Orthopedics

The cost of health care in the United States is increasing at an unsustainable rate.^1-3 To decrease or even reverse this trend, we must decrease the cost of care without adversely affecting quality. Porter⁴ defined value as the quality of care divided by its cost. The economics of total joint arthroplasty (TJA) has received a great deal of attention because of both increasing demand and increasing cost.^5-9 About 33% of all orthopedic surgeries and the majority of TJAs are paid for by Medicare.⁹ In recent years, the rate of reimbursement for orthopedic cases has steadily declined while the cost of implants has increased.^3,10,11 Given the significant cost of implants, health care providers in some subspecialties have focused on implant costs as a potential area for cost reduction.¹² For example, in TJA this has proved effective in reducing the overall cost, as has decreasing length of stay after surgery.^8,10,13-16

With little evidence suggesting any specific orthopedic implant has outcomes superior to those of others, with the exception of select poorly performing outliers, we must increase value of care by lowering the cost when considering these devices.^17,18 In addition, some experts have suggested that intraoperative waste is a significant factor in TJA cost, and it does contribute to the average implant cost for a TJA case.^6,19 Using data collected from 72 institutions, Zywiel and colleagues¹⁹ estimated the annual cost of wasted hip and knee arthroplasty implants to be more than $36 million in the United States.

However, considering the aging US population, TJA is not the only orthopedic surgery with increased demand. An estimated 600,000 spine surgeries are performed each year in the United States.²⁰ Between 1992 and 2003, Medicare spending for lumbar spinal fusion increased 500%.²¹ In addition, in a 15-month observational study of incidence of intraoperative waste in spine surgery, Soroceanu and colleagues²² reported waste occurring in 20% of spine procedures.

Although these studies have described implant waste in TJA and spine surgeries, little has been published on the cost of wasted implants in a center performing the full range of orthopedic procedures. In this article, we detail the implant waste costs incurred by surgeons for all orthopedic subspecialties at a single orthopedic specialty hospital over a 1-year period. Our study goals were to identify types of implants wasted, and incidence and cost of implant waste, for all total hip arthroplasties (THAs), total knee arthroplasties (TKAs), and lumbar spinal fusions performed at the hospital and to determine whether case volume or years in surgical practice affect the rate or cost of implants wasted.

Methods

We performed a retrospective economic analysis of 1 year of administrative implant data from our institution. Collected data were quantified and analyzed for factors that might explain any variance in implant waste among surgeons. We were granted exempt institutional review board status, as no patient information was involved in this study.

We reviewed the administrative implant data for the 12-month period beginning June 2012 and ending May 2013. For that period, number of cases in which an implant was used and number of cases in which an implant was wasted were recorded. For each instance of waste, type and cost of the wasted implant were entered into the administrative database. In addition, overall cost of implants for the year and cost of wasted implants were determined. Data were available for 81 surgeons across 8 orthopedic divisions (subspecialties). From this information, we determined percentage of cases in which waste occurred, percentage of total implant cost wasted, average cost of waste per case, and most commonly wasted implants. All 3 variables were also calculated for THAs, TKAs, and lumbar spinal fusion procedures.

Statistical Analysis

The data were analyzed to determine if surgeon case volume or years in surgical practice affected implant waste. All analyses were performed at department, division (subspecialty), and surgeon levels. Case volume was analyzed in 3 groups: top 25%, middle 50%, and lower 25%. Number of years in surgical practice was analyzed in 3 groups: fewer than 10 years, 10 to 19 years, and 20 years or more. Normality assumption of variables was tested using the Shapiro-Wilk test (P < .05). For between-group differences, 1-way analysis of variance and the Tukey honestly significant difference post hoc test were performed for variables with a normal distribution, and the Kruskal-Wallis and Mann-Whitney tests were performed for variables without a normal distribution.

For the subspecialty-level analyses, only the Adult Reconstruction, Sports Medicine, and Spine divisions were analyzed for the effects of volume, and only the Sports Medicine and Spine divisions were analyzed for the effect of surgical experience, as surgeon numbers were insufficient for adequate grouping(s).

Data are presented as means with corresponding 95% confidence intervals (CIs). Categorical variables are presented as counts with percentages. All statistical analyses were performed with SPSS Version 21.0 (IBM SPSS) statistical software. Statistical significance was set at .05.

Results

During the 1-year period, 8954 department cases involved an implant of any type. Waste occurred in 12% (1072) of these cases. The rate ranged from 8% in the Adult Reconstruction division to 30% in the Trauma division (Table 1), and the rate for individual surgeons ranged from 3% to 100%, though the surgeon with 100% performed only 1 case, and the next highest rate was 50%.

Total implant cost for our hospital during the period was $34,340,607. Of that total cost, 1.8% ($634,668) was lost because of implant waste. Percentage of total implant cost wasted ranged from 1.6% in the Adult Reconstruction division to 4.7% in the Sports Medicine division (Table 1). Percentage of total implant cost wasted for individual surgeons ranged from 0.2% to 16.1%. Tables 2 and 3 list the most commonly wasted implants by count and cost, respectively.

When total cost of wasted implants was averaged over all implant cases performed during the period, the loss resulting from waste amounted to $71 per case for the department and ranged from $21 per case for the Hand division to $105 per case for the Pediatric division (Table 1). For individual surgeons, the loss ranged from $4 to $250 per case.

During the period studied, an implant was wasted in 9% (100) of the 1076 primary THAs performed, 4% (42) of the 1003 primary TKAs, and 14% (30) of the 217 lumbar spinal fusions (Tables 4, 5).

There was no significant difference between groups for department (P = .46) or for the Adult Reconstruction (P = .83), Spine (P = .10), or Sports Medicine (P = .69) division. Analyzing for variance by years in surgical practice, we found a significant difference for department (P = .01) but not for the Adult Reconstruction (P = .12) or Spine (P = .14) division. The department difference resulted from a significant difference (P = .001; 95% CI, 1.112-17.408) between surgeons (<10 years of surgical practice) who wasted implants in 12.8% of their cases and surgeons (>20 years of surgical practice) who wasted implants in 9% of their cases (Table 4).

There was no significant difference between groups for department (P = .83) or for the Adult Reconstruction (P = .29) or Spine (P = .41) division when analyzed by years in surgical practice. Analyzing by case volume, we found a significant difference for the Sports Medicine division (P = .004): Percentage of total implant waste was significantly higher (P = .003; 95% CI, –12.61 to –2.97) for surgeons with the lower 25% of case volume (9.8%) than for surgeons with the middle 50% of case volume (3.5%) (Table 5). No other significant difference was found for department (P = .52) or for the Adult Reconstruction (P = .69) or Spine (P = .45) division.

Analyzing by case volume and years in surgical practice, we found no significant difference for department (case volume, P = .76; years in surgical practice, P = .07), Adult Reconstruction division (case volume, P = .47; years in surgical practice, P = .78), Spine division (case volume, P = .11; years in surgical practice, P = .15), or Sports Medicine division (case volume, P = .08).

Selected Procedures

Total Hip Arthroplasty. Regarding variance by case volume and years in surgical practice, we found no significant difference for any variable analyzed: percentage of cases with waste (volume, P = .072; years in practice, P = .076), percentage of total implant cost wasted (volume, P = .074; years in practice, P = .12), cost of waste per case (volume, P = .075; years in practice, P = .32).

Total Knee Arthroplasty. Regarding variance by years in surgical practice, we found no significant difference for any variable analyzed: percentage of cases with waste (P = .38), percentage of total implant cost wasted (P = .50), cost of waste per case (P = .50). Regarding variance by volume, there was no significant difference for percentage of cases with waste (P = .70) or cost of waste per case (P = .05), but we found a significant difference for percentage of total implant cost wasted (P = .038). That difference was caused by an outlier: One surgeon with the lower 25% of case volume wasted an implant in the only TKA he performed that year. Correction for the outlier removed the significance.

Posterior Lumbar Spinal Fusion. Regarding variance by case volume and years in surgical practice, we found no significant difference for any variable analyzed: percentage of cases with waste (volume, P = .36; years in surgical practice, P = .22), percentage of total implant cost wasted (volume, P = .33; years in surgical practice, P = .41), cost of waste per case (volume, P = .34; years in practice, P = .15).

Discussion

The steadily increasing demand for orthopedic surgeries and declining rates of reimbursement by Medicare and other insurance providers have led many hospitals to look for ways to control the cost of these surgeries. Reducing operating room costs, lowering implant prices, and shortening hospital stays have all proved successful.^6,15,20,23 One area that has not been thoroughly explored is the cost burden of wasted implants. Our findings suggest implant waste contributes significantly to the cost of orthopedic surgeries.

One weakness of this study is that its data, though encompassing all orthopedic subspecialties and procedures, come from a single teaching institution and therefore are less representative of all orthopedic departments across the United States. However, the findings are useful in that the analysis was performed across multiple specialties at a high-volume institution and may be applied to similar institutions. Another weakness of this study is that the data cover only 1 year. Collecting data over a longer period could improve the magnitude and power of the analysis. Nonetheless, 1 year of data is a good starting point in identifying the issues and guiding the initiation of measures to address them. Last, we did not explore the reason for each instance of waste during the period reviewed. Knowing the reason for implant waste would be helpful in developing strategies to reduce implant waste.

Our study results showed that, in 1 year, implant waste occurred in 1.8% of procedures that required an implant—representing a loss of $634,000. Other studies have quantified implant waste for selected procedures or single departments, but to our knowledge none has quantified implant waste for an entire orthopedic department or hospital. It is therefore difficult to compare our institutional results with other results. For instance, definitions of waste differ. A study that found waste in 20% of spine surgery cases²² included all intraoperative waste, whereas our 11% of spine cases were implant waste only. Similarly, though rates of implant waste in trauma cases differed significantly between a multi-institution study by Zywiel and colleagues²⁴ (0.6%) and our institution (30%), their study excluded arthroplasty cases from the trauma subset and reported implant waste for a single vendor, whereas we included arthroplasty cases and a wide array of implant vendors. In addition, costs cannot be directly compared because, in our study, implants wasted may have differed. Although the Trauma division had the highest incidence of waste (30%) in our analysis, it did not have the highest waste-related costs. Instead, the Adult Reconstruction division, with waste in 8% of cases, had the highest waste cost, $214,869. The cost difference is certainly the result of the difference in type of implants wasted. The implants most commonly wasted in the Trauma division were screws, which cost between $17 and $150; a single femoral stem, though wasted less often, cost significantly more, $2000 to $6000.

Our results showed a combined implant waste incidence of 6.8% for primary THA and primary TKA cases over the year. In their multi-institution study, Zywiel and colleagues¹⁹ reported a combined incidence of implant waste in 2% of THA and TKA cases. The difference is that Zywiel and colleagues¹⁹ reported data from a single implant vendor and included revision surgeries, hip hemiarthroplasties, and unicondylar knee arthroplasties. Another study reported implant waste in 5.7% of all TKA cases but did not specify whether revision or unicondylar arthroplasties were included.²⁵ For lumbar spinal fusion, we found an implant waste incidence of 14%. Given the lack of studies in this area, we cannot make a comparison of results.

To our knowledge, there has been no other study of the effects of case volume and years in surgical practice on implant waste. Our analysis showed that waste incidence was not related to surgeon case volume but was related to years in surgical practice. Incidence of waste was significantly lower among surgeons practicing 20 years or more than among surgeons practicing fewer than 10 years. The difference may be a reflection that case volume during a single year is not totally indicative of a surgeon’s lifetime case volume. For example, several surgeons with many years of experience and a significant lifetime case volume had an annual case volume in the lower 25% of the department because they were approaching retirement or had only recently joined the institution. More rigorous prospective studies are needed to further understand this relationship.

Conclusions

Our study demonstrated significant costs related to implant waste. These costs are important to consider not only for traditional cases, such as total joint and spine procedures, in which implant costs are routinely scrutinized, but for all subspecialties, such as sports medicine, in which the majority of cases are performed on an outpatient basis. Considering the estimated $36 million wasted during THAs and TKAs and $126 million wasted on spine surgeries in the United States annually, and the significant waste we observed in other orthopedic subspecialties, decreasing the rate of intraoperative waste during orthopedic surgeries represents another area that could provide significant cost reduction through implant cost savings.^19,22 A few successful programs have been reported. Soroceanu and colleagues²² found an almost 50% decrease in intraoperative waste during spine surgery after an educational program was used to address such waste. Elsewhere, use of a computer-based system (e.Label and Compatibility) led to an estimated cost reduction of $75,000 in implant waste.²⁵ Efforts to develop and implement other programs to reduce implant waste are needed and should be part of any orthopedic operating room cost reduction strategy.

The cost of health care in the United States is increasing at an unsustainable rate.^1-3 To decrease or even reverse this trend, we must decrease the cost of care without adversely affecting quality. Porter⁴ defined value as the quality of care divided by its cost. The economics of total joint arthroplasty (TJA) has received a great deal of attention because of both increasing demand and increasing cost.^5-9 About 33% of all orthopedic surgeries and the majority of TJAs are paid for by Medicare.⁹ In recent years, the rate of reimbursement for orthopedic cases has steadily declined while the cost of implants has increased.^3,10,11 Given the significant cost of implants, health care providers in some subspecialties have focused on implant costs as a potential area for cost reduction.¹² For example, in TJA this has proved effective in reducing the overall cost, as has decreasing length of stay after surgery.^8,10,13-16

With little evidence suggesting any specific orthopedic implant has outcomes superior to those of others, with the exception of select poorly performing outliers, we must increase value of care by lowering the cost when considering these devices.^17,18 In addition, some experts have suggested that intraoperative waste is a significant factor in TJA cost, and it does contribute to the average implant cost for a TJA case.^6,19 Using data collected from 72 institutions, Zywiel and colleagues¹⁹ estimated the annual cost of wasted hip and knee arthroplasty implants to be more than $36 million in the United States.

However, considering the aging US population, TJA is not the only orthopedic surgery with increased demand. An estimated 600,000 spine surgeries are performed each year in the United States.²⁰ Between 1992 and 2003, Medicare spending for lumbar spinal fusion increased 500%.²¹ In addition, in a 15-month observational study of incidence of intraoperative waste in spine surgery, Soroceanu and colleagues²² reported waste occurring in 20% of spine procedures.

Although these studies have described implant waste in TJA and spine surgeries, little has been published on the cost of wasted implants in a center performing the full range of orthopedic procedures. In this article, we detail the implant waste costs incurred by surgeons for all orthopedic subspecialties at a single orthopedic specialty hospital over a 1-year period. Our study goals were to identify types of implants wasted, and incidence and cost of implant waste, for all total hip arthroplasties (THAs), total knee arthroplasties (TKAs), and lumbar spinal fusions performed at the hospital and to determine whether case volume or years in surgical practice affect the rate or cost of implants wasted.

Methods

We performed a retrospective economic analysis of 1 year of administrative implant data from our institution. Collected data were quantified and analyzed for factors that might explain any variance in implant waste among surgeons. We were granted exempt institutional review board status, as no patient information was involved in this study.

We reviewed the administrative implant data for the 12-month period beginning June 2012 and ending May 2013. For that period, number of cases in which an implant was used and number of cases in which an implant was wasted were recorded. For each instance of waste, type and cost of the wasted implant were entered into the administrative database. In addition, overall cost of implants for the year and cost of wasted implants were determined. Data were available for 81 surgeons across 8 orthopedic divisions (subspecialties). From this information, we determined percentage of cases in which waste occurred, percentage of total implant cost wasted, average cost of waste per case, and most commonly wasted implants. All 3 variables were also calculated for THAs, TKAs, and lumbar spinal fusion procedures.

Statistical Analysis

The data were analyzed to determine if surgeon case volume or years in surgical practice affected implant waste. All analyses were performed at department, division (subspecialty), and surgeon levels. Case volume was analyzed in 3 groups: top 25%, middle 50%, and lower 25%. Number of years in surgical practice was analyzed in 3 groups: fewer than 10 years, 10 to 19 years, and 20 years or more. Normality assumption of variables was tested using the Shapiro-Wilk test (P < .05). For between-group differences, 1-way analysis of variance and the Tukey honestly significant difference post hoc test were performed for variables with a normal distribution, and the Kruskal-Wallis and Mann-Whitney tests were performed for variables without a normal distribution.

