Original Research

The Patient Protection and Affordable Care Act has increased the number of insured Americans by more than 20 million individuals.¹ Approximately half of the newly insured have an income at or below 138% of the poverty level and are on average younger, sicker, and more likely to report poor to fair health compared to those individuals who already had health care coverage.² Specialties such as dermatology are faced with the challenge of expanding access to these newly insured individuals while also improving quality of care.

Because of the complexity of defining quality in medicine, patient satisfaction is being used as a proxy for quality, with physicians evaluated and reimbursed based on patient satisfaction scores. Little research has been conducted to validate the relationship between patient satisfaction and quality; however, one study showed online reviews from patients on Yelp correlated with traditional markers of quality, such as mortality and readmission rates, lending credibility to the notion that patient satisfaction equates quality of care.³ Moreover, prospective studies have found positive correlations between patient satisfaction and compliance to therapy^4,5; however, these studies may not give a complete picture of the relationship between patient satisfaction and quality of care, as other studies also have illustrated that, more often than not, factors extrinsic to actual medical care (eg, time spent in the waiting room) play a considerable role in patient satisfaction scores.^6-9

When judging the quality of care that is provided, one study found that patients rate physicians based on interpersonal skills and not care delivered.⁸ Another important factor related to patient satisfaction is the anonymity of the surveys. Patients who have negative experiences are more likely to respond to online surveys than those who have positive experiences, skewing overall ratings.⁶ Additionally, because of Health Insurance Portability and Accountability Act regulations, physicians often are unable to respond directly to public patient reviews, resulting in an incomplete picture of the quality of care provided.

Ultimately, even if physicians do not agree that patient satisfaction correlates with quality of care, it is increasingly being used as a marker of such. Leading health care systems are embracing this new weight on patient satisfaction by increasing transparency and publishing patient satisfaction results online, allowing patients more access to physician reviews.

In dermatology, patient satisfaction serves an even more important role, as traditional markers of quality such as mortality and hospital readmission rates are not reasonable measures of patient care in this specialty, leaving patient satisfaction as one of the most accessible markers insurance companies and prospective patients can use to evaluate dermatologists. Furthermore, treatment modalities in dermatology often aim to improve quality of life, of which patient satisfaction arguably serves as an indicator. Ideally, patient satisfaction would allow physicians to identify areas where they may be better able to meet patients’ needs. However, patient satisfaction scores rarely are used as outcome measures in studies and are notoriously difficult to ascertain, as they tend to be inaccurate and may be unreliable in correlation with physician skill and training or may be skewed by patients’ desires to please their physicians.¹⁰ There also is a lack of standardized tools and scales to quantitatively judge outcomes in procedural surgeries.

Although patient satisfaction is being used as a measure of quality of care and is particularly necessary in a field such as dermatology that has outcome measures that are subjective in nature, there is a gap in the current literature regarding patient satisfaction and dermatology. To fill this gap, we conducted a prospective study of targeted interventions administered at outpatient dermatology clinics to determine if they resulted in statistically significant increases in patient satisfaction measures, particularly among Spanish-speaking patients.

Methods

We conducted a prospective study evaluating patient satisfaction in the outpatient dermatology clinics of LAC+USC Medical Center in Los Angeles, California, spanning over 1 year. During this time period, patients were randomly selected to participate and were asked to complete the Short-Form Patient Satisfaction Questionnaire (PSQ-18), which asked patients to rate their care experience on a 5-point Likert scale (1=strongly agree; 5=strongly disagree). The survey was separated into the following 7 subscales or categories looking at different aspects of care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with physician, and accessibility and convenience. Patients were given this survey both before and after targeted interventions to improve patient satisfaction were implemented. The targeted interventions were created based on literature review in the factors affecting patient satisfaction. The change in relative satisfaction was then determined using statistical analysis. The study was approved by the University of Southern California Health Science institutional review board.

Results

Of 470 patients surveyed, the average age was 49 years. Fifty percent of respondents were male, 70% self-identified as Hispanic, 45% spoke Spanish as their native language, and 69% reported a mean annual household income of less than $15,000. When scores were stratified, English-speaking patients were significantly more satisfied than Spanish-speaking patients in the categories of technical quality (P.0340), financial aspects (P.0301), interpersonal manner (P.0037), and time spent with physician (P.0059). Specifically, in the time spent with physician category, the lowest scores were found in females, patients aged 18 to 29 years, and patients with a mean annual household income less than $15,000. These demographics correlate well with many of the newly insured and intimate the need for improved patient satisfaction, particularly in this subset of patients.

After analyzing baseline patient satisfaction scores, we implemented targeted interventions such as creating a call tree, developing multilingual disease-specific patient handouts, instituting quarterly nursing in-services, which judged interpersonal and occupational nursing skills, and recruiting bilingual staff. These interventions were implemented simultaneously and were selected with the goal of reducing the impact of the language barrier between physicians and patients and increasing accessibility to clinics. Following approximately 3 months of these interventions, performance on many categories increased in our demographics that were lowest performing when we collected baseline data. In Spanish-speaking respondents, improvement in several categories approached statistical significance, including general satisfaction (P.110), interpersonal skills (P.080), and time spent with physician (P.096). When stratifying by income and age, patients with a mean annual household income less than $15,000 demonstrated an improved technical quality (P.066) subscale score, and participants aged 18 to 29 years showed improvement in both accessibility and convenience (P.053) and financial aspects (P.056) subscales.

Comment

The categories where improvements were found are noteworthy and suggest that certain aspects of care are more important than others. Although it seems intuitive that clinical acumen and training should be important contributors to patient satisfaction, one study that analyzed 1000 online comments regarding patient satisfaction with dermatologists on the website DrScore.com found that most comments concerned physician personality and interpersonal skills rather than medical judgment and acumen,⁴ suggesting that a patient’s perception of the character of the physician directly affects patient satisfaction scores. This notion was reiterated by other studies, including one that found that a patient’s perception of the physician’s kindness and empathy skills, is the most important measure of quality of care scores.⁸ Although this perception can be intimidating to some physicians, as certain interpersonal skills are difficult to change, it is reassuring to note that external environment and cues, such as the clinic building and staff, also seem to affect interpersonal ratings. As seen in our study, patient ratings of a physician’s interpersonal skills increased after educational materials for staff and patients were created and more bilingual staff was recruited. Other environmental changes, such as spending a few more minutes with patients and sitting down when talking to patients, are relatively easy to administer and can improve patient satisfaction scores.⁸

Although some of the scores in our study approached but did not reach statistical significance, likely because of a small sample size, they suggest that targeted interventions can improve patient satisfaction. They also suggested that targeted interventions are particularly useful in Spanish-speaking patients, younger patients, and patients from lower socioeconomic backgrounds, which are all characteristics of the newly insured under the Patient Protection and Affordable Health Care Act.

Our study also is unique in that dermatology as a specialty is lagging in quality improvement studies. In the few studies evaluating patient satisfaction in the literature, the care provided by dermatologists was painted in a positive light.^6,11 One study evaluated 45 dermatology practices and reported average patient satisfaction scores of 3.46 and 4.72 of 5 on Yelp and ZocDoc, respectively.¹¹ Another study looking at dermatologist ratings on DrScore.com found that the majority of patients were satisfied with the care they received.⁶

Although these studies seem encouraging, they have several limitations. First, their results were not stratified by patient demographics and therefore may not be generalizable to low-income populations that constitute much of the newly insured. Secondly, the observational nature and limited number of studies prohibit meaningful conclusions from being drawn and leave many questions unanswered. Additionally, although the raw patient satisfaction scores seem good, dermatology is lacking compared to the patient satisfaction scores within other specialties. A study of more than 28,000 Yelp reviews of 23 specialties found that dermatology ranked second to last, ahead of only psychiatry.⁷ Of course, given the observational nature of this study, it is impossible to generalize, as many confounders (eg, medical comorbidities, patient age) may have skewed the dermatology ranking. Regardless, there is always room for improvement, and luckily improving patient satisfaction is not an elusive goal.

Conclusion

As dermatologists, our interventions often improve quality of life; therefore, we are positioned to be leaders in the quality improvement field. Despite the numerous limitations of using patient satisfaction as a measure for quality of care, it is used by payers to determine reimbursement and patients to select providers. Encouraging initial data from our prospective study demonstrate that small interventions can increase patient satisfaction. Continued work to maximize patient satisfaction is needed to improve outcomes for our patients, help validate the quality of care being provided, and further solidify the importance of having insurers maintain sufficient dermatologists in their networks.

The Patient Protection and Affordable Care Act has increased the number of insured Americans by more than 20 million individuals.¹ Approximately half of the newly insured have an income at or below 138% of the poverty level and are on average younger, sicker, and more likely to report poor to fair health compared to those individuals who already had health care coverage.² Specialties such as dermatology are faced with the challenge of expanding access to these newly insured individuals while also improving quality of care.

Because of the complexity of defining quality in medicine, patient satisfaction is being used as a proxy for quality, with physicians evaluated and reimbursed based on patient satisfaction scores. Little research has been conducted to validate the relationship between patient satisfaction and quality; however, one study showed online reviews from patients on Yelp correlated with traditional markers of quality, such as mortality and readmission rates, lending credibility to the notion that patient satisfaction equates quality of care.³ Moreover, prospective studies have found positive correlations between patient satisfaction and compliance to therapy^4,5; however, these studies may not give a complete picture of the relationship between patient satisfaction and quality of care, as other studies also have illustrated that, more often than not, factors extrinsic to actual medical care (eg, time spent in the waiting room) play a considerable role in patient satisfaction scores.^6-9

When judging the quality of care that is provided, one study found that patients rate physicians based on interpersonal skills and not care delivered.⁸ Another important factor related to patient satisfaction is the anonymity of the surveys. Patients who have negative experiences are more likely to respond to online surveys than those who have positive experiences, skewing overall ratings.⁶ Additionally, because of Health Insurance Portability and Accountability Act regulations, physicians often are unable to respond directly to public patient reviews, resulting in an incomplete picture of the quality of care provided.

Ultimately, even if physicians do not agree that patient satisfaction correlates with quality of care, it is increasingly being used as a marker of such. Leading health care systems are embracing this new weight on patient satisfaction by increasing transparency and publishing patient satisfaction results online, allowing patients more access to physician reviews.

In dermatology, patient satisfaction serves an even more important role, as traditional markers of quality such as mortality and hospital readmission rates are not reasonable measures of patient care in this specialty, leaving patient satisfaction as one of the most accessible markers insurance companies and prospective patients can use to evaluate dermatologists. Furthermore, treatment modalities in dermatology often aim to improve quality of life, of which patient satisfaction arguably serves as an indicator. Ideally, patient satisfaction would allow physicians to identify areas where they may be better able to meet patients’ needs. However, patient satisfaction scores rarely are used as outcome measures in studies and are notoriously difficult to ascertain, as they tend to be inaccurate and may be unreliable in correlation with physician skill and training or may be skewed by patients’ desires to please their physicians.¹⁰ There also is a lack of standardized tools and scales to quantitatively judge outcomes in procedural surgeries.

Although patient satisfaction is being used as a measure of quality of care and is particularly necessary in a field such as dermatology that has outcome measures that are subjective in nature, there is a gap in the current literature regarding patient satisfaction and dermatology. To fill this gap, we conducted a prospective study of targeted interventions administered at outpatient dermatology clinics to determine if they resulted in statistically significant increases in patient satisfaction measures, particularly among Spanish-speaking patients.

Methods

We conducted a prospective study evaluating patient satisfaction in the outpatient dermatology clinics of LAC+USC Medical Center in Los Angeles, California, spanning over 1 year. During this time period, patients were randomly selected to participate and were asked to complete the Short-Form Patient Satisfaction Questionnaire (PSQ-18), which asked patients to rate their care experience on a 5-point Likert scale (1=strongly agree; 5=strongly disagree). The survey was separated into the following 7 subscales or categories looking at different aspects of care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with physician, and accessibility and convenience. Patients were given this survey both before and after targeted interventions to improve patient satisfaction were implemented. The targeted interventions were created based on literature review in the factors affecting patient satisfaction. The change in relative satisfaction was then determined using statistical analysis. The study was approved by the University of Southern California Health Science institutional review board.

Results

Of 470 patients surveyed, the average age was 49 years. Fifty percent of respondents were male, 70% self-identified as Hispanic, 45% spoke Spanish as their native language, and 69% reported a mean annual household income of less than $15,000. When scores were stratified, English-speaking patients were significantly more satisfied than Spanish-speaking patients in the categories of technical quality (P.0340), financial aspects (P.0301), interpersonal manner (P.0037), and time spent with physician (P.0059). Specifically, in the time spent with physician category, the lowest scores were found in females, patients aged 18 to 29 years, and patients with a mean annual household income less than $15,000. These demographics correlate well with many of the newly insured and intimate the need for improved patient satisfaction, particularly in this subset of patients.

After analyzing baseline patient satisfaction scores, we implemented targeted interventions such as creating a call tree, developing multilingual disease-specific patient handouts, instituting quarterly nursing in-services, which judged interpersonal and occupational nursing skills, and recruiting bilingual staff. These interventions were implemented simultaneously and were selected with the goal of reducing the impact of the language barrier between physicians and patients and increasing accessibility to clinics. Following approximately 3 months of these interventions, performance on many categories increased in our demographics that were lowest performing when we collected baseline data. In Spanish-speaking respondents, improvement in several categories approached statistical significance, including general satisfaction (P.110), interpersonal skills (P.080), and time spent with physician (P.096). When stratifying by income and age, patients with a mean annual household income less than $15,000 demonstrated an improved technical quality (P.066) subscale score, and participants aged 18 to 29 years showed improvement in both accessibility and convenience (P.053) and financial aspects (P.056) subscales.

Comment

The categories where improvements were found are noteworthy and suggest that certain aspects of care are more important than others. Although it seems intuitive that clinical acumen and training should be important contributors to patient satisfaction, one study that analyzed 1000 online comments regarding patient satisfaction with dermatologists on the website DrScore.com found that most comments concerned physician personality and interpersonal skills rather than medical judgment and acumen,⁴ suggesting that a patient’s perception of the character of the physician directly affects patient satisfaction scores. This notion was reiterated by other studies, including one that found that a patient’s perception of the physician’s kindness and empathy skills, is the most important measure of quality of care scores.⁸ Although this perception can be intimidating to some physicians, as certain interpersonal skills are difficult to change, it is reassuring to note that external environment and cues, such as the clinic building and staff, also seem to affect interpersonal ratings. As seen in our study, patient ratings of a physician’s interpersonal skills increased after educational materials for staff and patients were created and more bilingual staff was recruited. Other environmental changes, such as spending a few more minutes with patients and sitting down when talking to patients, are relatively easy to administer and can improve patient satisfaction scores.⁸

Although some of the scores in our study approached but did not reach statistical significance, likely because of a small sample size, they suggest that targeted interventions can improve patient satisfaction. They also suggested that targeted interventions are particularly useful in Spanish-speaking patients, younger patients, and patients from lower socioeconomic backgrounds, which are all characteristics of the newly insured under the Patient Protection and Affordable Health Care Act.

Our study also is unique in that dermatology as a specialty is lagging in quality improvement studies. In the few studies evaluating patient satisfaction in the literature, the care provided by dermatologists was painted in a positive light.^6,11 One study evaluated 45 dermatology practices and reported average patient satisfaction scores of 3.46 and 4.72 of 5 on Yelp and ZocDoc, respectively.¹¹ Another study looking at dermatologist ratings on DrScore.com found that the majority of patients were satisfied with the care they received.⁶

Although these studies seem encouraging, they have several limitations. First, their results were not stratified by patient demographics and therefore may not be generalizable to low-income populations that constitute much of the newly insured. Secondly, the observational nature and limited number of studies prohibit meaningful conclusions from being drawn and leave many questions unanswered. Additionally, although the raw patient satisfaction scores seem good, dermatology is lacking compared to the patient satisfaction scores within other specialties. A study of more than 28,000 Yelp reviews of 23 specialties found that dermatology ranked second to last, ahead of only psychiatry.⁷ Of course, given the observational nature of this study, it is impossible to generalize, as many confounders (eg, medical comorbidities, patient age) may have skewed the dermatology ranking. Regardless, there is always room for improvement, and luckily improving patient satisfaction is not an elusive goal.

Conclusion

As dermatologists, our interventions often improve quality of life; therefore, we are positioned to be leaders in the quality improvement field. Despite the numerous limitations of using patient satisfaction as a measure for quality of care, it is used by payers to determine reimbursement and patients to select providers. Encouraging initial data from our prospective study demonstrate that small interventions can increase patient satisfaction. Continued work to maximize patient satisfaction is needed to improve outcomes for our patients, help validate the quality of care being provided, and further solidify the importance of having insurers maintain sufficient dermatologists in their networks.

The Patient Protection and Affordable Care Act has increased the number of insured Americans by more than 20 million individuals.¹ Approximately half of the newly insured have an income at or below 138% of the poverty level and are on average younger, sicker, and more likely to report poor to fair health compared to those individuals who already had health care coverage.² Specialties such as dermatology are faced with the challenge of expanding access to these newly insured individuals while also improving quality of care.

Because of the complexity of defining quality in medicine, patient satisfaction is being used as a proxy for quality, with physicians evaluated and reimbursed based on patient satisfaction scores. Little research has been conducted to validate the relationship between patient satisfaction and quality; however, one study showed online reviews from patients on Yelp correlated with traditional markers of quality, such as mortality and readmission rates, lending credibility to the notion that patient satisfaction equates quality of care.³ Moreover, prospective studies have found positive correlations between patient satisfaction and compliance to therapy^4,5; however, these studies may not give a complete picture of the relationship between patient satisfaction and quality of care, as other studies also have illustrated that, more often than not, factors extrinsic to actual medical care (eg, time spent in the waiting room) play a considerable role in patient satisfaction scores.^6-9

When judging the quality of care that is provided, one study found that patients rate physicians based on interpersonal skills and not care delivered.⁸ Another important factor related to patient satisfaction is the anonymity of the surveys. Patients who have negative experiences are more likely to respond to online surveys than those who have positive experiences, skewing overall ratings.⁶ Additionally, because of Health Insurance Portability and Accountability Act regulations, physicians often are unable to respond directly to public patient reviews, resulting in an incomplete picture of the quality of care provided.

Ultimately, even if physicians do not agree that patient satisfaction correlates with quality of care, it is increasingly being used as a marker of such. Leading health care systems are embracing this new weight on patient satisfaction by increasing transparency and publishing patient satisfaction results online, allowing patients more access to physician reviews.

In dermatology, patient satisfaction serves an even more important role, as traditional markers of quality such as mortality and hospital readmission rates are not reasonable measures of patient care in this specialty, leaving patient satisfaction as one of the most accessible markers insurance companies and prospective patients can use to evaluate dermatologists. Furthermore, treatment modalities in dermatology often aim to improve quality of life, of which patient satisfaction arguably serves as an indicator. Ideally, patient satisfaction would allow physicians to identify areas where they may be better able to meet patients’ needs. However, patient satisfaction scores rarely are used as outcome measures in studies and are notoriously difficult to ascertain, as they tend to be inaccurate and may be unreliable in correlation with physician skill and training or may be skewed by patients’ desires to please their physicians.¹⁰ There also is a lack of standardized tools and scales to quantitatively judge outcomes in procedural surgeries.

