- Email: [email protected]
122. Five Year Results of the Prospective Randomized Multicenter FDA IDE ProDisc®-L Clinical Trial
62S
Proceedings of the NASS 23rd Annual Meeting / The Spine Journal 8 (2008) 1S–191S
loss was higher in the Kineflex group (113.9 vs. 64.1 cc; primarily due to one case). Clinically, both groups improved significantly with respect to VAS scores assessing pain and Oswestry scores assessing function (Figures 1 and 2). There were no significant differences in outcome between the two groups. The incidence and types of adverse events in the two groups were very similar. In both groups, disc height increased after TDR (Kineflex: 11.9 to 20.4 mm; Charite: 12.7 to 21.7 mm). The pattern of change in range of motion at the implanted level, as measured from flexion/extension radiographs, was similar in the two groups. Pre-operatively, the mean range of motion in the Kineflex group was 4.8 degree and at 12 months was 4.9 degrees. In the Charite´ group, the range of motion was 5.9 degrees pre-operatively and 4.6 degrees at 12 months post-operative.
Figure 1. The mean VAS scores indicated that both groups improved significantly after TDR and remained improved through the 12-month follow-up with no differences between groups. CONCLUSIONS: This study provides preliminary data from two sites participating in the FDA-regulated trial evaluating the Kineflex disc by comparing it to Charite. This prospective randomized study found that with respect to peri-operative data, clinical outcome, adverse events, and radiographic results, the two discs produced similar results. The 24month follow-up will be collected as patients reach that point. Also, data are being collected at other sites in accordance with the same protocol. This study reinforces that when rigorously adhering to a well-defined patient selection criteria, similar results are produced across different TDR implants.
Figure 2. The mean Oswestry scores improved significantly in both groups with no differences between groups.
FDA DEVICE/DRUG STATUS: Kineflex: Investigational/Not approved; Charite: Approved for this indication. doi:10.1016/j.spinee.2008.06.144
Friday, October 17, 2008 7:25–8:25 AM General Session: Best Papers 122. Five Year Results of the Prospective Randomized Multicenter FDA IDE ProDiscÒ-L Clinical Trial Rick Delamarter, MD1, Jack Zigler, MD2, Jeffrey M. Spivak, MD3, Raymond Linovitz, MD4, Guy O. Danielson, III, MD5, Thomas Haider, MD6, Frank P. Cammisa, Jr., MD7, James Zucherman, MD8, Richard A. Balderston, MD9, Scott Kitchell, MD10, Kevin Foley, MD11, Robert Watkins, MD12, David Bradford, MD13, James Yue, MD14, Hansen Yuan, MD15, Harry Herkowitz, MD16, John A. Bendo, MD3, Timothy Peppers, MD17, Barton Sachs, MD18, Federico P. Girardi, MD7, Michael A. Kropf, MD19, Jeffrey A. Goldstein, MD3; 1The Spine Institute, Santa Monica, CA, USA; 2Texas Back Institute, Plano, TX, USA; 3Hospital for Joint Diseases, New York, NY, USA; 4CORE Orthopaedic Medical Center, Encinitas, CA, USA; 5Texas Spine and Joint Hospital, Tyler, TX, USA; 6Riverside, CA, USA; 7Hospital for Special Surgery, New York, NY, USA; 8St. Mary’s Spine Center, San Francisco, CA, USA; 9Pennsylvania Hospital, Philadelphia, PA, USA; 10Orthopaedic Spine Associates, Eugene, OR, USA; 11University of Tennessee, Memphis, TN, USA; 12 Watkins Spine Group, Marina Del Rey, CA, USA; 13University of California, San Francisco, San Francisco, CA, USA; 14Yale University, New Haven, CT, USA; 15SUNY - Upstate Medical University, Syracuse, NY, USA; 16William Beaumont Hospital, Royal Oak, MI, USA; 17CORE Orthopedic Medical Center, Encinitas, CA, USA; 18Plano, TX, USA; 19The Spine Institute at Santa Monica, Santa Monica, CA, USA BACKGROUND CONTEXT: Previously, the 2-year follow-up results from the investigational device exemption (IDE) clinical trial of the ProDiscÒ-L (Synthes Spine Company, L.P., West Chester, PA) lumbar total disc replacement (TDR) were reported.1 Up until now, follow-up results of the ProDiscÒ-L study were only available to this 2 year time point, with longer term results not known. PURPOSE: To evaluate the safety and effectiveness of the ProDiscÒ-L TDR compared to spinal circumferential fusion surgery for the treatment of discogenic pain unresponsive to non-operative treatment at one vertebral level between L3 and S1, at 5-year follow-up of the same patient population. STUDY DESIGN/ SETTING: A prospective, randomized, multicenter, Food and Drug Administration (FDA)-regulated IDE clinical trial was conducted at 17 sites, utilizing