For the subspecialty-level analyses, only the Adult Reconstruction, Sports Medicine, and Spine divisions were analyzed for the effects of volume, and only the Sports Medicine and Spine divisions were analyzed for the effect of surgical experience, as surgeon numbers were insufficient for adequate grouping(s).

Data are presented as means with corresponding 95% confidence intervals (CIs). Categorical variables are presented as counts with percentages. All statistical analyses were performed with SPSS Version 21.0 (IBM SPSS) statistical software. Statistical significance was set at .05.

Results

During the 1-year period, 8954 department cases involved an implant of any type. Waste occurred in 12% (1072) of these cases. The rate ranged from 8% in the Adult Reconstruction division to 30% in the Trauma division (Table 1), and the rate for individual surgeons ranged from 3% to 100%, though the surgeon with 100% performed only 1 case, and the next highest rate was 50%.

Total implant cost for our hospital during the period was $34,340,607. Of that total cost, 1.8% ($634,668) was lost because of implant waste. Percentage of total implant cost wasted ranged from 1.6% in the Adult Reconstruction division to 4.7% in the Sports Medicine division (Table 1). Percentage of total implant cost wasted for individual surgeons ranged from 0.2% to 16.1%. Tables 2 and 3 list the most commonly wasted implants by count and cost, respectively.

When total cost of wasted implants was averaged over all implant cases performed during the period, the loss resulting from waste amounted to $71 per case for the department and ranged from $21 per case for the Hand division to $105 per case for the Pediatric division (Table 1). For individual surgeons, the loss ranged from $4 to $250 per case.

During the period studied, an implant was wasted in 9% (100) of the 1076 primary THAs performed, 4% (42) of the 1003 primary TKAs, and 14% (30) of the 217 lumbar spinal fusions (Tables 4, 5).

There was no significant difference between groups for department (P = .46) or for the Adult Reconstruction (P = .83), Spine (P = .10), or Sports Medicine (P = .69) division. Analyzing for variance by years in surgical practice, we found a significant difference for department (P = .01) but not for the Adult Reconstruction (P = .12) or Spine (P = .14) division. The department difference resulted from a significant difference (P = .001; 95% CI, 1.112-17.408) between surgeons (<10 years of surgical practice) who wasted implants in 12.8% of their cases and surgeons (>20 years of surgical practice) who wasted implants in 9% of their cases (Table 4).

There was no significant difference between groups for department (P = .83) or for the Adult Reconstruction (P = .29) or Spine (P = .41) division when analyzed by years in surgical practice. Analyzing by case volume, we found a significant difference for the Sports Medicine division (P = .004): Percentage of total implant waste was significantly higher (P = .003; 95% CI, –12.61 to –2.97) for surgeons with the lower 25% of case volume (9.8%) than for surgeons with the middle 50% of case volume (3.5%) (Table 5). No other significant difference was found for department (P = .52) or for the Adult Reconstruction (P = .69) or Spine (P = .45) division.

Analyzing by case volume and years in surgical practice, we found no significant difference for department (case volume, P = .76; years in surgical practice, P = .07), Adult Reconstruction division (case volume, P = .47; years in surgical practice, P = .78), Spine division (case volume, P = .11; years in surgical practice, P = .15), or Sports Medicine division (case volume, P = .08).

Selected Procedures

Total Hip Arthroplasty. Regarding variance by case volume and years in surgical practice, we found no significant difference for any variable analyzed: percentage of cases with waste (volume, P = .072; years in practice, P = .076), percentage of total implant cost wasted (volume, P = .074; years in practice, P = .12), cost of waste per case (volume, P = .075; years in practice, P = .32).

Total Knee Arthroplasty. Regarding variance by years in surgical practice, we found no significant difference for any variable analyzed: percentage of cases with waste (P = .38), percentage of total implant cost wasted (P = .50), cost of waste per case (P = .50). Regarding variance by volume, there was no significant difference for percentage of cases with waste (P = .70) or cost of waste per case (P = .05), but we found a significant difference for percentage of total implant cost wasted (P = .038). That difference was caused by an outlier: One surgeon with the lower 25% of case volume wasted an implant in the only TKA he performed that year. Correction for the outlier removed the significance.

Posterior Lumbar Spinal Fusion. Regarding variance by case volume and years in surgical practice, we found no significant difference for any variable analyzed: percentage of cases with waste (volume, P = .36; years in surgical practice, P = .22), percentage of total implant cost wasted (volume, P = .33; years in surgical practice, P = .41), cost of waste per case (volume, P = .34; years in practice, P = .15).

Discussion

The steadily increasing demand for orthopedic surgeries and declining rates of reimbursement by Medicare and other insurance providers have led many hospitals to look for ways to control the cost of these surgeries. Reducing operating room costs, lowering implant prices, and shortening hospital stays have all proved successful.^6,15,20,23 One area that has not been thoroughly explored is the cost burden of wasted implants. Our findings suggest implant waste contributes significantly to the cost of orthopedic surgeries.

One weakness of this study is that its data, though encompassing all orthopedic subspecialties and procedures, come from a single teaching institution and therefore are less representative of all orthopedic departments across the United States. However, the findings are useful in that the analysis was performed across multiple specialties at a high-volume institution and may be applied to similar institutions. Another weakness of this study is that the data cover only 1 year. Collecting data over a longer period could improve the magnitude and power of the analysis. Nonetheless, 1 year of data is a good starting point in identifying the issues and guiding the initiation of measures to address them. Last, we did not explore the reason for each instance of waste during the period reviewed. Knowing the reason for implant waste would be helpful in developing strategies to reduce implant waste.

Our study results showed that, in 1 year, implant waste occurred in 1.8% of procedures that required an implant—representing a loss of $634,000. Other studies have quantified implant waste for selected procedures or single departments, but to our knowledge none has quantified implant waste for an entire orthopedic department or hospital. It is therefore difficult to compare our institutional results with other results. For instance, definitions of waste differ. A study that found waste in 20% of spine surgery cases²² included all intraoperative waste, whereas our 11% of spine cases were implant waste only. Similarly, though rates of implant waste in trauma cases differed significantly between a multi-institution study by Zywiel and colleagues²⁴ (0.6%) and our institution (30%), their study excluded arthroplasty cases from the trauma subset and reported implant waste for a single vendor, whereas we included arthroplasty cases and a wide array of implant vendors. In addition, costs cannot be directly compared because, in our study, implants wasted may have differed. Although the Trauma division had the highest incidence of waste (30%) in our analysis, it did not have the highest waste-related costs. Instead, the Adult Reconstruction division, with waste in 8% of cases, had the highest waste cost, $214,869. The cost difference is certainly the result of the difference in type of implants wasted. The implants most commonly wasted in the Trauma division were screws, which cost between $17 and $150; a single femoral stem, though wasted less often, cost significantly more, $2000 to $6000.

Our results showed a combined implant waste incidence of 6.8% for primary THA and primary TKA cases over the year. In their multi-institution study, Zywiel and colleagues¹⁹ reported a combined incidence of implant waste in 2% of THA and TKA cases. The difference is that Zywiel and colleagues¹⁹ reported data from a single implant vendor and included revision surgeries, hip hemiarthroplasties, and unicondylar knee arthroplasties. Another study reported implant waste in 5.7% of all TKA cases but did not specify whether revision or unicondylar arthroplasties were included.²⁵ For lumbar spinal fusion, we found an implant waste incidence of 14%. Given the lack of studies in this area, we cannot make a comparison of results.

To our knowledge, there has been no other study of the effects of case volume and years in surgical practice on implant waste. Our analysis showed that waste incidence was not related to surgeon case volume but was related to years in surgical practice. Incidence of waste was significantly lower among surgeons practicing 20 years or more than among surgeons practicing fewer than 10 years. The difference may be a reflection that case volume during a single year is not totally indicative of a surgeon’s lifetime case volume. For example, several surgeons with many years of experience and a significant lifetime case volume had an annual case volume in the lower 25% of the department because they were approaching retirement or had only recently joined the institution. More rigorous prospective studies are needed to further understand this relationship.

Conclusions

Our study demonstrated significant costs related to implant waste. These costs are important to consider not only for traditional cases, such as total joint and spine procedures, in which implant costs are routinely scrutinized, but for all subspecialties, such as sports medicine, in which the majority of cases are performed on an outpatient basis. Considering the estimated $36 million wasted during THAs and TKAs and $126 million wasted on spine surgeries in the United States annually, and the significant waste we observed in other orthopedic subspecialties, decreasing the rate of intraoperative waste during orthopedic surgeries represents another area that could provide significant cost reduction through implant cost savings.^19,22 A few successful programs have been reported. Soroceanu and colleagues²² found an almost 50% decrease in intraoperative waste during spine surgery after an educational program was used to address such waste. Elsewhere, use of a computer-based system (e.Label and Compatibility) led to an estimated cost reduction of $75,000 in implant waste.²⁵ Efforts to develop and implement other programs to reduce implant waste are needed and should be part of any orthopedic operating room cost reduction strategy.

The cost of health care in the United States is increasing at an unsustainable rate.^1-3 To decrease or even reverse this trend, we must decrease the cost of care without adversely affecting quality. Porter⁴ defined value as the quality of care divided by its cost. The economics of total joint arthroplasty (TJA) has received a great deal of attention because of both increasing demand and increasing cost.^5-9 About 33% of all orthopedic surgeries and the majority of TJAs are paid for by Medicare.⁹ In recent years, the rate of reimbursement for orthopedic cases has steadily declined while the cost of implants has increased.^3,10,11 Given the significant cost of implants, health care providers in some subspecialties have focused on implant costs as a potential area for cost reduction.¹² For example, in TJA this has proved effective in reducing the overall cost, as has decreasing length of stay after surgery.^8,10,13-16

With little evidence suggesting any specific orthopedic implant has outcomes superior to those of others, with the exception of select poorly performing outliers, we must increase value of care by lowering the cost when considering these devices.^17,18 In addition, some experts have suggested that intraoperative waste is a significant factor in TJA cost, and it does contribute to the average implant cost for a TJA case.^6,19 Using data collected from 72 institutions, Zywiel and colleagues¹⁹ estimated the annual cost of wasted hip and knee arthroplasty implants to be more than $36 million in the United States.

However, considering the aging US population, TJA is not the only orthopedic surgery with increased demand. An estimated 600,000 spine surgeries are performed each year in the United States.²⁰ Between 1992 and 2003, Medicare spending for lumbar spinal fusion increased 500%.²¹ In addition, in a 15-month observational study of incidence of intraoperative waste in spine surgery, Soroceanu and colleagues²² reported waste occurring in 20% of spine procedures.

Although these studies have described implant waste in TJA and spine surgeries, little has been published on the cost of wasted implants in a center performing the full range of orthopedic procedures. In this article, we detail the implant waste costs incurred by surgeons for all orthopedic subspecialties at a single orthopedic specialty hospital over a 1-year period. Our study goals were to identify types of implants wasted, and incidence and cost of implant waste, for all total hip arthroplasties (THAs), total knee arthroplasties (TKAs), and lumbar spinal fusions performed at the hospital and to determine whether case volume or years in surgical practice affect the rate or cost of implants wasted.

Methods

We performed a retrospective economic analysis of 1 year of administrative implant data from our institution. Collected data were quantified and analyzed for factors that might explain any variance in implant waste among surgeons. We were granted exempt institutional review board status, as no patient information was involved in this study.

We reviewed the administrative implant data for the 12-month period beginning June 2012 and ending May 2013. For that period, number of cases in which an implant was used and number of cases in which an implant was wasted were recorded. For each instance of waste, type and cost of the wasted implant were entered into the administrative database. In addition, overall cost of implants for the year and cost of wasted implants were determined. Data were available for 81 surgeons across 8 orthopedic divisions (subspecialties). From this information, we determined percentage of cases in which waste occurred, percentage of total implant cost wasted, average cost of waste per case, and most commonly wasted implants. All 3 variables were also calculated for THAs, TKAs, and lumbar spinal fusion procedures.

Statistical Analysis

The data were analyzed to determine if surgeon case volume or years in surgical practice affected implant waste. All analyses were performed at department, division (subspecialty), and surgeon levels. Case volume was analyzed in 3 groups: top 25%, middle 50%, and lower 25%. Number of years in surgical practice was analyzed in 3 groups: fewer than 10 years, 10 to 19 years, and 20 years or more. Normality assumption of variables was tested using the Shapiro-Wilk test (P < .05). For between-group differences, 1-way analysis of variance and the Tukey honestly significant difference post hoc test were performed for variables with a normal distribution, and the Kruskal-Wallis and Mann-Whitney tests were performed for variables without a normal distribution.

For the subspecialty-level analyses, only the Adult Reconstruction, Sports Medicine, and Spine divisions were analyzed for the effects of volume, and only the Sports Medicine and Spine divisions were analyzed for the effect of surgical experience, as surgeon numbers were insufficient for adequate grouping(s).

Data are presented as means with corresponding 95% confidence intervals (CIs). Categorical variables are presented as counts with percentages. All statistical analyses were performed with SPSS Version 21.0 (IBM SPSS) statistical software. Statistical significance was set at .05.

Results

During the 1-year period, 8954 department cases involved an implant of any type. Waste occurred in 12% (1072) of these cases. The rate ranged from 8% in the Adult Reconstruction division to 30% in the Trauma division (Table 1), and the rate for individual surgeons ranged from 3% to 100%, though the surgeon with 100% performed only 1 case, and the next highest rate was 50%.

Total implant cost for our hospital during the period was $34,340,607. Of that total cost, 1.8% ($634,668) was lost because of implant waste. Percentage of total implant cost wasted ranged from 1.6% in the Adult Reconstruction division to 4.7% in the Sports Medicine division (Table 1). Percentage of total implant cost wasted for individual surgeons ranged from 0.2% to 16.1%. Tables 2 and 3 list the most commonly wasted implants by count and cost, respectively.

When total cost of wasted implants was averaged over all implant cases performed during the period, the loss resulting from waste amounted to $71 per case for the department and ranged from $21 per case for the Hand division to $105 per case for the Pediatric division (Table 1). For individual surgeons, the loss ranged from $4 to $250 per case.

During the period studied, an implant was wasted in 9% (100) of the 1076 primary THAs performed, 4% (42) of the 1003 primary TKAs, and 14% (30) of the 217 lumbar spinal fusions (Tables 4, 5).

There was no significant difference between groups for department (P = .46) or for the Adult Reconstruction (P = .83), Spine (P = .10), or Sports Medicine (P = .69) division. Analyzing for variance by years in surgical practice, we found a significant difference for department (P = .01) but not for the Adult Reconstruction (P = .12) or Spine (P = .14) division. The department difference resulted from a significant difference (P = .001; 95% CI, 1.112-17.408) between surgeons (<10 years of surgical practice) who wasted implants in 12.8% of their cases and surgeons (>20 years of surgical practice) who wasted implants in 9% of their cases (Table 4).

There was no significant difference between groups for department (P = .83) or for the Adult Reconstruction (P = .29) or Spine (P = .41) division when analyzed by years in surgical practice. Analyzing by case volume, we found a significant difference for the Sports Medicine division (P = .004): Percentage of total implant waste was significantly higher (P = .003; 95% CI, –12.61 to –2.97) for surgeons with the lower 25% of case volume (9.8%) than for surgeons with the middle 50% of case volume (3.5%) (Table 5). No other significant difference was found for department (P = .52) or for the Adult Reconstruction (P = .69) or Spine (P = .45) division.

Analyzing by case volume and years in surgical practice, we found no significant difference for department (case volume, P = .76; years in surgical practice, P = .07), Adult Reconstruction division (case volume, P = .47; years in surgical practice, P = .78), Spine division (case volume, P = .11; years in surgical practice, P = .15), or Sports Medicine division (case volume, P = .08).

Selected Procedures

Total Hip Arthroplasty. Regarding variance by case volume and years in surgical practice, we found no significant difference for any variable analyzed: percentage of cases with waste (volume, P = .072; years in practice, P = .076), percentage of total implant cost wasted (volume, P = .074; years in practice, P = .12), cost of waste per case (volume, P = .075; years in practice, P = .32).

