Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra, Mexico City, Mexico.
Investigation performed at the Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra, Mexico City, Mexico.
Am J Sports Med. 2021 Jul;49(8):2165-2176. doi: 10.1177/03635465211010487. Epub 2021 May 28.
Few randomized controlled trials with a midterm follow-up have compared matrix-assisted autologous chondrocyte transplantation (MACT) with microfracture (MFx) for knee cartilage lesions.
To compare the structural, clinical, and safety outcomes at midterm follow-up of MACT versus MFx for treating symptomatic knee cartilage lesions.
Randomized controlled trial; Level of evidence, 1.
A total of 48 patients aged between 18 and 50 years, with 1- to 4-cm International Cartilage Repair Society (ICRS) grade III to IV knee chondral lesions, were randomized in a 1:1 ratio to the MACT and MFx treatment groups. A sequential prospective evaluation was performed using magnetic resonance imaging (MRI) T2 mapping, the MOCART (magnetic resonance observation of cartilage repair tissue) score, second-look arthroscopic surgery, patient-reported outcome measures, the responder rate (based on achieving the minimal clinically important difference for the Knee injury and Osteoarthritis Outcome Score [KOOS] pain and KOOS Sport/Recreation), adverse events, and treatment failure (defined as a reoperation because of symptoms caused by the primary defect and the detachment or absence of >50% of the repaired tissue during revision surgery).
Overall, 35 patients (18 MACT and 17 MFx) with a mean chondral lesion size of 1.8 ± 0.8 cm (range, 1-4 cm) were followed up to a mean of 6 years postoperatively (range, 4-9 years). MACT demonstrated significantly better structural outcomes than MFx at 1 to 6 years postoperatively. At final follow-up, the MRI T2 mapping values of the repaired tissue were 37.7 ± 8.5 ms for MACT versus 46.4 ± 8.5 ms for MFx ( = .003), while the MOCART scores were 59.4 ± 17.3 and 42.4 ± 16.3, respectively ( = .006). More than 50% defect filling was seen in 95% of patients at 2 years and 82% at 6 years in the MACT group and in 67% at 2 years and 53% at 6 years in the MFx group. The second-look ICRS scores at 1 year were 10.7 ± 1.3 for MACT and 9.0 ± 1.8 for MFx ( = .001). Both groups showed significant clinical improvements at 6 years postoperatively compared with their preoperative status. Significant differences favoring the MACT group were observed at 2 years on the KOOS Activities of Daily Living ( = .043), at 4 years on all KOOS subscales (except Symptoms; < .05) and the Tegner scale ( = .008), and at 6 years on the Tegner scale ( = .010). The responder rates at 6 years were 53% and 77% for MFx and MACT, respectively. There were no reported treatment failures after MACT; the failure rate was 8.3% in the MFx group. Neither group had serious adverse events related to treatment.
Patients who underwent MACT had better structural outcomes than those who underwent MFx at 1 to 6 years postoperatively. Both groups of patients showed significant clinical improvements at final follow-up compared with their preoperative status. MACT showed superiority at 4 years for the majority of the KOOS subscales and for the Tegner scale at 4 to 6 years. The MACT group also had a higher responder rate and lower failure rate at final follow-up.
NCT01947374 (ClinicalTrials.gov identifier).
很少有中期随访的随机对照试验比较了基质辅助自体软骨细胞移植（MACT）与微骨折（MFx）治疗膝关节软骨病变。
比较 MACT 与 MFx 治疗有症状的膝关节软骨病变的中期结构、临床和安全性结果。
随机对照试验；证据等级，1 级。
共纳入 48 例年龄在 18 至 50 岁之间的患者，患有 1 至 4 cm 的国际软骨修复学会（ICRS）III 至 IV 级膝关节软骨病变，按照 1:1 的比例随机分为 MACT 和 MFx 治疗组。使用磁共振成像（MRI）T2 映射、MOCART（磁共振观察软骨修复组织）评分、二次关节镜检查、患者报告的结果测量、应答率（基于膝关节损伤和骨关节炎结果评分[KOOS]疼痛和 KOOS 运动/娱乐的最小临床重要差异实现）、不良事件和治疗失败（定义为由于原发性缺陷引起的症状以及在翻修手术中修复组织的>50%脱失或缺失而再次手术）进行连续前瞻性评估。
共有 35 例患者（18 例 MACT 和 17 例 MFx），平均软骨病变大小为 1.8 ± 0.8 cm（范围 1-4 cm），平均随访时间为 6 年（范围 4-9 年）。与 MFx 相比，MACT 在术后 1 至 6 年的结构结果显著更好。在最终随访时，MACT 修复组织的 MRI T2 映射值为 37.7 ± 8.5 ms，MFx 为 46.4 ± 8.5 ms（ =.003），而 MOCART 评分分别为 59.4 ± 17.3 和 42.4 ± 16.3（ =.006）。在 MACT 组中，2 年和 6 年时>50%的病变填充率分别为 95%和 82%，在 MFx 组中，2 年和 6 年时分别为 67%和 53%。在 MACT 组中，1 年时的二次 ICRS 评分分别为 10.7 ± 1.3，MFx 组为 9.0 ± 1.8（ =.001）。与术前相比，两组患者在术后 6 年均有显著的临床改善。与 MFx 组相比，MACT 组在术后 2 年的 KOOS 日常生活活动（ =.043）、4 年的所有 KOOS 子量表（除症状外；<.05）和 Tegner 量表（ =.008）、6 年的 Tegner 量表（ =.010）上均有显著差异。MFx 和 MACT 的应答率分别为 77%和 53%。MACT 组无治疗失败；MFx 组的失败率为 8.3%。两组均无与治疗相关的严重不良事件。
与 MFx 相比，MACT 患者在术后 1 至 6 年的结构结果更好。与术前相比，两组患者在最终随访时均有显著的临床改善。在 4 年时，MACT 在大多数 KOOS 子量表和 4 至 6 年时的 Tegner 量表上均具有优势。MACT 组在最终随访时的应答率更高，失败率更低。
NCT01947374（ClinicalTrials.gov 标识符）。