a 2:1 randomization ratio (ProDiscÒ-L: Fusion). PATIENT SAMPLE: A total of 236 patients were treated. OUTCOME MEASURES: Patient self-assessments, e.g., Oswestry Disability Index (ODI) low back pain questionnaire, SF-36 Health Survey, Visual Analog Scale (VAS) for pain and satisfaction, physical and neurological examination, and radiographic evaluation. METHODS: Patients were assessed pre-operatively and post-operatively at 6 weeks, 3, 6, 12, 18, 24, 36, 48, and 60 months. RESULTS: Patients in both groups improved significantly following surgery. Baseline pre-operative ODI values were not different (ProDiscÒ-L: 63.4612.6; Fusion: 62.7610.3; p50.6125). At 24 months, the mean score of the ProDiscÒ-L group was 34.5624.8 points for an average improvement from baseline of 28.9 points (46.1%), and the mean score of the Fusion group was 39.8624.3, for an average improvement from baseline of 22.9 points (36.0%). Average improvement stayed consistent out to 60 months with no statistical difference in mean score between 24 to 60 months in either treatment group. The VAS pain assessment showed statistically significant improvement from pre-operative levels regardless of treatment (p! 0.0001). VAS pain showed no deterioration over time out to 60 months. There was a statistically significant difference at 24 months in the VAS satisfaction score improvement in the ProDiscÒ-L patients
Proceedings of the NASS 23rd Annual Meeting / The Spine Journal 8 (2008) 1S–191S (p50.015), and satisfaction remained constant to the 60 month time point. Successful radiographic range of motion was achieved by 93.7% of the ProDiscÒ-L patients. CONCLUSIONS: This is the first reported 5-year study following the ProDiscÒ-L TDR. The data shows that significant clinical improvement was achieved and maintained in the ProDiscÒ-L patients out to 5 years with no worsening of outcomes from the 2-year levels. These results support earlier reports that ProDiscÒ-L TDR is a safe and effective surgical treatment of discogenic pain in patients who meet the study inclusion criteria. FDA DEVICE/DRUG STATUS: ProDisc-Lumbar: Approved for this indication. doi:10.1016/j.spinee.2008.06.146
123. A Prospective Randomized Study on the Long-term Effect of Lumbar Fusion on Adjacent Disc Degeneration Per Ekman, MD1, Hans Mo¨ller, MD,PhD2, Adel Shalabi, MD,PhD3, Yiang Xiao Yu, MD2, Rune Hedlund, MD, PhD4; 1Karolinska Institutet, Department of Clinical Science, Intervention and Technology (CLINTEC), Division of Orthopedics, Karolinska University Hospital Huddinge, SE141 86 Stockholm,, Stockholm, Sweden; 2Karolinska Institutet, Department of Clinical Science, Intervention and Technology (CLINTEC), Division of Orthopedics, Karolinska University Hospital Huddinge, Stockholm, Huddinge, Sweden; 3Karolinska Institutet, Department of Clinical Science, Intervention and Technology (CLINTEC), Division of Radiology, Karolinska University Hospital Huddinge, Stockholm, Sweden; 4 Department of Orthopedics, Sahlgrenska University Hospital, Go¨teborg, Sweden BACKGROUND CONTEXT: There is major controversy whether fusion can result in an accelerated adjacent segment disc degeneration (ASD). The existence and importance of ASD have previously not been demonstrated by RCTs. In spite of this a wide variety of spinal procedures, most notably disc prosthesis, are being offered because of the theoretical advantage of reducing the risk of ASD in the long term perspective. PURPOSE: To determine whether lumbar fusion in the long term accelerates degenerative changes in the adjacent disc and whether this affects outcome. STUDY DESIGN/ SETTING: A prospective randomized trial. PATIENT SAMPLE: 111 patients, aged 18–55, with isthmic spondylolisthesis were randomised to exercise (EX, n534) or posterolateral fusion (PLF, n577), with (n537) or without pedicle screw instrumentation (n540). The minimum 10 years FU rate was 72%, with a mean FU time of 12.6 years (range 10–17). OUTCOME MEASURES: Long term outcome questionnaires were obtained. Pain was assessed as Pain index (VAS). Functional Disability was measured by the Disability Rating Index (DRI) and the Oswestry Disability Index (ODI). Global outcome, as compared to the pre-treatment situation, was assessed by the patient into ‘‘much better’’, ‘‘better’’, ‘‘unchanged’’ or ‘‘worse’’. METHODS: Three radiographic methods of ASD quantification were used, i.e. two digital radiographic measurement methods and the semi quantitative UCLA grading scale. RESULTS: One digital measurement method showed a mean disc height reduction by 2% in the EX group and by 15% in the PLF group (p50.0016), and the other showed 0.5 mm more disc height reduction in the PLF compared to Ex group (ns). The UCLA grading scale showed normal discs in 100% of patients in the EX group, compared to 62% in the PLF group (p50.026). There were no significant differences between instrumented and non-instrumented patients. In the longitudinal analysis the posterior and anterior disc heights were significantly reduced in the PLF group, whereas in the EX group only the post disc height was significantly reduced. Except for global outcome, which was significantly better