Total Knee Arthroplasty. Regarding variance by years in surgical practice, we found no significant difference for any variable analyzed: percentage of cases with waste (P = .38), percentage of total implant cost wasted (P = .50), cost of waste per case (P = .50). Regarding variance by volume, there was no significant difference for percentage of cases with waste (P = .70) or cost of waste per case (P = .05), but we found a significant difference for percentage of total implant cost wasted (P = .038). That difference was caused by an outlier: One surgeon with the lower 25% of case volume wasted an implant in the only TKA he performed that year. Correction for the outlier removed the significance.

Posterior Lumbar Spinal Fusion. Regarding variance by case volume and years in surgical practice, we found no significant difference for any variable analyzed: percentage of cases with waste (volume, P = .36; years in surgical practice, P = .22), percentage of total implant cost wasted (volume, P = .33; years in surgical practice, P = .41), cost of waste per case (volume, P = .34; years in practice, P = .15).

Discussion

The steadily increasing demand for orthopedic surgeries and declining rates of reimbursement by Medicare and other insurance providers have led many hospitals to look for ways to control the cost of these surgeries. Reducing operating room costs, lowering implant prices, and shortening hospital stays have all proved successful.^6,15,20,23 One area that has not been thoroughly explored is the cost burden of wasted implants. Our findings suggest implant waste contributes significantly to the cost of orthopedic surgeries.

One weakness of this study is that its data, though encompassing all orthopedic subspecialties and procedures, come from a single teaching institution and therefore are less representative of all orthopedic departments across the United States. However, the findings are useful in that the analysis was performed across multiple specialties at a high-volume institution and may be applied to similar institutions. Another weakness of this study is that the data cover only 1 year. Collecting data over a longer period could improve the magnitude and power of the analysis. Nonetheless, 1 year of data is a good starting point in identifying the issues and guiding the initiation of measures to address them. Last, we did not explore the reason for each instance of waste during the period reviewed. Knowing the reason for implant waste would be helpful in developing strategies to reduce implant waste.

Our study results showed that, in 1 year, implant waste occurred in 1.8% of procedures that required an implant—representing a loss of $634,000. Other studies have quantified implant waste for selected procedures or single departments, but to our knowledge none has quantified implant waste for an entire orthopedic department or hospital. It is therefore difficult to compare our institutional results with other results. For instance, definitions of waste differ. A study that found waste in 20% of spine surgery cases²² included all intraoperative waste, whereas our 11% of spine cases were implant waste only. Similarly, though rates of implant waste in trauma cases differed significantly between a multi-institution study by Zywiel and colleagues²⁴ (0.6%) and our institution (30%), their study excluded arthroplasty cases from the trauma subset and reported implant waste for a single vendor, whereas we included arthroplasty cases and a wide array of implant vendors. In addition, costs cannot be directly compared because, in our study, implants wasted may have differed. Although the Trauma division had the highest incidence of waste (30%) in our analysis, it did not have the highest waste-related costs. Instead, the Adult Reconstruction division, with waste in 8% of cases, had the highest waste cost, $214,869. The cost difference is certainly the result of the difference in type of implants wasted. The implants most commonly wasted in the Trauma division were screws, which cost between $17 and $150; a single femoral stem, though wasted less often, cost significantly more, $2000 to $6000.

Our results showed a combined implant waste incidence of 6.8% for primary THA and primary TKA cases over the year. In their multi-institution study, Zywiel and colleagues¹⁹ reported a combined incidence of implant waste in 2% of THA and TKA cases. The difference is that Zywiel and colleagues¹⁹ reported data from a single implant vendor and included revision surgeries, hip hemiarthroplasties, and unicondylar knee arthroplasties. Another study reported implant waste in 5.7% of all TKA cases but did not specify whether revision or unicondylar arthroplasties were included.²⁵ For lumbar spinal fusion, we found an implant waste incidence of 14%. Given the lack of studies in this area, we cannot make a comparison of results.

To our knowledge, there has been no other study of the effects of case volume and years in surgical practice on implant waste. Our analysis showed that waste incidence was not related to surgeon case volume but was related to years in surgical practice. Incidence of waste was significantly lower among surgeons practicing 20 years or more than among surgeons practicing fewer than 10 years. The difference may be a reflection that case volume during a single year is not totally indicative of a surgeon’s lifetime case volume. For example, several surgeons with many years of experience and a significant lifetime case volume had an annual case volume in the lower 25% of the department because they were approaching retirement or had only recently joined the institution. More rigorous prospective studies are needed to further understand this relationship.

Conclusions

Our study demonstrated significant costs related to implant waste. These costs are important to consider not only for traditional cases, such as total joint and spine procedures, in which implant costs are routinely scrutinized, but for all subspecialties, such as sports medicine, in which the majority of cases are performed on an outpatient basis. Considering the estimated $36 million wasted during THAs and TKAs and $126 million wasted on spine surgeries in the United States annually, and the significant waste we observed in other orthopedic subspecialties, decreasing the rate of intraoperative waste during orthopedic surgeries represents another area that could provide significant cost reduction through implant cost savings.^19,22 A few successful programs have been reported. Soroceanu and colleagues²² found an almost 50% decrease in intraoperative waste during spine surgery after an educational program was used to address such waste. Elsewhere, use of a computer-based system (e.Label and Compatibility) led to an estimated cost reduction of $75,000 in implant waste.²⁵ Efforts to develop and implement other programs to reduce implant waste are needed and should be part of any orthopedic operating room cost reduction strategy.

In the United States, the landscape of health care is changing. Health care reform and fluctuating political and economic climates have affected and will continue to affect the practice of orthopedic surgery. Demand for musculoskeletal care and the costs of providing this care are exceeding available resources—which has led to an evolution in how we practice as individuals and in the institutions where we provide care. Patient safety, quality, and value have become the outcomes of importance. Orthopedic surgeons, as experts in musculoskeletal care, must be a part of these changes. In this review, we offer perspective on the changing face of orthopedic surgery in the modern US health care system.

1. Meeting the demand

Musculoskeletal conditions represent one of the most common and costly health issues in the United States, affecting individuals medically and economically and compromising their quality of life.^1,2 In 2008, more than 110 million US adults (1 in 2) reported having a musculoskeletal condition for more than 3 months, and almost 7% reported that a chronic musculoskeletal condition made routine activities of daily living significantly difficult.¹ Overall, in the United States, some of the most common chronic conditions are musculoskeletal in origin. These conditions include osteoarthritis and back pain.

Osteoarthritis is the leading cause of chronic pain and disability. Physician-diagnosed arthritis is expected to affect 25% of US adults by 2030,³ and in more than one-third of these patients arthritis limits work or other activity.⁴ Back pain is another of the most common debilitating conditions in the United States.^3,5 St Sauver and colleagues⁶ found that back pain is the third most common condition (23.9%) that prompts patients to seek health care—following skin-related problems (42.7%) and osteoarthritis/joint pain (33.6%).

As life expectancy increases, so do expectations of enjoying higher levels of activity into the later years. Patients expect to be as active in their geriatric years as they were in middle age, and many are able to do so. Amid the growing obesity epidemic and increased incidence of chronic comorbidities, however, the aging population not only is at substantial risk for developing a chronic musculoskeletal disorder but may face new challenges in accessing care.

Although orthopedic surgeons specialize in treating musculoskeletal conditions, up to 90% of common nonsurgical musculoskeletal complaints are thought to be manageable in the primary care setting.⁷ With a disproportionate increase in musculoskeletal demand against a relatively constant number of orthopedic providers,⁸ it is becoming increasingly important for nonorthopedists to adequately manage musculoskeletal conditions. Physiatrists, rheumatologists, internists, family practitioners, and the expanding field of sports medicine specialists provide primary care of musculoskeletal conditions. To meet the growing demand and to ensure that patients receive quality, sustainable, effective, and efficient care, orthopedic surgeons should be actively involved in training these providers. As high as the cost of managing musculoskeletal conditions can be, it is far less than the cost resulting from inadequate or improper management. There is already justification for formal development of a specialization in nonoperative management of musculoskeletal care. Establishing this specialization requires a multidisciplinary approach, with orthopedic surgery taking a lead role.

2. The cost equation

As the prevalence of orthopedic conditions increases, so does the cost of delivering musculoskeletal care. The economic implications of meeting this growing demand are an important area of concern for our health care system. Steadily increasing hospital expenses for personnel and services, rising costs of pharmaceuticals and laboratory tests, constant evolution of costly technology, and insurance/reimbursement rates that do not keep pace with rising costs all contribute to the rapid escalation of the “cost of care.”

Health care expenditures accounted for 17.2% of the US gross domestic product (GDP) in 2012 and are expected to represent 19.3% by 2023.⁹ For musculoskeletal disease, direct costs alone are expected to approach $510 billion, equaling 5% of GDP and representing almost 30% of all health care expenditures. In Medicare patients, osteoarthritis is the most expensive condition to treat overall, and 3 other musculoskeletal problems rank highly as well: femoral neck fractures (3rd), back pain (10th), and fractures of all types (16th).¹⁰ Clearly, musculoskeletal care is one of the most prevalent and expensive health conditions in the United States.

Part of the direct costs of care that consistently increase each year are the steadily increasing costs of technology, which is often considered synonymous with orthopedic care. Promotion of new and more costly implants is common in the absence of evidence supporting their use. However, use of new implants and technology is being scrutinized in an effort to strike the proper cost–benefit balance.

To change the slope of the cost curve, orthopedic surgeons should utilize technological advances that are proven to be clinically significant and economically feasible and should avoid modest improvements with limited clinical benefit and higher price tags. Unfortunately, this approach is not being taken. Minor modifications of implant designs are often marketed as “new and improved” to justify increased costs, and these implants often gain widespread use. A few may prove to be clinically better, but most will be only comparable to older, less expensive designs, and some may end up being clinical failures, discovered at great cost to patients and the health care system.^11,12

Orthopedic surgeons have an important role in this decision-making. We should strive for the best, most cost-effective outcomes for our patients. We should reject new technology that does not clearly improve outcomes. At the least, we should use the technology in a manufacturer-supported clinical trial to determine its superiority. Whether the improvement is in technique, implant design, or workflow efficiency, orthopedic surgeons must be actively involved in researching and developing the latest innovations and must help determine their prospective value by considering not only their potential clinical benefits but also their economic implications.

As the political and economic environment becomes more directed at the cost-containment and sustainability of care, there has been a clear shift in focus to quality and value rather than volume, giving rise to the “value-based care” approach. The “value equation,” in which value equals quality divided by cost, requires a clear measure of outcomes and an equally clear understanding of costs. Delivering high-quality care in a cost-conscious environment is an approach that every orthopedic surgeon should adopt. Widespread adoption of the value-based strategy by hospital systems and insurance companies is resulting in a paradigm shift away from more traditional volume-based metrics and in favor of value-based metrics, including quality measures, patient-reported outcomes, Hospital Consumer Assessment of Healthcare Providers and Systems, and physician-specific outcome measures.

The new paradigm has brought the bundled payment initiative (BPI), a strategy included in the Patient Protection and Affordable Care Act. The philosophy behind the BPI model is for hospital systems and physicians to control costs while maintaining and improving the quality of care. Measured by patient metrics (eg, clinical outcomes, patient satisfaction) and hospital metrics (eg, readmission rates, cost of care), bundled payments reimburse hospitals on the basis of cost of an entire episode of care rather than on the basis of individual procedures and services. This approach provides incentives for both physicians and hospitals to promote value-based care while emphasizing coordination of care among all members of the health care team.

Providing the best possible care for our patients while holding our practice to the highest standards is a central tenet of the practice of orthopedic surgery and should be independent of reimbursement strategies. Thus, to increase the value of care, we must establish practice models and strategies to optimize cost-efficiency while improving outcomes. As explained by Porter and Teisberg,¹³ it is important to be conscientious about cost, but above all we must not allow quality of health care delivery to be compromised when trying to improve the “value” of care. Through evidence-based management and a clear understanding of costs, we must develop cost-efficient practice models that sustainably deliver the highest value of care.

3. Evolving practice models

As the health care landscape continues to change, physician practice models evolve accordingly. Although the private practice model once dominated the physician workforce, this is no longer true, as there has been a significant shift to employer-based practice models. The multiple factors at work relate to changing patterns of reimbursement, increasing government regulations, and a general change in recent residency graduates’ expectations regarding work–life balance. Other catalysts are the shift from volume- to value-based care and the recognition that cost-effective health care is more easily achieved when physicians and their institutions are in alignment. Ultimately, physician–institution alignment is crucial in improving care and outcomes.

Physician–institution alignment requires further discussion. Ideally, it should strike the proper balance between physician autonomy and institutional priorities to ensure the highest quality care. Physicians and their institutions should align their interests in terms of patient safety, quality, and economics to create a work environment conducive to both patient/physician satisfaction and institutional success.¹⁴ As identified by Page and colleagues,¹⁵ the primary drivers of physician–institution alignment, specific to orthopedic surgery, are economic, regulatory, and cultural. In economics, implant selection and ancillary services are the important issues; in the regulatory area, cooperative efforts to address expanding state and federal requirements are needed; last, the primary cultural driver is delivery of care to an expanding, diverse patient population.

Physician–institution alignment brings opportunities for “gainsharing,” which can directly benefit individual physicians, physician groups, and departments. Gainsharing is classically defined as “arrangements in which a hospital gives physicians a percentage share of any reduction in the hospital’s costs for patient care attributable in part to the physicians’ efforts.”¹⁶ Modern gainsharing programs can be used by institutions to align the economic interests of physicians and hospitals, with the ultimate goal being to achieve a sustainable increase in the value and quality of care delivered to patients.¹³ Examples include efforts to reduce the cost of orthopedic implants, which is a major cost driver in orthopedic surgery. Our institution realized significant savings when surgeons were directly involved in the implant contracting process with strategic sourcing personnel. These savings were shared with the department to enhance research and education programs. BPI, a risk-sharing program in which Medicare and hospitals participate, incorporates gainsharing opportunities in which each participating physician can receive up to 50% of his or her previous Medicare billings when specific targets are achieved. BPI included 27 musculoskeletal diagnosis–related groups that could be developed into a bundled payment proposal. Our institution participated in a 90-day episode, for primary hip and knee arthroplasty and non–cervical spine fusion, that had very promising results.

Gainsharing offers physicians incentives to meet institution goals of improved outcomes and increased patient satisfaction while increasing oversight and accountability. When physician-specific outcomes do not meet the established goals in key areas (readmissions, thromboembolic complications, infections), it is only logical that steps will be taken to improve outcomes. Although physicians may not be used to this increased scrutiny, the goal of improving outcomes, even if it necessitates a change in an established approach to care, should be welcomed.

Physicians should be rewarded for good outcomes but not suboptimal outcomes. When outcomes are suboptimal, physicians should take a constructive approach to improve them. On the other hand, not being rewarded for unachieved goals can be perceived as being penalized. Additional monitoring may paradoxically lead physicians to avoid more “complex” cases, such as those of patients at higher risk for complications and poorer outcomes. An example is found in patient selection for surgery, in which issues like obesity, diabetes, and heart disease are known to negatively affect outcomes. In these models, “cherry-picking” is a well-recognized risk^17,18 that can compromise our ethical obligation to provide equal access for all patients. To offset this tendency, we should use a risk-stratification model in which all patients are not considered equal in the risks they present. A risk-adjustment approach benefits both patients and providers by identifying modifiable risk factors that can be addressed to positively affect outcomes. This risk-stratification approach further incentivizes the orthopedist to closely work with other health care providers to address the medical comorbidities that may negatively affect surgical outcomes.

4. Patient and physician expectations

Living in a technology-driven society in the age of information has had a major impact on patients’ attitudes and expectations about their care—and therefore on physicians’ practice methods. It is uncommon to evaluate a patient who has not already consulted the Internet about a problem. Patients now have much more information they can use to make decisions about their treatment, and, though many question the accuracy of Internet information, there is no argument that being more informed is beneficial. In this time of shared decision-making, it is absolutely essential that patients keep themselves informed.

It is crucial to align the expectations of both physicians and patients in order to achieve the best outcomes. Gaining a clear understanding of treatment goals, management, and potential complications consistently leads to improved patient satisfaction, more favorable clinical outcomes, and reduced risk of litigation.^19-22 Addressing patient concerns and expectations is significantly enhanced by a strong patient–physician relationship through clinical models focused on patient-centered care.

