一项前瞻性、随机、双盲临床试验,研究早期膝关节骨性关节炎患者在关节镜半月板切除术中使用自体骨髓供血浓缩物的疗效

Adam B. Yanke, Allen A. Yazdi, Alexander C. Weissman, Kyle R. Wagner, Zachary D. Meeker, Nolan B. Condron, Reem Y. Darwish, Justin Drager, Richard M. Danilkowicz, Brian Forsythe, Nikhil N. Verma, Brian J. Cole
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Cole","doi":"10.1177/03635465241275647","DOIUrl":null,"url":null,"abstract":"Background:Despite being recognized as a safe procedure with minimal reported complications, injecting autologous bone marrow aspirate concentrate (BMAC) as an adjuvant to arthroscopic partial meniscectomy (APM) for symptomatic patients with meniscal tears and concomitant knee osteoarthritis (OA) has not been studied in randomized controlled trials.Purpose:To compare patient-reported outcome measure (PROM) scores and radiographic outcomes in symptomatic patients with meniscal tears and concomitant mild knee OA who underwent APM with and without an autologous BMAC injection administered at the time of surgery.Study Design:Randomized controlled trial; Level of evidence, 1.Methods:Enrolled patients aged ≥18 years determined to have a symptomatic meniscal tear with concomitant mild knee OA suitable for APM and meeting inclusion and exclusion criteria were randomized into 2 groups: BMAC and control (no BMAC). 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引用次数: 0

摘要

背景:注射自体骨髓抽吸物浓缩物(BMAC)作为关节镜下半月板部分切除术(APM)的辅助手段治疗有症状的半月板撕裂并伴有膝关节骨性关节炎(OA)的患者,尽管被认为是一种并发症极少的安全手术,但尚未在随机对照试验中进行研究。研究设计:随机对照试验;证据级别:1。方法:将年龄≥18岁、被确定为有症状性半月板撕裂并伴有轻度膝关节OA、适合接受APM且符合纳入和排除标准的患者随机分为2组:BMAC组和对照组(无BMAC)。研究的主要终点是术后一年的国际膝关节文献委员会(IKDC)评分。次要终点包括术后1年的放射学结果(Kellgren-Lawrence分级)和各种PROM评分,包括IKDC评分、膝关节损伤和骨关节炎结果评分(KOOS)、视觉模拟量表和退伍军人兰德12项健康调查,时间分别为半月板切除术后3个月、6个月、1年和2年。两组患者在患者特征、术中变量、并发症、术前PROM评分或术前影像学检查结果等方面均无明显差异。术后 1 年,与对照组相比,BMAC 组的 IKDC 评分(P = .687)或放射学结果(所有放射学指标的 P > .05)均无明显改善。两组的次要 PROM 评分也无明显差异(所有 PROMs 均为 0.05)。然而,与对照组相比,BMAC 组术后 1 年的 KOOS 运动(分别为 100.0% vs 80.0%;P = .023)和 KOOS 症状(分别为 92.3% vs 68.0%;P = .038)达到最小临床重要差异的比率更高。除VR-12精神评分外,BMAC组和对照组术后所有时间点的所有PROM评分与基线相比均有显著改善。结论:在APM期间增加自体BMAC注射并不会导致术后1年IKDC评分或放射学结果发生显著变化。两组患者的次要PROM评分基本相当,但BMAC组患者术后1年的KOOS运动评分和KOOS症状评分的最小临床重要性差异更高。对于症状与半月板撕裂一致、同时伴有轻度OA的患者,在关节镜清创术基础上加用BMAC不会影响治疗效果。注册:NCT02582489 (ClinicalTrials.gov)
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Prospective, Randomized, Double-Blind Clinical Trial to Investigate the Efficacy of Autologous Bone Marrow Aspirate Concentrate During Arthroscopic Meniscectomy in Patients With Early Knee Osteoarthritis
Background:Despite being recognized as a safe procedure with minimal reported complications, injecting autologous bone marrow aspirate concentrate (BMAC) as an adjuvant to arthroscopic partial meniscectomy (APM) for symptomatic patients with meniscal tears and concomitant knee osteoarthritis (OA) has not been studied in randomized controlled trials.Purpose:To compare patient-reported outcome measure (PROM) scores and radiographic outcomes in symptomatic patients with meniscal tears and concomitant mild knee OA who underwent APM with and without an autologous BMAC injection administered at the time of surgery.Study Design:Randomized controlled trial; Level of evidence, 1.Methods:Enrolled patients aged ≥18 years determined to have a symptomatic meniscal tear with concomitant mild knee OA suitable for APM and meeting inclusion and exclusion criteria were randomized into 2 groups: BMAC and control (no BMAC). The primary endpoint of the study was the International Knee Documentation Committee (IKDC) score at 1 year postoperatively. Secondary endpoints included radiographic outcomes (Kellgren-Lawrence grade) at 1 year postoperatively and various PROM scores, including those for the IKDC, Knee injury and Osteoarthritis Outcome Score (KOOS), visual analog scale, and Veterans RAND 12-Item Health Survey, at 3 months, 6 months, 1 year, and 2 years after meniscectomy.Results:Of the 95 enrolled patients, 83 (87.4%) were included for final analysis. No significant differences were found between the groups with regard to patient characteristics, intraoperative variables, concomitant procedures, preoperative PROM scores, or preoperative radiographic findings. At 1 year postoperatively, the BMAC group failed to demonstrate significantly better IKDC scores ( P = .687) or radiographic outcomes ( P > .05 for all radiographic measures) compared with the control group. Secondary PROM scores also did not significantly differ between the groups ( P > .05 for all PROMs). However, there were higher achievement rates of the minimal clinically important difference for the KOOS Sport (100.0% vs 80.0%, respectively; P = .023) and KOOS Symptoms (92.3% vs 68.0%, respectively; P = .038) at 1 year postoperatively in the BMAC group than in the control group. All PROMs, excluding the VR-12 mental score, showed significant improvements compared with baseline at all postoperative time points for both the BMAC and control groups.Conclusion:The addition of an autologous BMAC injection during APM did not result in significant changes in IKDC scores or radiographic outcomes at the 1-year postoperative mark. Secondary PROM scores were generally comparable between the 2 groups, but there was higher minimal clinically important difference achievement for the KOOS Sport and KOOS Symptoms at 1 year postoperatively in the BMAC group. In patients with symptoms consistent with a meniscal tear who had concomitant mild OA, the addition of BMAC to arthroscopic debridement did not affect the outcome.Registration:NCT02582489 (ClinicalTrials.gov)
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