons were involved in their study. The follow-up rate is not clear. Their outcomes (with ours in parentheses for comparison) were active external rotation of 45° (42°), active elevation of 138° (137°), ASES of 84 (85), and SST of 9.2 (10). Norris and Iannotti² noted an overall complication rate of 13% (12% in our series). Their most common postoperative complications were RCF and glenoid loosening; ours were RCF and infection. Another multicenter study with short-term results using a contemporary prosthesis included 268 shoulders followed for a minimum of 12 months.¹ At final follow-up, Constant score was 97, active elevation was 145°, and the complication rate was 8.6%. Godenèche and colleagues¹ also noted a glenoid lucent-line rate of 58% and reported that rotator cuff pathology adversely affected outcome.

Although the overall clinical outcome results are encouraging and the complication rate is in the reported range, we believe that a focus on the major complication categories may have a significant positive impact on our patients. The present article places significant importance on reporting complications prospectively, which is more accurate than retrospective reporting. The rates of both RCF and infection, the most common complications in our study, need to be decreased. Aldinger and colleagues⁷ reported a 12% complication rate in 485 primary shoulder arthroplasties—a rate identical to ours here. In their study, nerve injuries and humeral fractures were both more common than rotator cuff tears. We think that rotator cuff deficiency after TSA is underreported because it is often based on revision surgery alone. It is also interesting that the majority of the cuff deficiencies were through the upper subscapularis rotator interval and were not a complete failure of the subscapularis repair. Not all these patients will undergo revision surgery. In the future, the RCF rate may drop with the increasingly common use of reverse shoulder arthroplasty for substandard rotator cuffs.

Use of this contemporary variable neck angle, variable version angle, dual eccentric shoulder arthroplasty with a replicator plate provides satisfying short-term clinical outcomes. Patients with less than optimal health (mean ASA, 2.57) seem to tolerate the procedure well. Continued focus on RCF and infection will have the greatest impact on the overall complication rate.

"Report to the Administrator’s Office for a discussion 7:00 am sharp,” reads the email on your phone. The phone log sheet from your administrator is handed to you as you are running to the operating room and reads, “Call back Mr. Smith’s health insurance company because your patient stayed overnight unexpectedly in the hospital, and if the return phone call is not received by 8:40 am the complete hospital stay will be disallowed.” The text message reads, “The head nurse from the emergency department wants to have a discussion with you tomorrow about what transpired in room 23 last night at 1:33 am.” Your physician assistant calls you because a recent history and physical examination from the out-of-state internist has not been cosigned by you, and, therefore, the patient is still in the admitting office; the admitting officer is waiting to go home and won’t accept the physician assistant’s signature.

This simple illustration of a surgeon’s typical morning is hardly hyperbole. Demands and finger-pointing are routine aspects of care, with a concurrent need to attribute blame and create a hostile work environment whether in the office, operating room, or floor of the hospital by anyone who can proudly say to the physician, “Gotcha!” The environment that produces this ethos is toxic and needs to be changed. While all members of a patient care team must be accountable, no member should be antagonistic toward another, and each member must feel a part of a working whole that is led by a competent, caring, and identifiable physician. Yes, the doctor must be the team captain; he or she must take back the reins of care immediately in order to provide the patient with the best possible outcome.

The loss of leadership can be traced back to the rise of regulatory controls put in place by government entities or local hospital administration to contain costs and limit liability. While the target goals of such measures are laudable, the negative impact on the doctor–patient relationship has been palpable and problematic and requires reassessment. The profession itself will be preserved by refocusing on the doctor–patient relationship and returning the physician to the role of team leader. Our patients deserve to feel as though their health care resides in the hands of the physician as the leader of a team that is pursuing a common goal: patient care with minimal distractions.

What, though, makes a great captain or leader? Sociologists have said that in a stable environment a “participatory model” of leadership is appropriate, while in a high-growth or changing environment, like the one in which we presently live, an “authoritative model” can be used to right the ship.^1,2 Many types of leaders exist within both models. Leaders who are “innovators” will design and bring new ideas and original thought but may generate too many ideas that can’t be implemented practically in the hospital setting. Leaders who are “developers” will build and move forward to achieve challenging goals but may be impatient when ideas do not work and may be perceived in many interdisciplinary meetings as unruly. “Bureaucratic” leaders, presently seen in many leadership positions, can be classified as stabilizers and, while they may maintain equilibrium and keep things running smoothly, they often insist on a policy for every situation, resulting in stasis and sometimes even paralysis of the surgical center or hospital system.