Although patient satisfaction is being used as a measure of quality of care and is particularly necessary in a field such as dermatology that has outcome measures that are subjective in nature, there is a gap in the current literature regarding patient satisfaction and dermatology. To fill this gap, we conducted a prospective study of targeted interventions administered at outpatient dermatology clinics to determine if they resulted in statistically significant increases in patient satisfaction measures, particularly among Spanish-speaking patients.

Methods

We conducted a prospective study evaluating patient satisfaction in the outpatient dermatology clinics of LAC+USC Medical Center in Los Angeles, California, spanning over 1 year. During this time period, patients were randomly selected to participate and were asked to complete the Short-Form Patient Satisfaction Questionnaire (PSQ-18), which asked patients to rate their care experience on a 5-point Likert scale (1=strongly agree; 5=strongly disagree). The survey was separated into the following 7 subscales or categories looking at different aspects of care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with physician, and accessibility and convenience. Patients were given this survey both before and after targeted interventions to improve patient satisfaction were implemented. The targeted interventions were created based on literature review in the factors affecting patient satisfaction. The change in relative satisfaction was then determined using statistical analysis. The study was approved by the University of Southern California Health Science institutional review board.

Results

Of 470 patients surveyed, the average age was 49 years. Fifty percent of respondents were male, 70% self-identified as Hispanic, 45% spoke Spanish as their native language, and 69% reported a mean annual household income of less than $15,000. When scores were stratified, English-speaking patients were significantly more satisfied than Spanish-speaking patients in the categories of technical quality (P.0340), financial aspects (P.0301), interpersonal manner (P.0037), and time spent with physician (P.0059). Specifically, in the time spent with physician category, the lowest scores were found in females, patients aged 18 to 29 years, and patients with a mean annual household income less than $15,000. These demographics correlate well with many of the newly insured and intimate the need for improved patient satisfaction, particularly in this subset of patients.

After analyzing baseline patient satisfaction scores, we implemented targeted interventions such as creating a call tree, developing multilingual disease-specific patient handouts, instituting quarterly nursing in-services, which judged interpersonal and occupational nursing skills, and recruiting bilingual staff. These interventions were implemented simultaneously and were selected with the goal of reducing the impact of the language barrier between physicians and patients and increasing accessibility to clinics. Following approximately 3 months of these interventions, performance on many categories increased in our demographics that were lowest performing when we collected baseline data. In Spanish-speaking respondents, improvement in several categories approached statistical significance, including general satisfaction (P.110), interpersonal skills (P.080), and time spent with physician (P.096). When stratifying by income and age, patients with a mean annual household income less than $15,000 demonstrated an improved technical quality (P.066) subscale score, and participants aged 18 to 29 years showed improvement in both accessibility and convenience (P.053) and financial aspects (P.056) subscales.

Comment

The categories where improvements were found are noteworthy and suggest that certain aspects of care are more important than others. Although it seems intuitive that clinical acumen and training should be important contributors to patient satisfaction, one study that analyzed 1000 online comments regarding patient satisfaction with dermatologists on the website DrScore.com found that most comments concerned physician personality and interpersonal skills rather than medical judgment and acumen,⁴ suggesting that a patient’s perception of the character of the physician directly affects patient satisfaction scores. This notion was reiterated by other studies, including one that found that a patient’s perception of the physician’s kindness and empathy skills, is the most important measure of quality of care scores.⁸ Although this perception can be intimidating to some physicians, as certain interpersonal skills are difficult to change, it is reassuring to note that external environment and cues, such as the clinic building and staff, also seem to affect interpersonal ratings. As seen in our study, patient ratings of a physician’s interpersonal skills increased after educational materials for staff and patients were created and more bilingual staff was recruited. Other environmental changes, such as spending a few more minutes with patients and sitting down when talking to patients, are relatively easy to administer and can improve patient satisfaction scores.⁸

Although some of the scores in our study approached but did not reach statistical significance, likely because of a small sample size, they suggest that targeted interventions can improve patient satisfaction. They also suggested that targeted interventions are particularly useful in Spanish-speaking patients, younger patients, and patients from lower socioeconomic backgrounds, which are all characteristics of the newly insured under the Patient Protection and Affordable Health Care Act.

Our study also is unique in that dermatology as a specialty is lagging in quality improvement studies. In the few studies evaluating patient satisfaction in the literature, the care provided by dermatologists was painted in a positive light.^6,11 One study evaluated 45 dermatology practices and reported average patient satisfaction scores of 3.46 and 4.72 of 5 on Yelp and ZocDoc, respectively.¹¹ Another study looking at dermatologist ratings on DrScore.com found that the majority of patients were satisfied with the care they received.⁶

Although these studies seem encouraging, they have several limitations. First, their results were not stratified by patient demographics and therefore may not be generalizable to low-income populations that constitute much of the newly insured. Secondly, the observational nature and limited number of studies prohibit meaningful conclusions from being drawn and leave many questions unanswered. Additionally, although the raw patient satisfaction scores seem good, dermatology is lacking compared to the patient satisfaction scores within other specialties. A study of more than 28,000 Yelp reviews of 23 specialties found that dermatology ranked second to last, ahead of only psychiatry.⁷ Of course, given the observational nature of this study, it is impossible to generalize, as many confounders (eg, medical comorbidities, patient age) may have skewed the dermatology ranking. Regardless, there is always room for improvement, and luckily improving patient satisfaction is not an elusive goal.

Conclusion

As dermatologists, our interventions often improve quality of life; therefore, we are positioned to be leaders in the quality improvement field. Despite the numerous limitations of using patient satisfaction as a measure for quality of care, it is used by payers to determine reimbursement and patients to select providers. Encouraging initial data from our prospective study demonstrate that small interventions can increase patient satisfaction. Continued work to maximize patient satisfaction is needed to improve outcomes for our patients, help validate the quality of care being provided, and further solidify the importance of having insurers maintain sufficient dermatologists in their networks.

Researching medical information currently is the third most common use of the Internet in the United States,¹ with the majority of adults using the Web as their first source for health information before seeing a physician.² When assessing health-related information online, resources can be grouped into 4 categories: (1) those attributed to self-proclaimed experts, (2) promotional, (3) social media, and (4) educational.³ Access to such a wide range of sources may give readers the opportunity to share personal anecdotes and opinions, thereby serving as a forum for information that essentially cannot be validated. Although such websites may include useful information and cite current literature, in other instances health-related information may be misleading or fabricated.³

In a study evaluating 291 skin conditions and related Google trends, acne, psoriasis, and eczema were among the most burdensome diseases, with acne yielding the highest number of search results.⁴ Results of the study indicated a positive correlation between disease burden and online search interest.⁴ The impact of these online searches and the validity of Google search results are topics worth considering, as more dermatology patients are relying on holistic and nonpharmaceutical approaches to treatment and disease management.⁵ The purpose of this study was to evaluate content on diet and dermatology available on the Internet for acne, psoriasis, and eczema.

Methods

Google searches were performed in December 2017 using the terms diet and acne, diet and psoriasis, and diet and eczema. The first 10 results for each respective search were reviewed for recommendations about which foods to incorporate in the diet and which to avoid. They also were classified according to the following 4 website categories: (1) those attributed to self-proclaimed experts, (2) promotional, (3) social media, and (4) educational. The recommendations gathered from the 30 websites were then compared to the current literature assessing the impact of diet on these respective conditions by conducting PubMed searches of articles indexed for MEDLINE using the same terms.

Results

The results of this study are outlined in the eTable.

Acne
Our Google search using the term diet and acne produced 17,500,000 results. Of the first 10 search results, 40% (4/10) were websites attributed to self-proclaimed experts, 40% (4/10) were educational resources, and 20% (2/10) were promotional websites. Most of the websites advised acne patients to avoid high glycemic index foods (90% [9/10]) and dairy products (90% [9/10]). When discussing which foods to include in the diet, 70% (7/10) of websites recommended that patients incorporate omega-3 fatty acids and antioxidants in the diet.

Research has shown that a low glycemic index diet can lead to a decrease in patients’ acne lesion counts in some instances.^6,7 In a case-controlled study of 2258 patients on a popular weight loss diet that emphasized low glycemic index foods, 87% of participants reported a reduction in acne and 91% reported a decrease in their dosage or number of acne medications.⁷ Still, the exact correlation between acne development and consumption of glycemic index foods has not been confirmed. However, high glycemic index diets have been linked to hyperinsulinemia, indicating that insulin levels may play a role in acne formation.⁸ The majority of other currently available studies evaluated the potential link between dairy consumption and acne. A retrospective analysis of 47,355 women spanning 12 weeks showed a positive link between increased dairy consumption, specifically skim milk, and acne formation. Despite the positive trend, limitations such as recall bias made it difficult to draw a conclusion based on these findings.⁹ However, results of a longitudinal questionnaire-based population study evaluating the impact of dairy consumption on acne in 2489 adolescent patients confirmed a positive correlation.¹⁰ Studies conducted in 2009 and 2011 concluded that milk consumption results in elevated insulinlike growth factor 1 levels, which were linked to comedogenesis.^8,11

Currently, there are well-described mechanisms to explain the association of dairy consumption and glycemic index with acne. Confirming a correlation between acne development and dairy consumption suggests that a dairy-free diet may benefit acne patients.⁵ Other trials indicate that low glycemic index diets are beneficial in treating acne.^6,7 Therefore, some of the recommendations made in our search results may be of merit; however, there is minimal evidence proving the benefits of the other dietary recommendations made in the websites we evaluated.

Psoriasis
Our Google search using the term diet and psoriasis yielded a total of 9,420,000 results. Of the first 10 search results, 40% (4/10) were websites attributed to self-proclaimed experts, 30% (3/10) were promotional, and 30% (3/10) were educational. Seventy percent (7/10) of websites recommended avoiding alcohol and 60% (6/10) recommended avoiding gluten, with others discouraging consumption of red meat. Most of the websites encouraged patients to consume omega-3 fatty acids and antioxidants, while a few also recommended vitamins A, D, and E, as well as evening primrose oil supplements.

Although current research indicates a positive correlation between excessive alcohol use and psoriasis severity, it is still unclear whether alcohol consumption can be directly linked to the disease.^12-14 Likewise, despite belief that increased oxidative stress likely contributes to inflammation in psoriasis, there is little evidence linking antioxidants to improvement in psoriasis symptoms.¹² However, the current literature is inconsistent regarding the effects of fish oil supplementation on psoriasis.¹² In a randomized double-blind study of 145 patients, there was no significant difference in psoriasis area and severity index scores between a control group and a treatment group receiving fish oil supplementation.¹⁵ In another RCT of 45 participants, those given daily very long-chain omega-3 fatty acid supplements saw no difference in psoriasis symptoms.¹⁵ Despite debate, literature assessing the impact of gluten-free diets has described improvement in psoriasis lesions in patients with celiac-specific antibodies.¹⁶ Although some observational studies described vitamin D supplementation to be beneficial in the treatment of psoriatic lesions, a more recent RCT found no significant difference between control and treatment groups.^17-19

Studies also have revealed that certain eating patterns, such as those associated with the Mediterranean diet that is rich in fruits, vegetables, whole grains, and omega-3 fatty acids may be linked to improved endothelial function scores and reduced C-reactive protein and IL-18levels.^20,21 In a double-blind RCT of 75 patients with plaque psoriasis, mean (SD) psoriasis area and severity index scores decreased by 11.2 (9.8) in a group treated with omega-3 fatty acids compared to 7.5 (8.8) with omega-6 fatty acids (P=.048).²²

Although excessive alcohol use may be linked to psoriasis, there is no conclusive evidence indicating causation, thereby discrediting online claims.^12-14 Research has revealed that gluten-free diets in psoriasis patients with celiac disease may improve psoriasis treatment¹⁶; however, sufficient evidence is lacking for diets low in gluten and high in polyunsaturated fatty acids or antioxidant supplementation. Of the dietary supplements recommended in the search results we reviewed, fish oil appears to be the most promising, but no recommendations can be made based on the current research.

Eczema
Our Google search using the term diet and eczema yielded 1,160,000 results, with 50% (5/10) of websites attributed to self-proclaimed experts, 30% (3/10) to educational websites, and 20% (2/10) to promotional sites. Of the first 10 results, 80% (8/10) recommended that patients with eczema avoid milk/dairy and 50% (5/10) advised to avoid soy and wheat/gluten. Other websites indicated to avoid eggs, nuts, and artificial sweeteners. Patients were encouraged to incorporate omega-3 fatty acids in their diets, and a few sites recommended bananas, coconut oil, olive oil, and various teas.

In a review of 11 studies with a total of 596 participants, supplementation with vitamins D and E, fish oil, olive oil, and linoleic acid was evaluated for the treatment of eczema.²³ Although results indicated modest improvement of eczema severity with supplementation of fish oil, evidence favoring this treatment is limited and unconvincing. Furthermore, some evidence indicates that elimination diets are only appropriate for patients with food allergies.²⁴ In a study evaluating an egg-free and dairy-free diet for eczema patients, only participants with positive egg-specific serum IgE levels saw improvement in disease severity.²³ Even though IgE-mediated food allergies have been reported in 40% of children with moderate eczema, the contribution of these allergies to eczema is questionable.²⁵

There is little evidence in the literature to indicate a definitive correlation between the foods mentioned in the search results we evaluated and the development of eczema; however, for patients with food allergies and eczema, elimination diets may decrease disease severity.^25,26 There is insufficient evidence to suggest a benefit from evening primrose oil or fish oil supplementation, thereby debunking claims found online.

Comment

Although our Google search results included a wide range of sources and information regarding diet and dermatologic conditions such as acne, psoriasis, and eczema, most of the information we found was either unfounded or misleading. Study limitations in the current literature include small sample size, potential recall bias, lack of appropriate controls, incomplete reported results, and the failure to clearly define skin changes.

When considering the accuracy and type of information regarding skin conditions that is available on the Internet, it is important to note that most of the results we reviewed were webpages attributed to self-proclaimed experts. Although educational websites also were included in the search results, whether or not patients prefer or understand the content of such websites is still unknown; therefore, health organizations should consider revising online patient education materials to allow universal comprehension.²⁷

Furthermore, it is important to consider the impact that widespread Internet access may have on the physician-patient relationship. Having access to health-related information online and being able to potentially self-diagnose could delay or deter patients from seeking professional advice or care.³ A study evaluating the impact of online searches on the physician-patient relationship among 175 patients determined that 36.5% of patients gathered information online prior to their consultation with a physician, while 67.3% chose to complement the information given to them by their physician with online resources.²⁸ Based on these statistics, it is important that physicians be up-to-date with Internet discourse to discredit unfounded recommendations. Ultimately, when it comes to diet and dermatology, patients ought to be skeptical of the information currently available on the Internet, given that most of it is unsubstantiated by medical research.

Researching medical information currently is the third most common use of the Internet in the United States,¹ with the majority of adults using the Web as their first source for health information before seeing a physician.² When assessing health-related information online, resources can be grouped into 4 categories: (1) those attributed to self-proclaimed experts, (2) promotional, (3) social media, and (4) educational.³ Access to such a wide range of sources may give readers the opportunity to share personal anecdotes and opinions, thereby serving as a forum for information that essentially cannot be validated. Although such websites may include useful information and cite current literature, in other instances health-related information may be misleading or fabricated.³

In a study evaluating 291 skin conditions and related Google trends, acne, psoriasis, and eczema were among the most burdensome diseases, with acne yielding the highest number of search results.⁴ Results of the study indicated a positive correlation between disease burden and online search interest.⁴ The impact of these online searches and the validity of Google search results are topics worth considering, as more dermatology patients are relying on holistic and nonpharmaceutical approaches to treatment and disease management.⁵ The purpose of this study was to evaluate content on diet and dermatology available on the Internet for acne, psoriasis, and eczema.

Methods

Google searches were performed in December 2017 using the terms diet and acne, diet and psoriasis, and diet and eczema. The first 10 results for each respective search were reviewed for recommendations about which foods to incorporate in the diet and which to avoid. They also were classified according to the following 4 website categories: (1) those attributed to self-proclaimed experts, (2) promotional, (3) social media, and (4) educational. The recommendations gathered from the 30 websites were then compared to the current literature assessing the impact of diet on these respective conditions by conducting PubMed searches of articles indexed for MEDLINE using the same terms.

Results

The results of this study are outlined in the eTable.

Acne
Our Google search using the term diet and acne produced 17,500,000 results. Of the first 10 search results, 40% (4/10) were websites attributed to self-proclaimed experts, 40% (4/10) were educational resources, and 20% (2/10) were promotional websites. Most of the websites advised acne patients to avoid high glycemic index foods (90% [9/10]) and dairy products (90% [9/10]). When discussing which foods to include in the diet, 70% (7/10) of websites recommended that patients incorporate omega-3 fatty acids and antioxidants in the diet.

Research has shown that a low glycemic index diet can lead to a decrease in patients’ acne lesion counts in some instances.^6,7 In a case-controlled study of 2258 patients on a popular weight loss diet that emphasized low glycemic index foods, 87% of participants reported a reduction in acne and 91% reported a decrease in their dosage or number of acne medications.⁷ Still, the exact correlation between acne development and consumption of glycemic index foods has not been confirmed. However, high glycemic index diets have been linked to hyperinsulinemia, indicating that insulin levels may play a role in acne formation.⁸ The majority of other currently available studies evaluated the potential link between dairy consumption and acne. A retrospective analysis of 47,355 women spanning 12 weeks showed a positive link between increased dairy consumption, specifically skim milk, and acne formation. Despite the positive trend, limitations such as recall bias made it difficult to draw a conclusion based on these findings.⁹ However, results of a longitudinal questionnaire-based population study evaluating the impact of dairy consumption on acne in 2489 adolescent patients confirmed a positive correlation.¹⁰ Studies conducted in 2009 and 2011 concluded that milk consumption results in elevated insulinlike growth factor 1 levels, which were linked to comedogenesis.^8,11

Currently, there are well-described mechanisms to explain the association of dairy consumption and glycemic index with acne. Confirming a correlation between acne development and dairy consumption suggests that a dairy-free diet may benefit acne patients.⁵ Other trials indicate that low glycemic index diets are beneficial in treating acne.^6,7 Therefore, some of the recommendations made in our search results may be of merit; however, there is minimal evidence proving the benefits of the other dietary recommendations made in the websites we evaluated.

Psoriasis
Our Google search using the term diet and psoriasis yielded a total of 9,420,000 results. Of the first 10 search results, 40% (4/10) were websites attributed to self-proclaimed experts, 30% (3/10) were promotional, and 30% (3/10) were educational. Seventy percent (7/10) of websites recommended avoiding alcohol and 60% (6/10) recommended avoiding gluten, with others discouraging consumption of red meat. Most of the websites encouraged patients to consume omega-3 fatty acids and antioxidants, while a few also recommended vitamins A, D, and E, as well as evening primrose oil supplements.