63S
for patients without ASD, the clinical outcome was not statistically different in patients with and without ASD. CONCLUSIONS: The long term RCT shows that fusion accelerates degenerative changes at the adjacent level compared to natural history. The clinical importance of ASD seems limited, with only the more severe forms affecting outcome. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi:10.1016/j.spinee.2008.06.147
124. Athletic Performance Outcomes Following Lumbar Discectomy in Professional Basketball Players Okechukwu Anakwenze, MD1, Surena Namdari, MD1, Joshua Auerbach, MD1, Zachary Weidner, BA2, Keith Baldwin, MD1, Brian Sennett, MD1; 1 The University of Pennsylvania, Philadelphia, PA, USA; 2The University of Pennsylvania School of Medicine, Philadelphia, PA, USA BACKGROUND CONTEXT: Herniated nucleus pulposus (HNP) in the lumbar spine continues to be a major source of morbidity and financial burden in the United States. Lumbar diskectomy provides symptomatic relief and improved functionality in the vast majority of patients as assessed by validated clinical outcomes measures such as Oswestry Disability Index, Visual Analog Scale, and SF-36. Among professional athletes, however, the goal of lumbar HNP treated by diskectomy is to not only improve functional status, but ultimately to return the player to pre-injury athletic performance levels. Although functional outcomes in elite athletes with lumbar HNP have been previously described, an analysis of athletic performance profiles before and after diskectomy has never been done. PURPOSE: The purpose of this study was to determine the athletic performance profiles following lumbar diskectomy in a cohort of National Basketball Association (NBA) players. STUDY DESIGN/ SETTING: Retrospective case series. PATIENT SAMPLE: Twenty-six NBA players who underwent lumbar discectomy for symptomatic lumbar HNP were identified. Two players were eliminated because they had no pre-operative data. Six players never returned to play post-operatively. Eighteen NBA players had data for the year preceding the surgery, and the year immediately following surgery. These players were used as our sample population. OUTCOME MEASURES: Paired T-tests were conducted on the following parameters; games played, minutes per game, points per 40 minutes, rebounds per 40 minutes, assists per 40 minutes, steals per 40 minutes, blocks per 40 minutes and shooting percentage. METHODS: Players were identified through press releases, player profiles and injury reports. We searched for players that had undergone surgery between 1991 and 2007. Each player was used as their own control for the purposes of comparison for the paired T-tests. A cutoff value of 0.05 was selected for statistical significance. Since all parameters were measures of performance, the p values were not corrected for multiple tests. Only 10 of the 18 returned for a second year post surgery. These 10 were compared to the 8 that did not return using univariate logistic regression to determine if there were any factors significantly related to whether or not a player returned postoperatively. RESULTS: One year postoperatively players averaged 20.1 (p50.001) fewer games played than they did the season preceding surgery. In addition, their average field goal percentage decreased by an average of 6.5% (p50.001). They also scored 2.41 fewer points per game (p50.048) and had 1.3 fewer rebounds per game (p50.024). There were no other statistically significant differences noted pre-operatively versus post-operatively. Notably, no parameter was significantly different per 40 minutes of play. Only 10 of the eighteen players (56%) played the 2nd season following surgery. No single factor (age at the time of surgery, experience, height, weight, BMI, position, or All-Star status) was found to significantly influence whether a player returned for greater than 1 season.
