Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, New York, U.S.A..
Knee Preservation and Cartilage Restoration Center, OrthoIndy, Indianapolis, Indiana, U.S.A.
Arthroscopy. 2021 Jul;37(7):2246-2257. doi: 10.1016/j.arthro.2021.02.044. Epub 2021 Mar 12.
The purpose of this study is to determine the efficacy of amniotic suspension allograft (ASA) compared to hyaluronic acid (HA) and saline at up to 12 months of follow-up through the use of patient-reported outcomes, immunoglobulin levels, and anti-human leukocyte antigen (HLA) levels.
Within this multicenter study, 200 patients were randomized 1:1:1 to a single intra-articular injection of saline, HA, or ASA. Patient-reported outcomes, including Knee Injury and Osteoarthritis Outcome Score (KOOS) and visual analog scale (VAS) score, were collected at multiple time points (baseline, 1 week, 6 weeks, 3 months, 6 months) out to 12 months to assess improvements in pain and function. Radiographs at baseline and 12 months were taken to determine radiographic changes, while blood was collected at baseline, 6 weeks, and 6 months to determine changes in immunoglobulins and anti-HLA levels. Statistical analyses were performed using last observation carried forward and mixed effects model for repeated measures.
Treatment with ASA resulted in significant improvements in KOOS and VAS scores that were maintained through 12 months (P < .05). Treatment with ASA resulted in a 63.2% responder rate at 12 months using the Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International simplified definition. There were no significant differences between groups for radiographic measures in the index knee, immunoglobulins, C-reactive protein, or anti-HLA serum levels (P > .05). The number and type of adverse events (AEs) reported for ASA were comparable to the HA injection group, while no treatment-emergent AEs were reported for the saline group.
This randomized controlled trial of ASA vs HA and saline for the treatment of symptomatic knee osteoarthritis demonstrated clinically meaningful improved outcomes with ASA over the controls out to 12 months postinjection. No concerning immunologic or adverse reactions to the ASA injection were identified with regards to severe AEs, immunoglobulin, or anti-HLA levels.
Level I, randomized controlled multicenter trial.
本研究旨在通过患者报告的结果、免疫球蛋白水平和抗人类白细胞抗原（HLA）水平，确定羊膜悬浮同种异体移植物（ASA）在 12 个月的随访中与透明质酸（HA）和生理盐水相比的疗效。
在这项多中心研究中，200 名患者按 1:1:1 的比例随机分为生理盐水、HA 或 ASA 单关节内注射。患者报告的结果，包括膝关节损伤和骨关节炎结果评分（KOOS）和视觉模拟评分（VAS），在多个时间点（基线、1 周、6 周、3 个月、6 个月）进行收集，以评估疼痛和功能的改善情况。在基线和 12 个月拍摄 X 光片以确定放射学变化，同时在基线、6 周和 6 个月采集血液以确定免疫球蛋白和抗 HLA 水平的变化。使用最后观察到的向前和重复测量的混合效应模型进行统计分析。
ASA 治疗组在 KOOS 和 VAS 评分方面取得了显著改善，这些改善在 12 个月时得到了维持（P<.05）。使用关节炎临床试验结局测量-骨关节炎研究协会国际简化定义，ASA 治疗组在 12 个月时的应答率为 63.2%。在指数膝关节的放射学指标、免疫球蛋白、C 反应蛋白或抗 HLA 血清水平方面，各组之间无显著差异（P>.05）。ASA 组报告的不良事件（AE）的数量和类型与 HA 注射组相当，而生理盐水组没有报告治疗相关的 AE。
这项针对 ASA 与 HA 和生理盐水治疗症状性膝骨关节炎的随机对照试验表明，在注射后 12 个月内，ASA 与对照组相比，具有临床意义的改善结果。在严重 AE、免疫球蛋白或抗 HLA 水平方面，没有发现对 ASA 注射的免疫或不良反应。
一级，随机对照多中心试验。