Although current research indicates a positive correlation between excessive alcohol use and psoriasis severity, it is still unclear whether alcohol consumption can be directly linked to the disease.^12-14 Likewise, despite belief that increased oxidative stress likely contributes to inflammation in psoriasis, there is little evidence linking antioxidants to improvement in psoriasis symptoms.¹² However, the current literature is inconsistent regarding the effects of fish oil supplementation on psoriasis.¹² In a randomized double-blind study of 145 patients, there was no significant difference in psoriasis area and severity index scores between a control group and a treatment group receiving fish oil supplementation.¹⁵ In another RCT of 45 participants, those given daily very long-chain omega-3 fatty acid supplements saw no difference in psoriasis symptoms.¹⁵ Despite debate, literature assessing the impact of gluten-free diets has described improvement in psoriasis lesions in patients with celiac-specific antibodies.¹⁶ Although some observational studies described vitamin D supplementation to be beneficial in the treatment of psoriatic lesions, a more recent RCT found no significant difference between control and treatment groups.^17-19

Studies also have revealed that certain eating patterns, such as those associated with the Mediterranean diet that is rich in fruits, vegetables, whole grains, and omega-3 fatty acids may be linked to improved endothelial function scores and reduced C-reactive protein and IL-18levels.^20,21 In a double-blind RCT of 75 patients with plaque psoriasis, mean (SD) psoriasis area and severity index scores decreased by 11.2 (9.8) in a group treated with omega-3 fatty acids compared to 7.5 (8.8) with omega-6 fatty acids (P=.048).²²

Although excessive alcohol use may be linked to psoriasis, there is no conclusive evidence indicating causation, thereby discrediting online claims.^12-14 Research has revealed that gluten-free diets in psoriasis patients with celiac disease may improve psoriasis treatment¹⁶; however, sufficient evidence is lacking for diets low in gluten and high in polyunsaturated fatty acids or antioxidant supplementation. Of the dietary supplements recommended in the search results we reviewed, fish oil appears to be the most promising, but no recommendations can be made based on the current research.

Eczema
Our Google search using the term diet and eczema yielded 1,160,000 results, with 50% (5/10) of websites attributed to self-proclaimed experts, 30% (3/10) to educational websites, and 20% (2/10) to promotional sites. Of the first 10 results, 80% (8/10) recommended that patients with eczema avoid milk/dairy and 50% (5/10) advised to avoid soy and wheat/gluten. Other websites indicated to avoid eggs, nuts, and artificial sweeteners. Patients were encouraged to incorporate omega-3 fatty acids in their diets, and a few sites recommended bananas, coconut oil, olive oil, and various teas.

In a review of 11 studies with a total of 596 participants, supplementation with vitamins D and E, fish oil, olive oil, and linoleic acid was evaluated for the treatment of eczema.²³ Although results indicated modest improvement of eczema severity with supplementation of fish oil, evidence favoring this treatment is limited and unconvincing. Furthermore, some evidence indicates that elimination diets are only appropriate for patients with food allergies.²⁴ In a study evaluating an egg-free and dairy-free diet for eczema patients, only participants with positive egg-specific serum IgE levels saw improvement in disease severity.²³ Even though IgE-mediated food allergies have been reported in 40% of children with moderate eczema, the contribution of these allergies to eczema is questionable.²⁵

There is little evidence in the literature to indicate a definitive correlation between the foods mentioned in the search results we evaluated and the development of eczema; however, for patients with food allergies and eczema, elimination diets may decrease disease severity.^25,26 There is insufficient evidence to suggest a benefit from evening primrose oil or fish oil supplementation, thereby debunking claims found online.

Comment

Although our Google search results included a wide range of sources and information regarding diet and dermatologic conditions such as acne, psoriasis, and eczema, most of the information we found was either unfounded or misleading. Study limitations in the current literature include small sample size, potential recall bias, lack of appropriate controls, incomplete reported results, and the failure to clearly define skin changes.

When considering the accuracy and type of information regarding skin conditions that is available on the Internet, it is important to note that most of the results we reviewed were webpages attributed to self-proclaimed experts. Although educational websites also were included in the search results, whether or not patients prefer or understand the content of such websites is still unknown; therefore, health organizations should consider revising online patient education materials to allow universal comprehension.²⁷

Furthermore, it is important to consider the impact that widespread Internet access may have on the physician-patient relationship. Having access to health-related information online and being able to potentially self-diagnose could delay or deter patients from seeking professional advice or care.³ A study evaluating the impact of online searches on the physician-patient relationship among 175 patients determined that 36.5% of patients gathered information online prior to their consultation with a physician, while 67.3% chose to complement the information given to them by their physician with online resources.²⁸ Based on these statistics, it is important that physicians be up-to-date with Internet discourse to discredit unfounded recommendations. Ultimately, when it comes to diet and dermatology, patients ought to be skeptical of the information currently available on the Internet, given that most of it is unsubstantiated by medical research.

Researching medical information currently is the third most common use of the Internet in the United States,¹ with the majority of adults using the Web as their first source for health information before seeing a physician.² When assessing health-related information online, resources can be grouped into 4 categories: (1) those attributed to self-proclaimed experts, (2) promotional, (3) social media, and (4) educational.³ Access to such a wide range of sources may give readers the opportunity to share personal anecdotes and opinions, thereby serving as a forum for information that essentially cannot be validated. Although such websites may include useful information and cite current literature, in other instances health-related information may be misleading or fabricated.³

In a study evaluating 291 skin conditions and related Google trends, acne, psoriasis, and eczema were among the most burdensome diseases, with acne yielding the highest number of search results.⁴ Results of the study indicated a positive correlation between disease burden and online search interest.⁴ The impact of these online searches and the validity of Google search results are topics worth considering, as more dermatology patients are relying on holistic and nonpharmaceutical approaches to treatment and disease management.⁵ The purpose of this study was to evaluate content on diet and dermatology available on the Internet for acne, psoriasis, and eczema.

Methods

Google searches were performed in December 2017 using the terms diet and acne, diet and psoriasis, and diet and eczema. The first 10 results for each respective search were reviewed for recommendations about which foods to incorporate in the diet and which to avoid. They also were classified according to the following 4 website categories: (1) those attributed to self-proclaimed experts, (2) promotional, (3) social media, and (4) educational. The recommendations gathered from the 30 websites were then compared to the current literature assessing the impact of diet on these respective conditions by conducting PubMed searches of articles indexed for MEDLINE using the same terms.

Results

The results of this study are outlined in the eTable.

Acne
Our Google search using the term diet and acne produced 17,500,000 results. Of the first 10 search results, 40% (4/10) were websites attributed to self-proclaimed experts, 40% (4/10) were educational resources, and 20% (2/10) were promotional websites. Most of the websites advised acne patients to avoid high glycemic index foods (90% [9/10]) and dairy products (90% [9/10]). When discussing which foods to include in the diet, 70% (7/10) of websites recommended that patients incorporate omega-3 fatty acids and antioxidants in the diet.

Research has shown that a low glycemic index diet can lead to a decrease in patients’ acne lesion counts in some instances.^6,7 In a case-controlled study of 2258 patients on a popular weight loss diet that emphasized low glycemic index foods, 87% of participants reported a reduction in acne and 91% reported a decrease in their dosage or number of acne medications.⁷ Still, the exact correlation between acne development and consumption of glycemic index foods has not been confirmed. However, high glycemic index diets have been linked to hyperinsulinemia, indicating that insulin levels may play a role in acne formation.⁸ The majority of other currently available studies evaluated the potential link between dairy consumption and acne. A retrospective analysis of 47,355 women spanning 12 weeks showed a positive link between increased dairy consumption, specifically skim milk, and acne formation. Despite the positive trend, limitations such as recall bias made it difficult to draw a conclusion based on these findings.⁹ However, results of a longitudinal questionnaire-based population study evaluating the impact of dairy consumption on acne in 2489 adolescent patients confirmed a positive correlation.¹⁰ Studies conducted in 2009 and 2011 concluded that milk consumption results in elevated insulinlike growth factor 1 levels, which were linked to comedogenesis.^8,11

Currently, there are well-described mechanisms to explain the association of dairy consumption and glycemic index with acne. Confirming a correlation between acne development and dairy consumption suggests that a dairy-free diet may benefit acne patients.⁵ Other trials indicate that low glycemic index diets are beneficial in treating acne.^6,7 Therefore, some of the recommendations made in our search results may be of merit; however, there is minimal evidence proving the benefits of the other dietary recommendations made in the websites we evaluated.

Psoriasis
Our Google search using the term diet and psoriasis yielded a total of 9,420,000 results. Of the first 10 search results, 40% (4/10) were websites attributed to self-proclaimed experts, 30% (3/10) were promotional, and 30% (3/10) were educational. Seventy percent (7/10) of websites recommended avoiding alcohol and 60% (6/10) recommended avoiding gluten, with others discouraging consumption of red meat. Most of the websites encouraged patients to consume omega-3 fatty acids and antioxidants, while a few also recommended vitamins A, D, and E, as well as evening primrose oil supplements.

Although current research indicates a positive correlation between excessive alcohol use and psoriasis severity, it is still unclear whether alcohol consumption can be directly linked to the disease.^12-14 Likewise, despite belief that increased oxidative stress likely contributes to inflammation in psoriasis, there is little evidence linking antioxidants to improvement in psoriasis symptoms.¹² However, the current literature is inconsistent regarding the effects of fish oil supplementation on psoriasis.¹² In a randomized double-blind study of 145 patients, there was no significant difference in psoriasis area and severity index scores between a control group and a treatment group receiving fish oil supplementation.¹⁵ In another RCT of 45 participants, those given daily very long-chain omega-3 fatty acid supplements saw no difference in psoriasis symptoms.¹⁵ Despite debate, literature assessing the impact of gluten-free diets has described improvement in psoriasis lesions in patients with celiac-specific antibodies.¹⁶ Although some observational studies described vitamin D supplementation to be beneficial in the treatment of psoriatic lesions, a more recent RCT found no significant difference between control and treatment groups.^17-19

Studies also have revealed that certain eating patterns, such as those associated with the Mediterranean diet that is rich in fruits, vegetables, whole grains, and omega-3 fatty acids may be linked to improved endothelial function scores and reduced C-reactive protein and IL-18levels.^20,21 In a double-blind RCT of 75 patients with plaque psoriasis, mean (SD) psoriasis area and severity index scores decreased by 11.2 (9.8) in a group treated with omega-3 fatty acids compared to 7.5 (8.8) with omega-6 fatty acids (P=.048).²²

Although excessive alcohol use may be linked to psoriasis, there is no conclusive evidence indicating causation, thereby discrediting online claims.^12-14 Research has revealed that gluten-free diets in psoriasis patients with celiac disease may improve psoriasis treatment¹⁶; however, sufficient evidence is lacking for diets low in gluten and high in polyunsaturated fatty acids or antioxidant supplementation. Of the dietary supplements recommended in the search results we reviewed, fish oil appears to be the most promising, but no recommendations can be made based on the current research.

Eczema
Our Google search using the term diet and eczema yielded 1,160,000 results, with 50% (5/10) of websites attributed to self-proclaimed experts, 30% (3/10) to educational websites, and 20% (2/10) to promotional sites. Of the first 10 results, 80% (8/10) recommended that patients with eczema avoid milk/dairy and 50% (5/10) advised to avoid soy and wheat/gluten. Other websites indicated to avoid eggs, nuts, and artificial sweeteners. Patients were encouraged to incorporate omega-3 fatty acids in their diets, and a few sites recommended bananas, coconut oil, olive oil, and various teas.

In a review of 11 studies with a total of 596 participants, supplementation with vitamins D and E, fish oil, olive oil, and linoleic acid was evaluated for the treatment of eczema.²³ Although results indicated modest improvement of eczema severity with supplementation of fish oil, evidence favoring this treatment is limited and unconvincing. Furthermore, some evidence indicates that elimination diets are only appropriate for patients with food allergies.²⁴ In a study evaluating an egg-free and dairy-free diet for eczema patients, only participants with positive egg-specific serum IgE levels saw improvement in disease severity.²³ Even though IgE-mediated food allergies have been reported in 40% of children with moderate eczema, the contribution of these allergies to eczema is questionable.²⁵

There is little evidence in the literature to indicate a definitive correlation between the foods mentioned in the search results we evaluated and the development of eczema; however, for patients with food allergies and eczema, elimination diets may decrease disease severity.^25,26 There is insufficient evidence to suggest a benefit from evening primrose oil or fish oil supplementation, thereby debunking claims found online.

Comment

Although our Google search results included a wide range of sources and information regarding diet and dermatologic conditions such as acne, psoriasis, and eczema, most of the information we found was either unfounded or misleading. Study limitations in the current literature include small sample size, potential recall bias, lack of appropriate controls, incomplete reported results, and the failure to clearly define skin changes.

When considering the accuracy and type of information regarding skin conditions that is available on the Internet, it is important to note that most of the results we reviewed were webpages attributed to self-proclaimed experts. Although educational websites also were included in the search results, whether or not patients prefer or understand the content of such websites is still unknown; therefore, health organizations should consider revising online patient education materials to allow universal comprehension.²⁷

Furthermore, it is important to consider the impact that widespread Internet access may have on the physician-patient relationship. Having access to health-related information online and being able to potentially self-diagnose could delay or deter patients from seeking professional advice or care.³ A study evaluating the impact of online searches on the physician-patient relationship among 175 patients determined that 36.5% of patients gathered information online prior to their consultation with a physician, while 67.3% chose to complement the information given to them by their physician with online resources.²⁸ Based on these statistics, it is important that physicians be up-to-date with Internet discourse to discredit unfounded recommendations. Ultimately, when it comes to diet and dermatology, patients ought to be skeptical of the information currently available on the Internet, given that most of it is unsubstantiated by medical research.

ABSTRACT

Current literature regarding complications following total joint arthroplasty have primarily focused on patients with osteoarthritis (OA), with less emphasis on the trends and in-hospital outcomes of rheumatoid arthritis (RA) patients undergoing these procedures. The purpose of this study is to analyze the outcomes and trends of RA patients undergoing total knee arthroplasty (TKA) or total hip arthroplasty (THA) compared to OA patients.

Data from the Nationwide Inpatient Sample from 2006 to 2011 was extracted using the International Classification of Diseases, Ninth Revision codes for patients that received a TKA or THA. Outcome measures included cardiovascular complications, cerebrovascular complications, pulmonary complications, wound dehiscence, and infection. Inpatient and hospital demographics including primary diagnosis, age, gender, primary payer, hospital teaching status, Charlson Comorbidity Index score, hospital bed size, location, and median household income were analyzed.

Logistic regression analysis of OA vs RA patients with patient outcomes revealed that osteoarthritic THA candidates had lower risk for cardiovascular complications, pulmonary complications, wound dehiscence, infections, and systemic complications, compared to rheumatoid patients. There was a significantly elevated risk of cerebrovascular complication in osteoarthritic THA compared to RA THA. OA patients undergoing TKA had significantly higher risk for cardiovascular and cerebrovascular complications. There were significant decreases in mechanical wounds, infection, and systemic complications in the OA TKA patients.

RA patients are at higher risk for postoperative infection, wound dehiscence, and systemic complications after TKA and THA compared to OA patients. These findings highlight the importance of preoperative medical clearance and management to optimize RA patients and improve the postoperative outcomes.

Continue to: RA is a chronic systemic inflammatory disease...

Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease that causes joint deterioration, leading to pain, disability, systemic complications, short lifespan, and decline in quality of life.^1-3 The deterioration primarily affects the synovial membranes of joints, causing arthritis and resulting in extra-articular sequelae such as cardiovascular disease,⁴ pulmonary disease,⁵ and increased infection rates.^3,6 RA is the most prevalent inflammatory arthritis worldwide and affects up to 50 cases per 100,000 in both the US and northern Europe.^2,7-9 Although the gold standard of care for these patients is medical management with immunosuppressant drugs such as disease-modifying anti-rheumatic drugs (DMARDs), total joint arthroplasty (TJA) remains an important tool in the management of joint deterioration in such patients.

Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are common procedures utilized to treat disorders that cause joint pain and hindered joint mobility, including osteoarthritis (OA) and RA. Given the aging population, the amount of TKAs and THAs performed in the US has consistently increased each year, with the vast majority of this increase composed of patients with OA.¹⁰ As a result, previous studies investigated the trends and outcomes of these procedures in patients with OA, but relatively less is known about the outcomes and trends of patients with RA undergoing the same surgeries.

Given that RA is a fundamentally different condition with its own pathological characteristics, an understanding of how these differences may impact postoperative outcomes in patients with RA is important. This study aims to present a comparative analysis of the trends and postoperative outcomes between patients with RA and OA undergoing TKA and THA (Figure 1, Tables 1 and 2).

Table 1. Demographics of Total Knee Arthroplasty Patients Based on Primary Diagnosis of Osteoarthritis

Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis.

Table 2. Demographics of Total Hip Arthroplasty Patients Based on Primary Diagnosis of Osteoarthritis or Rheumatoid Arthritis

Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis

Continue to: Methods...

METHODS

Exemptions were obtained from the Institutional Review Board. Data from the Nationwide Inpatient Sample (NIS) from 2006 to 2011 were extracted using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes for patients that received primary TKA or THA, as well as their comorbid conditions. No patients or populations were excluded from the sampling process. A list of all independent variables collected for analysis and provision of relevant ICD-9 codes is included in Figure 1. The NIS is the largest all-payer stratified survey of inpatient care in the US healthcare system. As of 2011, each year provides information on approximately 8 million inpatient stays from about 1000 hospitals in 46 states. All discharges from sampled hospitals are also represented in the database. All patient information is protected, and all methods were conducted in accordance with the highest ethical standards of Human and Animal Rights Research.

STATISTICAL ANALYSIS

SAS 9.2 and PROC FREQ statistics software were used to generate P values (chi square result) and analyze the trends (Cochran-Armitage). Results were weighted utilizing standard discharge weights from the NIS to ensure accurate comparison of data from different time points. P < .05 was considered statistically significant. Multivariable logistic regression analyses were performed to generate odds ratio and 95% confidence limits to assess outcomes across different demographic variables.

RESULTS

Data on 337,082 and 1,362,241 patients undergoing THA or TKA, respectively, between 2006 and 2011 were analyzed. Patients in both groups were further differentiated by a diagnosis of either OA or RA. OA was the most common diagnosis, constituting 96.8% of all arthritic THA and TKA patients. From 2006 to 2011, a 36% and 34% increase in total number of THAs and TKAs, respectively, were reported. The number of patients with OA undergoing THA and TKA steadily increased from 2006 to 2011 (Figure 2). The number of THA and TKA procedures in patients with RA followed a similar trend but at a comparatively slower rate (Figure 3). The TKA geographical trends mirrored those observed with THA. The majority of operations were performed at urban hospitals (89% THA, 87% TKA; P < .0001). Among patients with RA and OA, the majority of TKAs (47.77%; P < .0001) took place in urban non-teaching hospitals than in urban teaching hospitals (39.26%). This pattern was not the same for THA, with 44.94% being performed at urban teaching hospitals and 44.05% at urban non-teaching institutions (P < .0001). Rural hospitals accounted for a low percentage of operations for both procedures: 10.46% of THA and 12.36% of TKA (P < .0001). Large institutions (based on the number of beds) claimed the majority of cases (59% of THA and TKA).

Logistic regression analysis and odds ratios of patients with OA vs those with RA with patient outcomes adjusted for age, Charlson Comorbidity Index (CCI) score, and gender revealed that patients with OA undergoing THA had lower risk for cardiovascular (0.674; confidence interval (CI) 0.587-0.774) and pulmonary complications (0.416; CI 0.384-0.450), wound dehiscence (0.647; CI 0.561-0.747), infections (0.258; CI 0.221-0.301), and systemic complications (0.625; CI 0.562-0.695) than patients with RA. Patients with OA exhibited statistically significantly higher odds of experiencing cerebrovascular complications after THA than those with RA (1.946; CI 1.673-2.236) (Table 3). In a similar logistic regression analysis of OA vs RA in TKA, which was adjusted for age, CCI score, and gender, patients with OA had significantly higher risk for cardiovascular (1.329; CI 1.069-1.651) and cerebrovascular complications (1.635; CI 1.375-1.943) than patients with RA. Significant decreases in wound dehiscence (0.757; CI 0.639-0.896), infection (0.331; CI 0.286-0.383), and systemic complication (0.641; CI 0.565-0.729) were noted in the patients with OA and TKA (Table 4).