I believe that health management and patient care require the simultaneous use of the authoritative and participatory models to encourage innovation, set attainable short- and long-term goals, and maintain the physician as the team leader. To lead effectively under this hybrid model, the physician must be accessible and fair, a teacher and a student, and a risk-taker, but, ultimately, at the end of every day, the physician must be accountable.

The time has come for physician leaders to assemble the troops: administrators, clinical providers, and nonclinical support staff. To paraphrase John Quincy Adams, in your actions inspire others to dream more and become more; then, and only then, are you an excellent leader. A secret to effective leadership is in finding one’s voice and acknowledging strengths and weaknesses. The leader must recruit other leaders who are very different from himself or herself and must listen to them deeply and trust them completely. One of our former first ladies said wisely, “A leader takes people where they want to go. A great leader takes people where they don’t necessarily want to go, but ought to be.” To truly find this leadership model, we as busy surgeons must spend some concentrated time away from our patients and exciting research to sit in the room with our nurses, administrators, and all other members of the health care community and listen to their thoughts and understand their concerns. We must understand policy to assess if it is reasonable and, if it is not, to reject it and propose more effective and appropriate rules for good care. We must remove from leadership positions those that do not have the interest of the patient as their primary concern. We must challenge any policy that does not have the patient’s interest and health as its raison d’etre. We must be proactive and not reactive. We must be ready to stand tall and politely question when dictated to unless evidence-based medical reasons can be presented.

You may ask, therefore, where should we lead? The answer is obvious! We need to be involved in every aspect of this great profession. We need to be the leaders of hospital systems, we need to be in charge of research institutions, and, as always, we need to be the chief of the operating room and the chief within each room as the team leader for the nurse, anesthesiologist, and nonclinical staff in order to safely guide our patients through the stress of a medical crisis or routine intervention. We need to find those of us with other degrees, whether MPH, MBA, MHA, or JD, and place those physicians in positions of business and political leadership as well as in leadership positions in hospitals and private practitioner offices. We need to encourage our medical students, residents, and fellows to continue their rigorous training to include an understanding of health care policy and economics so as to help manage and resolve the crisis at hand.

We must now navigate the sea of change to allow for continuity of care and not throw up our arms in despair. The role of physician as private practitioner or as full-time faculty member has its origins deeply imbedded in the roots of our profession, and this traditional role as caretaker and scientist must continue. But in this century, we need to be leaders in the political and business communities as well. This vision requires a new and fresh momentum. We cannot sit idly by as patient care becomes increasingly managed by nonphysicians. The time has come to use our unique position as doctors to frame the debate, participate in the discussion, and lead our profession and the management of health care toward calmer waters with compassion, science, and responsibility. To do this, we must demand transparency, proceed with respect, and require excellence from everyone around us and make sure it is demanded from all of us.◾

"Report to the Administrator’s Office for a discussion 7:00 am sharp,” reads the email on your phone. The phone log sheet from your administrator is handed to you as you are running to the operating room and reads, “Call back Mr. Smith’s health insurance company because your patient stayed overnight unexpectedly in the hospital, and if the return phone call is not received by 8:40 am the complete hospital stay will be disallowed.” The text message reads, “The head nurse from the emergency department wants to have a discussion with you tomorrow about what transpired in room 23 last night at 1:33 am.” Your physician assistant calls you because a recent history and physical examination from the out-of-state internist has not been cosigned by you, and, therefore, the patient is still in the admitting office; the admitting officer is waiting to go home and won’t accept the physician assistant’s signature.

This simple illustration of a surgeon’s typical morning is hardly hyperbole. Demands and finger-pointing are routine aspects of care, with a concurrent need to attribute blame and create a hostile work environment whether in the office, operating room, or floor of the hospital by anyone who can proudly say to the physician, “Gotcha!” The environment that produces this ethos is toxic and needs to be changed. While all members of a patient care team must be accountable, no member should be antagonistic toward another, and each member must feel a part of a working whole that is led by a competent, caring, and identifiable physician. Yes, the doctor must be the team captain; he or she must take back the reins of care immediately in order to provide the patient with the best possible outcome.

The loss of leadership can be traced back to the rise of regulatory controls put in place by government entities or local hospital administration to contain costs and limit liability. While the target goals of such measures are laudable, the negative impact on the doctor–patient relationship has been palpable and problematic and requires reassessment. The profession itself will be preserved by refocusing on the doctor–patient relationship and returning the physician to the role of team leader. Our patients deserve to feel as though their health care resides in the hands of the physician as the leader of a team that is pursuing a common goal: patient care with minimal distractions.