Now considered a standard of care, the patient-centered model has changed the way we practice. The foundation of the patient-centered approach is to strengthen the patient–physician relationship by empowering patients to become active decision-makers in the management of their own health. The role of orthopedists in this model is to provide patients with information and insight into their conditions in order to facilitate shared decision-making. Our role should be to guide patients to make educated and informed decisions. Doing so enhances communication, thereby strengthening the patient–physician relationship, and places both patient and physician expectations in perspective. Patient-reported outcomes, satisfaction rates, symptomatic burdens, and costs of care are all positively correlated with strong communication and realistic expectations achieved through a patient-centered approach.^21,23

The evolution of clinical practice has been influenced by factors ranging from external forces (eg, changing political and economic climates) to social trends (use of social media and the Internet). Technology has been a driving force in our rapidly changing clinical environment, significantly altering the way we practice. Although we must be careful in how we use it, new technology can certainly work to our advantage. We have a plethora of medical information at our fingertips, and, with physician-directed guidance, our patients can become more informed than ever before. This is the principle of patient-centered medicine and shared decision-making, and its utility will only increase in importance.

5. The role of advocacy

The central tenet of orthopedic practice has always been a focus on patients. We continually strive to improve patient outcomes, reduce costs, and work efficiently in our practices and facilities. Although we can focus on our individual practices, we cannot ignore the influence and impact of the political system on our performance. Federal and state regulations give physicians and insurance companies an uneven playing field. This imbalance requires that physicians be more active in health care policymaking and advocacy. Although we are more involved than ever before, our influence is far less than what we would like it to be, perhaps partly because of the nature of the political process but perhaps also because of physicians’ resistance to becoming involved.

As experts in the treatment of musculoskeletal conditions, we should be at the forefront of health care policy development—a position we have not been able to attain. Although many factors contribute to our lack of a “seat at the table,” we must recognize our reluctance as a group to support advocacy, either financially or through personal time commitment. The American Association of Orthopaedic Surgeons (AAOS) Orthopaedic Political Action Committee has never been able to obtain donations from more than 30% of AAOS members. Although this committee historically has been successful, we could be much more so if we had financial support from 90% of members. There are many ways to be actively involved in advocacy. One way is to join local and state orthopedic societies and support their advocacy efforts. State orthopedic societies work closely with the AAOS Office of Government Relations to coordinate advocacy and direct efforts and resources to areas of greatest need. Knowing local congressional representatives and communicating with them about issues we face in our practices make our issues “real.” Some of our colleagues have even successfully run for office in Congress, and they certainly deserve our support. Advocacy will absolutely play an increasingly important role as federal and state governments expand their involvement in health care. Our role should be to get involved, at least to some degree. We need to recognize that our strength is in our numbers, as the few cannot accomplish nearly as much as the many.

Summary

Orthopedic surgeons are practicing in the midst of almost constant change—evolving patient care, shifts in employment models, advances in technology, modern patient expectations, and an increasingly complex regulatory environment. Even in this context, however, our goal remains unchanged: to give our patients the highest-quality care possible. Our core values as orthopedic surgeons and physicians are dedication, commitment, and service to patients and to our profession. As US health care continues to evolve, we must evolve as well, with an emphasis on expanding our role in the health care policy debate.

In the United States, the landscape of health care is changing. Health care reform and fluctuating political and economic climates have affected and will continue to affect the practice of orthopedic surgery. Demand for musculoskeletal care and the costs of providing this care are exceeding available resources—which has led to an evolution in how we practice as individuals and in the institutions where we provide care. Patient safety, quality, and value have become the outcomes of importance. Orthopedic surgeons, as experts in musculoskeletal care, must be a part of these changes. In this review, we offer perspective on the changing face of orthopedic surgery in the modern US health care system.

1. Meeting the demand

Musculoskeletal conditions represent one of the most common and costly health issues in the United States, affecting individuals medically and economically and compromising their quality of life.^1,2 In 2008, more than 110 million US adults (1 in 2) reported having a musculoskeletal condition for more than 3 months, and almost 7% reported that a chronic musculoskeletal condition made routine activities of daily living significantly difficult.¹ Overall, in the United States, some of the most common chronic conditions are musculoskeletal in origin. These conditions include osteoarthritis and back pain.

Osteoarthritis is the leading cause of chronic pain and disability. Physician-diagnosed arthritis is expected to affect 25% of US adults by 2030,³ and in more than one-third of these patients arthritis limits work or other activity.⁴ Back pain is another of the most common debilitating conditions in the United States.^3,5 St Sauver and colleagues⁶ found that back pain is the third most common condition (23.9%) that prompts patients to seek health care—following skin-related problems (42.7%) and osteoarthritis/joint pain (33.6%).

As life expectancy increases, so do expectations of enjoying higher levels of activity into the later years. Patients expect to be as active in their geriatric years as they were in middle age, and many are able to do so. Amid the growing obesity epidemic and increased incidence of chronic comorbidities, however, the aging population not only is at substantial risk for developing a chronic musculoskeletal disorder but may face new challenges in accessing care.

Although orthopedic surgeons specialize in treating musculoskeletal conditions, up to 90% of common nonsurgical musculoskeletal complaints are thought to be manageable in the primary care setting.⁷ With a disproportionate increase in musculoskeletal demand against a relatively constant number of orthopedic providers,⁸ it is becoming increasingly important for nonorthopedists to adequately manage musculoskeletal conditions. Physiatrists, rheumatologists, internists, family practitioners, and the expanding field of sports medicine specialists provide primary care of musculoskeletal conditions. To meet the growing demand and to ensure that patients receive quality, sustainable, effective, and efficient care, orthopedic surgeons should be actively involved in training these providers. As high as the cost of managing musculoskeletal conditions can be, it is far less than the cost resulting from inadequate or improper management. There is already justification for formal development of a specialization in nonoperative management of musculoskeletal care. Establishing this specialization requires a multidisciplinary approach, with orthopedic surgery taking a lead role.

2. The cost equation

As the prevalence of orthopedic conditions increases, so does the cost of delivering musculoskeletal care. The economic implications of meeting this growing demand are an important area of concern for our health care system. Steadily increasing hospital expenses for personnel and services, rising costs of pharmaceuticals and laboratory tests, constant evolution of costly technology, and insurance/reimbursement rates that do not keep pace with rising costs all contribute to the rapid escalation of the “cost of care.”

Health care expenditures accounted for 17.2% of the US gross domestic product (GDP) in 2012 and are expected to represent 19.3% by 2023.⁹ For musculoskeletal disease, direct costs alone are expected to approach $510 billion, equaling 5% of GDP and representing almost 30% of all health care expenditures. In Medicare patients, osteoarthritis is the most expensive condition to treat overall, and 3 other musculoskeletal problems rank highly as well: femoral neck fractures (3rd), back pain (10th), and fractures of all types (16th).¹⁰ Clearly, musculoskeletal care is one of the most prevalent and expensive health conditions in the United States.

Part of the direct costs of care that consistently increase each year are the steadily increasing costs of technology, which is often considered synonymous with orthopedic care. Promotion of new and more costly implants is common in the absence of evidence supporting their use. However, use of new implants and technology is being scrutinized in an effort to strike the proper cost–benefit balance.

To change the slope of the cost curve, orthopedic surgeons should utilize technological advances that are proven to be clinically significant and economically feasible and should avoid modest improvements with limited clinical benefit and higher price tags. Unfortunately, this approach is not being taken. Minor modifications of implant designs are often marketed as “new and improved” to justify increased costs, and these implants often gain widespread use. A few may prove to be clinically better, but most will be only comparable to older, less expensive designs, and some may end up being clinical failures, discovered at great cost to patients and the health care system.^11,12

Orthopedic surgeons have an important role in this decision-making. We should strive for the best, most cost-effective outcomes for our patients. We should reject new technology that does not clearly improve outcomes. At the least, we should use the technology in a manufacturer-supported clinical trial to determine its superiority. Whether the improvement is in technique, implant design, or workflow efficiency, orthopedic surgeons must be actively involved in researching and developing the latest innovations and must help determine their prospective value by considering not only their potential clinical benefits but also their economic implications.

As the political and economic environment becomes more directed at the cost-containment and sustainability of care, there has been a clear shift in focus to quality and value rather than volume, giving rise to the “value-based care” approach. The “value equation,” in which value equals quality divided by cost, requires a clear measure of outcomes and an equally clear understanding of costs. Delivering high-quality care in a cost-conscious environment is an approach that every orthopedic surgeon should adopt. Widespread adoption of the value-based strategy by hospital systems and insurance companies is resulting in a paradigm shift away from more traditional volume-based metrics and in favor of value-based metrics, including quality measures, patient-reported outcomes, Hospital Consumer Assessment of Healthcare Providers and Systems, and physician-specific outcome measures.

The new paradigm has brought the bundled payment initiative (BPI), a strategy included in the Patient Protection and Affordable Care Act. The philosophy behind the BPI model is for hospital systems and physicians to control costs while maintaining and improving the quality of care. Measured by patient metrics (eg, clinical outcomes, patient satisfaction) and hospital metrics (eg, readmission rates, cost of care), bundled payments reimburse hospitals on the basis of cost of an entire episode of care rather than on the basis of individual procedures and services. This approach provides incentives for both physicians and hospitals to promote value-based care while emphasizing coordination of care among all members of the health care team.

Providing the best possible care for our patients while holding our practice to the highest standards is a central tenet of the practice of orthopedic surgery and should be independent of reimbursement strategies. Thus, to increase the value of care, we must establish practice models and strategies to optimize cost-efficiency while improving outcomes. As explained by Porter and Teisberg,¹³ it is important to be conscientious about cost, but above all we must not allow quality of health care delivery to be compromised when trying to improve the “value” of care. Through evidence-based management and a clear understanding of costs, we must develop cost-efficient practice models that sustainably deliver the highest value of care.

3. Evolving practice models

As the health care landscape continues to change, physician practice models evolve accordingly. Although the private practice model once dominated the physician workforce, this is no longer true, as there has been a significant shift to employer-based practice models. The multiple factors at work relate to changing patterns of reimbursement, increasing government regulations, and a general change in recent residency graduates’ expectations regarding work–life balance. Other catalysts are the shift from volume- to value-based care and the recognition that cost-effective health care is more easily achieved when physicians and their institutions are in alignment. Ultimately, physician–institution alignment is crucial in improving care and outcomes.

Physician–institution alignment requires further discussion. Ideally, it should strike the proper balance between physician autonomy and institutional priorities to ensure the highest quality care. Physicians and their institutions should align their interests in terms of patient safety, quality, and economics to create a work environment conducive to both patient/physician satisfaction and institutional success.¹⁴ As identified by Page and colleagues,¹⁵ the primary drivers of physician–institution alignment, specific to orthopedic surgery, are economic, regulatory, and cultural. In economics, implant selection and ancillary services are the important issues; in the regulatory area, cooperative efforts to address expanding state and federal requirements are needed; last, the primary cultural driver is delivery of care to an expanding, diverse patient population.

Physician–institution alignment brings opportunities for “gainsharing,” which can directly benefit individual physicians, physician groups, and departments. Gainsharing is classically defined as “arrangements in which a hospital gives physicians a percentage share of any reduction in the hospital’s costs for patient care attributable in part to the physicians’ efforts.”¹⁶ Modern gainsharing programs can be used by institutions to align the economic interests of physicians and hospitals, with the ultimate goal being to achieve a sustainable increase in the value and quality of care delivered to patients.¹³ Examples include efforts to reduce the cost of orthopedic implants, which is a major cost driver in orthopedic surgery. Our institution realized significant savings when surgeons were directly involved in the implant contracting process with strategic sourcing personnel. These savings were shared with the department to enhance research and education programs. BPI, a risk-sharing program in which Medicare and hospitals participate, incorporates gainsharing opportunities in which each participating physician can receive up to 50% of his or her previous Medicare billings when specific targets are achieved. BPI included 27 musculoskeletal diagnosis–related groups that could be developed into a bundled payment proposal. Our institution participated in a 90-day episode, for primary hip and knee arthroplasty and non–cervical spine fusion, that had very promising results.

Gainsharing offers physicians incentives to meet institution goals of improved outcomes and increased patient satisfaction while increasing oversight and accountability. When physician-specific outcomes do not meet the established goals in key areas (readmissions, thromboembolic complications, infections), it is only logical that steps will be taken to improve outcomes. Although physicians may not be used to this increased scrutiny, the goal of improving outcomes, even if it necessitates a change in an established approach to care, should be welcomed.

Physicians should be rewarded for good outcomes but not suboptimal outcomes. When outcomes are suboptimal, physicians should take a constructive approach to improve them. On the other hand, not being rewarded for unachieved goals can be perceived as being penalized. Additional monitoring may paradoxically lead physicians to avoid more “complex” cases, such as those of patients at higher risk for complications and poorer outcomes. An example is found in patient selection for surgery, in which issues like obesity, diabetes, and heart disease are known to negatively affect outcomes. In these models, “cherry-picking” is a well-recognized risk^17,18 that can compromise our ethical obligation to provide equal access for all patients. To offset this tendency, we should use a risk-stratification model in which all patients are not considered equal in the risks they present. A risk-adjustment approach benefits both patients and providers by identifying modifiable risk factors that can be addressed to positively affect outcomes. This risk-stratification approach further incentivizes the orthopedist to closely work with other health care providers to address the medical comorbidities that may negatively affect surgical outcomes.

4. Patient and physician expectations

Living in a technology-driven society in the age of information has had a major impact on patients’ attitudes and expectations about their care—and therefore on physicians’ practice methods. It is uncommon to evaluate a patient who has not already consulted the Internet about a problem. Patients now have much more information they can use to make decisions about their treatment, and, though many question the accuracy of Internet information, there is no argument that being more informed is beneficial. In this time of shared decision-making, it is absolutely essential that patients keep themselves informed.

It is crucial to align the expectations of both physicians and patients in order to achieve the best outcomes. Gaining a clear understanding of treatment goals, management, and potential complications consistently leads to improved patient satisfaction, more favorable clinical outcomes, and reduced risk of litigation.^19-22 Addressing patient concerns and expectations is significantly enhanced by a strong patient–physician relationship through clinical models focused on patient-centered care.

Now considered a standard of care, the patient-centered model has changed the way we practice. The foundation of the patient-centered approach is to strengthen the patient–physician relationship by empowering patients to become active decision-makers in the management of their own health. The role of orthopedists in this model is to provide patients with information and insight into their conditions in order to facilitate shared decision-making. Our role should be to guide patients to make educated and informed decisions. Doing so enhances communication, thereby strengthening the patient–physician relationship, and places both patient and physician expectations in perspective. Patient-reported outcomes, satisfaction rates, symptomatic burdens, and costs of care are all positively correlated with strong communication and realistic expectations achieved through a patient-centered approach.^21,23

The evolution of clinical practice has been influenced by factors ranging from external forces (eg, changing political and economic climates) to social trends (use of social media and the Internet). Technology has been a driving force in our rapidly changing clinical environment, significantly altering the way we practice. Although we must be careful in how we use it, new technology can certainly work to our advantage. We have a plethora of medical information at our fingertips, and, with physician-directed guidance, our patients can become more informed than ever before. This is the principle of patient-centered medicine and shared decision-making, and its utility will only increase in importance.

5. The role of advocacy

The central tenet of orthopedic practice has always been a focus on patients. We continually strive to improve patient outcomes, reduce costs, and work efficiently in our practices and facilities. Although we can focus on our individual practices, we cannot ignore the influence and impact of the political system on our performance. Federal and state regulations give physicians and insurance companies an uneven playing field. This imbalance requires that physicians be more active in health care policymaking and advocacy. Although we are more involved than ever before, our influence is far less than what we would like it to be, perhaps partly because of the nature of the political process but perhaps also because of physicians’ resistance to becoming involved.

As experts in the treatment of musculoskeletal conditions, we should be at the forefront of health care policy development—a position we have not been able to attain. Although many factors contribute to our lack of a “seat at the table,” we must recognize our reluctance as a group to support advocacy, either financially or through personal time commitment. The American Association of Orthopaedic Surgeons (AAOS) Orthopaedic Political Action Committee has never been able to obtain donations from more than 30% of AAOS members. Although this committee historically has been successful, we could be much more so if we had financial support from 90% of members. There are many ways to be actively involved in advocacy. One way is to join local and state orthopedic societies and support their advocacy efforts. State orthopedic societies work closely with the AAOS Office of Government Relations to coordinate advocacy and direct efforts and resources to areas of greatest need. Knowing local congressional representatives and communicating with them about issues we face in our practices make our issues “real.” Some of our colleagues have even successfully run for office in Congress, and they certainly deserve our support. Advocacy will absolutely play an increasingly important role as federal and state governments expand their involvement in health care. Our role should be to get involved, at least to some degree. We need to recognize that our strength is in our numbers, as the few cannot accomplish nearly as much as the many.