Table 3. Odds Ratio for In-Hospital Complications Following THA for OA Patients vs RA Patients

Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis; THA, total hip arthroplasty.

Table 4. Odds Ratio for In-Hospital Complications Following TKA for OA Patients vs RA Patients

Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis; TKA, total knee arthroplasty.

Continue to: Discussion...

DISCUSSION

Our results showed a continuous yearly increase from 2006 to 2011 in THA and TKA procedures at a rate of 36% and 34%, respectively; this result was consistent with existing literature.¹¹ Despite a substantial increase in the amount of total THA and TKA procedures, the ratio of patients with RA undergoing these operations has decreased or remained nearly the same. Similar effects were found in Japan and the US when examining patients with RA undergoing TJA procedures between 2001 and 2007 and between 1992 and 2005, respectively.^12-14 This observation may be explained by the advances and early initiation of pharmacologic treatment and the widespread use of DMARDs such as methotrexate (MTX), azathioprine, leflunomide, hydroxychloroquine, and biological response modifiers TNF-α and interleukin-1.¹⁵ These medications have drastically improved survival rates of patients with RA with impressive capabilities in symptom relief.¹⁵ With the increasing use of DMARDs and aggressive treatment early on in the disease process, patients with RA are showing markedly slow progression of joint deterioration, leading to a decreased need for orthopedic intervention compared with the general population.^13,15

When analyzing the complication rates for patients undergoing TKA and THA, we observed that patients with RA exhibited a significant increase in the rates of infections, wound dehiscence, and systemic complications prior to discharge from the hospital compared with the OA population. The increased risk of infections was reported in previous studies assessing postoperative complication rates in TJA.^16,17 A study utilizing the Norwegian Arthroplasty Registry noted an increased risk of late infection in patients with RA, leading to increased rates of revision TJA in comparison with patients with OA.¹⁶ Another study, which was based on the Canadian Institute for Health Information Discharge Abstract Database, showed that patients with RA are at an increased risk of infection only after THA and interestingly not after TKA.¹⁷ Although our study did not identify the causes of the increased infection rate, the inherent nature of the disease and the immunomodulatory drugs used to treat it may contribute to this increased infectious risk in patients with RA.^6,18 Immunosuppressive DMARDs are some of the widely used medications employed to treat RA and are prime suspects of causing increased infection rates.¹⁵ The perioperative use of MTX has not been shown to cause short-term increases in infection for patients undergoing orthopedic intervention, but leflunomide and TNF-α inhibitors have been shown to cause a significant several-fold increase in risk for surgical wound infections.^19,20

All patients with RA presented with significant increases for infection, wound dehiscence, and systemic complications, whereas only patients with RA undergoing THA showed increased risk of pulmonary and cardiovascular complications when compared with patients with OA. Surprisingly, in TKA, patients with RA were at a significantly decreased risk of cardiovascular complications. This observation was interesting due to cardiovascular disease being one of RA's most notable extra-articular features.^4,21

Patients with RA undergoing TJA also showed significantly lower cerebrovascular complications than patients with OA. The significant reduction in risk for these complications has not been previously reported in the current literature, and it was an unexpected finding as past studies have found an increased risk in cerebrovascular disease in patients with RA. RA is an inflammatory disease exhibiting the upregulation of procoagulation factors,²² so we expected patients with RA to be at an increased risk for cerebrovascular and cardiovascular complications over patients with OA. Although we are unsure why these results were observed, we postulate that pharmaceutical interventions may confer some protection to patients with RA. For example, aspirin is commonly utilized in RA for its protective anti-platelet effect²³ and may be a contributing factor to why we found low postoperative complication rates in cerebrovascular disease. However, the reason why aspirin may be protective against cerebrovascular and not cardiovascular complications remains unclear. Moreover, most guidelines suggest that aspirin be stopped prior to surgery.²⁴ Although patients with RA were younger than those with OA, age was accounted for when analyzing the data.

A major strength of the study was the large sample size and the adjustment of potential confounding variables when examining the difference in complications between RA and OA. It is also a national US study that utilizes a validated database. Given that the patient samples in the NIS are reported in a uniform and de-identified manner, the database is considered ideal and has been extensively used for retrospective large observational cohort studies.²⁵ However, the study also had some limitations due to the retrospective and administrative nature of the NIS database. Only data concerning patient complications during their inpatient stay at the hospital were available. Patients who may develop complications following discharge were not included in the data, providing a very small window of time for analysis. Another limitation with the database was its lack of ability to identify the severity of each patient's disease process or the medical treatment they received perioperatively. Finally, no patient-reported outcomes were determined, which would provide information on whether these complications affect the patients’ postoperational satisfaction in regard to their pain and disability.

CONCLUSION

As RA patients continue to utilize joint arthroplasty to repair deteriorated joints, understanding of how the disease process and its medical management may impact patient outcomes is important. This article reports significantly higher postoperational infection rates in RA than in patients with OA, which may be due to the medical management of the disease. Although new medications have been introduced and are being used to treat patients with RA, they have not altered the complication rate following TJA in this patient population. Thus, surgeons and other members of the management team should be familiar with the common medical conditions, co-morbidities, and medical treatments/side effects that are encountered in patients with RA. Future studies should delve into possible differences in long-term outcomes of patients with RA undergoing TKA and THA, as well as whether certain perioperative strategies and therapies (medical or physical) may decrease complications and improve outcomes.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

Current literature regarding complications following total joint arthroplasty have primarily focused on patients with osteoarthritis (OA), with less emphasis on the trends and in-hospital outcomes of rheumatoid arthritis (RA) patients undergoing these procedures. The purpose of this study is to analyze the outcomes and trends of RA patients undergoing total knee arthroplasty (TKA) or total hip arthroplasty (THA) compared to OA patients.

Data from the Nationwide Inpatient Sample from 2006 to 2011 was extracted using the International Classification of Diseases, Ninth Revision codes for patients that received a TKA or THA. Outcome measures included cardiovascular complications, cerebrovascular complications, pulmonary complications, wound dehiscence, and infection. Inpatient and hospital demographics including primary diagnosis, age, gender, primary payer, hospital teaching status, Charlson Comorbidity Index score, hospital bed size, location, and median household income were analyzed.

Logistic regression analysis of OA vs RA patients with patient outcomes revealed that osteoarthritic THA candidates had lower risk for cardiovascular complications, pulmonary complications, wound dehiscence, infections, and systemic complications, compared to rheumatoid patients. There was a significantly elevated risk of cerebrovascular complication in osteoarthritic THA compared to RA THA. OA patients undergoing TKA had significantly higher risk for cardiovascular and cerebrovascular complications. There were significant decreases in mechanical wounds, infection, and systemic complications in the OA TKA patients.

RA patients are at higher risk for postoperative infection, wound dehiscence, and systemic complications after TKA and THA compared to OA patients. These findings highlight the importance of preoperative medical clearance and management to optimize RA patients and improve the postoperative outcomes.

Continue to: RA is a chronic systemic inflammatory disease...

Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease that causes joint deterioration, leading to pain, disability, systemic complications, short lifespan, and decline in quality of life.^1-3 The deterioration primarily affects the synovial membranes of joints, causing arthritis and resulting in extra-articular sequelae such as cardiovascular disease,⁴ pulmonary disease,⁵ and increased infection rates.^3,6 RA is the most prevalent inflammatory arthritis worldwide and affects up to 50 cases per 100,000 in both the US and northern Europe.^2,7-9 Although the gold standard of care for these patients is medical management with immunosuppressant drugs such as disease-modifying anti-rheumatic drugs (DMARDs), total joint arthroplasty (TJA) remains an important tool in the management of joint deterioration in such patients.

Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are common procedures utilized to treat disorders that cause joint pain and hindered joint mobility, including osteoarthritis (OA) and RA. Given the aging population, the amount of TKAs and THAs performed in the US has consistently increased each year, with the vast majority of this increase composed of patients with OA.¹⁰ As a result, previous studies investigated the trends and outcomes of these procedures in patients with OA, but relatively less is known about the outcomes and trends of patients with RA undergoing the same surgeries.

Given that RA is a fundamentally different condition with its own pathological characteristics, an understanding of how these differences may impact postoperative outcomes in patients with RA is important. This study aims to present a comparative analysis of the trends and postoperative outcomes between patients with RA and OA undergoing TKA and THA (Figure 1, Tables 1 and 2).

Table 1. Demographics of Total Knee Arthroplasty Patients Based on Primary Diagnosis of Osteoarthritis

Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis.

Table 2. Demographics of Total Hip Arthroplasty Patients Based on Primary Diagnosis of Osteoarthritis or Rheumatoid Arthritis

Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis

Continue to: Methods...

METHODS

Exemptions were obtained from the Institutional Review Board. Data from the Nationwide Inpatient Sample (NIS) from 2006 to 2011 were extracted using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes for patients that received primary TKA or THA, as well as their comorbid conditions. No patients or populations were excluded from the sampling process. A list of all independent variables collected for analysis and provision of relevant ICD-9 codes is included in Figure 1. The NIS is the largest all-payer stratified survey of inpatient care in the US healthcare system. As of 2011, each year provides information on approximately 8 million inpatient stays from about 1000 hospitals in 46 states. All discharges from sampled hospitals are also represented in the database. All patient information is protected, and all methods were conducted in accordance with the highest ethical standards of Human and Animal Rights Research.

STATISTICAL ANALYSIS

SAS 9.2 and PROC FREQ statistics software were used to generate P values (chi square result) and analyze the trends (Cochran-Armitage). Results were weighted utilizing standard discharge weights from the NIS to ensure accurate comparison of data from different time points. P < .05 was considered statistically significant. Multivariable logistic regression analyses were performed to generate odds ratio and 95% confidence limits to assess outcomes across different demographic variables.

RESULTS

Data on 337,082 and 1,362,241 patients undergoing THA or TKA, respectively, between 2006 and 2011 were analyzed. Patients in both groups were further differentiated by a diagnosis of either OA or RA. OA was the most common diagnosis, constituting 96.8% of all arthritic THA and TKA patients. From 2006 to 2011, a 36% and 34% increase in total number of THAs and TKAs, respectively, were reported. The number of patients with OA undergoing THA and TKA steadily increased from 2006 to 2011 (Figure 2). The number of THA and TKA procedures in patients with RA followed a similar trend but at a comparatively slower rate (Figure 3). The TKA geographical trends mirrored those observed with THA. The majority of operations were performed at urban hospitals (89% THA, 87% TKA; P < .0001). Among patients with RA and OA, the majority of TKAs (47.77%; P < .0001) took place in urban non-teaching hospitals than in urban teaching hospitals (39.26%). This pattern was not the same for THA, with 44.94% being performed at urban teaching hospitals and 44.05% at urban non-teaching institutions (P < .0001). Rural hospitals accounted for a low percentage of operations for both procedures: 10.46% of THA and 12.36% of TKA (P < .0001). Large institutions (based on the number of beds) claimed the majority of cases (59% of THA and TKA).

Logistic regression analysis and odds ratios of patients with OA vs those with RA with patient outcomes adjusted for age, Charlson Comorbidity Index (CCI) score, and gender revealed that patients with OA undergoing THA had lower risk for cardiovascular (0.674; confidence interval (CI) 0.587-0.774) and pulmonary complications (0.416; CI 0.384-0.450), wound dehiscence (0.647; CI 0.561-0.747), infections (0.258; CI 0.221-0.301), and systemic complications (0.625; CI 0.562-0.695) than patients with RA. Patients with OA exhibited statistically significantly higher odds of experiencing cerebrovascular complications after THA than those with RA (1.946; CI 1.673-2.236) (Table 3). In a similar logistic regression analysis of OA vs RA in TKA, which was adjusted for age, CCI score, and gender, patients with OA had significantly higher risk for cardiovascular (1.329; CI 1.069-1.651) and cerebrovascular complications (1.635; CI 1.375-1.943) than patients with RA. Significant decreases in wound dehiscence (0.757; CI 0.639-0.896), infection (0.331; CI 0.286-0.383), and systemic complication (0.641; CI 0.565-0.729) were noted in the patients with OA and TKA (Table 4).

Table 3. Odds Ratio for In-Hospital Complications Following THA for OA Patients vs RA Patients

Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis; THA, total hip arthroplasty.

Table 4. Odds Ratio for In-Hospital Complications Following TKA for OA Patients vs RA Patients

Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis; TKA, total knee arthroplasty.

Continue to: Discussion...

DISCUSSION

Our results showed a continuous yearly increase from 2006 to 2011 in THA and TKA procedures at a rate of 36% and 34%, respectively; this result was consistent with existing literature.¹¹ Despite a substantial increase in the amount of total THA and TKA procedures, the ratio of patients with RA undergoing these operations has decreased or remained nearly the same. Similar effects were found in Japan and the US when examining patients with RA undergoing TJA procedures between 2001 and 2007 and between 1992 and 2005, respectively.^12-14 This observation may be explained by the advances and early initiation of pharmacologic treatment and the widespread use of DMARDs such as methotrexate (MTX), azathioprine, leflunomide, hydroxychloroquine, and biological response modifiers TNF-α and interleukin-1.¹⁵ These medications have drastically improved survival rates of patients with RA with impressive capabilities in symptom relief.¹⁵ With the increasing use of DMARDs and aggressive treatment early on in the disease process, patients with RA are showing markedly slow progression of joint deterioration, leading to a decreased need for orthopedic intervention compared with the general population.^13,15

When analyzing the complication rates for patients undergoing TKA and THA, we observed that patients with RA exhibited a significant increase in the rates of infections, wound dehiscence, and systemic complications prior to discharge from the hospital compared with the OA population. The increased risk of infections was reported in previous studies assessing postoperative complication rates in TJA.^16,17 A study utilizing the Norwegian Arthroplasty Registry noted an increased risk of late infection in patients with RA, leading to increased rates of revision TJA in comparison with patients with OA.¹⁶ Another study, which was based on the Canadian Institute for Health Information Discharge Abstract Database, showed that patients with RA are at an increased risk of infection only after THA and interestingly not after TKA.¹⁷ Although our study did not identify the causes of the increased infection rate, the inherent nature of the disease and the immunomodulatory drugs used to treat it may contribute to this increased infectious risk in patients with RA.^6,18 Immunosuppressive DMARDs are some of the widely used medications employed to treat RA and are prime suspects of causing increased infection rates.¹⁵ The perioperative use of MTX has not been shown to cause short-term increases in infection for patients undergoing orthopedic intervention, but leflunomide and TNF-α inhibitors have been shown to cause a significant several-fold increase in risk for surgical wound infections.^19,20

All patients with RA presented with significant increases for infection, wound dehiscence, and systemic complications, whereas only patients with RA undergoing THA showed increased risk of pulmonary and cardiovascular complications when compared with patients with OA. Surprisingly, in TKA, patients with RA were at a significantly decreased risk of cardiovascular complications. This observation was interesting due to cardiovascular disease being one of RA's most notable extra-articular features.^4,21

Patients with RA undergoing TJA also showed significantly lower cerebrovascular complications than patients with OA. The significant reduction in risk for these complications has not been previously reported in the current literature, and it was an unexpected finding as past studies have found an increased risk in cerebrovascular disease in patients with RA. RA is an inflammatory disease exhibiting the upregulation of procoagulation factors,²² so we expected patients with RA to be at an increased risk for cerebrovascular and cardiovascular complications over patients with OA. Although we are unsure why these results were observed, we postulate that pharmaceutical interventions may confer some protection to patients with RA. For example, aspirin is commonly utilized in RA for its protective anti-platelet effect²³ and may be a contributing factor to why we found low postoperative complication rates in cerebrovascular disease. However, the reason why aspirin may be protective against cerebrovascular and not cardiovascular complications remains unclear. Moreover, most guidelines suggest that aspirin be stopped prior to surgery.²⁴ Although patients with RA were younger than those with OA, age was accounted for when analyzing the data.

A major strength of the study was the large sample size and the adjustment of potential confounding variables when examining the difference in complications between RA and OA. It is also a national US study that utilizes a validated database. Given that the patient samples in the NIS are reported in a uniform and de-identified manner, the database is considered ideal and has been extensively used for retrospective large observational cohort studies.²⁵ However, the study also had some limitations due to the retrospective and administrative nature of the NIS database. Only data concerning patient complications during their inpatient stay at the hospital were available. Patients who may develop complications following discharge were not included in the data, providing a very small window of time for analysis. Another limitation with the database was its lack of ability to identify the severity of each patient's disease process or the medical treatment they received perioperatively. Finally, no patient-reported outcomes were determined, which would provide information on whether these complications affect the patients’ postoperational satisfaction in regard to their pain and disability.

CONCLUSION

As RA patients continue to utilize joint arthroplasty to repair deteriorated joints, understanding of how the disease process and its medical management may impact patient outcomes is important. This article reports significantly higher postoperational infection rates in RA than in patients with OA, which may be due to the medical management of the disease. Although new medications have been introduced and are being used to treat patients with RA, they have not altered the complication rate following TJA in this patient population. Thus, surgeons and other members of the management team should be familiar with the common medical conditions, co-morbidities, and medical treatments/side effects that are encountered in patients with RA. Future studies should delve into possible differences in long-term outcomes of patients with RA undergoing TKA and THA, as well as whether certain perioperative strategies and therapies (medical or physical) may decrease complications and improve outcomes.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

Current literature regarding complications following total joint arthroplasty have primarily focused on patients with osteoarthritis (OA), with less emphasis on the trends and in-hospital outcomes of rheumatoid arthritis (RA) patients undergoing these procedures. The purpose of this study is to analyze the outcomes and trends of RA patients undergoing total knee arthroplasty (TKA) or total hip arthroplasty (THA) compared to OA patients.

Data from the Nationwide Inpatient Sample from 2006 to 2011 was extracted using the International Classification of Diseases, Ninth Revision codes for patients that received a TKA or THA. Outcome measures included cardiovascular complications, cerebrovascular complications, pulmonary complications, wound dehiscence, and infection. Inpatient and hospital demographics including primary diagnosis, age, gender, primary payer, hospital teaching status, Charlson Comorbidity Index score, hospital bed size, location, and median household income were analyzed.

Logistic regression analysis of OA vs RA patients with patient outcomes revealed that osteoarthritic THA candidates had lower risk for cardiovascular complications, pulmonary complications, wound dehiscence, infections, and systemic complications, compared to rheumatoid patients. There was a significantly elevated risk of cerebrovascular complication in osteoarthritic THA compared to RA THA. OA patients undergoing TKA had significantly higher risk for cardiovascular and cerebrovascular complications. There were significant decreases in mechanical wounds, infection, and systemic complications in the OA TKA patients.

RA patients are at higher risk for postoperative infection, wound dehiscence, and systemic complications after TKA and THA compared to OA patients. These findings highlight the importance of preoperative medical clearance and management to optimize RA patients and improve the postoperative outcomes.

