ABSTRACT
Abstract: We previously conducted a single-arm, prospective study in which 31 patients (mean age [and standard deviation], 42.5 ± 11.3 years) with cartilage lesions were treated with use of the BioPoly Partial Resurfacing Knee Implant. Treatment outcomes were compared with those reported for the standard of care, microfracture. We found that the mean KOOS (Knee injury and Osteoarthritis Outcome Score) Quality of Life score at 5 years in the BioPoly cohort was noninferior to (p = 0.004), and indeed greater than (p = 0.021), that in the microfracture cohort. The BioPoly cohort demonstrated improvement in the mean scores for all KOOS domains at every postoperative time point (p < 0.025). The mean score for the visual analog scale (VAS) for pain significantly improved (p < 0.025) at all time points up to 4 years and trended toward significant improvement at 5 years (p = 0.027). This study indicated that the BioPoly implant was safe, provided significant improvement starting at 6 months and continuing to 5 years, and provided greater improvement than microfracture for some outcome measures. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
ABSTRACT
BACKGROUND: Current treatments for focal chondral and osteochondral lesions of the femoral condyle have been associated with variable outcomes. We conducted a clinical trial of the BioPoly RS Partial Resurfacing Knee Implant to address this unmet need. METHODS: We performed a single-arm, prospective study in which 33 patients with focal cartilage lesions affecting the femoral condyle were managed with the BioPoly RS Partial Resurfacing Knee Implant. Knee injury and Osteoarthritis Outcome Score (KOOS) scores, a visual analog scale (VAS) for pain, the Short Form-36 (SF-36) physical component score , and the Tegner activity score were used to assess outcomes preoperatively and at 6 months, 1 year, and 2 years postoperatively. The KOOS outcomes at 2 years were compared with historical outcomes following microfracture treatment. RESULTS: We found significant and clinically meaningful improvements in the KOOS scores, VAS pain score, and SF-36 physical component score (p < 0.025) when the values at all 3 postoperative time points were compared with the preoperative scores, and we also found significant improvements when the Tegner activity score at 2 years was compared with the preoperative score (p < 0.025). More than half of the cohort of patients had had a previous failure of cartilage-repair procedures. No significant differences were detected between younger patients (≤40 years) and older patients (>40 years). When compared with historical microfracture data, the BioPoly RS Implant demonstrated significantly superior KOOS scores for quality of life and sports. CONCLUSIONS: The present study indicated that the BioPoly RS Partial Resurfacing Knee Implant is safe, that it resulted in significantly improved knee function by 6 months, and that this improvement was sustained for 2 years regardless of patient age. The BioPoly RS Knee Implant allows return to a higher level of sporting activity than microfracture. Additional long-term follow-up is needed to determine the long-term effects of the device. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
ABSTRACT
OBJECTIVE: Autologous chondrocyte transplantation has become an established therapy for full-thickness cartilage defects. Cell-seeded collagen matrix-supported autologous chondrocyte transplantation (ACT-CS) has been introduced as a modification of conventional ACT, which allows easier handling and is intended to combine the advantages of using a cell suspension (i.e., cell viability and mitotic activity) with the stability and self-containment provided by a matrix of biomaterials. Unlike other techniques and products, this seeding step can be easily applied using a porcine collagen type I/III membrane and autologous chondrocytes in an operating room setting. Although some suturing is required, this technique provides the distinct advantage of not requiring a water-tight seal of the bilayer membrane, as is required using the classic cell suspension technique. Comparable to other modifications of ACT, the ACT-CS procedure requires a specific surgical technique that focuses on the following important details: (1) accurate debridement of the cartilage defect; (2) preparation of the cells, and seeding and containment of the cells within the transplantation site; and (3) sealing and suturing around the defect. DESIGN: A consensus meeting of leading European orthopedic surgeons specializing in cartilage repair was convened to discuss and standardize the surgical aspects of this technique. RESULTS & CONCLUSIONS: The present article describes and discusses the adoption of these best surgical practices for implementing the ACT-CS technique, including more detailed descriptions of each phase of the surgery in order to standardize and optimize patient outcomes.
ABSTRACT
OBJECTIVE: To assess the clinical outcome of patients treated with autologous chondrocyte implantation using ChondroCelect in daily practice. METHODS: The study is a cross-sectional analysis of an open-label, noninterventional cohort. The setting was a compassionate use program, involving 43 orthopaedic centers in 7 European countries. The participants were patients treated with ChondroCelect between October 13, 2004 and July 2, 2008. The measurements used were Clinical Global Impression-Improvement and -Efficacy and solicited adverse event reports. RESULTS: Safety data were collected from 334 patients (90.3%), and effectiveness data were from 282 (76.2%) of the 370 patients treated. Mean age at baseline was 33.6 years (range, 12-57 years), 57% were male, and mean body mass index was 25 kg/m(2). Mean follow-up was 2.2 years (range, 0.4-4.1 years). A femoral condyle lesion was reported in 66% (288/379) and a patellar lesion in 19% (84/379). Mean lesion size was 3.5 cm(2); a collagen membrane was used in 92.4% (328/355). A therapeutic effect was reported in 89% (234/264) of patients overall and in 87% (40/46) of patellar lesion patients. Rates of much or very much improved patients were similar in patients with short- (<18 months: 71% [115/163]) and long-term follow-up (>18 months: 68% [70/103]) (P = 0.68) and were independent of lesion size (>4 cm(2): 75.5% [37/49]; ≤4 cm(2): 67.7% [111/164]) (P = 0.38). Adverse events were similar to those reported in the randomized trial with the same product, with more arthrofibrosis, more reduced joint mobility, and more crepitations reported in patellar lesions. Overall, less cartilage hypertrophy was noted, probably due to the use of a biological membrane cover. CONCLUSIONS: Implantation of ChondroCelect appeared to result in a positive benefit/risk ratio when used in an unselected heterogenous population, irrespective of the follow-up period, lesion size, and type of lesion treated.
ABSTRACT
Autologous chondrocyte implantation is an advanced, cell-based orthobiological technology used for the treatment of chondral defects of the knee. It has been in clinical use since 1987 and has been performed on 12 000 patients internationally; but despite having been in clinical use for more than 15 years, the evidence base for rehabilitation after autologous chondrocyte implantation is notably deficient. The authors review current clinical practice and present an overview of the principles behind autologous chondrocyte implantation rehabilitation practices. They examine the main rehabilitation components and discuss their practical applications within the overall treatment program, with the aim of facilitating the formulation of appropriate, individualized patient rehabilitation protocols for autologous chondrocyte implantation.