Summary

Orthopedic surgeons are practicing in the midst of almost constant change—evolving patient care, shifts in employment models, advances in technology, modern patient expectations, and an increasingly complex regulatory environment. Even in this context, however, our goal remains unchanged: to give our patients the highest-quality care possible. Our core values as orthopedic surgeons and physicians are dedication, commitment, and service to patients and to our profession. As US health care continues to evolve, we must evolve as well, with an emphasis on expanding our role in the health care policy debate.

In the United States, the landscape of health care is changing. Health care reform and fluctuating political and economic climates have affected and will continue to affect the practice of orthopedic surgery. Demand for musculoskeletal care and the costs of providing this care are exceeding available resources—which has led to an evolution in how we practice as individuals and in the institutions where we provide care. Patient safety, quality, and value have become the outcomes of importance. Orthopedic surgeons, as experts in musculoskeletal care, must be a part of these changes. In this review, we offer perspective on the changing face of orthopedic surgery in the modern US health care system.

1. Meeting the demand

Musculoskeletal conditions represent one of the most common and costly health issues in the United States, affecting individuals medically and economically and compromising their quality of life.^1,2 In 2008, more than 110 million US adults (1 in 2) reported having a musculoskeletal condition for more than 3 months, and almost 7% reported that a chronic musculoskeletal condition made routine activities of daily living significantly difficult.¹ Overall, in the United States, some of the most common chronic conditions are musculoskeletal in origin. These conditions include osteoarthritis and back pain.

Osteoarthritis is the leading cause of chronic pain and disability. Physician-diagnosed arthritis is expected to affect 25% of US adults by 2030,³ and in more than one-third of these patients arthritis limits work or other activity.⁴ Back pain is another of the most common debilitating conditions in the United States.^3,5 St Sauver and colleagues⁶ found that back pain is the third most common condition (23.9%) that prompts patients to seek health care—following skin-related problems (42.7%) and osteoarthritis/joint pain (33.6%).

As life expectancy increases, so do expectations of enjoying higher levels of activity into the later years. Patients expect to be as active in their geriatric years as they were in middle age, and many are able to do so. Amid the growing obesity epidemic and increased incidence of chronic comorbidities, however, the aging population not only is at substantial risk for developing a chronic musculoskeletal disorder but may face new challenges in accessing care.

Although orthopedic surgeons specialize in treating musculoskeletal conditions, up to 90% of common nonsurgical musculoskeletal complaints are thought to be manageable in the primary care setting.⁷ With a disproportionate increase in musculoskeletal demand against a relatively constant number of orthopedic providers,⁸ it is becoming increasingly important for nonorthopedists to adequately manage musculoskeletal conditions. Physiatrists, rheumatologists, internists, family practitioners, and the expanding field of sports medicine specialists provide primary care of musculoskeletal conditions. To meet the growing demand and to ensure that patients receive quality, sustainable, effective, and efficient care, orthopedic surgeons should be actively involved in training these providers. As high as the cost of managing musculoskeletal conditions can be, it is far less than the cost resulting from inadequate or improper management. There is already justification for formal development of a specialization in nonoperative management of musculoskeletal care. Establishing this specialization requires a multidisciplinary approach, with orthopedic surgery taking a lead role.

2. The cost equation

As the prevalence of orthopedic conditions increases, so does the cost of delivering musculoskeletal care. The economic implications of meeting this growing demand are an important area of concern for our health care system. Steadily increasing hospital expenses for personnel and services, rising costs of pharmaceuticals and laboratory tests, constant evolution of costly technology, and insurance/reimbursement rates that do not keep pace with rising costs all contribute to the rapid escalation of the “cost of care.”

Health care expenditures accounted for 17.2% of the US gross domestic product (GDP) in 2012 and are expected to represent 19.3% by 2023.⁹ For musculoskeletal disease, direct costs alone are expected to approach $510 billion, equaling 5% of GDP and representing almost 30% of all health care expenditures. In Medicare patients, osteoarthritis is the most expensive condition to treat overall, and 3 other musculoskeletal problems rank highly as well: femoral neck fractures (3rd), back pain (10th), and fractures of all types (16th).¹⁰ Clearly, musculoskeletal care is one of the most prevalent and expensive health conditions in the United States.

Part of the direct costs of care that consistently increase each year are the steadily increasing costs of technology, which is often considered synonymous with orthopedic care. Promotion of new and more costly implants is common in the absence of evidence supporting their use. However, use of new implants and technology is being scrutinized in an effort to strike the proper cost–benefit balance.

To change the slope of the cost curve, orthopedic surgeons should utilize technological advances that are proven to be clinically significant and economically feasible and should avoid modest improvements with limited clinical benefit and higher price tags. Unfortunately, this approach is not being taken. Minor modifications of implant designs are often marketed as “new and improved” to justify increased costs, and these implants often gain widespread use. A few may prove to be clinically better, but most will be only comparable to older, less expensive designs, and some may end up being clinical failures, discovered at great cost to patients and the health care system.^11,12

Orthopedic surgeons have an important role in this decision-making. We should strive for the best, most cost-effective outcomes for our patients. We should reject new technology that does not clearly improve outcomes. At the least, we should use the technology in a manufacturer-supported clinical trial to determine its superiority. Whether the improvement is in technique, implant design, or workflow efficiency, orthopedic surgeons must be actively involved in researching and developing the latest innovations and must help determine their prospective value by considering not only their potential clinical benefits but also their economic implications.

As the political and economic environment becomes more directed at the cost-containment and sustainability of care, there has been a clear shift in focus to quality and value rather than volume, giving rise to the “value-based care” approach. The “value equation,” in which value equals quality divided by cost, requires a clear measure of outcomes and an equally clear understanding of costs. Delivering high-quality care in a cost-conscious environment is an approach that every orthopedic surgeon should adopt. Widespread adoption of the value-based strategy by hospital systems and insurance companies is resulting in a paradigm shift away from more traditional volume-based metrics and in favor of value-based metrics, including quality measures, patient-reported outcomes, Hospital Consumer Assessment of Healthcare Providers and Systems, and physician-specific outcome measures.

The new paradigm has brought the bundled payment initiative (BPI), a strategy included in the Patient Protection and Affordable Care Act. The philosophy behind the BPI model is for hospital systems and physicians to control costs while maintaining and improving the quality of care. Measured by patient metrics (eg, clinical outcomes, patient satisfaction) and hospital metrics (eg, readmission rates, cost of care), bundled payments reimburse hospitals on the basis of cost of an entire episode of care rather than on the basis of individual procedures and services. This approach provides incentives for both physicians and hospitals to promote value-based care while emphasizing coordination of care among all members of the health care team.

Providing the best possible care for our patients while holding our practice to the highest standards is a central tenet of the practice of orthopedic surgery and should be independent of reimbursement strategies. Thus, to increase the value of care, we must establish practice models and strategies to optimize cost-efficiency while improving outcomes. As explained by Porter and Teisberg,¹³ it is important to be conscientious about cost, but above all we must not allow quality of health care delivery to be compromised when trying to improve the “value” of care. Through evidence-based management and a clear understanding of costs, we must develop cost-efficient practice models that sustainably deliver the highest value of care.

3. Evolving practice models

As the health care landscape continues to change, physician practice models evolve accordingly. Although the private practice model once dominated the physician workforce, this is no longer true, as there has been a significant shift to employer-based practice models. The multiple factors at work relate to changing patterns of reimbursement, increasing government regulations, and a general change in recent residency graduates’ expectations regarding work–life balance. Other catalysts are the shift from volume- to value-based care and the recognition that cost-effective health care is more easily achieved when physicians and their institutions are in alignment. Ultimately, physician–institution alignment is crucial in improving care and outcomes.

Physician–institution alignment requires further discussion. Ideally, it should strike the proper balance between physician autonomy and institutional priorities to ensure the highest quality care. Physicians and their institutions should align their interests in terms of patient safety, quality, and economics to create a work environment conducive to both patient/physician satisfaction and institutional success.¹⁴ As identified by Page and colleagues,¹⁵ the primary drivers of physician–institution alignment, specific to orthopedic surgery, are economic, regulatory, and cultural. In economics, implant selection and ancillary services are the important issues; in the regulatory area, cooperative efforts to address expanding state and federal requirements are needed; last, the primary cultural driver is delivery of care to an expanding, diverse patient population.

Physician–institution alignment brings opportunities for “gainsharing,” which can directly benefit individual physicians, physician groups, and departments. Gainsharing is classically defined as “arrangements in which a hospital gives physicians a percentage share of any reduction in the hospital’s costs for patient care attributable in part to the physicians’ efforts.”¹⁶ Modern gainsharing programs can be used by institutions to align the economic interests of physicians and hospitals, with the ultimate goal being to achieve a sustainable increase in the value and quality of care delivered to patients.¹³ Examples include efforts to reduce the cost of orthopedic implants, which is a major cost driver in orthopedic surgery. Our institution realized significant savings when surgeons were directly involved in the implant contracting process with strategic sourcing personnel. These savings were shared with the department to enhance research and education programs. BPI, a risk-sharing program in which Medicare and hospitals participate, incorporates gainsharing opportunities in which each participating physician can receive up to 50% of his or her previous Medicare billings when specific targets are achieved. BPI included 27 musculoskeletal diagnosis–related groups that could be developed into a bundled payment proposal. Our institution participated in a 90-day episode, for primary hip and knee arthroplasty and non–cervical spine fusion, that had very promising results.

Gainsharing offers physicians incentives to meet institution goals of improved outcomes and increased patient satisfaction while increasing oversight and accountability. When physician-specific outcomes do not meet the established goals in key areas (readmissions, thromboembolic complications, infections), it is only logical that steps will be taken to improve outcomes. Although physicians may not be used to this increased scrutiny, the goal of improving outcomes, even if it necessitates a change in an established approach to care, should be welcomed.

Physicians should be rewarded for good outcomes but not suboptimal outcomes. When outcomes are suboptimal, physicians should take a constructive approach to improve them. On the other hand, not being rewarded for unachieved goals can be perceived as being penalized. Additional monitoring may paradoxically lead physicians to avoid more “complex” cases, such as those of patients at higher risk for complications and poorer outcomes. An example is found in patient selection for surgery, in which issues like obesity, diabetes, and heart disease are known to negatively affect outcomes. In these models, “cherry-picking” is a well-recognized risk^17,18 that can compromise our ethical obligation to provide equal access for all patients. To offset this tendency, we should use a risk-stratification model in which all patients are not considered equal in the risks they present. A risk-adjustment approach benefits both patients and providers by identifying modifiable risk factors that can be addressed to positively affect outcomes. This risk-stratification approach further incentivizes the orthopedist to closely work with other health care providers to address the medical comorbidities that may negatively affect surgical outcomes.

4. Patient and physician expectations

Living in a technology-driven society in the age of information has had a major impact on patients’ attitudes and expectations about their care—and therefore on physicians’ practice methods. It is uncommon to evaluate a patient who has not already consulted the Internet about a problem. Patients now have much more information they can use to make decisions about their treatment, and, though many question the accuracy of Internet information, there is no argument that being more informed is beneficial. In this time of shared decision-making, it is absolutely essential that patients keep themselves informed.

It is crucial to align the expectations of both physicians and patients in order to achieve the best outcomes. Gaining a clear understanding of treatment goals, management, and potential complications consistently leads to improved patient satisfaction, more favorable clinical outcomes, and reduced risk of litigation.^19-22 Addressing patient concerns and expectations is significantly enhanced by a strong patient–physician relationship through clinical models focused on patient-centered care.

Now considered a standard of care, the patient-centered model has changed the way we practice. The foundation of the patient-centered approach is to strengthen the patient–physician relationship by empowering patients to become active decision-makers in the management of their own health. The role of orthopedists in this model is to provide patients with information and insight into their conditions in order to facilitate shared decision-making. Our role should be to guide patients to make educated and informed decisions. Doing so enhances communication, thereby strengthening the patient–physician relationship, and places both patient and physician expectations in perspective. Patient-reported outcomes, satisfaction rates, symptomatic burdens, and costs of care are all positively correlated with strong communication and realistic expectations achieved through a patient-centered approach.^21,23

The evolution of clinical practice has been influenced by factors ranging from external forces (eg, changing political and economic climates) to social trends (use of social media and the Internet). Technology has been a driving force in our rapidly changing clinical environment, significantly altering the way we practice. Although we must be careful in how we use it, new technology can certainly work to our advantage. We have a plethora of medical information at our fingertips, and, with physician-directed guidance, our patients can become more informed than ever before. This is the principle of patient-centered medicine and shared decision-making, and its utility will only increase in importance.

5. The role of advocacy

The central tenet of orthopedic practice has always been a focus on patients. We continually strive to improve patient outcomes, reduce costs, and work efficiently in our practices and facilities. Although we can focus on our individual practices, we cannot ignore the influence and impact of the political system on our performance. Federal and state regulations give physicians and insurance companies an uneven playing field. This imbalance requires that physicians be more active in health care policymaking and advocacy. Although we are more involved than ever before, our influence is far less than what we would like it to be, perhaps partly because of the nature of the political process but perhaps also because of physicians’ resistance to becoming involved.

As experts in the treatment of musculoskeletal conditions, we should be at the forefront of health care policy development—a position we have not been able to attain. Although many factors contribute to our lack of a “seat at the table,” we must recognize our reluctance as a group to support advocacy, either financially or through personal time commitment. The American Association of Orthopaedic Surgeons (AAOS) Orthopaedic Political Action Committee has never been able to obtain donations from more than 30% of AAOS members. Although this committee historically has been successful, we could be much more so if we had financial support from 90% of members. There are many ways to be actively involved in advocacy. One way is to join local and state orthopedic societies and support their advocacy efforts. State orthopedic societies work closely with the AAOS Office of Government Relations to coordinate advocacy and direct efforts and resources to areas of greatest need. Knowing local congressional representatives and communicating with them about issues we face in our practices make our issues “real.” Some of our colleagues have even successfully run for office in Congress, and they certainly deserve our support. Advocacy will absolutely play an increasingly important role as federal and state governments expand their involvement in health care. Our role should be to get involved, at least to some degree. We need to recognize that our strength is in our numbers, as the few cannot accomplish nearly as much as the many.

Summary

Orthopedic surgeons are practicing in the midst of almost constant change—evolving patient care, shifts in employment models, advances in technology, modern patient expectations, and an increasingly complex regulatory environment. Even in this context, however, our goal remains unchanged: to give our patients the highest-quality care possible. Our core values as orthopedic surgeons and physicians are dedication, commitment, and service to patients and to our profession. As US health care continues to evolve, we must evolve as well, with an emphasis on expanding our role in the health care policy debate.

Health care financing and the nature of orthopedic practice have changed dramatically in recent years and will continue to do so. Driving these changes is the emphasis on “value,” defined by Porter1 as the quality of care divided by the cost of care, as opposed to the traditional volume-based care, in which reimbursement is based on a fee for services rendered. Exploring this concept of value in orthopedic care is a favorite topic of mine, succinctly summarized by Black and Warner2 in their 2013 article in  The American Journal of Orthopedics. Two papers in this current issue of The American Journal of Orthopedics make important points regarding value and the orthopedic surgeon.       

In “Orthopedic Implant Waste: Analysis and Quantification” (pages 554-560), Payne and colleagues examine the costs of wasted implants across 8 orthopedic subspecialties at  1 academic institution over the course of 12 months. The take-home points were these: wasted implants accounted for nearly 2% of the implant cost of the institution; the incidence of waste was related to surgeons with less experience (in practice less than 10 years) but not case volumes (ie, busier surgeons); and nearly two-thirds of the cost of wasted implants occurred in total joint and spine fusion cases.