Continue to: RA is a chronic systemic inflammatory disease...

Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease that causes joint deterioration, leading to pain, disability, systemic complications, short lifespan, and decline in quality of life.^1-3 The deterioration primarily affects the synovial membranes of joints, causing arthritis and resulting in extra-articular sequelae such as cardiovascular disease,⁴ pulmonary disease,⁵ and increased infection rates.^3,6 RA is the most prevalent inflammatory arthritis worldwide and affects up to 50 cases per 100,000 in both the US and northern Europe.^2,7-9 Although the gold standard of care for these patients is medical management with immunosuppressant drugs such as disease-modifying anti-rheumatic drugs (DMARDs), total joint arthroplasty (TJA) remains an important tool in the management of joint deterioration in such patients.

Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are common procedures utilized to treat disorders that cause joint pain and hindered joint mobility, including osteoarthritis (OA) and RA. Given the aging population, the amount of TKAs and THAs performed in the US has consistently increased each year, with the vast majority of this increase composed of patients with OA.¹⁰ As a result, previous studies investigated the trends and outcomes of these procedures in patients with OA, but relatively less is known about the outcomes and trends of patients with RA undergoing the same surgeries.

Given that RA is a fundamentally different condition with its own pathological characteristics, an understanding of how these differences may impact postoperative outcomes in patients with RA is important. This study aims to present a comparative analysis of the trends and postoperative outcomes between patients with RA and OA undergoing TKA and THA (Figure 1, Tables 1 and 2).

Table 1. Demographics of Total Knee Arthroplasty Patients Based on Primary Diagnosis of Osteoarthritis

Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis.

Table 2. Demographics of Total Hip Arthroplasty Patients Based on Primary Diagnosis of Osteoarthritis or Rheumatoid Arthritis

Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis

Continue to: Methods...

METHODS

Exemptions were obtained from the Institutional Review Board. Data from the Nationwide Inpatient Sample (NIS) from 2006 to 2011 were extracted using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes for patients that received primary TKA or THA, as well as their comorbid conditions. No patients or populations were excluded from the sampling process. A list of all independent variables collected for analysis and provision of relevant ICD-9 codes is included in Figure 1. The NIS is the largest all-payer stratified survey of inpatient care in the US healthcare system. As of 2011, each year provides information on approximately 8 million inpatient stays from about 1000 hospitals in 46 states. All discharges from sampled hospitals are also represented in the database. All patient information is protected, and all methods were conducted in accordance with the highest ethical standards of Human and Animal Rights Research.

STATISTICAL ANALYSIS

SAS 9.2 and PROC FREQ statistics software were used to generate P values (chi square result) and analyze the trends (Cochran-Armitage). Results were weighted utilizing standard discharge weights from the NIS to ensure accurate comparison of data from different time points. P < .05 was considered statistically significant. Multivariable logistic regression analyses were performed to generate odds ratio and 95% confidence limits to assess outcomes across different demographic variables.

RESULTS

Data on 337,082 and 1,362,241 patients undergoing THA or TKA, respectively, between 2006 and 2011 were analyzed. Patients in both groups were further differentiated by a diagnosis of either OA or RA. OA was the most common diagnosis, constituting 96.8% of all arthritic THA and TKA patients. From 2006 to 2011, a 36% and 34% increase in total number of THAs and TKAs, respectively, were reported. The number of patients with OA undergoing THA and TKA steadily increased from 2006 to 2011 (Figure 2). The number of THA and TKA procedures in patients with RA followed a similar trend but at a comparatively slower rate (Figure 3). The TKA geographical trends mirrored those observed with THA. The majority of operations were performed at urban hospitals (89% THA, 87% TKA; P < .0001). Among patients with RA and OA, the majority of TKAs (47.77%; P < .0001) took place in urban non-teaching hospitals than in urban teaching hospitals (39.26%). This pattern was not the same for THA, with 44.94% being performed at urban teaching hospitals and 44.05% at urban non-teaching institutions (P < .0001). Rural hospitals accounted for a low percentage of operations for both procedures: 10.46% of THA and 12.36% of TKA (P < .0001). Large institutions (based on the number of beds) claimed the majority of cases (59% of THA and TKA).

Logistic regression analysis and odds ratios of patients with OA vs those with RA with patient outcomes adjusted for age, Charlson Comorbidity Index (CCI) score, and gender revealed that patients with OA undergoing THA had lower risk for cardiovascular (0.674; confidence interval (CI) 0.587-0.774) and pulmonary complications (0.416; CI 0.384-0.450), wound dehiscence (0.647; CI 0.561-0.747), infections (0.258; CI 0.221-0.301), and systemic complications (0.625; CI 0.562-0.695) than patients with RA. Patients with OA exhibited statistically significantly higher odds of experiencing cerebrovascular complications after THA than those with RA (1.946; CI 1.673-2.236) (Table 3). In a similar logistic regression analysis of OA vs RA in TKA, which was adjusted for age, CCI score, and gender, patients with OA had significantly higher risk for cardiovascular (1.329; CI 1.069-1.651) and cerebrovascular complications (1.635; CI 1.375-1.943) than patients with RA. Significant decreases in wound dehiscence (0.757; CI 0.639-0.896), infection (0.331; CI 0.286-0.383), and systemic complication (0.641; CI 0.565-0.729) were noted in the patients with OA and TKA (Table 4).

Table 3. Odds Ratio for In-Hospital Complications Following THA for OA Patients vs RA Patients

Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis; THA, total hip arthroplasty.

Table 4. Odds Ratio for In-Hospital Complications Following TKA for OA Patients vs RA Patients

Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis; TKA, total knee arthroplasty.

Continue to: Discussion...

DISCUSSION

Our results showed a continuous yearly increase from 2006 to 2011 in THA and TKA procedures at a rate of 36% and 34%, respectively; this result was consistent with existing literature.¹¹ Despite a substantial increase in the amount of total THA and TKA procedures, the ratio of patients with RA undergoing these operations has decreased or remained nearly the same. Similar effects were found in Japan and the US when examining patients with RA undergoing TJA procedures between 2001 and 2007 and between 1992 and 2005, respectively.^12-14 This observation may be explained by the advances and early initiation of pharmacologic treatment and the widespread use of DMARDs such as methotrexate (MTX), azathioprine, leflunomide, hydroxychloroquine, and biological response modifiers TNF-α and interleukin-1.¹⁵ These medications have drastically improved survival rates of patients with RA with impressive capabilities in symptom relief.¹⁵ With the increasing use of DMARDs and aggressive treatment early on in the disease process, patients with RA are showing markedly slow progression of joint deterioration, leading to a decreased need for orthopedic intervention compared with the general population.^13,15

When analyzing the complication rates for patients undergoing TKA and THA, we observed that patients with RA exhibited a significant increase in the rates of infections, wound dehiscence, and systemic complications prior to discharge from the hospital compared with the OA population. The increased risk of infections was reported in previous studies assessing postoperative complication rates in TJA.^16,17 A study utilizing the Norwegian Arthroplasty Registry noted an increased risk of late infection in patients with RA, leading to increased rates of revision TJA in comparison with patients with OA.¹⁶ Another study, which was based on the Canadian Institute for Health Information Discharge Abstract Database, showed that patients with RA are at an increased risk of infection only after THA and interestingly not after TKA.¹⁷ Although our study did not identify the causes of the increased infection rate, the inherent nature of the disease and the immunomodulatory drugs used to treat it may contribute to this increased infectious risk in patients with RA.^6,18 Immunosuppressive DMARDs are some of the widely used medications employed to treat RA and are prime suspects of causing increased infection rates.¹⁵ The perioperative use of MTX has not been shown to cause short-term increases in infection for patients undergoing orthopedic intervention, but leflunomide and TNF-α inhibitors have been shown to cause a significant several-fold increase in risk for surgical wound infections.^19,20

All patients with RA presented with significant increases for infection, wound dehiscence, and systemic complications, whereas only patients with RA undergoing THA showed increased risk of pulmonary and cardiovascular complications when compared with patients with OA. Surprisingly, in TKA, patients with RA were at a significantly decreased risk of cardiovascular complications. This observation was interesting due to cardiovascular disease being one of RA's most notable extra-articular features.^4,21

Patients with RA undergoing TJA also showed significantly lower cerebrovascular complications than patients with OA. The significant reduction in risk for these complications has not been previously reported in the current literature, and it was an unexpected finding as past studies have found an increased risk in cerebrovascular disease in patients with RA. RA is an inflammatory disease exhibiting the upregulation of procoagulation factors,²² so we expected patients with RA to be at an increased risk for cerebrovascular and cardiovascular complications over patients with OA. Although we are unsure why these results were observed, we postulate that pharmaceutical interventions may confer some protection to patients with RA. For example, aspirin is commonly utilized in RA for its protective anti-platelet effect²³ and may be a contributing factor to why we found low postoperative complication rates in cerebrovascular disease. However, the reason why aspirin may be protective against cerebrovascular and not cardiovascular complications remains unclear. Moreover, most guidelines suggest that aspirin be stopped prior to surgery.²⁴ Although patients with RA were younger than those with OA, age was accounted for when analyzing the data.

A major strength of the study was the large sample size and the adjustment of potential confounding variables when examining the difference in complications between RA and OA. It is also a national US study that utilizes a validated database. Given that the patient samples in the NIS are reported in a uniform and de-identified manner, the database is considered ideal and has been extensively used for retrospective large observational cohort studies.²⁵ However, the study also had some limitations due to the retrospective and administrative nature of the NIS database. Only data concerning patient complications during their inpatient stay at the hospital were available. Patients who may develop complications following discharge were not included in the data, providing a very small window of time for analysis. Another limitation with the database was its lack of ability to identify the severity of each patient's disease process or the medical treatment they received perioperatively. Finally, no patient-reported outcomes were determined, which would provide information on whether these complications affect the patients’ postoperational satisfaction in regard to their pain and disability.

CONCLUSION

As RA patients continue to utilize joint arthroplasty to repair deteriorated joints, understanding of how the disease process and its medical management may impact patient outcomes is important. This article reports significantly higher postoperational infection rates in RA than in patients with OA, which may be due to the medical management of the disease. Although new medications have been introduced and are being used to treat patients with RA, they have not altered the complication rate following TJA in this patient population. Thus, surgeons and other members of the management team should be familiar with the common medical conditions, co-morbidities, and medical treatments/side effects that are encountered in patients with RA. Future studies should delve into possible differences in long-term outcomes of patients with RA undergoing TKA and THA, as well as whether certain perioperative strategies and therapies (medical or physical) may decrease complications and improve outcomes.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

The articular surface replacement (ASR) monoblock metal-on-metal acetabular component was recalled due to a higher than expected early failure rate. We evaluated the survivorship of the device and variables that may be predictive of failure at a minimum of 5-year follow-up. A single-center, single-surgeon retrospective review was conducted in patients who received the DePuy Synthes ASR™ XL Acetabular hip system from December 2005 to November 2009. Mean values and percentages were calculated and compared using the Fisher’s exact test, simple logistic regression, and Student’s t-test. The significance level was P ≤ .05. This study included 29 patients (24 males, 5 females) with 32 ASR™ XL acetabular hip systems. Mean age and body mass index (BMI) reached 55.2 years and 28.9 kg/m², respectively. Mean postoperative follow-up was 6.2 years. A total of 2 patients (6.9%) died of an unrelated cause and 1 patient was lost to follow-up (3.4%), leaving 26 patients with 28 hip replacements, all of whom were available for follow-up. The 5-year revision rate was 34.4% (10 patients with 11 hip replacements). Mean time to revision was 3.1 years. Age (P = .76), gender (P = .49), BMI (P = .29), acetabular component abduction angle (P = .12), and acetabulum size (P = .59) were not associated with the increased rate for hip failure. Blood cobalt (7.6 vs 6.8 µg/L, P = .58) and chromium (5.0 vs 2.2 µg/L, P = .31) levels were not significantly higher in the revised group when compared with those of the unrevised group. In the revised group, a 91% decrease in cobalt and 78% decrease in chromium levels were observed at a mean of 6 months following the revision. This study demonstrates a high rate of failure of ASR acetabular components used in total hip arthroplasty at a minimum of 5 years of follow-up. No variable that was predictive of failure could be identified in this series. Close clinical surveillance of these patients is required.

Continue to: Metal-on-metal...

Metal-on-metal (MoM) articulations have been widely explored as an alternative to polyethylene bearings in total hip arthroplasty (THA), with proposed benefits including improved range of motion, lower dislocation rates, and enhanced durability.¹ Comprising cobalt and chromium, these MoM bearings gained widespread popularity in the United States, particularly in younger and more active patients looking for longer lasting devices.

The articular surface replacement (ASR) acetabular system (DePuy Synthes) was approved for sale by the US Food and Drug Administration in 2003 and implanted in an estimated 93,000 cases.² Since then, however, the early failure rate of the prosthesis has been well documented,^3-5 leading to a formal global product recall in August 2010. The Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) was amongst the first to report a 6.4% rate of failure of the device at 3 years when inserted with a Corail stem.⁶ An acceptable upper rate of hip prosthesis failure is considered to reach 1% per year, with the majority of implants reporting well below this value. A 10.9% failure rate at 5 years was documented when the prosthesis was inserted for resurfacing. The National Joint Registry of England and Wales confirmed these findings and observed a 13% and 12% rate of failure at 5 years for the acetabular and resurfacing systems, respectively.² With the notable failure of the ASR system, this study reports our single-center 5-year survivorship experience and evaluates any variable that might be predictive of an early failure to aid in patient counseling.

METHODS

A single-center, single-surgeon, retrospective review of a consecutive series of patients was performed from December 2005 to November 2009. This study included all patients who underwent a primary THA with a DePuy Synthes ASR™ XL Acetabular hip system. No patients were excluded. Institutional Review Board approval was obtained. Patient demographics comprising of age, gender, and body mass index (BMI) were recorded. The primary endpoint of this study was 5-year survivorship rates. Secondary endpoints included duration to revision surgery, blood cobalt and chromium levels, time interval of blood ion tests, acetabulum size, acetabular component abduction angle, and duration to follow-up.

Candidates for the ASR™ XL Acetabular hip system included young patients and/or those considered to be physically active. In a select few, ASR devices were implanted upon patient request.

All patients underwent primary total hip replacement with a DePuy Synthes ASR™ XL uncemented acetabular component and an uncemented femoral stem (DePuy Synthes, Summit, or Tri-Lock) inserted via a standard posterior approach (Figure 1). Acetabulum sizes ranged from 52 mm to 68 mm in diameter.

All patients were followed-up yearly in the outpatient setting. Routine (yearly) metal-ion level sampling (whole blood) was started in 2010 for all patients. Laboratory tests were conducted at a single laboratory (Lab Corp.). Abduction cup inclination angles were measured by the providing surgeon using digital radiology software (GE Centricity systems).

The Student’s t-test was used to compare mean values (such as age, BMI, and metal ion levels) between the failure and no-failure groups. The 2-sided Fisher’s exact test analyzed differences in gender. Simple logistic regression analyzed variables associated with the failure group. Significance was P ≤ .05.

Continue to: Results...

RESULTS

A total of 29 patients (24 males, 5 females) with 32 ASR hip replacements were included in this study. Indications for surgery comprised osteoarthritis (28 hips, 87.5%) and avascular necrosis of the hip (4 hips, 12.5%). Mean age and BMI were 55.2 years and 28.9 kg/m², respectively. A total of 2 patients (6.9%) died of an unrelated cause (1 myocardial infarct, 1 suicide), and 1 patient was lost to follow-up (3.4%), leaving 26 patients with 28 hip replacements, all of whom finished a 5-year minimum follow-up.

No implant failures were noted in the first year. The 5-year revision rate reached 34.4% (10 patients with 11 hip replacements). Mean time to revision for this subgroup was 3.1 years. Overall, an implant failure was observed in 37.5% of patients (11 patients with 12 hip replacements) at a mean postoperative follow-up of 6.2 years (Figure 2). Indications for implant revision were pain in 11 (92.7%) cases and infection in 1 (8.3%).

Of the 11 hips revised due to pain, 9 were performed by the original surgeon (8 were completed with primary acetabular components, 1 with a revision shell). Figure 3 shows a bilateral revision performed with primary acetabular components and retained DePuy Synthes Pinnacle femoral stems. In all these cases except 1, the ASR component was grossly loose. One case presented with pseudotumor and impingement between the femoral prosthetic neck and acetabular component after migration of a loose component. After revision, the patient returned with substantial anterior hip pain and heterotopic ossification, and failed conservative treatment, requiring another surgery with prosthesis retention, removal of heterotopic ossification, and iliopsoas lengthening. The surgery successfully relieved the symptoms. No other patients required additional surgery after their revision. In comparison to the original ASR component, the revision shell was 2 to 4 mm larger in diameter. No patient required component revision at a mean of 2.9 years after the revision surgery.

The patient with secondary revision developed a hematogenous streptococcal infection after a dental procedure performed without prophylactic antibiotics. The patient was initially lost to follow-up after the primary surgery and reported no antecedent pain prior to the revision. A substantial metal fluid collection was identified in the hip at the time of débridement and without component loosening. After débridement, the patient developed persistent metal stained wound drainage, necessitating ultimate successful treatment with a 2-stage exchange procedure.

Age (P = .76), gender (P = .49), BMI (P = .29), acetabular component abduction angle (P = .12), and acetabulum size (P = .59) were not associated with an increased rate for hip failure (Table). Blood cobalt (7.6 vs 6.8 µg/L, P = .58) and chromium (5.0 vs 2.2 µg/L, P = .31) levels were not significantly higher in the revised group when compared with those of the unrevised group. The upper limits of blood cobalt and chromium levels reached 18.9 and 15.9 µg/L for the revised group and 16.8 and 5.4 µg/L for the non-revised group, respectively. In the revised group, a 91% decrease in cobalt and 78% decrease in chromium levels were observed at a mean of 6 months after the revision (Figure 4).

Table. Variables Not Associated with Early ASR Failure

Continue to: Discussion...

DISCUSSION

According to the Center for Disease Control and Prevention, 310,800 total hip replacements were performed among inpatients aged 45 years and older in the US in 2010.⁷ Specifically, in the 55- to 64-year-old age group, the number of procedures performed tripled from 2000 through 2010. As younger and more active patients opt for hip replacements, a growing need for prosthesis with enhanced durability is observed.

Despite the early proposed advantages of large head MoM bearings, our retrospective study of the DePuy Synthes ASR™ XL Acetabular hip system yielded 15.6% and 34.4% failure rates at 3 and 5 years, respectively. These higher-than-expected rates of failure are consistent with published data. The British Hip Society reported a 21% to 35% revision rate at 4 years and 49% at 6 years for the ASR XL prosthesis.⁸ In comparison, other MoM prosthesis, on average, report a 12% to 15% rate of failure at 5 years.

