Division of Orthopedics and Traumatology, Department of Musculoskeletal Sciences, University Hospitals, Catholic University of Leuven, Belgium.
Am J Sports Med. 2011 Dec;39(12):2566-74. doi: 10.1177/0363546511422220. Epub 2011 Sep 9.
Characterized chondrocyte implantation (CCI) results in significantly better early structural tissue regeneration than microfracture (MF), and CCI has a midterm clinical benefit over microfracture.
This study was undertaken to evaluate the 5-year clinical outcome of CCI in a randomized comparison with MF for the treatment of symptomatic cartilage defects of the femoral condyles of the knee.
Randomized controlled trial; Level of evidence, 1.
Participants aged 18 to 50 years with a symptomatic isolated International Cartilage Repair Society (ICRS) grade III or IV cartilage lesion of the femoral condyles between 1 and 5 cm(2) were randomized to either CCI or MF. Clinical outcomes were measured up to 60 months after surgery using the Knee Injury and Osteoarthritis Outcome Score (KOOS). The main outcome parameter was change from baseline in overall KOOS (oKOOS). Adverse events were monitored.
Fifty-one participants were treated with CCI and 61 with MF. On average, clinical benefit was maintained through the 60-month follow-up period. The average change from baseline in oKOOS was not different between both groups (least squares [LS] mean ± standard error [SE] 18.84 ± 3.58 for CCI vs 13.21 ± 5.63 for MF; P = .116). Treatment failures were comparable (n = 7 in CCI vs n = 10 in MF), although MF failures tended to occur earlier. Subgroup analysis revealed that CCI resulted in better outcome in participants with time since symptom onset of less than 3 years, which was statistically significant and clinically relevant (change in oKOOS <3 years mean ± SE 25.96 ± 3.45 for CCI vs 15.28 ± 3.17 for MF; P = .026 vs oKOOS >3 years mean ± SE 13.09 ± 4.78 for CCI vs 17.02 ± 4.50 for MF, P = .554). Other subgroup analyses such as age (cutoff 35 years) did not show a difference. Female patients showed more failures irrespective of treatment.
At 5 years after treatment, clinical outcomes for CCI and MF were comparable. In the early treatment group, CCI obtained statistically significant and clinically relevant better results than MF. Delayed treatment resulted in less predictable outcomes for CCI. These results provide strong evidence that time since onset of symptoms is an essential variable that should be taken into account in future treatment algorithms for cartilage repair of the knee.
与微骨折术（MF）相比，特征性软骨细胞植入术（CCI）在早期结构组织再生方面效果显著更好，并且 CCI 在中期临床疗效方面优于微骨折术。
本研究旨在通过与 MF 进行随机对照比较，评估 CCI 在治疗膝关节股骨髁症状性软骨缺损方面的 5 年临床疗效。
随机对照试验；证据水平，1 级。
参与者年龄在 18 至 50 岁之间，患有症状性的孤立性国际软骨修复协会（ICRS）III 或 IV 级软骨损伤，病变面积在 1 至 5cm2之间，被随机分为 CCI 或 MF 组。术后通过膝关节损伤和骨关节炎结果评分（KOOS）测量长达 60 个月的临床结果。主要观察指标为基线时整体 KOOS（oKOOS）的变化。监测不良事件。
51 名参与者接受 CCI 治疗，61 名参与者接受 MF 治疗。平均而言，临床疗效在 60 个月的随访期间得到维持。两组之间的 oKOOS 基线变化无差异（最小二乘[LS]平均值±标准误差[SE]CCI 组为 18.84±3.58，MF 组为 13.21±5.63；P=0.116）。CCI 组和 MF 组的治疗失败率相当（CCI 组 7 例，MF 组 10 例），尽管 MF 组的失败发生时间较早。亚组分析显示，对于发病时间少于 3 年的患者，CCI 治疗效果更好，且具有统计学意义和临床相关性（发病时间少于 3 年的 oKOOS 变化的均值±SE CCI 组为 25.96±3.45，MF 组为 15.28±3.17；P=0.026；发病时间大于 3 年的 oKOOS 变化的均值±SE CCI 组为 13.09±4.78，MF 组为 17.02±4.50，P=0.554）。其他亚组分析，如年龄（以 35 岁为界），未显示出差异。女性患者无论接受何种治疗，失败率均较高。
治疗 5 年后，CCI 和 MF 的临床结果相当。在早期治疗组中，CCI 比 MF 获得了统计学意义和临床相关的更好的结果。延迟治疗会导致 CCI 的结果更不可预测。这些结果提供了强有力的证据，表明症状出现时间是一个重要的变量，在未来的膝关节软骨修复治疗算法中应该考虑到这一变量。
