Orfanos Georgios, McCarthy Helen Samantha, Williams Michael, Dugard Naomi, Gallacher Peter Denis, Glover Alexander William, Roberts Sally, Wright Karina Therese, Kuiper Jan Herman
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust, Oswestry, UK.
School of Pharmacy and Bioengineering, Keele University, Keele, UK.
Cartilage. 2024 Oct 31:19476035241279943. doi: 10.1177/19476035241279943.
Traditional autologous chondrocyte implantation (ACI) involves arthroscopically harvesting a cartilage biopsy (stage 1), followed by arthrotomy 3 to 4 weeks later to apply a periosteal patch and implant culture-expanded chondrocytes underneath (stage 2). This study aimed to determine if patch application during stage 1 rather than stage 2 improved clinical outcome.
A randomized controlled trial was conducted from 1998 to 2001. Patients were randomized to receive either traditional ACI (control/late) or ACI with "early" patch during stage 1 (intervention/early). Clinical outcome (Lysholm score) was assessed pre-operatively and annually post-operatively.
Seventy-seven patients were recruited, with 40 patients randomized to the early and 37 to the late patch group. The overall mean pre-operative Lysholm score was 51.8 (range 11-89) and significantly improved by 11.1 points (95% confidence interval [CI] = 4.8 to 17.4) at mean 12.7 years (range 1.5-23.7) follow-up. Latest mean Lysholm scores for the early and late groups were 68.4 (95% CI = 19 to 100) versus 56.7 (95% CI = 18 to 98). Adjusted for covariate imbalances, no evidence was found for a difference between the groups (mean difference = 8.5, 95% CI = -5.2 to 22.2, = 0.22). Twenty-year survival until any re-operation or arthroplasty was 59.6%/82.1% for the early and 56.8%/69.5% for the late group, with no evidence for a difference.
ACI is an effective durable treatment for cartilage defects, with high levels of patient satisfaction and low failure rates. No evidence was found that applying the periosteal patch at the time of chondrocyte harvest improved long-term Lysholm scores or survival until any re-operation or arthroplasty.
传统的自体软骨细胞植入术（ACI）包括通过关节镜获取软骨活检样本（第1阶段），然后在3至4周后进行切开手术，以应用骨膜补片并在其下方植入培养扩增的软骨细胞（第2阶段）。本研究旨在确定在第1阶段而非第2阶段应用补片是否能改善临床结果。
1998年至2001年进行了一项随机对照试验。患者被随机分为接受传统ACI（对照组/晚期）或在第1阶段接受“早期”补片的ACI（干预组/早期）。术前和术后每年评估临床结果（Lysholm评分）。
招募了77名患者，40名患者被随机分配到早期补片组，37名患者被随机分配到晚期补片组。术前Lysholm评分的总体平均值为51.8（范围11 - 89），在平均12.7年（范围1.5 - 23.7）的随访中显著提高了11.1分（95%置信区间[CI] = 4.8至17.4）。早期和晚期组的最新平均Lysholm评分分别为68.4（95%CI = 19至100）和56.7（95%CI = 18至98）。对协变量不平衡进行调整后，未发现两组之间存在差异的证据（平均差异 = 8.5，95%CI = -5.2至22.2，P = 0.22）。早期组和晚期组直到任何再次手术或关节成形术的20年生存率分别为59.6%/82.1%和56.8%/69.5%，未发现差异证据。
ACI是治疗软骨缺损的一种有效且持久的方法，患者满意度高且失败率低。未发现有证据表明在收获软骨细胞时应用骨膜补片能改善长期Lysholm评分或直到任何再次手术或关节成形术的生存率。