Considerable controversy surrounds the causes of adverse wear failure in MoM bearings.^9,10 The non-modular design of the ASR prostheses is frequently implicated as a cause of early failure. The lack of a central hole in the 1-piece component compromises the tactile feel of insertion, thereby reducing the surgeon’s ability to assess complete seating.¹¹ This condition may potentially increase the abduction angle at the time of insertion. Screw fixation of the non-modular device is not possible. The ASR XL device (148^° to 160^°) is less than a hemisphere (180^°) in size and hence features a diminished functional articular surface, further compromising implant fixation.¹¹ The functional articular surface is defined as the optimal surface area (10 mm) needed for a MoM implant.¹² Griffin and colleagues¹³ reported a 48 mm ASR XL component, when implanted at 45^° of abduction, to function similar to an implant at 59^° of abduction, leading to diminished lubrication, metallosis, and edge loading. The version of the acetabular component may similarly and adversely affect implant wear characteristics. Furthermore, the variable thickness of the implant, which is thicker at the dome and thinner at the rim, may further promote edge loading by shifting the center of rotation of the femoral head out from the center of the acetabular prosthesis.¹¹ Studies have also shown that increased wear of the MoM articulation is associated with an acetabular component inclination angle in excess of 55^°10,14 and a failure of fixation at time of implantation.¹⁵ This study, however, found no correlation between the abduction angle and risk of early implant failure for the ASR acetabular component. No correlation was also detected between the acetabulum size and revision surgery.

The AOANJRR reported loosening (44%), infection (20%), metal sensitivity (12%), fracture (9%), and dislocation of prosthesis (7%) as the indications for revision surgery for the ASR prosthesis.⁶ Furthermore, a single-center retrospective review of 70 consecutive MoM THAs with ultra-large diameter femoral head and monoblock acetabular components showed that 17.1% required revision within 3 years for loosening, pain, and squeaking.¹ Overall, 28.6% of patients reported implant dysfunction. In this study, we observed a similar rate of failure at 3 years (15.6%) for pain (11) and infection (1). The revision surgery successfully relieved all of these symptoms. One patient presented with heterotopic ossification and anterior hip pain after the original revision and required additional surgery with prosthesis retention. No patient in this series required repeat component revisions at a mean of 2.9 years after surgery. In all but 1 case, primary acetabular components were used in the revision, and in all cases except that with infection, the femoral component was retained. Replacement shells were 2 to 4 mm larger in diameter than the original ASR component.

Recently, concerns have arisen regarding the long-term effects of serum cobalt and chromium metal ions levels. Studies have shown increased serum metal ion levels,¹⁵ groin pain,¹⁶ pseudotumor formation,¹⁷ and metallosis¹⁸ after the implantation of MoM bearings. In a case study by Mao and colleagues,¹⁹ 1 patient reported headaches, anorexia, continuous metallic taste in her mouth, and weight loss. A cerebrospinal fluid analysis revealed cobalt and chromium levels at 9 and 13 nmol/L, respectively, indicating that these metal ions can cross the blood-brain barrier. Another patient reported painful muscle fatigue, night cramps, fainting spells, cognitive decline, and an inability to climb stairs. His serum cobalt level reached 258 nmol/L (reference range, 0-20 nmol/L), and chromium level totaled 88 nmol/L (reference range, 0-100 nmol/L). At 8-week follow-up after revision surgery, the symptoms of the patient had resolved, with serum cobalt levels dropping to 42 nmol/L.¹⁹ None of the patients in this study presented with any signs or symptoms of metal toxicity. The upper limits of blood cobalt and chromium levels in our study population reached 18.9 and 15.9 µg/L for the revised group and 16.8 and 5.4 µg/L for the non-revised group, respectively. However, we noted a similar drop in post-revision blood cobalt (91% decrease) and chromium (78% decrease) levels.

In summary, our data showed a high revision rate of the DePuy Synthes ASR™ XL Acetabular hip system. Our findings are consistent with internationally published data. In the absence of reliable predictors of early failure, continued close clinical surveillance and laboratory monitoring of these patients are warranted.

CONCLUSION

This study demonstrates the high failure rate of the DePuy Synthes ASR™ XL Acetabular hip system used in THA at a minimum of 5 years of follow-up. No variable that was predictive of failure could be identified in this series. Close clinical surveillance of these patients is therefore required. Metal levels dropped quickly after revision, and the revision surgery can generally be performed with slightly larger primary components. Symptomatic patients with ASR hip replacements, regardless of blood metal-ion levels, were candidates for the revision surgery. Not all failed hips exhibited substantially elevated metal levels. Asymptomatic patients with high blood metal-ion levels should be closely followed-up and revision surgery should be strongly considered, consistent with recently published guidelines.²⁰

ABSTRACT

The articular surface replacement (ASR) monoblock metal-on-metal acetabular component was recalled due to a higher than expected early failure rate. We evaluated the survivorship of the device and variables that may be predictive of failure at a minimum of 5-year follow-up. A single-center, single-surgeon retrospective review was conducted in patients who received the DePuy Synthes ASR™ XL Acetabular hip system from December 2005 to November 2009. Mean values and percentages were calculated and compared using the Fisher’s exact test, simple logistic regression, and Student’s t-test. The significance level was P ≤ .05. This study included 29 patients (24 males, 5 females) with 32 ASR™ XL acetabular hip systems. Mean age and body mass index (BMI) reached 55.2 years and 28.9 kg/m², respectively. Mean postoperative follow-up was 6.2 years. A total of 2 patients (6.9%) died of an unrelated cause and 1 patient was lost to follow-up (3.4%), leaving 26 patients with 28 hip replacements, all of whom were available for follow-up. The 5-year revision rate was 34.4% (10 patients with 11 hip replacements). Mean time to revision was 3.1 years. Age (P = .76), gender (P = .49), BMI (P = .29), acetabular component abduction angle (P = .12), and acetabulum size (P = .59) were not associated with the increased rate for hip failure. Blood cobalt (7.6 vs 6.8 µg/L, P = .58) and chromium (5.0 vs 2.2 µg/L, P = .31) levels were not significantly higher in the revised group when compared with those of the unrevised group. In the revised group, a 91% decrease in cobalt and 78% decrease in chromium levels were observed at a mean of 6 months following the revision. This study demonstrates a high rate of failure of ASR acetabular components used in total hip arthroplasty at a minimum of 5 years of follow-up. No variable that was predictive of failure could be identified in this series. Close clinical surveillance of these patients is required.

Continue to: Metal-on-metal...

Metal-on-metal (MoM) articulations have been widely explored as an alternative to polyethylene bearings in total hip arthroplasty (THA), with proposed benefits including improved range of motion, lower dislocation rates, and enhanced durability.¹ Comprising cobalt and chromium, these MoM bearings gained widespread popularity in the United States, particularly in younger and more active patients looking for longer lasting devices.

The articular surface replacement (ASR) acetabular system (DePuy Synthes) was approved for sale by the US Food and Drug Administration in 2003 and implanted in an estimated 93,000 cases.² Since then, however, the early failure rate of the prosthesis has been well documented,^3-5 leading to a formal global product recall in August 2010. The Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) was amongst the first to report a 6.4% rate of failure of the device at 3 years when inserted with a Corail stem.⁶ An acceptable upper rate of hip prosthesis failure is considered to reach 1% per year, with the majority of implants reporting well below this value. A 10.9% failure rate at 5 years was documented when the prosthesis was inserted for resurfacing. The National Joint Registry of England and Wales confirmed these findings and observed a 13% and 12% rate of failure at 5 years for the acetabular and resurfacing systems, respectively.² With the notable failure of the ASR system, this study reports our single-center 5-year survivorship experience and evaluates any variable that might be predictive of an early failure to aid in patient counseling.

METHODS

A single-center, single-surgeon, retrospective review of a consecutive series of patients was performed from December 2005 to November 2009. This study included all patients who underwent a primary THA with a DePuy Synthes ASR™ XL Acetabular hip system. No patients were excluded. Institutional Review Board approval was obtained. Patient demographics comprising of age, gender, and body mass index (BMI) were recorded. The primary endpoint of this study was 5-year survivorship rates. Secondary endpoints included duration to revision surgery, blood cobalt and chromium levels, time interval of blood ion tests, acetabulum size, acetabular component abduction angle, and duration to follow-up.

Candidates for the ASR™ XL Acetabular hip system included young patients and/or those considered to be physically active. In a select few, ASR devices were implanted upon patient request.

All patients underwent primary total hip replacement with a DePuy Synthes ASR™ XL uncemented acetabular component and an uncemented femoral stem (DePuy Synthes, Summit, or Tri-Lock) inserted via a standard posterior approach (Figure 1). Acetabulum sizes ranged from 52 mm to 68 mm in diameter.

All patients were followed-up yearly in the outpatient setting. Routine (yearly) metal-ion level sampling (whole blood) was started in 2010 for all patients. Laboratory tests were conducted at a single laboratory (Lab Corp.). Abduction cup inclination angles were measured by the providing surgeon using digital radiology software (GE Centricity systems).

The Student’s t-test was used to compare mean values (such as age, BMI, and metal ion levels) between the failure and no-failure groups. The 2-sided Fisher’s exact test analyzed differences in gender. Simple logistic regression analyzed variables associated with the failure group. Significance was P ≤ .05.

Continue to: Results...

RESULTS

A total of 29 patients (24 males, 5 females) with 32 ASR hip replacements were included in this study. Indications for surgery comprised osteoarthritis (28 hips, 87.5%) and avascular necrosis of the hip (4 hips, 12.5%). Mean age and BMI were 55.2 years and 28.9 kg/m², respectively. A total of 2 patients (6.9%) died of an unrelated cause (1 myocardial infarct, 1 suicide), and 1 patient was lost to follow-up (3.4%), leaving 26 patients with 28 hip replacements, all of whom finished a 5-year minimum follow-up.

No implant failures were noted in the first year. The 5-year revision rate reached 34.4% (10 patients with 11 hip replacements). Mean time to revision for this subgroup was 3.1 years. Overall, an implant failure was observed in 37.5% of patients (11 patients with 12 hip replacements) at a mean postoperative follow-up of 6.2 years (Figure 2). Indications for implant revision were pain in 11 (92.7%) cases and infection in 1 (8.3%).

Of the 11 hips revised due to pain, 9 were performed by the original surgeon (8 were completed with primary acetabular components, 1 with a revision shell). Figure 3 shows a bilateral revision performed with primary acetabular components and retained DePuy Synthes Pinnacle femoral stems. In all these cases except 1, the ASR component was grossly loose. One case presented with pseudotumor and impingement between the femoral prosthetic neck and acetabular component after migration of a loose component. After revision, the patient returned with substantial anterior hip pain and heterotopic ossification, and failed conservative treatment, requiring another surgery with prosthesis retention, removal of heterotopic ossification, and iliopsoas lengthening. The surgery successfully relieved the symptoms. No other patients required additional surgery after their revision. In comparison to the original ASR component, the revision shell was 2 to 4 mm larger in diameter. No patient required component revision at a mean of 2.9 years after the revision surgery.

The patient with secondary revision developed a hematogenous streptococcal infection after a dental procedure performed without prophylactic antibiotics. The patient was initially lost to follow-up after the primary surgery and reported no antecedent pain prior to the revision. A substantial metal fluid collection was identified in the hip at the time of débridement and without component loosening. After débridement, the patient developed persistent metal stained wound drainage, necessitating ultimate successful treatment with a 2-stage exchange procedure.

Age (P = .76), gender (P = .49), BMI (P = .29), acetabular component abduction angle (P = .12), and acetabulum size (P = .59) were not associated with an increased rate for hip failure (Table). Blood cobalt (7.6 vs 6.8 µg/L, P = .58) and chromium (5.0 vs 2.2 µg/L, P = .31) levels were not significantly higher in the revised group when compared with those of the unrevised group. The upper limits of blood cobalt and chromium levels reached 18.9 and 15.9 µg/L for the revised group and 16.8 and 5.4 µg/L for the non-revised group, respectively. In the revised group, a 91% decrease in cobalt and 78% decrease in chromium levels were observed at a mean of 6 months after the revision (Figure 4).

Table. Variables Not Associated with Early ASR Failure

Continue to: Discussion...

DISCUSSION

According to the Center for Disease Control and Prevention, 310,800 total hip replacements were performed among inpatients aged 45 years and older in the US in 2010.⁷ Specifically, in the 55- to 64-year-old age group, the number of procedures performed tripled from 2000 through 2010. As younger and more active patients opt for hip replacements, a growing need for prosthesis with enhanced durability is observed.

Despite the early proposed advantages of large head MoM bearings, our retrospective study of the DePuy Synthes ASR™ XL Acetabular hip system yielded 15.6% and 34.4% failure rates at 3 and 5 years, respectively. These higher-than-expected rates of failure are consistent with published data. The British Hip Society reported a 21% to 35% revision rate at 4 years and 49% at 6 years for the ASR XL prosthesis.⁸ In comparison, other MoM prosthesis, on average, report a 12% to 15% rate of failure at 5 years.

Considerable controversy surrounds the causes of adverse wear failure in MoM bearings.^9,10 The non-modular design of the ASR prostheses is frequently implicated as a cause of early failure. The lack of a central hole in the 1-piece component compromises the tactile feel of insertion, thereby reducing the surgeon’s ability to assess complete seating.¹¹ This condition may potentially increase the abduction angle at the time of insertion. Screw fixation of the non-modular device is not possible. The ASR XL device (148^° to 160^°) is less than a hemisphere (180^°) in size and hence features a diminished functional articular surface, further compromising implant fixation.¹¹ The functional articular surface is defined as the optimal surface area (10 mm) needed for a MoM implant.¹² Griffin and colleagues¹³ reported a 48 mm ASR XL component, when implanted at 45^° of abduction, to function similar to an implant at 59^° of abduction, leading to diminished lubrication, metallosis, and edge loading. The version of the acetabular component may similarly and adversely affect implant wear characteristics. Furthermore, the variable thickness of the implant, which is thicker at the dome and thinner at the rim, may further promote edge loading by shifting the center of rotation of the femoral head out from the center of the acetabular prosthesis.¹¹ Studies have also shown that increased wear of the MoM articulation is associated with an acetabular component inclination angle in excess of 55^°10,14 and a failure of fixation at time of implantation.¹⁵ This study, however, found no correlation between the abduction angle and risk of early implant failure for the ASR acetabular component. No correlation was also detected between the acetabulum size and revision surgery.

The AOANJRR reported loosening (44%), infection (20%), metal sensitivity (12%), fracture (9%), and dislocation of prosthesis (7%) as the indications for revision surgery for the ASR prosthesis.⁶ Furthermore, a single-center retrospective review of 70 consecutive MoM THAs with ultra-large diameter femoral head and monoblock acetabular components showed that 17.1% required revision within 3 years for loosening, pain, and squeaking.¹ Overall, 28.6% of patients reported implant dysfunction. In this study, we observed a similar rate of failure at 3 years (15.6%) for pain (11) and infection (1). The revision surgery successfully relieved all of these symptoms. One patient presented with heterotopic ossification and anterior hip pain after the original revision and required additional surgery with prosthesis retention. No patient in this series required repeat component revisions at a mean of 2.9 years after surgery. In all but 1 case, primary acetabular components were used in the revision, and in all cases except that with infection, the femoral component was retained. Replacement shells were 2 to 4 mm larger in diameter than the original ASR component.

Recently, concerns have arisen regarding the long-term effects of serum cobalt and chromium metal ions levels. Studies have shown increased serum metal ion levels,¹⁵ groin pain,¹⁶ pseudotumor formation,¹⁷ and metallosis¹⁸ after the implantation of MoM bearings. In a case study by Mao and colleagues,¹⁹ 1 patient reported headaches, anorexia, continuous metallic taste in her mouth, and weight loss. A cerebrospinal fluid analysis revealed cobalt and chromium levels at 9 and 13 nmol/L, respectively, indicating that these metal ions can cross the blood-brain barrier. Another patient reported painful muscle fatigue, night cramps, fainting spells, cognitive decline, and an inability to climb stairs. His serum cobalt level reached 258 nmol/L (reference range, 0-20 nmol/L), and chromium level totaled 88 nmol/L (reference range, 0-100 nmol/L). At 8-week follow-up after revision surgery, the symptoms of the patient had resolved, with serum cobalt levels dropping to 42 nmol/L.¹⁹ None of the patients in this study presented with any signs or symptoms of metal toxicity. The upper limits of blood cobalt and chromium levels in our study population reached 18.9 and 15.9 µg/L for the revised group and 16.8 and 5.4 µg/L for the non-revised group, respectively. However, we noted a similar drop in post-revision blood cobalt (91% decrease) and chromium (78% decrease) levels.

In summary, our data showed a high revision rate of the DePuy Synthes ASR™ XL Acetabular hip system. Our findings are consistent with internationally published data. In the absence of reliable predictors of early failure, continued close clinical surveillance and laboratory monitoring of these patients are warranted.

CONCLUSION

This study demonstrates the high failure rate of the DePuy Synthes ASR™ XL Acetabular hip system used in THA at a minimum of 5 years of follow-up. No variable that was predictive of failure could be identified in this series. Close clinical surveillance of these patients is therefore required. Metal levels dropped quickly after revision, and the revision surgery can generally be performed with slightly larger primary components. Symptomatic patients with ASR hip replacements, regardless of blood metal-ion levels, were candidates for the revision surgery. Not all failed hips exhibited substantially elevated metal levels. Asymptomatic patients with high blood metal-ion levels should be closely followed-up and revision surgery should be strongly considered, consistent with recently published guidelines.²⁰

ABSTRACT

The articular surface replacement (ASR) monoblock metal-on-metal acetabular component was recalled due to a higher than expected early failure rate. We evaluated the survivorship of the device and variables that may be predictive of failure at a minimum of 5-year follow-up. A single-center, single-surgeon retrospective review was conducted in patients who received the DePuy Synthes ASR™ XL Acetabular hip system from December 2005 to November 2009. Mean values and percentages were calculated and compared using the Fisher’s exact test, simple logistic regression, and Student’s t-test. The significance level was P ≤ .05. This study included 29 patients (24 males, 5 females) with 32 ASR™ XL acetabular hip systems. Mean age and body mass index (BMI) reached 55.2 years and 28.9 kg/m², respectively. Mean postoperative follow-up was 6.2 years. A total of 2 patients (6.9%) died of an unrelated cause and 1 patient was lost to follow-up (3.4%), leaving 26 patients with 28 hip replacements, all of whom were available for follow-up. The 5-year revision rate was 34.4% (10 patients with 11 hip replacements). Mean time to revision was 3.1 years. Age (P = .76), gender (P = .49), BMI (P = .29), acetabular component abduction angle (P = .12), and acetabulum size (P = .59) were not associated with the increased rate for hip failure. Blood cobalt (7.6 vs 6.8 µg/L, P = .58) and chromium (5.0 vs 2.2 µg/L, P = .31) levels were not significantly higher in the revised group when compared with those of the unrevised group. In the revised group, a 91% decrease in cobalt and 78% decrease in chromium levels were observed at a mean of 6 months following the revision. This study demonstrates a high rate of failure of ASR acetabular components used in total hip arthroplasty at a minimum of 5 years of follow-up. No variable that was predictive of failure could be identified in this series. Close clinical surveillance of these patients is required.

Continue to: Metal-on-metal...

Metal-on-metal (MoM) articulations have been widely explored as an alternative to polyethylene bearings in total hip arthroplasty (THA), with proposed benefits including improved range of motion, lower dislocation rates, and enhanced durability.¹ Comprising cobalt and chromium, these MoM bearings gained widespread popularity in the United States, particularly in younger and more active patients looking for longer lasting devices.