What, though, makes a great captain or leader? Sociologists have said that in a stable environment a “participatory model” of leadership is appropriate, while in a high-growth or changing environment, like the one in which we presently live, an “authoritative model” can be used to right the ship.^1,2 Many types of leaders exist within both models. Leaders who are “innovators” will design and bring new ideas and original thought but may generate too many ideas that can’t be implemented practically in the hospital setting. Leaders who are “developers” will build and move forward to achieve challenging goals but may be impatient when ideas do not work and may be perceived in many interdisciplinary meetings as unruly. “Bureaucratic” leaders, presently seen in many leadership positions, can be classified as stabilizers and, while they may maintain equilibrium and keep things running smoothly, they often insist on a policy for every situation, resulting in stasis and sometimes even paralysis of the surgical center or hospital system.

I believe that health management and patient care require the simultaneous use of the authoritative and participatory models to encourage innovation, set attainable short- and long-term goals, and maintain the physician as the team leader. To lead effectively under this hybrid model, the physician must be accessible and fair, a teacher and a student, and a risk-taker, but, ultimately, at the end of every day, the physician must be accountable.

The time has come for physician leaders to assemble the troops: administrators, clinical providers, and nonclinical support staff. To paraphrase John Quincy Adams, in your actions inspire others to dream more and become more; then, and only then, are you an excellent leader. A secret to effective leadership is in finding one’s voice and acknowledging strengths and weaknesses. The leader must recruit other leaders who are very different from himself or herself and must listen to them deeply and trust them completely. One of our former first ladies said wisely, “A leader takes people where they want to go. A great leader takes people where they don’t necessarily want to go, but ought to be.” To truly find this leadership model, we as busy surgeons must spend some concentrated time away from our patients and exciting research to sit in the room with our nurses, administrators, and all other members of the health care community and listen to their thoughts and understand their concerns. We must understand policy to assess if it is reasonable and, if it is not, to reject it and propose more effective and appropriate rules for good care. We must remove from leadership positions those that do not have the interest of the patient as their primary concern. We must challenge any policy that does not have the patient’s interest and health as its raison d’etre. We must be proactive and not reactive. We must be ready to stand tall and politely question when dictated to unless evidence-based medical reasons can be presented.

You may ask, therefore, where should we lead? The answer is obvious! We need to be involved in every aspect of this great profession. We need to be the leaders of hospital systems, we need to be in charge of research institutions, and, as always, we need to be the chief of the operating room and the chief within each room as the team leader for the nurse, anesthesiologist, and nonclinical staff in order to safely guide our patients through the stress of a medical crisis or routine intervention. We need to find those of us with other degrees, whether MPH, MBA, MHA, or JD, and place those physicians in positions of business and political leadership as well as in leadership positions in hospitals and private practitioner offices. We need to encourage our medical students, residents, and fellows to continue their rigorous training to include an understanding of health care policy and economics so as to help manage and resolve the crisis at hand.

We must now navigate the sea of change to allow for continuity of care and not throw up our arms in despair. The role of physician as private practitioner or as full-time faculty member has its origins deeply imbedded in the roots of our profession, and this traditional role as caretaker and scientist must continue. But in this century, we need to be leaders in the political and business communities as well. This vision requires a new and fresh momentum. We cannot sit idly by as patient care becomes increasingly managed by nonphysicians. The time has come to use our unique position as doctors to frame the debate, participate in the discussion, and lead our profession and the management of health care toward calmer waters with compassion, science, and responsibility. To do this, we must demand transparency, proceed with respect, and require excellence from everyone around us and make sure it is demanded from all of us.◾

"Report to the Administrator’s Office for a discussion 7:00 am sharp,” reads the email on your phone. The phone log sheet from your administrator is handed to you as you are running to the operating room and reads, “Call back Mr. Smith’s health insurance company because your patient stayed overnight unexpectedly in the hospital, and if the return phone call is not received by 8:40 am the complete hospital stay will be disallowed.” The text message reads, “The head nurse from the emergency department wants to have a discussion with you tomorrow about what transpired in room 23 last night at 1:33 am.” Your physician assistant calls you because a recent history and physical examination from the out-of-state internist has not been cosigned by you, and, therefore, the patient is still in the admitting office; the admitting officer is waiting to go home and won’t accept the physician assistant’s signature.