Proceedings of the NASS 23rd Annual Meeting / The Spine Journal 8 (2008) 1S–191S
loss was higher in the Kineflex group (113.9 vs. 64.1 cc; primarily due to one case). Clinically, both groups improved significantly with respect to VAS scores assessing pain and Oswestry scores assessing function (Figures 1 and 2). There were no significant differences in outcome between the two groups. The incidence and types of adverse events in the two groups were very similar. In both groups, disc height increased after TDR (Kineflex: 11.9 to 20.4 mm; Charite: 12.7 to 21.7 mm). The pattern of change in range of motion at the implanted level, as measured from flexion/extension radiographs, was similar in the two groups. Pre-operatively, the mean range of motion in the Kineflex group was 4.8 degree and at 12 months was 4.9 degrees. In the Charite´ group, the range of motion was 5.9 degrees pre-operatively and 4.6 degrees at 12 months post-operative.
Figure 1. The mean VAS scores indicated that both groups improved significantly after TDR and remained improved through the 12-month follow-up with no differences between groups. CONCLUSIONS: This study provides preliminary data from two sites participating in the FDA-regulated trial evaluating the Kineflex disc by comparing it to Charite. This prospective randomized study found that with respect to peri-operative data, clinical outcome, adverse events, and radiographic results, the two discs produced similar results. The 24month follow-up will be collected as patients reach that point. Also, data are being collected at other sites in accordance with the same protocol. This study reinforces that when rigorously adhering to a well-defined patient selection criteria, similar results are produced across different TDR implants.
Figure 2. The mean Oswestry scores improved significantly in both groups with no differences between groups.
FDA DEVICE/DRUG STATUS: Kineflex: Investigational/Not approved; Charite: Approved for this indication. doi:10.1016/j.spinee.2008.06.144
Friday, October 17, 2008 7:25–8:25 AM General Session: Best Papers 122. Five Year Results of the Prospective Randomized Multicenter FDA IDE ProDiscÒ-L Clinical Trial Rick Delamarter, MD1, Jack Zigler, MD2, Jeffrey M. Spivak, MD3, Raymond Linovitz, MD4, Guy O. Danielson, III, MD5, Thomas Haider, MD6, Frank P. Cammisa, Jr., MD7, James Zucherman, MD8, Richard A. Balderston, MD9, Scott Kitchell, MD10, Kevin Foley, MD11, Robert Watkins, MD12, David Bradford, MD13, James Yue, MD14, Hansen Yuan, MD15, Harry Herkowitz, MD16, John A. Bendo, MD3, Timothy Peppers, MD17, Barton Sachs, MD18, Federico P. Girardi, MD7, Michael A. Kropf, MD19, Jeffrey A. Goldstein, MD3; 1The Spine Institute, Santa Monica, CA, USA; 2Texas Back Institute, Plano, TX, USA; 3Hospital for Joint Diseases, New York, NY, USA; 4CORE Orthopaedic Medical Center, Encinitas, CA, USA; 5Texas Spine and Joint Hospital, Tyler, TX, USA; 6Riverside, CA, USA; 7Hospital for Special Surgery, New York, NY, USA; 8St. Mary’s Spine Center, San Francisco, CA, USA; 9Pennsylvania Hospital, Philadelphia, PA, USA; 10Orthopaedic Spine Associates, Eugene, OR, USA; 11University of Tennessee, Memphis, TN, USA; 12 Watkins Spine Group, Marina Del Rey, CA, USA; 13University of California, San Francisco, San Francisco, CA, USA; 14Yale University, New Haven, CT, USA; 15SUNY - Upstate Medical University, Syracuse, NY, USA; 16William Beaumont Hospital, Royal Oak, MI, USA; 17CORE Orthopedic Medical Center, Encinitas, CA, USA; 18Plano, TX, USA; 19The Spine Institute at Santa Monica, Santa Monica, CA, USA BACKGROUND CONTEXT: Previously, the 2-year follow-up results from the investigational device exemption (IDE) clinical trial of the ProDiscÒ-L (Synthes Spine Company, L.P., West Chester, PA) lumbar total disc replacement (TDR) were reported.1 Up until now, follow-up results of the ProDiscÒ-L study were only available to this 2 year time point, with longer term results not known. PURPOSE: To evaluate the safety and effectiveness of the ProDiscÒ-L TDR compared to spinal circumferential fusion surgery for the treatment of discogenic pain unresponsive to non-operative treatment at one vertebral level between L3 and S1, at 5-year follow-up of the same patient population. STUDY DESIGN/ SETTING: A prospective, randomized, multicenter, Food and Drug Administration (FDA)-regulated IDE clinical trial was conducted at 17 sites, utilizing a 2:1 randomization ratio (ProDiscÒ-L: Fusion). PATIENT SAMPLE: A total of 236 patients