The articular surface replacement (ASR) acetabular system (DePuy Synthes) was approved for sale by the US Food and Drug Administration in 2003 and implanted in an estimated 93,000 cases.² Since then, however, the early failure rate of the prosthesis has been well documented,^3-5 leading to a formal global product recall in August 2010. The Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) was amongst the first to report a 6.4% rate of failure of the device at 3 years when inserted with a Corail stem.⁶ An acceptable upper rate of hip prosthesis failure is considered to reach 1% per year, with the majority of implants reporting well below this value. A 10.9% failure rate at 5 years was documented when the prosthesis was inserted for resurfacing. The National Joint Registry of England and Wales confirmed these findings and observed a 13% and 12% rate of failure at 5 years for the acetabular and resurfacing systems, respectively.² With the notable failure of the ASR system, this study reports our single-center 5-year survivorship experience and evaluates any variable that might be predictive of an early failure to aid in patient counseling.

METHODS

A single-center, single-surgeon, retrospective review of a consecutive series of patients was performed from December 2005 to November 2009. This study included all patients who underwent a primary THA with a DePuy Synthes ASR™ XL Acetabular hip system. No patients were excluded. Institutional Review Board approval was obtained. Patient demographics comprising of age, gender, and body mass index (BMI) were recorded. The primary endpoint of this study was 5-year survivorship rates. Secondary endpoints included duration to revision surgery, blood cobalt and chromium levels, time interval of blood ion tests, acetabulum size, acetabular component abduction angle, and duration to follow-up.

Candidates for the ASR™ XL Acetabular hip system included young patients and/or those considered to be physically active. In a select few, ASR devices were implanted upon patient request.

All patients underwent primary total hip replacement with a DePuy Synthes ASR™ XL uncemented acetabular component and an uncemented femoral stem (DePuy Synthes, Summit, or Tri-Lock) inserted via a standard posterior approach (Figure 1). Acetabulum sizes ranged from 52 mm to 68 mm in diameter.

All patients were followed-up yearly in the outpatient setting. Routine (yearly) metal-ion level sampling (whole blood) was started in 2010 for all patients. Laboratory tests were conducted at a single laboratory (Lab Corp.). Abduction cup inclination angles were measured by the providing surgeon using digital radiology software (GE Centricity systems).

The Student’s t-test was used to compare mean values (such as age, BMI, and metal ion levels) between the failure and no-failure groups. The 2-sided Fisher’s exact test analyzed differences in gender. Simple logistic regression analyzed variables associated with the failure group. Significance was P ≤ .05.

Continue to: Results...

RESULTS

A total of 29 patients (24 males, 5 females) with 32 ASR hip replacements were included in this study. Indications for surgery comprised osteoarthritis (28 hips, 87.5%) and avascular necrosis of the hip (4 hips, 12.5%). Mean age and BMI were 55.2 years and 28.9 kg/m², respectively. A total of 2 patients (6.9%) died of an unrelated cause (1 myocardial infarct, 1 suicide), and 1 patient was lost to follow-up (3.4%), leaving 26 patients with 28 hip replacements, all of whom finished a 5-year minimum follow-up.

No implant failures were noted in the first year. The 5-year revision rate reached 34.4% (10 patients with 11 hip replacements). Mean time to revision for this subgroup was 3.1 years. Overall, an implant failure was observed in 37.5% of patients (11 patients with 12 hip replacements) at a mean postoperative follow-up of 6.2 years (Figure 2). Indications for implant revision were pain in 11 (92.7%) cases and infection in 1 (8.3%).

Of the 11 hips revised due to pain, 9 were performed by the original surgeon (8 were completed with primary acetabular components, 1 with a revision shell). Figure 3 shows a bilateral revision performed with primary acetabular components and retained DePuy Synthes Pinnacle femoral stems. In all these cases except 1, the ASR component was grossly loose. One case presented with pseudotumor and impingement between the femoral prosthetic neck and acetabular component after migration of a loose component. After revision, the patient returned with substantial anterior hip pain and heterotopic ossification, and failed conservative treatment, requiring another surgery with prosthesis retention, removal of heterotopic ossification, and iliopsoas lengthening. The surgery successfully relieved the symptoms. No other patients required additional surgery after their revision. In comparison to the original ASR component, the revision shell was 2 to 4 mm larger in diameter. No patient required component revision at a mean of 2.9 years after the revision surgery.

The patient with secondary revision developed a hematogenous streptococcal infection after a dental procedure performed without prophylactic antibiotics. The patient was initially lost to follow-up after the primary surgery and reported no antecedent pain prior to the revision. A substantial metal fluid collection was identified in the hip at the time of débridement and without component loosening. After débridement, the patient developed persistent metal stained wound drainage, necessitating ultimate successful treatment with a 2-stage exchange procedure.

Age (P = .76), gender (P = .49), BMI (P = .29), acetabular component abduction angle (P = .12), and acetabulum size (P = .59) were not associated with an increased rate for hip failure (Table). Blood cobalt (7.6 vs 6.8 µg/L, P = .58) and chromium (5.0 vs 2.2 µg/L, P = .31) levels were not significantly higher in the revised group when compared with those of the unrevised group. The upper limits of blood cobalt and chromium levels reached 18.9 and 15.9 µg/L for the revised group and 16.8 and 5.4 µg/L for the non-revised group, respectively. In the revised group, a 91% decrease in cobalt and 78% decrease in chromium levels were observed at a mean of 6 months after the revision (Figure 4).

Table. Variables Not Associated with Early ASR Failure

Continue to: Discussion...

DISCUSSION

According to the Center for Disease Control and Prevention, 310,800 total hip replacements were performed among inpatients aged 45 years and older in the US in 2010.⁷ Specifically, in the 55- to 64-year-old age group, the number of procedures performed tripled from 2000 through 2010. As younger and more active patients opt for hip replacements, a growing need for prosthesis with enhanced durability is observed.

Despite the early proposed advantages of large head MoM bearings, our retrospective study of the DePuy Synthes ASR™ XL Acetabular hip system yielded 15.6% and 34.4% failure rates at 3 and 5 years, respectively. These higher-than-expected rates of failure are consistent with published data. The British Hip Society reported a 21% to 35% revision rate at 4 years and 49% at 6 years for the ASR XL prosthesis.⁸ In comparison, other MoM prosthesis, on average, report a 12% to 15% rate of failure at 5 years.

Considerable controversy surrounds the causes of adverse wear failure in MoM bearings.^9,10 The non-modular design of the ASR prostheses is frequently implicated as a cause of early failure. The lack of a central hole in the 1-piece component compromises the tactile feel of insertion, thereby reducing the surgeon’s ability to assess complete seating.¹¹ This condition may potentially increase the abduction angle at the time of insertion. Screw fixation of the non-modular device is not possible. The ASR XL device (148^° to 160^°) is less than a hemisphere (180^°) in size and hence features a diminished functional articular surface, further compromising implant fixation.¹¹ The functional articular surface is defined as the optimal surface area (10 mm) needed for a MoM implant.¹² Griffin and colleagues¹³ reported a 48 mm ASR XL component, when implanted at 45^° of abduction, to function similar to an implant at 59^° of abduction, leading to diminished lubrication, metallosis, and edge loading. The version of the acetabular component may similarly and adversely affect implant wear characteristics. Furthermore, the variable thickness of the implant, which is thicker at the dome and thinner at the rim, may further promote edge loading by shifting the center of rotation of the femoral head out from the center of the acetabular prosthesis.¹¹ Studies have also shown that increased wear of the MoM articulation is associated with an acetabular component inclination angle in excess of 55^°10,14 and a failure of fixation at time of implantation.¹⁵ This study, however, found no correlation between the abduction angle and risk of early implant failure for the ASR acetabular component. No correlation was also detected between the acetabulum size and revision surgery.

The AOANJRR reported loosening (44%), infection (20%), metal sensitivity (12%), fracture (9%), and dislocation of prosthesis (7%) as the indications for revision surgery for the ASR prosthesis.⁶ Furthermore, a single-center retrospective review of 70 consecutive MoM THAs with ultra-large diameter femoral head and monoblock acetabular components showed that 17.1% required revision within 3 years for loosening, pain, and squeaking.¹ Overall, 28.6% of patients reported implant dysfunction. In this study, we observed a similar rate of failure at 3 years (15.6%) for pain (11) and infection (1). The revision surgery successfully relieved all of these symptoms. One patient presented with heterotopic ossification and anterior hip pain after the original revision and required additional surgery with prosthesis retention. No patient in this series required repeat component revisions at a mean of 2.9 years after surgery. In all but 1 case, primary acetabular components were used in the revision, and in all cases except that with infection, the femoral component was retained. Replacement shells were 2 to 4 mm larger in diameter than the original ASR component.

Recently, concerns have arisen regarding the long-term effects of serum cobalt and chromium metal ions levels. Studies have shown increased serum metal ion levels,¹⁵ groin pain,¹⁶ pseudotumor formation,¹⁷ and metallosis¹⁸ after the implantation of MoM bearings. In a case study by Mao and colleagues,¹⁹ 1 patient reported headaches, anorexia, continuous metallic taste in her mouth, and weight loss. A cerebrospinal fluid analysis revealed cobalt and chromium levels at 9 and 13 nmol/L, respectively, indicating that these metal ions can cross the blood-brain barrier. Another patient reported painful muscle fatigue, night cramps, fainting spells, cognitive decline, and an inability to climb stairs. His serum cobalt level reached 258 nmol/L (reference range, 0-20 nmol/L), and chromium level totaled 88 nmol/L (reference range, 0-100 nmol/L). At 8-week follow-up after revision surgery, the symptoms of the patient had resolved, with serum cobalt levels dropping to 42 nmol/L.¹⁹ None of the patients in this study presented with any signs or symptoms of metal toxicity. The upper limits of blood cobalt and chromium levels in our study population reached 18.9 and 15.9 µg/L for the revised group and 16.8 and 5.4 µg/L for the non-revised group, respectively. However, we noted a similar drop in post-revision blood cobalt (91% decrease) and chromium (78% decrease) levels.

In summary, our data showed a high revision rate of the DePuy Synthes ASR™ XL Acetabular hip system. Our findings are consistent with internationally published data. In the absence of reliable predictors of early failure, continued close clinical surveillance and laboratory monitoring of these patients are warranted.

CONCLUSION

This study demonstrates the high failure rate of the DePuy Synthes ASR™ XL Acetabular hip system used in THA at a minimum of 5 years of follow-up. No variable that was predictive of failure could be identified in this series. Close clinical surveillance of these patients is therefore required. Metal levels dropped quickly after revision, and the revision surgery can generally be performed with slightly larger primary components. Symptomatic patients with ASR hip replacements, regardless of blood metal-ion levels, were candidates for the revision surgery. Not all failed hips exhibited substantially elevated metal levels. Asymptomatic patients with high blood metal-ion levels should be closely followed-up and revision surgery should be strongly considered, consistent with recently published guidelines.²⁰

ABSTRACT

Gustilo IIIB injuries of the tibia with segmental bone loss continue to be a difficult reconstructive problem. The serratus anterior-latissimus-rib (SALR) composite flap consists of bone and muscle; this flap can provide soft tissue coverage and vascularized bone in a single surgical procedure. The purpose of this study is to describe the use of the SALR flap for the treatment of a large open tibia fracture with segmental bone loss, with a specific focus on postoperative complications, limb salvage, and time to union.

We reviewed the medical records of patients undergoing an SALR flap (n = 5) for the treatment of Gustilo Type IIIB tibia fractures within 1 month of injury. We compared the mechanism of injury, injury severity score, time from injury to free tissue transfer, complications, and time to radiographic and clinical union.

All patients were male, with a mean age of 25 years. On average, patients underwent free tissue transfer within 1 week of injury. The average time to radiographic union was 7 months. Two patients underwent reoperation. There were no graft failures.

Free SALR flaps can be a useful option for the treatment of high-energy tibia fractures with extensive soft tissue and bone loss. These flaps provide immediate osseous and soft tissue reconstruction with an acceptable complication profile.

Reconstruction of the lower extremity following Gustilo’s grade IIIB injuries is difficult due to loss of both combined soft tissue and segmental bone loss. Since these injuries necessitate the need for soft tissue flap coverage along with vascularized bone grafting, free fibula flaps have classically been used for reconstruction.^1-3 In the setting of bilateral lower extremity injury, the contralateral fibula is often not appropriate to harvest and transfer; therefore, other sources of vascularized bone grafts must be utilized including vascularized iliac crest and rib.^1-5 The vascularized iliac crest graft is insufficient to provide the bony reconstruction of bone defects >6 cm to 7 cm and does not have a reliable skin paddle.⁴ In contrast, free composite serratus anterior-latissimus-rib (SALR) flaps can provide both long segments of vascularized bone and abundant soft tissue coverage for large segmental defects.^1-5

Continue to: Free fibula grafts have been considered...

MATERIALS AND METHODS

Following approval from our Institutional Review Board, we retrospectively reviewed the medical records of patients undergoing a free composite SALR flap (n = 5) for the treatment of a severe open tibia fracture within 1 month of injury. All patients sustained open injuries classified as IIIB on the Gustilo-Anderson scale.¹⁰ Medical records were examined for the mechanism of injury (MOI), injury severity score (ISS), time from injury to free tissue transfer, medical comorbidities, surgical complications, and time to radiographic and clinical union. Radiographic union was determined by the presence of bridging bone on 3 of 4 of cortices on plain film radiographs.

All patients were male (n = 5), with a mean age of 25 years (range, 19-30 years) at the time of injury (Table). 

Table. Demographics and Outcomes of Patients Undergoing Free Tissue Transfer

The MOI included motorcycle collisions (n = 2), pedestrian struck by car (n = 1), motor vehicle collisions (n = 1), and direct blow to the leg (n = 1). The mean ISS of the cohort was 18 (range, 10-34) (Table). On average, patients underwent free tissue transfer within 1 week (range, 3 days to 2 weeks) from the time of injury. Patients in this cohort were followed clinically for a mean of 4 years (range, 1-6 years) after surgery. Patients were non-weight-bearing for an average of 5 months (range, 4-6 months) following their reconstructions.

RESULTS

All flaps survived. The mean time to radiographic and clinical union was 7 months (range, 6-9 months). Two patients underwent reoperation. One patient underwent a bone grafting procedure for a delayed union at 6 months postoperative, and 1 patient underwent irrigation and débridement of superficial soft tissue infection. Donor site complications occurred in 2 patients, including chronic rib pain (n = 1) and a pleural effusion requiring drainage (n = 1). At the last follow-up, all ribs had incorporated, and all patients were weight-bearing as tolerated on the limb.

CASE EXAMPLE

A 22-year-old male smoker was transferred to our facility after a motor vehicle accident with bilateral tibia fractures, 1 closed and 1 open with significant bone loss (Figures 1A, 1B). 

Continue to: Surgical Technique...

SURGICAL TECHNIQUE

The patient is placed in the lateral decubitus position during the procedure. A 2-team approach is used for dissection of the flap and preparation of recipient vessels to decrease operative time. A J-shaped incision is started on the chest at the mid-axillary line and extended just over the fifth and sixth rib. The incision can be made to fall into the intermammary crease in a woman to hide the scar. The dissection begins by exposing the anterior border of the latissimus muscle (Figure 2A). Next, the latissimus is dissected to reveal the thoracodorsal vessels (Figure 2B). At this level, the thoracodorsal vessel can be traced into the axilla. The branch going into the fifth, sixth, and lower slips of the serratus are dissected. The long thoracic nerve and the thoracodorsal nerve are preserved during the dissection (Figure 2C). The fifth, sixth, and seventh slips of the serratus are preferentially included in the dissection while leaving the most superior slips of the serratus to preserve scapular stability. Dissection begins by identifying 2 adjacent rib sections of the fifth and sixth or sixth and seventh ribs. The defect in the lower extremity determines the length of rib harvested. The serratus slips are then divided anteriorly over the chest wall. The dissection is extended to the intercostal spaces of the fourth and fifth ribs. The supraperiosteal dissection is performed at the anterior margin of the rib (Figure 2D). 

Continue to: Following the surgical procedure...

DISCUSSION

High-energy open injuries to the lower extremities are devastating injuries, with a high rate of late amputation and poor functional outcomes.^11-13 Vascularized bone grafting provides both essential osteoinductive and osteoconductive properties to segmental bone defects in areas with inadequate soft tissue coverage, particularly in the setting of >6 cm of bone loss.^4,14 The results of this study show that acute reconstruction of the lower limb with a composite vascularized SALR graft is a reliable procedure with an acceptable complication profile.

The timing of soft tissue coverage should be performed as soon as the patient is medically stable enough to undergo a reconstructive procedure, ideally within 7 to 10 days; and this timetable has been shown to decrease rates of infection and free flap failure.^15-19 Early coverage provides both control of the soft-tissue envelope and reduces the risk of losing bone.¹ Unlike the timing of coverage, the staging of the procedure is controversial. Proponents of the 2-stage free tissue (soft tissue followed by bony flap) transfer feel that although the tissue may not be infected at the time of coverage, it is contaminated with bacteria at the time of bone reconstruction, and as such is at high risk for both infection and complications.²⁰ Unlike 2-stage procedures, single-stage coverage provides immediate soft tissue coverage, as well as bony support. This reduces the time to bony union and negates the need for repeated surgery in a mangled extremity where secondary surgery is complicated by both scar tissue and altered anatomy.^1,2 Furthermore, it has been shown that there is no difference in the rates of infection when performing a single-stage compared with a 2-stage procedure.⁹ In this study, SALR flaps were typically performed within 2 weeks following an injury as a single procedure. We feel this resulted in the low number of complications in the SALR group.

Unlike free fibulas, rib flaps are easily pedicled with an associated soft-tissue flap due to their blood supply, making them ideal for 1-stage reconstruction. The rib has a dual blood supply: 1 from the posterior intercostal artery, and the other, an abundant periosteal blood supply, from the serratus anterior muscle.⁴ The blood supply to the serratus anterior comes from the thoracodorsal artery, and usually provides 14 cm of a large-caliber pedicle, making it a reliable flap for soft tissue reconstruction.^21,22 Another unique feature of the blood supply to this flap is the amount of soft tissue available for both harvest and transfer; larger portions of serratus muscle and latissimus muscle can be harvested if necessary to cover the soft tissue defect.⁴

Comminuted tibias with segmental bone loss are difficult to manage since they are associated with bony as well as soft tissue defects.^1,12,13,23 These injuries are ideal candidates for a single-stage reconstruction using a vascularized SALR flap. In our series, the use of an SALR flap resulted ultimately in a 100% union and limb salvage rate, with no flap failures and a low complication profile. Unlike the SALR, free fibular flaps must be transferred along with a separate latissimus dorsi flap to provide enough soft tissue coverage necessary for reconstructing large Gustilo IIIB injuries, which could increase the risk of flap failure. Since ribs are composed of membranous bone and have a similar cross-sectional area to both metacarpal and metatarsals, there are concerns regarding the biomechanical properties of ribs for weight-bearing.^4,22,24-26 To compensate for this relatively small cross-sectional area, 2 ribs (either consecutive or alternative) are frequently harvested.^1,4,5,23 Previous studies examining the use of ribs for bony reconstruction have frequently supplemented the rib reconstruction to the tibia using screws and external fixation alone.^1,4,5,23 In our series, all SALR grafts were supported with the use of an intramedullary nail (n = 3) or locked plating (n = 1). The use of this supplemental fixation of the SALR graft allowed our patients to return to full weight-bearing (mean, 6 months) much earlier than the length of time cited in previous reports (12 months) examining these injuries.^1,4,5,23

Continue to: There are several limitations...