This simple illustration of a surgeon’s typical morning is hardly hyperbole. Demands and finger-pointing are routine aspects of care, with a concurrent need to attribute blame and create a hostile work environment whether in the office, operating room, or floor of the hospital by anyone who can proudly say to the physician, “Gotcha!” The environment that produces this ethos is toxic and needs to be changed. While all members of a patient care team must be accountable, no member should be antagonistic toward another, and each member must feel a part of a working whole that is led by a competent, caring, and identifiable physician. Yes, the doctor must be the team captain; he or she must take back the reins of care immediately in order to provide the patient with the best possible outcome.

The loss of leadership can be traced back to the rise of regulatory controls put in place by government entities or local hospital administration to contain costs and limit liability. While the target goals of such measures are laudable, the negative impact on the doctor–patient relationship has been palpable and problematic and requires reassessment. The profession itself will be preserved by refocusing on the doctor–patient relationship and returning the physician to the role of team leader. Our patients deserve to feel as though their health care resides in the hands of the physician as the leader of a team that is pursuing a common goal: patient care with minimal distractions.

What, though, makes a great captain or leader? Sociologists have said that in a stable environment a “participatory model” of leadership is appropriate, while in a high-growth or changing environment, like the one in which we presently live, an “authoritative model” can be used to right the ship.^1,2 Many types of leaders exist within both models. Leaders who are “innovators” will design and bring new ideas and original thought but may generate too many ideas that can’t be implemented practically in the hospital setting. Leaders who are “developers” will build and move forward to achieve challenging goals but may be impatient when ideas do not work and may be perceived in many interdisciplinary meetings as unruly. “Bureaucratic” leaders, presently seen in many leadership positions, can be classified as stabilizers and, while they may maintain equilibrium and keep things running smoothly, they often insist on a policy for every situation, resulting in stasis and sometimes even paralysis of the surgical center or hospital system.

I believe that health management and patient care require the simultaneous use of the authoritative and participatory models to encourage innovation, set attainable short- and long-term goals, and maintain the physician as the team leader. To lead effectively under this hybrid model, the physician must be accessible and fair, a teacher and a student, and a risk-taker, but, ultimately, at the end of every day, the physician must be accountable.

The time has come for physician leaders to assemble the troops: administrators, clinical providers, and nonclinical support staff. To paraphrase John Quincy Adams, in your actions inspire others to dream more and become more; then, and only then, are you an excellent leader. A secret to effective leadership is in finding one’s voice and acknowledging strengths and weaknesses. The leader must recruit other leaders who are very different from himself or herself and must listen to them deeply and trust them completely. One of our former first ladies said wisely, “A leader takes people where they want to go. A great leader takes people where they don’t necessarily want to go, but ought to be.” To truly find this leadership model, we as busy surgeons must spend some concentrated time away from our patients and exciting research to sit in the room with our nurses, administrators, and all other members of the health care community and listen to their thoughts and understand their concerns. We must understand policy to assess if it is reasonable and, if it is not, to reject it and propose more effective and appropriate rules for good care. We must remove from leadership positions those that do not have the interest of the patient as their primary concern. We must challenge any policy that does not have the patient’s interest and health as its raison d’etre. We must be proactive and not reactive. We must be ready to stand tall and politely question when dictated to unless evidence-based medical reasons can be presented.

You may ask, therefore, where should we lead? The answer is obvious! We need to be involved in every aspect of this great profession. We need to be the leaders of hospital systems, we need to be in charge of research institutions, and, as always, we need to be the chief of the operating room and the chief within each room as the team leader for the nurse, anesthesiologist, and nonclinical staff in order to safely guide our patients through the stress of a medical crisis or routine intervention. We need to find those of us with other degrees, whether MPH, MBA, MHA, or JD, and place those physicians in positions of business and political leadership as well as in leadership positions in hospitals and private practitioner offices. We need to encourage our medical students, residents, and fellows to continue their rigorous training to include an understanding of health care policy and economics so as to help manage and resolve the crisis at hand.

We must now navigate the sea of change to allow for continuity of care and not throw up our arms in despair. The role of physician as private practitioner or as full-time faculty member has its origins deeply imbedded in the roots of our profession, and this traditional role as caretaker and scientist must continue. But in this century, we need to be leaders in the political and business communities as well. This vision requires a new and fresh momentum. We cannot sit idly by as patient care becomes increasingly managed by nonphysicians. The time has come to use our unique position as doctors to frame the debate, participate in the discussion, and lead our profession and the management of health care toward calmer waters with compassion, science, and responsibility. To do this, we must demand transparency, proceed with respect, and require excellence from everyone around us and make sure it is demanded from all of us.◾