A prospective study of autologous chondrocyte implantation in patients with failed prior treatment for articular cartilage defect of the knee: Results of the study of the treatment of articular repair (STAR) clinical trial

Background: This is a prospective clinical study to assess the effectiveness of autologous chondrocyte implantation in patients who failed prior treatments for articular cartilage defects of the knee. Hypothesis: Autologous chondrocyte implantation provides clinical benefit in patients with failed articular cartilage treatments. Study Design: Cohort study; Level of evidence, 2. Methods: One hundred fifty-four patients with failed treatment for articular cartilage defects of the knee received autologous chondrocyte implantation in a multicenter, prospective study. Follow-up was 48 months. Outcomes included change from baseline in knee function, knee pain, quality of life, and overall health. Duration of benefit after autologous chondrocyte implantation was compared with the failed prior non-autologous chondrocyte implantation procedure. Safety information was recorded. Additional analyses were performed on the 2 major cohorts of prior procedures entered into the study, marrow-stimulation technique or debridement alone, to assess if there were any significant differences in baseline characteristics, outcomes, or prognosis between the 2 groups. Results: One hundred twenty-six patients (82%) completed the protocol. Seventy-six percent of patients were treatment successes at study end, while 24% were deemed treatment failures. Preoperative mean knee pain score was 3.0 (SD, 1.8; 0 = severe, 10 = normal). Mean improvements were observed from baseline to all time points (P <.001) for all outcome measures. Preoperative to 48-month values, respectively, were as follows: On the Knee injury and Osteoarthritis Outcome Score subscales of pain: 48.7 to 72.2; other symptoms: 51.8 to 70.8; sports/recreation: 25.8 to 55.8; knee quality of life: 20.9 to 52.2; and activities of daily living: 58.6 to 81.0; on the Modified Cincinnati Overall Knee score: 3.3 to 6.3; on the visual analog scale: 28.8 to 69.9; and on the SF-36 Overall Physical Health: 33.0 to 44.4. Results did not differ between patients whose primary surgery had been a marrow-stimulating procedure and those whose primary procedure had been a debridement alone. The median difference in duration of benefit between autologous chondrocyte implantation and the failed non-autologous chondrocyte implantation prior procedure was at least 31 months (P <.001). Seventy-six patients (49%) had subsequent surgical procedure(s), predominantly arthroscopic. Need for a subsequent surgical procedure was not predictive of failure. Conclusion: Patients with moderate to large chondral lesions with failed prior cartilage treatments can expect sustained and clinically meaningful improvement in pain and function after autologous chondrocyte implantation. The subsequent surgical procedure rate observed in this study (49% overall; 40% related to autologous chondrocyte implantation) appears higher than generally reported after autologous chondrocyte implantation.