were treated. OUTCOME MEASURES: Patient self-assessments, e.g., Oswestry Disability Index (ODI) low back pain questionnaire, SF-36 Health Survey, Visual Analog Scale (VAS) for pain and satisfaction, physical and neurological examination, and radiographic evaluation. METHODS: Patients were assessed pre-operatively and post-operatively at 6 weeks, 3, 6, 12, 18, 24, 36, 48, and 60 months. RESULTS: Patients in both groups improved significantly following surgery. Baseline pre-operative ODI values were not different (ProDiscÒ-L: 63.4612.6; Fusion: 62.7610.3; p50.6125). At 24 months, the mean score of the ProDiscÒ-L group was 34.5624.8 points for an average improvement from baseline of 28.9 points (46.1%), and the mean score of the Fusion group was 39.8624.3, for an average improvement from baseline of 22.9 points (36.0%). Average improvement stayed consistent out to 60 months with no statistical difference in mean score between 24 to 60 months in either treatment group. The VAS pain assessment showed statistically significant improvement from pre-operative levels regardless of treatment (p! 0.0001). VAS pain showed no deterioration over time out to 60 months. There was a statistically significant difference at 24 months in the VAS satisfaction score improvement in the ProDiscÒ-L patients
Proceedings of the NASS 23rd Annual Meeting / The Spine Journal 8 (2008) 1S–191S (p50.015), and satisfaction remained constant to the 60 month time point. Successful radiographic range of motion was achieved by 93.7% of the ProDiscÒ-L patients. CONCLUSIONS: This is the first reported 5-year study following the ProDiscÒ-L TDR. The data shows that significant clinical improvement was achieved and maintained in the ProDiscÒ-L patients out to 5 years with no worsening of outcomes from the 2-year levels. These results support earlier reports that ProDiscÒ-L TDR is a safe and effective surgical treatment of discogenic pain in patients who meet the study inclusion criteria. FDA DEVICE/DRUG STATUS: ProDisc-Lumbar: Approved for this indication. doi:10.1016/j.spinee.2008.06.146
123. A Prospective Randomized Study on the Long-term Effect of Lumbar Fusion on Adjacent Disc Degeneration Per Ekman, MD1, Hans Mo¨ller, MD,PhD2, Adel Shalabi, MD,PhD3, Yiang Xiao Yu, MD2, Rune Hedlund, MD, PhD4; 1Karolinska Institutet, Department of Clinical Science, Intervention and Technology (CLINTEC), Division of Orthopedics, Karolinska University Hospital Huddinge, SE141 86 Stockholm,, Stockholm, Sweden; 2Karolinska Institutet, Department of Clinical Science, Intervention and Technology (CLINTEC), Division of Orthopedics, Karolinska University Hospital Huddinge, Stockholm, Huddinge, Sweden; 3Karolinska Institutet, Department of Clinical Science, Intervention and Technology (CLINTEC), Division of Radiology, Karolinska University Hospital Huddinge, Stockholm, Sweden; 4 Department of Orthopedics, Sahlgrenska University Hospital, Go¨teborg, Sweden BACKGROUND CONTEXT: There is major controversy whether fusion can result in an accelerated adjacent segment disc degeneration (ASD). The existence and importance of ASD have previously not been demonstrated by RCTs. In spite of this a wide variety of spinal procedures, most notably disc prosthesis, are being offered because of the theoretical advantage of reducing the risk of ASD in the long term perspective. PURPOSE: To determine whether lumbar fusion in the long term accelerates degenerative changes in the adjacent disc and whether this affects outcome. STUDY DESIGN/ SETTING: A prospective randomized trial. PATIENT SAMPLE: 111 patients, aged 18–55, with isthmic spondylolisthesis were randomised to exercise (EX, n534) or posterolateral fusion (PLF, n577), with (n537) or without pedicle screw instrumentation (n540). The minimum 10 years FU rate was 72%, with a mean FU time of 12.6 years (range 10–17). OUTCOME MEASURES: Long term outcome questionnaires were obtained. Pain was assessed as Pain index (VAS). Functional Disability was measured by the Disability Rating Index (DRI) and the Oswestry Disability Index (ODI). Global outcome, as compared to the pre-treatment situation, was assessed by the patient into ‘‘much better’’, ‘‘better’’, ‘‘unchanged’’ or ‘‘worse’’. METHODS: Three radiographic methods of ASD quantification were used, i.e. two digital radiographic measurement methods and the semi quantitative UCLA grading scale. RESULTS: One digital measurement method showed a mean disc height reduction by 2% in the EX group and by 15% in the PLF group (p50.0016), and the other showed 0.5 mm more disc height reduction in the PLF compared to Ex group (ns). The UCLA grading scale showed normal discs in 100% of patients in the EX group, compared to 62% in the PLF group (p50.026). There were no significant differences between instrumented and non-instrumented patients. In the longitudinal analysis the posterior and anterior disc heights were significantly reduced in the PLF group, whereas in the EX group only the post disc height was significantly reduced. Except for global outcome, which was significantly better