At my institution, orthopedic implants represent one of the 3 major costs of inpatient hospital care (the other 2 being operating room time and length of stay). Hence, a 2% savings of total implant costs by minimizing waste can make a significant difference in an institution’s profit margin. Since the attending surgeon makes the intraoperative decision on implant type, the burden of minimizing implant waste falls primarily on the orthopedic surgeon. This is just one example of how the individual orthopedic surgeon can improve “value” by decreasing the “cost” of care.

In “Orthopedics in US Health Care” (pages 538-541), Yu and Zuckerman review 5 points on the evolving role orthopedic surgery plays in the changing landscape of US health care. Among many important topics reviewed, the authors raise  2 important issues specifically related to value and the orthopedic surgeon that I believe warrant special attention.

In point 2, “The Cost Equation,” Yu and Zuckerman state that new technology (always more expensive than existing technology!) must “clearly improve outcomes” prior to its introduction to the market. The adage “newer is better” is sometimes true, but new and more expensive technology (which increases the denominator of the “value” quotient) must afford even greater improvement in quality outcomes to justify its widespread use. Hence, as practicing orthopedic surgeons, we should resist the temptation to embrace new technology without clear evidence that said new technology actually improves the quality of care.

The second topic of interest to me is how we measure “outcomes” in this new value-driven health care world. While many important outcome metrics can be measured by hospital data systems, such as length of stay, unscheduled returns to the operating room, transfusion and infection rates, and 30-day readmissions, equally important clinical outcomes (eg, pain and function scores, joint range of motion and strength, and radiographic findings) are obtained primarily from office-based outpatient medical records. These clinically based quality metrics are far more difficult to obtain for individual practicing orthopedic surgeons and require an investment of time and staff to gather meaningful data. How to record and incorporate these clinical outcomes remains a challenge for the practicing orthopedic surgeon, especially in the nonacademic setting, but these clinical metrics must be a component in the “value equation.”

The concept of value in orthopedic surgery will be the primary driver of future health care financing and policies. To succeed in this changing world, orthopedic surgeons will need to not only understand this new paradigm  “value = quality/cost,” but be fundamentally involved in the process, institutionally and politically, that both defines and  rewards value.

Health care financing and the nature of orthopedic practice have changed dramatically in recent years and will continue to do so. Driving these changes is the emphasis on “value,” defined by Porter1 as the quality of care divided by the cost of care, as opposed to the traditional volume-based care, in which reimbursement is based on a fee for services rendered. Exploring this concept of value in orthopedic care is a favorite topic of mine, succinctly summarized by Black and Warner2 in their 2013 article in  The American Journal of Orthopedics. Two papers in this current issue of The American Journal of Orthopedics make important points regarding value and the orthopedic surgeon.       

In “Orthopedic Implant Waste: Analysis and Quantification” (pages 554-560), Payne and colleagues examine the costs of wasted implants across 8 orthopedic subspecialties at  1 academic institution over the course of 12 months. The take-home points were these: wasted implants accounted for nearly 2% of the implant cost of the institution; the incidence of waste was related to surgeons with less experience (in practice less than 10 years) but not case volumes (ie, busier surgeons); and nearly two-thirds of the cost of wasted implants occurred in total joint and spine fusion cases.

At my institution, orthopedic implants represent one of the 3 major costs of inpatient hospital care (the other 2 being operating room time and length of stay). Hence, a 2% savings of total implant costs by minimizing waste can make a significant difference in an institution’s profit margin. Since the attending surgeon makes the intraoperative decision on implant type, the burden of minimizing implant waste falls primarily on the orthopedic surgeon. This is just one example of how the individual orthopedic surgeon can improve “value” by decreasing the “cost” of care.

In “Orthopedics in US Health Care” (pages 538-541), Yu and Zuckerman review 5 points on the evolving role orthopedic surgery plays in the changing landscape of US health care. Among many important topics reviewed, the authors raise  2 important issues specifically related to value and the orthopedic surgeon that I believe warrant special attention.

In point 2, “The Cost Equation,” Yu and Zuckerman state that new technology (always more expensive than existing technology!) must “clearly improve outcomes” prior to its introduction to the market. The adage “newer is better” is sometimes true, but new and more expensive technology (which increases the denominator of the “value” quotient) must afford even greater improvement in quality outcomes to justify its widespread use. Hence, as practicing orthopedic surgeons, we should resist the temptation to embrace new technology without clear evidence that said new technology actually improves the quality of care.

The second topic of interest to me is how we measure “outcomes” in this new value-driven health care world. While many important outcome metrics can be measured by hospital data systems, such as length of stay, unscheduled returns to the operating room, transfusion and infection rates, and 30-day readmissions, equally important clinical outcomes (eg, pain and function scores, joint range of motion and strength, and radiographic findings) are obtained primarily from office-based outpatient medical records. These clinically based quality metrics are far more difficult to obtain for individual practicing orthopedic surgeons and require an investment of time and staff to gather meaningful data. How to record and incorporate these clinical outcomes remains a challenge for the practicing orthopedic surgeon, especially in the nonacademic setting, but these clinical metrics must be a component in the “value equation.”

The concept of value in orthopedic surgery will be the primary driver of future health care financing and policies. To succeed in this changing world, orthopedic surgeons will need to not only understand this new paradigm  “value = quality/cost,” but be fundamentally involved in the process, institutionally and politically, that both defines and  rewards value.

Health care financing and the nature of orthopedic practice have changed dramatically in recent years and will continue to do so. Driving these changes is the emphasis on “value,” defined by Porter1 as the quality of care divided by the cost of care, as opposed to the traditional volume-based care, in which reimbursement is based on a fee for services rendered. Exploring this concept of value in orthopedic care is a favorite topic of mine, succinctly summarized by Black and Warner2 in their 2013 article in  The American Journal of Orthopedics. Two papers in this current issue of The American Journal of Orthopedics make important points regarding value and the orthopedic surgeon.       

In “Orthopedic Implant Waste: Analysis and Quantification” (pages 554-560), Payne and colleagues examine the costs of wasted implants across 8 orthopedic subspecialties at  1 academic institution over the course of 12 months. The take-home points were these: wasted implants accounted for nearly 2% of the implant cost of the institution; the incidence of waste was related to surgeons with less experience (in practice less than 10 years) but not case volumes (ie, busier surgeons); and nearly two-thirds of the cost of wasted implants occurred in total joint and spine fusion cases.

At my institution, orthopedic implants represent one of the 3 major costs of inpatient hospital care (the other 2 being operating room time and length of stay). Hence, a 2% savings of total implant costs by minimizing waste can make a significant difference in an institution’s profit margin. Since the attending surgeon makes the intraoperative decision on implant type, the burden of minimizing implant waste falls primarily on the orthopedic surgeon. This is just one example of how the individual orthopedic surgeon can improve “value” by decreasing the “cost” of care.

In “Orthopedics in US Health Care” (pages 538-541), Yu and Zuckerman review 5 points on the evolving role orthopedic surgery plays in the changing landscape of US health care. Among many important topics reviewed, the authors raise  2 important issues specifically related to value and the orthopedic surgeon that I believe warrant special attention.

In point 2, “The Cost Equation,” Yu and Zuckerman state that new technology (always more expensive than existing technology!) must “clearly improve outcomes” prior to its introduction to the market. The adage “newer is better” is sometimes true, but new and more expensive technology (which increases the denominator of the “value” quotient) must afford even greater improvement in quality outcomes to justify its widespread use. Hence, as practicing orthopedic surgeons, we should resist the temptation to embrace new technology without clear evidence that said new technology actually improves the quality of care.

The second topic of interest to me is how we measure “outcomes” in this new value-driven health care world. While many important outcome metrics can be measured by hospital data systems, such as length of stay, unscheduled returns to the operating room, transfusion and infection rates, and 30-day readmissions, equally important clinical outcomes (eg, pain and function scores, joint range of motion and strength, and radiographic findings) are obtained primarily from office-based outpatient medical records. These clinically based quality metrics are far more difficult to obtain for individual practicing orthopedic surgeons and require an investment of time and staff to gather meaningful data. How to record and incorporate these clinical outcomes remains a challenge for the practicing orthopedic surgeon, especially in the nonacademic setting, but these clinical metrics must be a component in the “value equation.”

The concept of value in orthopedic surgery will be the primary driver of future health care financing and policies. To succeed in this changing world, orthopedic surgeons will need to not only understand this new paradigm  “value = quality/cost,” but be fundamentally involved in the process, institutionally and politically, that both defines and  rewards value.

Osteosarcoma, a primary malignant tumor of the skeleton, is characterized by direct formation of immature bone or osteoid tissue by tumor cells. The World Health Organization histologic classification of bone tumors divides osteosarcoma into central and surface tumors and recognizes a number of subtypes within each group.¹ The present review refers only to the classic central high-grade primary osteosarcoma of bone, which represents about 90% of all osteosarcoma cases. Classic osteosarcoma represents about 15% of all biopsy-analyzed primary bone tumors.¹ It is the third most common type of neoplasia, preceded by leukemia and lymphoma among older children and adolescents aged 12 to 18 years.² High-grade primary osteosarcoma is the most common primary skeletal tumor of childhood and adolescence, with an overall annual incidence of 5.6 cases per million children under age 15 years.^3-5 Peak incidence is in the second decade of life, and males are affected slightly more often than females.^2,6 The period of highest incidence coincides with the growth spurt of the long bones. Osteosarcoma preferentially affects the metaphysis of long bones, the 3 main sites being distal femur, tibia, and proximal humerus.²

Historical Perspective

For most of the 20th century, the 5-year survival rate for classic primary osteosarcoma was under 20%.⁷ In the 1970s, the first revolution in osteosarcoma treatment arrived with the introduction of adjuvant chemotherapy, which increased survival rates to 50%.^8-10 During this expansion of research, several chemotherapeutics (eg, vincristine, bleomycin, dactinomycin) were discarded for poor effectiveness, and others (eg, cisplatin, ifosfamide) were added to doxorubicin and methotrexate, improving 5-year disease-free survival to about 70% in patients with nonmetastatic osteosarcoma. In another significant advance, adjuvant chemotherapy was supplemented with intensive preoperative chemotherapy, resulting in 5-year tumor-free survival that has ranged from 50% to 75% for high-grade osteosarcoma.^5,11,12 Adding neoadjuvant chemotherapy and histologic response has allowed for evaluation of surgical margins and early treatment of microscopic disease. Thus, effective limb-sparing procedures can be performed, and the incidence of amputation has decreased from 90% to between 10% and 20%.^13,14 However, statistical improvements in survival associated with neoadjuvant treatment may simply delay time of recurrence and metastasis.¹⁵ In addition, though chemotherapy has improved survival in osteogenic sarcoma, many have written that this improvement appears to reflect mainly the increase in the intensity of the chemotherapy used, which also leads to a higher propensity for side effects.¹⁶

Despite research and advances in chemotherapy regimens, the prognosis of patients with osteosarcoma remains highly variable and often dismal. Mirabello and colleagues¹⁷ examined osteosarcoma incidence and survival rates between 1973 and 2004 and found that, with the introduction of neoadjuvant chemotherapy, survival rates improved significantly between 1973 and 1983 and between 1984 and 1993, but there was little improvement between 1993 and 2004.

The long-term outcome for patients with metastatic disease is poor. Investigators have found that 11% to 20% of patients have pulmonary metastasis at initial diagnosis. About half of patients without pulmonary metastases develop them later in the disease course.¹⁸ Survival rates for patients with metastasis at initial presentation have ranged from 10% to 40%.¹⁹ Recurrent disease still occurs in 30% to 40% of patients, and more than 70% of them die of the tumor.¹⁵ The survivors of osteosarcoma are then at increased risk for chronic medical conditions and adverse health status because of the osteosarcoma-related treatments.²⁰

Prognostic Factors

It is important to understand and exploit the influences of different prognostic factors in treating patients with osteosarcoma.⁷ These factors are important in establishing the best treatment for the individual. Thus, more aggressive treatments can be started in patients with prognostic factors that pose a higher risk of relapse.²¹ A number of clinical and pathologic features (eg, tumor site, size, subtype; patient sex and age; high alkaline phosphatase or high lactate dehydrogenase [LDH] values; multidrug resistance; genetic variations) have prognostic significance but often with contradictory results because of lack of uniformity in patient analyses and methods.¹⁵

Survival for patients with primary osteosarcoma has been analyzed with respect to tumor size and location.⁷ Studies have found higher survival rates for patients with smaller tumors (<10 cm) and more distal tumor locations.⁷ These superior survival rates may be the result of earlier detection of tumors and more options for surgical resection of smaller, distal tumors.

Serum LDH levels have helped in risk stratification of patients. High LDH often occurred at time of relapse, and relapse with high LDH correlated with poor prognosis. Meyers and colleagues²² found that 5-year disease-free survival was 72% for patients with normal LDH at presentation and 54% for patients with elevated LDH at presentation.

Several studies have shown that percentage of tumor necrosis on histology is strongly correlated with good prognosis.²¹ Most groups now define a good histologic response as less than 10% viable tumor cells at time of surgery, and a poor response as more than 10%.²³ Results of the Pediatric Oncology Group (POG) protocol for localized osteosarcoma (POG 9351), or Children’s Cancer Group (CCG) 7921, found 45% of patients had favorable responses (>90% necrosis) after preoperative chemotherapy.²⁴ However, several clinicians have recently questioned this finding.

Overall, the prognosis for classic osteosarcoma of the extremity remains highly variable, and there has been little improvement over the past 20 years. The prognosis for younger patients, patients with spinal disease, and patients with metastatic disease remains poor. Although some prognostic factors have been identified and shown to predict a good outcome, it seems few patients have these positive factors. In this article, we describe the literature review and meta-analysis we performed to better define recent survival trends for patients with primary osteosarcoma.

Methods

The MEDLINE, PubMed, and Cochrane databases were searched for eligible studies published in English between 2000 and 2011—a decade of recently reported research. We applied the search strategy [“osteosarcoma” OR “osteogenic sarcoma”] AND [“prognosis” OR “treatment” OR “survival”] and selected reports that specifically addressed factors predicting survival in patients with osteosarcoma—reports that were limited to primary osteosarcoma of the pelvis or extremity and provided 5-year overall survival (OS) data. Abstracts of the selected articles were independently reviewed, and the inclusion and exclusion criteria were applied. We excluded basic science studies and those without pediatric patients, those without primary osteosarcoma, those with periosteal or parosteal osteosarcoma, and those that did not report 5-year OS data.

Statistical Analysis

Number or proportion of patients (whichever was reported) with 5-year OS and number or proportion of patients with 90% necrosis were extracted from each study. For each trial, proportion of patients with 5-year OS and 95% confidence intervals (CIs) and proportion of patients achieving 90% necrosis and 95% CIs were determined. We also calculated proportion of patients with 5-year OS and proportion of patients with 90% necrosis with corresponding 95% CIs of studies that included patients with nonmetastatic disease.

We assessed statistical heterogeneity among trials included in the meta-analysis using the Cochran Q test. Inconsistency was quantified with the I² statistic, which estimates percentage of total across-studies variation caused by heterogeneity rather than chance.²⁵ We considered I² higher than 50% as indicating substantial heterogeneity. When substantial heterogeneity was not found, the pooled estimate calculated on the basis of the fixed-effects model was reported using the inverse variance method. When substantial heterogeneity was found, the pooled estimate calculated on the basis of a random-effects model was reported using the DerSimonian and Laird²⁶ method, which takes both within- and between-study variations into account.

Publication bias was assessed through funnel plots and with Begg and Egger tests.^27,28 Two-tailed P < .05 was considered statistically significant. All statistical analyses were performed with Stata/SE Version 11.0 (StataCorp).

Results

Our literature search yielded 597 articles. We cross-referenced these articles with the MEDLINE, PubMed, and Cochrane search results using the same keywords and discarded the duplicates. The abstracts of these articles were then reviewed in detail. The 40 articles^{4,6,11,12,14,15,17-19,21,29-58} that met our study inclusion criteria reported on studies that included patients with metastatic and nonmetastatic osteosarcoma. Because of the significant difference in OS of patients with metastatic disease, we also analyzed articles that included only patients with nonmetastatic disease. Sixteen articles^{6,14,15,29,32-35,39,47,48,51,53,54,55,57} were included in the analysis of patients with nonmetastatic disease.

