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关节镜下基质辅助自体软骨细胞移植与微骨折术:一项前瞻性随机试验的 6 年随访结果。

Arthroscopic Matrix-Assisted Autologous Chondrocyte Transplantation Versus Microfracture: A 6-Year Follow-up of a Prospective Randomized Trial.

机构信息

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.

出版信息

Am J Sports Med. 2021 Jul;49(8):2165-2176. doi: 10.1177/03635465211010487. Epub 2021 May 28.

Abstract

BACKGROUND

Few randomized controlled trials with a midterm follow-up have compared matrix-assisted autologous chondrocyte transplantation (MACT) with microfracture (MFx) for knee cartilage lesions.

PURPOSE

To compare the structural, clinical, and safety outcomes at midterm follow-up of MACT versus MFx for treating symptomatic knee cartilage lesions.

STUDY DESIGN

Randomized controlled trial; Level of evidence, 1.

METHODS

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).

RESULTS

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.

CONCLUSION

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.

REGISTRATION

NCT01947374 (ClinicalTrials.gov identifier).

摘要

背景

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。

目的

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。

研究设计

随机对照试验;证据等级,1 级。

方法

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。

结果

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。

结论

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。

登记

NCT01947374(ClinicalTrials.gov 标识符)。

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