There are several limitations to this study. The small sample size and retrospective nature of the study limits the amount of data we are able to collect from the medical record and places obvious constraints on the analysis. Although all these procedures were performed at 1 institution, multiple providers were involved in the reconstruction of these injuries, and there is no standard protocol for their treatment. Similarly, although other forms of extremity reconstruction were used during this time period, there was no standard protocol that could serve as a comparator for patients who underwent an SALR compared with other reconstructive procedures.

Overall, SALR grafts provide an excellent option for 1-stage reconstruction of severe, open lower extremity injuries. In this series we noted a 100% graft success rate with an acceptable complication profile.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

Gustilo IIIB injuries of the tibia with segmental bone loss continue to be a difficult reconstructive problem. The serratus anterior-latissimus-rib (SALR) composite flap consists of bone and muscle; this flap can provide soft tissue coverage and vascularized bone in a single surgical procedure. The purpose of this study is to describe the use of the SALR flap for the treatment of a large open tibia fracture with segmental bone loss, with a specific focus on postoperative complications, limb salvage, and time to union.

We reviewed the medical records of patients undergoing an SALR flap (n = 5) for the treatment of Gustilo Type IIIB tibia fractures within 1 month of injury. We compared the mechanism of injury, injury severity score, time from injury to free tissue transfer, complications, and time to radiographic and clinical union.

All patients were male, with a mean age of 25 years. On average, patients underwent free tissue transfer within 1 week of injury. The average time to radiographic union was 7 months. Two patients underwent reoperation. There were no graft failures.

Free SALR flaps can be a useful option for the treatment of high-energy tibia fractures with extensive soft tissue and bone loss. These flaps provide immediate osseous and soft tissue reconstruction with an acceptable complication profile.

Reconstruction of the lower extremity following Gustilo’s grade IIIB injuries is difficult due to loss of both combined soft tissue and segmental bone loss. Since these injuries necessitate the need for soft tissue flap coverage along with vascularized bone grafting, free fibula flaps have classically been used for reconstruction.^1-3 In the setting of bilateral lower extremity injury, the contralateral fibula is often not appropriate to harvest and transfer; therefore, other sources of vascularized bone grafts must be utilized including vascularized iliac crest and rib.^1-5 The vascularized iliac crest graft is insufficient to provide the bony reconstruction of bone defects >6 cm to 7 cm and does not have a reliable skin paddle.⁴ In contrast, free composite serratus anterior-latissimus-rib (SALR) flaps can provide both long segments of vascularized bone and abundant soft tissue coverage for large segmental defects.^1-5

Continue to: Free fibula grafts have been considered...

MATERIALS AND METHODS

Following approval from our Institutional Review Board, we retrospectively reviewed the medical records of patients undergoing a free composite SALR flap (n = 5) for the treatment of a severe open tibia fracture within 1 month of injury. All patients sustained open injuries classified as IIIB on the Gustilo-Anderson scale.¹⁰ Medical records were examined for the mechanism of injury (MOI), injury severity score (ISS), time from injury to free tissue transfer, medical comorbidities, surgical complications, and time to radiographic and clinical union. Radiographic union was determined by the presence of bridging bone on 3 of 4 of cortices on plain film radiographs.

All patients were male (n = 5), with a mean age of 25 years (range, 19-30 years) at the time of injury (Table). 

Table. Demographics and Outcomes of Patients Undergoing Free Tissue Transfer

The MOI included motorcycle collisions (n = 2), pedestrian struck by car (n = 1), motor vehicle collisions (n = 1), and direct blow to the leg (n = 1). The mean ISS of the cohort was 18 (range, 10-34) (Table). On average, patients underwent free tissue transfer within 1 week (range, 3 days to 2 weeks) from the time of injury. Patients in this cohort were followed clinically for a mean of 4 years (range, 1-6 years) after surgery. Patients were non-weight-bearing for an average of 5 months (range, 4-6 months) following their reconstructions.

RESULTS

All flaps survived. The mean time to radiographic and clinical union was 7 months (range, 6-9 months). Two patients underwent reoperation. One patient underwent a bone grafting procedure for a delayed union at 6 months postoperative, and 1 patient underwent irrigation and débridement of superficial soft tissue infection. Donor site complications occurred in 2 patients, including chronic rib pain (n = 1) and a pleural effusion requiring drainage (n = 1). At the last follow-up, all ribs had incorporated, and all patients were weight-bearing as tolerated on the limb.

CASE EXAMPLE

A 22-year-old male smoker was transferred to our facility after a motor vehicle accident with bilateral tibia fractures, 1 closed and 1 open with significant bone loss (Figures 1A, 1B). 

Continue to: Surgical Technique...

SURGICAL TECHNIQUE

The patient is placed in the lateral decubitus position during the procedure. A 2-team approach is used for dissection of the flap and preparation of recipient vessels to decrease operative time. A J-shaped incision is started on the chest at the mid-axillary line and extended just over the fifth and sixth rib. The incision can be made to fall into the intermammary crease in a woman to hide the scar. The dissection begins by exposing the anterior border of the latissimus muscle (Figure 2A). Next, the latissimus is dissected to reveal the thoracodorsal vessels (Figure 2B). At this level, the thoracodorsal vessel can be traced into the axilla. The branch going into the fifth, sixth, and lower slips of the serratus are dissected. The long thoracic nerve and the thoracodorsal nerve are preserved during the dissection (Figure 2C). The fifth, sixth, and seventh slips of the serratus are preferentially included in the dissection while leaving the most superior slips of the serratus to preserve scapular stability. Dissection begins by identifying 2 adjacent rib sections of the fifth and sixth or sixth and seventh ribs. The defect in the lower extremity determines the length of rib harvested. The serratus slips are then divided anteriorly over the chest wall. The dissection is extended to the intercostal spaces of the fourth and fifth ribs. The supraperiosteal dissection is performed at the anterior margin of the rib (Figure 2D). 

Continue to: Following the surgical procedure...

DISCUSSION

High-energy open injuries to the lower extremities are devastating injuries, with a high rate of late amputation and poor functional outcomes.^11-13 Vascularized bone grafting provides both essential osteoinductive and osteoconductive properties to segmental bone defects in areas with inadequate soft tissue coverage, particularly in the setting of >6 cm of bone loss.^4,14 The results of this study show that acute reconstruction of the lower limb with a composite vascularized SALR graft is a reliable procedure with an acceptable complication profile.

The timing of soft tissue coverage should be performed as soon as the patient is medically stable enough to undergo a reconstructive procedure, ideally within 7 to 10 days; and this timetable has been shown to decrease rates of infection and free flap failure.^15-19 Early coverage provides both control of the soft-tissue envelope and reduces the risk of losing bone.¹ Unlike the timing of coverage, the staging of the procedure is controversial. Proponents of the 2-stage free tissue (soft tissue followed by bony flap) transfer feel that although the tissue may not be infected at the time of coverage, it is contaminated with bacteria at the time of bone reconstruction, and as such is at high risk for both infection and complications.²⁰ Unlike 2-stage procedures, single-stage coverage provides immediate soft tissue coverage, as well as bony support. This reduces the time to bony union and negates the need for repeated surgery in a mangled extremity where secondary surgery is complicated by both scar tissue and altered anatomy.^1,2 Furthermore, it has been shown that there is no difference in the rates of infection when performing a single-stage compared with a 2-stage procedure.⁹ In this study, SALR flaps were typically performed within 2 weeks following an injury as a single procedure. We feel this resulted in the low number of complications in the SALR group.

Unlike free fibulas, rib flaps are easily pedicled with an associated soft-tissue flap due to their blood supply, making them ideal for 1-stage reconstruction. The rib has a dual blood supply: 1 from the posterior intercostal artery, and the other, an abundant periosteal blood supply, from the serratus anterior muscle.⁴ The blood supply to the serratus anterior comes from the thoracodorsal artery, and usually provides 14 cm of a large-caliber pedicle, making it a reliable flap for soft tissue reconstruction.^21,22 Another unique feature of the blood supply to this flap is the amount of soft tissue available for both harvest and transfer; larger portions of serratus muscle and latissimus muscle can be harvested if necessary to cover the soft tissue defect.⁴

Comminuted tibias with segmental bone loss are difficult to manage since they are associated with bony as well as soft tissue defects.^1,12,13,23 These injuries are ideal candidates for a single-stage reconstruction using a vascularized SALR flap. In our series, the use of an SALR flap resulted ultimately in a 100% union and limb salvage rate, with no flap failures and a low complication profile. Unlike the SALR, free fibular flaps must be transferred along with a separate latissimus dorsi flap to provide enough soft tissue coverage necessary for reconstructing large Gustilo IIIB injuries, which could increase the risk of flap failure. Since ribs are composed of membranous bone and have a similar cross-sectional area to both metacarpal and metatarsals, there are concerns regarding the biomechanical properties of ribs for weight-bearing.^4,22,24-26 To compensate for this relatively small cross-sectional area, 2 ribs (either consecutive or alternative) are frequently harvested.^1,4,5,23 Previous studies examining the use of ribs for bony reconstruction have frequently supplemented the rib reconstruction to the tibia using screws and external fixation alone.^1,4,5,23 In our series, all SALR grafts were supported with the use of an intramedullary nail (n = 3) or locked plating (n = 1). The use of this supplemental fixation of the SALR graft allowed our patients to return to full weight-bearing (mean, 6 months) much earlier than the length of time cited in previous reports (12 months) examining these injuries.^1,4,5,23

Continue to: There are several limitations...

There are several limitations to this study. The small sample size and retrospective nature of the study limits the amount of data we are able to collect from the medical record and places obvious constraints on the analysis. Although all these procedures were performed at 1 institution, multiple providers were involved in the reconstruction of these injuries, and there is no standard protocol for their treatment. Similarly, although other forms of extremity reconstruction were used during this time period, there was no standard protocol that could serve as a comparator for patients who underwent an SALR compared with other reconstructive procedures.

Overall, SALR grafts provide an excellent option for 1-stage reconstruction of severe, open lower extremity injuries. In this series we noted a 100% graft success rate with an acceptable complication profile.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

Gustilo IIIB injuries of the tibia with segmental bone loss continue to be a difficult reconstructive problem. The serratus anterior-latissimus-rib (SALR) composite flap consists of bone and muscle; this flap can provide soft tissue coverage and vascularized bone in a single surgical procedure. The purpose of this study is to describe the use of the SALR flap for the treatment of a large open tibia fracture with segmental bone loss, with a specific focus on postoperative complications, limb salvage, and time to union.

We reviewed the medical records of patients undergoing an SALR flap (n = 5) for the treatment of Gustilo Type IIIB tibia fractures within 1 month of injury. We compared the mechanism of injury, injury severity score, time from injury to free tissue transfer, complications, and time to radiographic and clinical union.

All patients were male, with a mean age of 25 years. On average, patients underwent free tissue transfer within 1 week of injury. The average time to radiographic union was 7 months. Two patients underwent reoperation. There were no graft failures.

Free SALR flaps can be a useful option for the treatment of high-energy tibia fractures with extensive soft tissue and bone loss. These flaps provide immediate osseous and soft tissue reconstruction with an acceptable complication profile.

Reconstruction of the lower extremity following Gustilo’s grade IIIB injuries is difficult due to loss of both combined soft tissue and segmental bone loss. Since these injuries necessitate the need for soft tissue flap coverage along with vascularized bone grafting, free fibula flaps have classically been used for reconstruction.^1-3 In the setting of bilateral lower extremity injury, the contralateral fibula is often not appropriate to harvest and transfer; therefore, other sources of vascularized bone grafts must be utilized including vascularized iliac crest and rib.^1-5 The vascularized iliac crest graft is insufficient to provide the bony reconstruction of bone defects >6 cm to 7 cm and does not have a reliable skin paddle.⁴ In contrast, free composite serratus anterior-latissimus-rib (SALR) flaps can provide both long segments of vascularized bone and abundant soft tissue coverage for large segmental defects.^1-5

Continue to: Free fibula grafts have been considered...

MATERIALS AND METHODS

Following approval from our Institutional Review Board, we retrospectively reviewed the medical records of patients undergoing a free composite SALR flap (n = 5) for the treatment of a severe open tibia fracture within 1 month of injury. All patients sustained open injuries classified as IIIB on the Gustilo-Anderson scale.¹⁰ Medical records were examined for the mechanism of injury (MOI), injury severity score (ISS), time from injury to free tissue transfer, medical comorbidities, surgical complications, and time to radiographic and clinical union. Radiographic union was determined by the presence of bridging bone on 3 of 4 of cortices on plain film radiographs.

All patients were male (n = 5), with a mean age of 25 years (range, 19-30 years) at the time of injury (Table). 

Table. Demographics and Outcomes of Patients Undergoing Free Tissue Transfer

The MOI included motorcycle collisions (n = 2), pedestrian struck by car (n = 1), motor vehicle collisions (n = 1), and direct blow to the leg (n = 1). The mean ISS of the cohort was 18 (range, 10-34) (Table). On average, patients underwent free tissue transfer within 1 week (range, 3 days to 2 weeks) from the time of injury. Patients in this cohort were followed clinically for a mean of 4 years (range, 1-6 years) after surgery. Patients were non-weight-bearing for an average of 5 months (range, 4-6 months) following their reconstructions.

RESULTS

All flaps survived. The mean time to radiographic and clinical union was 7 months (range, 6-9 months). Two patients underwent reoperation. One patient underwent a bone grafting procedure for a delayed union at 6 months postoperative, and 1 patient underwent irrigation and débridement of superficial soft tissue infection. Donor site complications occurred in 2 patients, including chronic rib pain (n = 1) and a pleural effusion requiring drainage (n = 1). At the last follow-up, all ribs had incorporated, and all patients were weight-bearing as tolerated on the limb.

CASE EXAMPLE

A 22-year-old male smoker was transferred to our facility after a motor vehicle accident with bilateral tibia fractures, 1 closed and 1 open with significant bone loss (Figures 1A, 1B). 

Continue to: Surgical Technique...

SURGICAL TECHNIQUE

The patient is placed in the lateral decubitus position during the procedure. A 2-team approach is used for dissection of the flap and preparation of recipient vessels to decrease operative time. A J-shaped incision is started on the chest at the mid-axillary line and extended just over the fifth and sixth rib. The incision can be made to fall into the intermammary crease in a woman to hide the scar. The dissection begins by exposing the anterior border of the latissimus muscle (Figure 2A). Next, the latissimus is dissected to reveal the thoracodorsal vessels (Figure 2B). At this level, the thoracodorsal vessel can be traced into the axilla. The branch going into the fifth, sixth, and lower slips of the serratus are dissected. The long thoracic nerve and the thoracodorsal nerve are preserved during the dissection (Figure 2C). The fifth, sixth, and seventh slips of the serratus are preferentially included in the dissection while leaving the most superior slips of the serratus to preserve scapular stability. Dissection begins by identifying 2 adjacent rib sections of the fifth and sixth or sixth and seventh ribs. The defect in the lower extremity determines the length of rib harvested. The serratus slips are then divided anteriorly over the chest wall. The dissection is extended to the intercostal spaces of the fourth and fifth ribs. The supraperiosteal dissection is performed at the anterior margin of the rib (Figure 2D). 

Continue to: Following the surgical procedure...

DISCUSSION

High-energy open injuries to the lower extremities are devastating injuries, with a high rate of late amputation and poor functional outcomes.^11-13 Vascularized bone grafting provides both essential osteoinductive and osteoconductive properties to segmental bone defects in areas with inadequate soft tissue coverage, particularly in the setting of >6 cm of bone loss.^4,14 The results of this study show that acute reconstruction of the lower limb with a composite vascularized SALR graft is a reliable procedure with an acceptable complication profile.

The timing of soft tissue coverage should be performed as soon as the patient is medically stable enough to undergo a reconstructive procedure, ideally within 7 to 10 days; and this timetable has been shown to decrease rates of infection and free flap failure.^15-19 Early coverage provides both control of the soft-tissue envelope and reduces the risk of losing bone.¹ Unlike the timing of coverage, the staging of the procedure is controversial. Proponents of the 2-stage free tissue (soft tissue followed by bony flap) transfer feel that although the tissue may not be infected at the time of coverage, it is contaminated with bacteria at the time of bone reconstruction, and as such is at high risk for both infection and complications.²⁰ Unlike 2-stage procedures, single-stage coverage provides immediate soft tissue coverage, as well as bony support. This reduces the time to bony union and negates the need for repeated surgery in a mangled extremity where secondary surgery is complicated by both scar tissue and altered anatomy.^1,2 Furthermore, it has been shown that there is no difference in the rates of infection when performing a single-stage compared with a 2-stage procedure.⁹ In this study, SALR flaps were typically performed within 2 weeks following an injury as a single procedure. We feel this resulted in the low number of complications in the SALR group.

Unlike free fibulas, rib flaps are easily pedicled with an associated soft-tissue flap due to their blood supply, making them ideal for 1-stage reconstruction. The rib has a dual blood supply: 1 from the posterior intercostal artery, and the other, an abundant periosteal blood supply, from the serratus anterior muscle.⁴ The blood supply to the serratus anterior comes from the thoracodorsal artery, and usually provides 14 cm of a large-caliber pedicle, making it a reliable flap for soft tissue reconstruction.^21,22 Another unique feature of the blood supply to this flap is the amount of soft tissue available for both harvest and transfer; larger portions of serratus muscle and latissimus muscle can be harvested if necessary to cover the soft tissue defect.⁴

Comminuted tibias with segmental bone loss are difficult to manage since they are associated with bony as well as soft tissue defects.^1,12,13,23 These injuries are ideal candidates for a single-stage reconstruction using a vascularized SALR flap. In our series, the use of an SALR flap resulted ultimately in a 100% union and limb salvage rate, with no flap failures and a low complication profile. Unlike the SALR, free fibular flaps must be transferred along with a separate latissimus dorsi flap to provide enough soft tissue coverage necessary for reconstructing large Gustilo IIIB injuries, which could increase the risk of flap failure. Since ribs are composed of membranous bone and have a similar cross-sectional area to both metacarpal and metatarsals, there are concerns regarding the biomechanical properties of ribs for weight-bearing.^4,22,24-26 To compensate for this relatively small cross-sectional area, 2 ribs (either consecutive or alternative) are frequently harvested.^1,4,5,23 Previous studies examining the use of ribs for bony reconstruction have frequently supplemented the rib reconstruction to the tibia using screws and external fixation alone.^1,4,5,23 In our series, all SALR grafts were supported with the use of an intramedullary nail (n = 3) or locked plating (n = 1). The use of this supplemental fixation of the SALR graft allowed our patients to return to full weight-bearing (mean, 6 months) much earlier than the length of time cited in previous reports (12 months) examining these injuries.^1,4,5,23

Continue to: There are several limitations...

There are several limitations to this study. The small sample size and retrospective nature of the study limits the amount of data we are able to collect from the medical record and places obvious constraints on the analysis. Although all these procedures were performed at 1 institution, multiple providers were involved in the reconstruction of these injuries, and there is no standard protocol for their treatment. Similarly, although other forms of extremity reconstruction were used during this time period, there was no standard protocol that could serve as a comparator for patients who underwent an SALR compared with other reconstructive procedures.

Overall, SALR grafts provide an excellent option for 1-stage reconstruction of severe, open lower extremity injuries. In this series we noted a 100% graft success rate with an acceptable complication profile.

This paper will be judged for the Resident Writer’s Award.