Figure 1 shows 5-year OS for each of the 40 studies. For studies that compared survival of different groups of patients, the survival of each group is shown separately. For example, Bacci and colleagues³⁹ divided patients into adolescent and preadolescent groups and reported 5-year OS for each. In our analysis, we treated each group independently and reported their 5-year OS separately. For each study, 5-year OS, weight of study, and CI are included. Five-year OS ranged from 19% to 94%. Analysis was performed to determine 5-year OS for all studies based on weight given to each study. The random-effects model used for this analysis (heterogeneity test, Q = 656.23; P < .001; I² = 93.4%) showed 5-year OS of 63% (95% CI, 60%-66%) for studies that included patients with metastatic and nonmetastatic osteosarcoma.

Figure 2 shows 5-year OS (range, 53%-94%) for each of the 16 studies that included only patients with nonmetastatic disease. The random-effects model used for this analysis (heterogeneity test, Q = 142.08; P < .001; I² = 89.4%) showed 5-year OS of 71% (95% CI, 67%-76%) for studies that included only patients with nonmetastatic disease.

We then examined percentage of patients achieving 90% necrosis on histology in each study. Several studies included in the OS analysis did not report percentage necrosis, leaving 29 studies for the necrosis analysis. Of these 29 studies, all 29 included patients with metastatic and nonmetastatic disease,^{4,6,11,14,15,18,19,21,29,31-36,37,39,40,43-47,49,50,54-57,59} and 13 included only patients with nonmetastatic disease.^{6,14,15,29,32-35,40,47,54,55,57} Again, because of the known difference in prognosis between patients with metastatic disease and patients with nonmetastatic disease, we performed separate analyses, one for the combined dataset of all 29 studies (Figure 3) and the other for the 13 nonmetastatic studies (Figure 4). Random-effects models showed 90% necrosis for 50% of patients in both analyses: studies that included patients with metastatic and nonmetastatic disease (95% CI, 45%-54%; heterogeneity test, Q = 692.88; P < .001; I² = 95.5%) and nonmetastatic studies (95% CI, 41%-59%; heterogeneity test, Q = 385.42; P < .001; I² = 96.9%).

We also performed a meta-regression analysis that included necrosis as a continuous variable for both the overall dataset and the nonmetastatic dataset. Five-year OS was plotted against percentage of patients achieving 90% tumor necrosis for each study. The results are plotted in Figure 5 (combined dataset).

No evidence of publication bias was detected for 5-year OS or percentage necrosis for the analyses of the combined datasets by either Egger test or Begg test. For 5-year OS, Ps were .21 (Egger) and .19 (Begg); for percentage necrosis, Ps were .10 (Egger) and .62 (Begg). In addition, no evidence of publication bias was detected for the analyses of the nonmetastatic studies by either test. For 5-year OS, Ps were .55 (Egger) and .41 (Begg); for percentage necrosis, Ps were .42 (Egger) and .95 (Begg).

Discussion

Five-year OS was 63% (95% CI, 60%-66%) for studies that included patients with metastatic and nonmetastatic osteosarcoma and 71% (95% CI, 67%-76%) for studies that included only patients with nonmetastatic osteosarcoma. These percentages fall within the range found in the literature. Mankin and colleagues³⁷ reviewed 648 cases of patients with osteosarcoma treated at Massachusetts General Hospital in 2004; OS was 68%. In 2011, Sampo and colleagues⁶⁰ reported 10-year OS of 63% for patients with metastatic and nonmetastatic disease and 73% for patients with local disease at presentation. Five-year OS rates in the literature are consistently about 70%. Ferrari and colleagues⁶¹ reported 5-year OS of 73% and 74% for 230 patients treated with 2 different neoadjuvant chemotherapy regimens between 2001 and 2006. The consistency in 5-year OS suggests OS of pediatric patients with osteosarcoma has plateaued, and there has been no significant improvement in survival of patients with osteosarcoma over the past 30 years.

Histologic response to preoperative chemotherapy is strongly associated with survival in pediatric osteosarcoma. Bielack and colleagues³¹ reported 5-year OS of 75% to 80% for patients who responded well to preoperative chemotherapy (>90% tumor necrosis) and 45% to 55% for patients who responded poorly (<10% necrosis). In our meta-analysis of studies that included patients with nonmetastatic osteosarcoma, 50% achieved necrosis of more than 90%. Percentage of patients achieving necrosis of more than 90% has been about 45%, according to past reports. In 2012, Ferrari and colleagues⁶¹ reported that 45% of 230 patients treated with neoadjuvant chemotherapy achieved more than 90% tumor necrosis. Therefore, 5-year OS and percentage of patients achieving 90% necrosis are consistent with previous reports, though this also suggests these numbers have remained constant over the past several decades.

Despite its expansive scale, our study has several important limitations. Data were extracted from published studies, and individual patient data were not available, so we were not able to assess the effects of risk factors (eg, tumor size, location) on 5-year OS. We could not correlate the proportion of patients with 90% necrosis to 5-year OS, as studies did not report OS by necrosis strata. Also, because our numbers were derived from published studies, they may not accurately represent outcomes in the community as a whole. In addition, several successive studies may contain duplicate patient cases. We limited our search to studies published since 2000 to include patients recently diagnosed and treated for osteosarcoma; however, several studies published after 2000 also included patients diagnosed and treated before 2000. Several of these studies are from countries outside the United States and may have a significantly different incidence of osteosarcoma as well as treatment methods and survival rates.

Although this meta-analysis suggests 5-year OS remains about 70% for patients with primary nonmetastatic osteosarcoma, we cannot settle on this conclusion because of the many differences between the studies we included. Therefore, more studies of patients diagnosed and treated within the past 10 years are needed to confirm our beliefs about patient survival.

Osteosarcoma, a primary malignant tumor of the skeleton, is characterized by direct formation of immature bone or osteoid tissue by tumor cells. The World Health Organization histologic classification of bone tumors divides osteosarcoma into central and surface tumors and recognizes a number of subtypes within each group.¹ The present review refers only to the classic central high-grade primary osteosarcoma of bone, which represents about 90% of all osteosarcoma cases. Classic osteosarcoma represents about 15% of all biopsy-analyzed primary bone tumors.¹ It is the third most common type of neoplasia, preceded by leukemia and lymphoma among older children and adolescents aged 12 to 18 years.² High-grade primary osteosarcoma is the most common primary skeletal tumor of childhood and adolescence, with an overall annual incidence of 5.6 cases per million children under age 15 years.^3-5 Peak incidence is in the second decade of life, and males are affected slightly more often than females.^2,6 The period of highest incidence coincides with the growth spurt of the long bones. Osteosarcoma preferentially affects the metaphysis of long bones, the 3 main sites being distal femur, tibia, and proximal humerus.²

Historical Perspective

For most of the 20th century, the 5-year survival rate for classic primary osteosarcoma was under 20%.⁷ In the 1970s, the first revolution in osteosarcoma treatment arrived with the introduction of adjuvant chemotherapy, which increased survival rates to 50%.^8-10 During this expansion of research, several chemotherapeutics (eg, vincristine, bleomycin, dactinomycin) were discarded for poor effectiveness, and others (eg, cisplatin, ifosfamide) were added to doxorubicin and methotrexate, improving 5-year disease-free survival to about 70% in patients with nonmetastatic osteosarcoma. In another significant advance, adjuvant chemotherapy was supplemented with intensive preoperative chemotherapy, resulting in 5-year tumor-free survival that has ranged from 50% to 75% for high-grade osteosarcoma.^5,11,12 Adding neoadjuvant chemotherapy and histologic response has allowed for evaluation of surgical margins and early treatment of microscopic disease. Thus, effective limb-sparing procedures can be performed, and the incidence of amputation has decreased from 90% to between 10% and 20%.^13,14 However, statistical improvements in survival associated with neoadjuvant treatment may simply delay time of recurrence and metastasis.¹⁵ In addition, though chemotherapy has improved survival in osteogenic sarcoma, many have written that this improvement appears to reflect mainly the increase in the intensity of the chemotherapy used, which also leads to a higher propensity for side effects.¹⁶

Despite research and advances in chemotherapy regimens, the prognosis of patients with osteosarcoma remains highly variable and often dismal. Mirabello and colleagues¹⁷ examined osteosarcoma incidence and survival rates between 1973 and 2004 and found that, with the introduction of neoadjuvant chemotherapy, survival rates improved significantly between 1973 and 1983 and between 1984 and 1993, but there was little improvement between 1993 and 2004.

The long-term outcome for patients with metastatic disease is poor. Investigators have found that 11% to 20% of patients have pulmonary metastasis at initial diagnosis. About half of patients without pulmonary metastases develop them later in the disease course.¹⁸ Survival rates for patients with metastasis at initial presentation have ranged from 10% to 40%.¹⁹ Recurrent disease still occurs in 30% to 40% of patients, and more than 70% of them die of the tumor.¹⁵ The survivors of osteosarcoma are then at increased risk for chronic medical conditions and adverse health status because of the osteosarcoma-related treatments.²⁰

Prognostic Factors

It is important to understand and exploit the influences of different prognostic factors in treating patients with osteosarcoma.⁷ These factors are important in establishing the best treatment for the individual. Thus, more aggressive treatments can be started in patients with prognostic factors that pose a higher risk of relapse.²¹ A number of clinical and pathologic features (eg, tumor site, size, subtype; patient sex and age; high alkaline phosphatase or high lactate dehydrogenase [LDH] values; multidrug resistance; genetic variations) have prognostic significance but often with contradictory results because of lack of uniformity in patient analyses and methods.¹⁵

Survival for patients with primary osteosarcoma has been analyzed with respect to tumor size and location.⁷ Studies have found higher survival rates for patients with smaller tumors (<10 cm) and more distal tumor locations.⁷ These superior survival rates may be the result of earlier detection of tumors and more options for surgical resection of smaller, distal tumors.

Serum LDH levels have helped in risk stratification of patients. High LDH often occurred at time of relapse, and relapse with high LDH correlated with poor prognosis. Meyers and colleagues²² found that 5-year disease-free survival was 72% for patients with normal LDH at presentation and 54% for patients with elevated LDH at presentation.

Several studies have shown that percentage of tumor necrosis on histology is strongly correlated with good prognosis.²¹ Most groups now define a good histologic response as less than 10% viable tumor cells at time of surgery, and a poor response as more than 10%.²³ Results of the Pediatric Oncology Group (POG) protocol for localized osteosarcoma (POG 9351), or Children’s Cancer Group (CCG) 7921, found 45% of patients had favorable responses (>90% necrosis) after preoperative chemotherapy.²⁴ However, several clinicians have recently questioned this finding.

Overall, the prognosis for classic osteosarcoma of the extremity remains highly variable, and there has been little improvement over the past 20 years. The prognosis for younger patients, patients with spinal disease, and patients with metastatic disease remains poor. Although some prognostic factors have been identified and shown to predict a good outcome, it seems few patients have these positive factors. In this article, we describe the literature review and meta-analysis we performed to better define recent survival trends for patients with primary osteosarcoma.

Methods

The MEDLINE, PubMed, and Cochrane databases were searched for eligible studies published in English between 2000 and 2011—a decade of recently reported research. We applied the search strategy [“osteosarcoma” OR “osteogenic sarcoma”] AND [“prognosis” OR “treatment” OR “survival”] and selected reports that specifically addressed factors predicting survival in patients with osteosarcoma—reports that were limited to primary osteosarcoma of the pelvis or extremity and provided 5-year overall survival (OS) data. Abstracts of the selected articles were independently reviewed, and the inclusion and exclusion criteria were applied. We excluded basic science studies and those without pediatric patients, those without primary osteosarcoma, those with periosteal or parosteal osteosarcoma, and those that did not report 5-year OS data.

Statistical Analysis

Number or proportion of patients (whichever was reported) with 5-year OS and number or proportion of patients with 90% necrosis were extracted from each study. For each trial, proportion of patients with 5-year OS and 95% confidence intervals (CIs) and proportion of patients achieving 90% necrosis and 95% CIs were determined. We also calculated proportion of patients with 5-year OS and proportion of patients with 90% necrosis with corresponding 95% CIs of studies that included patients with nonmetastatic disease.

We assessed statistical heterogeneity among trials included in the meta-analysis using the Cochran Q test. Inconsistency was quantified with the I² statistic, which estimates percentage of total across-studies variation caused by heterogeneity rather than chance.²⁵ We considered I² higher than 50% as indicating substantial heterogeneity. When substantial heterogeneity was not found, the pooled estimate calculated on the basis of the fixed-effects model was reported using the inverse variance method. When substantial heterogeneity was found, the pooled estimate calculated on the basis of a random-effects model was reported using the DerSimonian and Laird²⁶ method, which takes both within- and between-study variations into account.

Publication bias was assessed through funnel plots and with Begg and Egger tests.^27,28 Two-tailed P < .05 was considered statistically significant. All statistical analyses were performed with Stata/SE Version 11.0 (StataCorp).

Results

Our literature search yielded 597 articles. We cross-referenced these articles with the MEDLINE, PubMed, and Cochrane search results using the same keywords and discarded the duplicates. The abstracts of these articles were then reviewed in detail. The 40 articles^{4,6,11,12,14,15,17-19,21,29-58} that met our study inclusion criteria reported on studies that included patients with metastatic and nonmetastatic osteosarcoma. Because of the significant difference in OS of patients with metastatic disease, we also analyzed articles that included only patients with nonmetastatic disease. Sixteen articles^{6,14,15,29,32-35,39,47,48,51,53,54,55,57} were included in the analysis of patients with nonmetastatic disease.

Figure 1 shows 5-year OS for each of the 40 studies. For studies that compared survival of different groups of patients, the survival of each group is shown separately. For example, Bacci and colleagues³⁹ divided patients into adolescent and preadolescent groups and reported 5-year OS for each. In our analysis, we treated each group independently and reported their 5-year OS separately. For each study, 5-year OS, weight of study, and CI are included. Five-year OS ranged from 19% to 94%. Analysis was performed to determine 5-year OS for all studies based on weight given to each study. The random-effects model used for this analysis (heterogeneity test, Q = 656.23; P < .001; I² = 93.4%) showed 5-year OS of 63% (95% CI, 60%-66%) for studies that included patients with metastatic and nonmetastatic osteosarcoma.

Figure 2 shows 5-year OS (range, 53%-94%) for each of the 16 studies that included only patients with nonmetastatic disease. The random-effects model used for this analysis (heterogeneity test, Q = 142.08; P < .001; I² = 89.4%) showed 5-year OS of 71% (95% CI, 67%-76%) for studies that included only patients with nonmetastatic disease.

We then examined percentage of patients achieving 90% necrosis on histology in each study. Several studies included in the OS analysis did not report percentage necrosis, leaving 29 studies for the necrosis analysis. Of these 29 studies, all 29 included patients with metastatic and nonmetastatic disease,^{4,6,11,14,15,18,19,21,29,31-36,37,39,40,43-47,49,50,54-57,59} and 13 included only patients with nonmetastatic disease.^{6,14,15,29,32-35,40,47,54,55,57} Again, because of the known difference in prognosis between patients with metastatic disease and patients with nonmetastatic disease, we performed separate analyses, one for the combined dataset of all 29 studies (Figure 3) and the other for the 13 nonmetastatic studies (Figure 4). Random-effects models showed 90% necrosis for 50% of patients in both analyses: studies that included patients with metastatic and nonmetastatic disease (95% CI, 45%-54%; heterogeneity test, Q = 692.88; P < .001; I² = 95.5%) and nonmetastatic studies (95% CI, 41%-59%; heterogeneity test, Q = 385.42; P < .001; I² = 96.9%).

We also performed a meta-regression analysis that included necrosis as a continuous variable for both the overall dataset and the nonmetastatic dataset. Five-year OS was plotted against percentage of patients achieving 90% tumor necrosis for each study. The results are plotted in Figure 5 (combined dataset).

No evidence of publication bias was detected for 5-year OS or percentage necrosis for the analyses of the combined datasets by either Egger test or Begg test. For 5-year OS, Ps were .21 (Egger) and .19 (Begg); for percentage necrosis, Ps were .10 (Egger) and .62 (Begg). In addition, no evidence of publication bias was detected for the analyses of the nonmetastatic studies by either test. For 5-year OS, Ps were .55 (Egger) and .41 (Begg); for percentage necrosis, Ps were .42 (Egger) and .95 (Begg).

