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Minimum 10-Year Clinical and Radiological Outcomes of a Randomized Controlled Trial Evaluating 2 Different Approaches to Full Weightbearing After Matrix-Induced Autologous Chondrocyte Implantation.
The American Journal of Sports Medicine ( IF 4.2 ) Pub Date : 2019-11-25 , DOI: 10.1177/0363546519886548
Jay R Ebert 1, 2 , Michael Fallon 3 , Timothy R Ackland 1 , Gregory C Janes 4 , David J Wood 5
Affiliation  

BACKGROUND Longer term outcomes after matrix-induced autologous chondrocyte implantation (MACI) are lacking, while early postoperative weightbearing (WB) management has traditionally been conservative. PURPOSE To investigate the longer term clinical and radiological outcomes after an 8-week (vs 12-week) WB protocol after MACI. STUDY DESIGN Randomized controlled trial; Level of evidence, 1. METHODS A randomized study design allocated 70 patients to an 8- (n = 34) or 12-week (n = 36) approach to full WB after MACI of the medial or lateral femoral condyle. Patients were evaluated preoperatively; at 3, 12, and 24 months after surgery; and at 5 and 10 years after surgery. At 10 years (range, 10.5-11.5 years), 60 patients (85.7%; 8 weeks: n = 29; 12 weeks: n = 31) were available for review. Clinical outcomes included patient-reported outcomes, maximal isokinetic knee extensor and flexor strength, and functional hop capacity. High-resolution magnetic resonance imaging (MRI) was undertaken to assess the quality and quantity of repair tissue per the MOCART (magnetic resonance observation of cartilage repair tissue) system. A combined MRI composite score was also evaluated. RESULTS Clinical and MRI-based scores for the full cohort significantly improved (P < .05) over the 10-year period. Apart from the Tegner activity score, which improved (P = .041), as well as tissue structure (P = .030), which deteriorated, there were no further statistically significant changes (P > .05) from 5 to 10 years. There were no 10-year differences between the 2 WB rehabilitation groups. At 10 years, 81.5% and 82.8% of patients in the 8- and 12-week groups, respectively, demonstrated good-excellent tissue infill. Graft failure was observed on MRI at 10 years in 7 patients overall, which included 4 located on 10-year MRI (8 weeks: n = 1; 12 weeks: n = 3) and a further 3 patients (8 weeks: n = 1; 12 weeks: n = 2) not included in the current analysis who proceeded to total knee arthroplasty. At 10 years, 93.3% of patients were satisfied with MACI for relieving their pain, with 83.3% satisfied with their ability to participate in sport. CONCLUSION MACI provided high satisfaction levels and tissue durability beyond 10 years. The outcomes of this randomized trial demonstrate a safe 8-week WB rehabilitation protocol without jeopardizing longer term outcomes.

中文翻译:

至少10年临床和放射学结果的随机对照试验评估了基质诱导的自体软骨细胞植入后满负荷的2种不同方法。

背景技术缺乏基质诱导的自体软骨细胞植入(MACI)后的长期结果,而传统上术后早期的负重(WB)管理传统上是保守的。目的研究MACI后8周(与12周相比)的WB方案后的长期临床和放射学结局。研究设计随机对照试验;证据等级,1。方法一项随机研究设计将70例患者在内侧或外侧股骨MAC发生MACI后采用8(n = 34)或12周(n = 36)的方法进行全WB。术前对患者进行了评估;术后3、12和24个月;以及手术后5年和10年。在10年(范围10.5-11.5年)时,有60例患者(85.7%; 8周:n = 29; 12周:n = 31)可供回顾。临床结局包括患者报告的结局,最大等速膝关节伸肌和屈肌力量以及功能性跳跃能力。进行了高分辨率磁共振成像(MRI),以根据MOCART(软骨修复组织的磁共振观察)系统评估修复组织的质量和数量。还对MRI综合评分进行了评估。结果整个队列的临床和MRI评分在10年期间显着改善(P <.05)。除了改善的Tegner活性评分(P = .041)和恶化的组织结构(P = .030),在5至10年内没有进一步的统计学显着变化(P> .05)。2个WB康复组之间没有10年的差异。在10年时,第8周和第12周组的患者分别占81.5%和82.8%,展示了出色的组织填充。共有10位患者在10年MRI上观察到了移植失败,其中4位位于10年MRI(8周:n = 1; 12周:n = 3)和另外3位患者(8周:n = 1) ; 12周:n = 2)目前不包括进行全膝关节置换术的患者。10年时,93.3%的患者对MACI缓解疼痛感到满意,而83.3%的患者对参加运动的能力感到满意。结论MACI提供了超过10年的高满意度和组织耐久性。该随机试验的结果证明了安全的8周WB康复方案,而不会损害长期结果。n = 3)和另外3例患者(8周:n = 1; 12周:n = 2)未包括在当前分析中,他们进行了全膝关节置换术。10年时,93.3%的患者对MACI缓解疼痛感到满意,而83.3%的患者对参加运动的能力感到满意。结论MACI提供了超过10年的高满意度和组织耐久性。该随机试验的结果证明了安全的8周WB康复方案,而不会损害长期结果。n = 3)和另外3例患者(8周:n = 1; 12周:n = 2)未包括在当前分析中,他们进行了全膝关节置换术。10年时,93.3%的患者对MACI缓解疼痛感到满意,而83.3%的患者对参加运动的能力感到满意。结论MACI提供了超过10年的高满意度和组织耐久性。该随机试验的结果证明了安全的8周WB康复方案,而不会损害长期结果。结论MACI提供了超过10年的高满意度和组织耐久性。该随机试验的结果证明了安全的8周WB康复方案,而不会损害长期结果。结论MACI提供了超过10年的高满意度和组织耐久性。这项随机试验的结果证明了安全的8周WB康复方案,且不会损害长期结果。
更新日期:2019-12-27
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