63S
for patients without ASD, the clinical outcome was not statistically different in patients with and without ASD. CONCLUSIONS: The long term RCT shows that fusion accelerates degenerative changes at the adjacent level compared to natural history. The clinical importance of ASD seems limited, with only the more severe forms affecting outcome. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi:10.1016/j.spinee.2008.06.147
124. Athletic Performance Outcomes Following Lumbar Discectomy in Professional Basketball Players Okechukwu Anakwenze, MD1, Surena Namdari, MD1, Joshua Auerbach, MD1, Zachary Weidner, BA2, Keith Baldwin, MD1, Brian Sennett, MD1; 1 The University of Pennsylvania, Philadelphia, PA, USA; 2The University of Pennsylvania School of Medicine, Philadelphia, PA, USA BACKGROUND CONTEXT: Herniated nucleus pulposus (HNP) in the lumbar spine continues to be a major source of morbidity and financial burden in the United States. Lumbar diskectomy provides symptomatic relief and improved functionality in the vast majority of patients as assessed by validated clinical outcomes measures such as Oswestry Disability Index, Visual Analog Scale, and SF-36. Among professional athletes, however, the goal of lumbar HNP treated by diskectomy is to not only improve functional status, but ultimately to return the player to pre-injury athletic performance levels. Although functional outcomes in elite athletes with lumbar HNP have been previously described, an analysis of athletic performance profiles before and after diskectomy has never been done. PURPOSE: The purpose of this study was to determine the athletic performance profiles following lumbar diskectomy in a cohort of National Basketball Association (NBA) players. STUDY DESIGN/ SETTING: Retrospective case series. PATIENT SAMPLE: Twenty-six NBA players who underwent lumbar discectomy for symptomatic lumbar HNP were identified. Two players were eliminated because they had no pre-operative data. Six players never returned to play post-operatively. Eighteen NBA players had data for the year preceding the surgery, and the year immediately following surgery. These players were used as our sample population. OUTCOME MEASURES: Paired T-tests were conducted on the following parameters; games played, minutes per game, points per 40 minutes, rebounds per 40 minutes, assists per 40 minutes, steals per 40 minutes, blocks per 40 minutes and shooting percentage. METHODS: Players were identified through press releases, player profiles and injury reports. We searched for players that had undergone surgery between 1991 and 2007. Each player was used as their own control for the purposes of comparison for the paired T-tests. A cutoff value of 0.05 was selected for statistical significance. Since all parameters were measures of performance, the p values were not corrected for multiple tests. Only 10 of the 18 returned for a second year post surgery. These 10 were compared to the 8 that did not return using univariate logistic regression to determine if there were any factors significantly related to whether or not a player returned postoperatively. RESULTS: One year postoperatively players averaged 20.1 (p50.001) fewer games played than they did the season preceding surgery. In addition, their average field goal percentage decreased by an average of 6.5% (p50.001). They also scored 2.41 fewer points per game (p50.048) and had 1.3 fewer rebounds per game (p50.024). There were no other statistically significant differences noted pre-operatively versus post-operatively. Notably, no parameter was significantly different per 40 minutes of play. Only 10 of the eighteen players (56%) played the 2nd season following surgery. No single factor (age at the time of surgery, experience, height, weight, BMI, position, or All-Star status) was found to significantly influence whether a player returned for greater than 1 season.