Discussion

Five-year OS was 63% (95% CI, 60%-66%) for studies that included patients with metastatic and nonmetastatic osteosarcoma and 71% (95% CI, 67%-76%) for studies that included only patients with nonmetastatic osteosarcoma. These percentages fall within the range found in the literature. Mankin and colleagues³⁷ reviewed 648 cases of patients with osteosarcoma treated at Massachusetts General Hospital in 2004; OS was 68%. In 2011, Sampo and colleagues⁶⁰ reported 10-year OS of 63% for patients with metastatic and nonmetastatic disease and 73% for patients with local disease at presentation. Five-year OS rates in the literature are consistently about 70%. Ferrari and colleagues⁶¹ reported 5-year OS of 73% and 74% for 230 patients treated with 2 different neoadjuvant chemotherapy regimens between 2001 and 2006. The consistency in 5-year OS suggests OS of pediatric patients with osteosarcoma has plateaued, and there has been no significant improvement in survival of patients with osteosarcoma over the past 30 years.

Histologic response to preoperative chemotherapy is strongly associated with survival in pediatric osteosarcoma. Bielack and colleagues³¹ reported 5-year OS of 75% to 80% for patients who responded well to preoperative chemotherapy (>90% tumor necrosis) and 45% to 55% for patients who responded poorly (<10% necrosis). In our meta-analysis of studies that included patients with nonmetastatic osteosarcoma, 50% achieved necrosis of more than 90%. Percentage of patients achieving necrosis of more than 90% has been about 45%, according to past reports. In 2012, Ferrari and colleagues⁶¹ reported that 45% of 230 patients treated with neoadjuvant chemotherapy achieved more than 90% tumor necrosis. Therefore, 5-year OS and percentage of patients achieving 90% necrosis are consistent with previous reports, though this also suggests these numbers have remained constant over the past several decades.

Despite its expansive scale, our study has several important limitations. Data were extracted from published studies, and individual patient data were not available, so we were not able to assess the effects of risk factors (eg, tumor size, location) on 5-year OS. We could not correlate the proportion of patients with 90% necrosis to 5-year OS, as studies did not report OS by necrosis strata. Also, because our numbers were derived from published studies, they may not accurately represent outcomes in the community as a whole. In addition, several successive studies may contain duplicate patient cases. We limited our search to studies published since 2000 to include patients recently diagnosed and treated for osteosarcoma; however, several studies published after 2000 also included patients diagnosed and treated before 2000. Several of these studies are from countries outside the United States and may have a significantly different incidence of osteosarcoma as well as treatment methods and survival rates.

Although this meta-analysis suggests 5-year OS remains about 70% for patients with primary nonmetastatic osteosarcoma, we cannot settle on this conclusion because of the many differences between the studies we included. Therefore, more studies of patients diagnosed and treated within the past 10 years are needed to confirm our beliefs about patient survival.

Osteosarcoma, a primary malignant tumor of the skeleton, is characterized by direct formation of immature bone or osteoid tissue by tumor cells. The World Health Organization histologic classification of bone tumors divides osteosarcoma into central and surface tumors and recognizes a number of subtypes within each group.¹ The present review refers only to the classic central high-grade primary osteosarcoma of bone, which represents about 90% of all osteosarcoma cases. Classic osteosarcoma represents about 15% of all biopsy-analyzed primary bone tumors.¹ It is the third most common type of neoplasia, preceded by leukemia and lymphoma among older children and adolescents aged 12 to 18 years.² High-grade primary osteosarcoma is the most common primary skeletal tumor of childhood and adolescence, with an overall annual incidence of 5.6 cases per million children under age 15 years.^3-5 Peak incidence is in the second decade of life, and males are affected slightly more often than females.^2,6 The period of highest incidence coincides with the growth spurt of the long bones. Osteosarcoma preferentially affects the metaphysis of long bones, the 3 main sites being distal femur, tibia, and proximal humerus.²

Historical Perspective

For most of the 20th century, the 5-year survival rate for classic primary osteosarcoma was under 20%.⁷ In the 1970s, the first revolution in osteosarcoma treatment arrived with the introduction of adjuvant chemotherapy, which increased survival rates to 50%.^8-10 During this expansion of research, several chemotherapeutics (eg, vincristine, bleomycin, dactinomycin) were discarded for poor effectiveness, and others (eg, cisplatin, ifosfamide) were added to doxorubicin and methotrexate, improving 5-year disease-free survival to about 70% in patients with nonmetastatic osteosarcoma. In another significant advance, adjuvant chemotherapy was supplemented with intensive preoperative chemotherapy, resulting in 5-year tumor-free survival that has ranged from 50% to 75% for high-grade osteosarcoma.^5,11,12 Adding neoadjuvant chemotherapy and histologic response has allowed for evaluation of surgical margins and early treatment of microscopic disease. Thus, effective limb-sparing procedures can be performed, and the incidence of amputation has decreased from 90% to between 10% and 20%.^13,14 However, statistical improvements in survival associated with neoadjuvant treatment may simply delay time of recurrence and metastasis.¹⁵ In addition, though chemotherapy has improved survival in osteogenic sarcoma, many have written that this improvement appears to reflect mainly the increase in the intensity of the chemotherapy used, which also leads to a higher propensity for side effects.¹⁶

Despite research and advances in chemotherapy regimens, the prognosis of patients with osteosarcoma remains highly variable and often dismal. Mirabello and colleagues¹⁷ examined osteosarcoma incidence and survival rates between 1973 and 2004 and found that, with the introduction of neoadjuvant chemotherapy, survival rates improved significantly between 1973 and 1983 and between 1984 and 1993, but there was little improvement between 1993 and 2004.

The long-term outcome for patients with metastatic disease is poor. Investigators have found that 11% to 20% of patients have pulmonary metastasis at initial diagnosis. About half of patients without pulmonary metastases develop them later in the disease course.¹⁸ Survival rates for patients with metastasis at initial presentation have ranged from 10% to 40%.¹⁹ Recurrent disease still occurs in 30% to 40% of patients, and more than 70% of them die of the tumor.¹⁵ The survivors of osteosarcoma are then at increased risk for chronic medical conditions and adverse health status because of the osteosarcoma-related treatments.²⁰

Prognostic Factors

It is important to understand and exploit the influences of different prognostic factors in treating patients with osteosarcoma.⁷ These factors are important in establishing the best treatment for the individual. Thus, more aggressive treatments can be started in patients with prognostic factors that pose a higher risk of relapse.²¹ A number of clinical and pathologic features (eg, tumor site, size, subtype; patient sex and age; high alkaline phosphatase or high lactate dehydrogenase [LDH] values; multidrug resistance; genetic variations) have prognostic significance but often with contradictory results because of lack of uniformity in patient analyses and methods.¹⁵

Survival for patients with primary osteosarcoma has been analyzed with respect to tumor size and location.⁷ Studies have found higher survival rates for patients with smaller tumors (<10 cm) and more distal tumor locations.⁷ These superior survival rates may be the result of earlier detection of tumors and more options for surgical resection of smaller, distal tumors.

Serum LDH levels have helped in risk stratification of patients. High LDH often occurred at time of relapse, and relapse with high LDH correlated with poor prognosis. Meyers and colleagues²² found that 5-year disease-free survival was 72% for patients with normal LDH at presentation and 54% for patients with elevated LDH at presentation.

Several studies have shown that percentage of tumor necrosis on histology is strongly correlated with good prognosis.²¹ Most groups now define a good histologic response as less than 10% viable tumor cells at time of surgery, and a poor response as more than 10%.²³ Results of the Pediatric Oncology Group (POG) protocol for localized osteosarcoma (POG 9351), or Children’s Cancer Group (CCG) 7921, found 45% of patients had favorable responses (>90% necrosis) after preoperative chemotherapy.²⁴ However, several clinicians have recently questioned this finding.

Overall, the prognosis for classic osteosarcoma of the extremity remains highly variable, and there has been little improvement over the past 20 years. The prognosis for younger patients, patients with spinal disease, and patients with metastatic disease remains poor. Although some prognostic factors have been identified and shown to predict a good outcome, it seems few patients have these positive factors. In this article, we describe the literature review and meta-analysis we performed to better define recent survival trends for patients with primary osteosarcoma.

Methods

The MEDLINE, PubMed, and Cochrane databases were searched for eligible studies published in English between 2000 and 2011—a decade of recently reported research. We applied the search strategy [“osteosarcoma” OR “osteogenic sarcoma”] AND [“prognosis” OR “treatment” OR “survival”] and selected reports that specifically addressed factors predicting survival in patients with osteosarcoma—reports that were limited to primary osteosarcoma of the pelvis or extremity and provided 5-year overall survival (OS) data. Abstracts of the selected articles were independently reviewed, and the inclusion and exclusion criteria were applied. We excluded basic science studies and those without pediatric patients, those without primary osteosarcoma, those with periosteal or parosteal osteosarcoma, and those that did not report 5-year OS data.

Statistical Analysis

Number or proportion of patients (whichever was reported) with 5-year OS and number or proportion of patients with 90% necrosis were extracted from each study. For each trial, proportion of patients with 5-year OS and 95% confidence intervals (CIs) and proportion of patients achieving 90% necrosis and 95% CIs were determined. We also calculated proportion of patients with 5-year OS and proportion of patients with 90% necrosis with corresponding 95% CIs of studies that included patients with nonmetastatic disease.

We assessed statistical heterogeneity among trials included in the meta-analysis using the Cochran Q test. Inconsistency was quantified with the I² statistic, which estimates percentage of total across-studies variation caused by heterogeneity rather than chance.²⁵ We considered I² higher than 50% as indicating substantial heterogeneity. When substantial heterogeneity was not found, the pooled estimate calculated on the basis of the fixed-effects model was reported using the inverse variance method. When substantial heterogeneity was found, the pooled estimate calculated on the basis of a random-effects model was reported using the DerSimonian and Laird²⁶ method, which takes both within- and between-study variations into account.

Publication bias was assessed through funnel plots and with Begg and Egger tests.^27,28 Two-tailed P < .05 was considered statistically significant. All statistical analyses were performed with Stata/SE Version 11.0 (StataCorp).

Results

Our literature search yielded 597 articles. We cross-referenced these articles with the MEDLINE, PubMed, and Cochrane search results using the same keywords and discarded the duplicates. The abstracts of these articles were then reviewed in detail. The 40 articles^{4,6,11,12,14,15,17-19,21,29-58} that met our study inclusion criteria reported on studies that included patients with metastatic and nonmetastatic osteosarcoma. Because of the significant difference in OS of patients with metastatic disease, we also analyzed articles that included only patients with nonmetastatic disease. Sixteen articles^{6,14,15,29,32-35,39,47,48,51,53,54,55,57} were included in the analysis of patients with nonmetastatic disease.

Figure 1 shows 5-year OS for each of the 40 studies. For studies that compared survival of different groups of patients, the survival of each group is shown separately. For example, Bacci and colleagues³⁹ divided patients into adolescent and preadolescent groups and reported 5-year OS for each. In our analysis, we treated each group independently and reported their 5-year OS separately. For each study, 5-year OS, weight of study, and CI are included. Five-year OS ranged from 19% to 94%. Analysis was performed to determine 5-year OS for all studies based on weight given to each study. The random-effects model used for this analysis (heterogeneity test, Q = 656.23; P < .001; I² = 93.4%) showed 5-year OS of 63% (95% CI, 60%-66%) for studies that included patients with metastatic and nonmetastatic osteosarcoma.

Figure 2 shows 5-year OS (range, 53%-94%) for each of the 16 studies that included only patients with nonmetastatic disease. The random-effects model used for this analysis (heterogeneity test, Q = 142.08; P < .001; I² = 89.4%) showed 5-year OS of 71% (95% CI, 67%-76%) for studies that included only patients with nonmetastatic disease.

We then examined percentage of patients achieving 90% necrosis on histology in each study. Several studies included in the OS analysis did not report percentage necrosis, leaving 29 studies for the necrosis analysis. Of these 29 studies, all 29 included patients with metastatic and nonmetastatic disease,^{4,6,11,14,15,18,19,21,29,31-36,37,39,40,43-47,49,50,54-57,59} and 13 included only patients with nonmetastatic disease.^{6,14,15,29,32-35,40,47,54,55,57} Again, because of the known difference in prognosis between patients with metastatic disease and patients with nonmetastatic disease, we performed separate analyses, one for the combined dataset of all 29 studies (Figure 3) and the other for the 13 nonmetastatic studies (Figure 4). Random-effects models showed 90% necrosis for 50% of patients in both analyses: studies that included patients with metastatic and nonmetastatic disease (95% CI, 45%-54%; heterogeneity test, Q = 692.88; P < .001; I² = 95.5%) and nonmetastatic studies (95% CI, 41%-59%; heterogeneity test, Q = 385.42; P < .001; I² = 96.9%).

We also performed a meta-regression analysis that included necrosis as a continuous variable for both the overall dataset and the nonmetastatic dataset. Five-year OS was plotted against percentage of patients achieving 90% tumor necrosis for each study. The results are plotted in Figure 5 (combined dataset).

No evidence of publication bias was detected for 5-year OS or percentage necrosis for the analyses of the combined datasets by either Egger test or Begg test. For 5-year OS, Ps were .21 (Egger) and .19 (Begg); for percentage necrosis, Ps were .10 (Egger) and .62 (Begg). In addition, no evidence of publication bias was detected for the analyses of the nonmetastatic studies by either test. For 5-year OS, Ps were .55 (Egger) and .41 (Begg); for percentage necrosis, Ps were .42 (Egger) and .95 (Begg).

Discussion

Five-year OS was 63% (95% CI, 60%-66%) for studies that included patients with metastatic and nonmetastatic osteosarcoma and 71% (95% CI, 67%-76%) for studies that included only patients with nonmetastatic osteosarcoma. These percentages fall within the range found in the literature. Mankin and colleagues³⁷ reviewed 648 cases of patients with osteosarcoma treated at Massachusetts General Hospital in 2004; OS was 68%. In 2011, Sampo and colleagues⁶⁰ reported 10-year OS of 63% for patients with metastatic and nonmetastatic disease and 73% for patients with local disease at presentation. Five-year OS rates in the literature are consistently about 70%. Ferrari and colleagues⁶¹ reported 5-year OS of 73% and 74% for 230 patients treated with 2 different neoadjuvant chemotherapy regimens between 2001 and 2006. The consistency in 5-year OS suggests OS of pediatric patients with osteosarcoma has plateaued, and there has been no significant improvement in survival of patients with osteosarcoma over the past 30 years.

Histologic response to preoperative chemotherapy is strongly associated with survival in pediatric osteosarcoma. Bielack and colleagues³¹ reported 5-year OS of 75% to 80% for patients who responded well to preoperative chemotherapy (>90% tumor necrosis) and 45% to 55% for patients who responded poorly (<10% necrosis). In our meta-analysis of studies that included patients with nonmetastatic osteosarcoma, 50% achieved necrosis of more than 90%. Percentage of patients achieving necrosis of more than 90% has been about 45%, according to past reports. In 2012, Ferrari and colleagues⁶¹ reported that 45% of 230 patients treated with neoadjuvant chemotherapy achieved more than 90% tumor necrosis. Therefore, 5-year OS and percentage of patients achieving 90% necrosis are consistent with previous reports, though this also suggests these numbers have remained constant over the past several decades.

Despite its expansive scale, our study has several important limitations. Data were extracted from published studies, and individual patient data were not available, so we were not able to assess the effects of risk factors (eg, tumor size, location) on 5-year OS. We could not correlate the proportion of patients with 90% necrosis to 5-year OS, as studies did not report OS by necrosis strata. Also, because our numbers were derived from published studies, they may not accurately represent outcomes in the community as a whole. In addition, several successive studies may contain duplicate patient cases. We limited our search to studies published since 2000 to include patients recently diagnosed and treated for osteosarcoma; however, several studies published after 2000 also included patients diagnosed and treated before 2000. Several of these studies are from countries outside the United States and may have a significantly different incidence of osteosarcoma as well as treatment methods and survival rates.

Although this meta-analysis suggests 5-year OS remains about 70% for patients with primary nonmetastatic osteosarcoma, we cannot settle on this conclusion because of the many differences between the studies we included. Therefore, more studies of patients diagnosed and treated within the past 10 years are needed to confirm our beliefs about patient survival.