Background:

Intra-articular microfragmented adipose tissue (MF-AT) injections have been proposed for the treatment of knee osteoarthritis (OA).

Purpose:

To compare a single injection of MF-AT or platelet-rich plasma (PRP) in terms of clinical outcomes and OA progression.

Study Design:

Randomized controlled trial; Level of evidence, 1.

Methods:

A total of 118 patients with symptomatic knee OA were randomized to receive a single intra-articular injection of MF-AT or PRP. Patients were evaluated before the injection and at 1, 3, 6, 12, and 24 months with the International Knee Documentation Committee (IKDC) subjective score, Knee injury and Osteoarthritis Outcome Score (KOOS) subscales, EuroQol visual analogue scale (EQ-VAS), EuroQol 5 dimensions (EQ-5D), and visual analogue scale (VAS) for pain. Primary outcomes were the IKDC subjective score and the KOOS pain subscore at 6 months. Knees were evaluated at baseline and at 6, 12, and 24 months with radiography and high-resolution magnetic resonance imaging (MRI) using the Whole-Organ Magnetic Resonance Imaging Score (WORMS).

Results:

Both MF-AT and PRP provided a statistically and clinically significant improvement up to 24 months. The improvement in the IKDC subjective score from baseline to 6 months was similar in both MF-AT (41.1 ± 16.3 to 57.3 ± 18.8) and PRP (44.8 ± 17.3 to 58.4 ± 18.1) groups (P < .0005). The improvement in the KOOS pain subscore from baseline to 6 months was similar in both the MF-AT (58.4 ± 15.9 to 75.8 ± 17.4) and PRP (63.5 ± 17.8 to 75.5 ± 16.1) groups (P < .0005). Overall, no differences were found between the MF-AT and PRP groups in terms of clinical outcomes, adverse events (18.9% and 10.9%, respectively), and failures (15.1% and 25.5%, respectively). Radiographic and MRI findings did not show changes after the injection. As a secondary outcome, more patients in the MF-AT group with moderate/severe OA reached the minimal clinically important difference for the IKDC score at 6 months compared with the PRP group (75.0% vs 34.6%, respectively; P = .005).

Conclusion:

A single intra-articular injection of MF-AT was not superior to PRP, with comparable low numbers of failures and adverse events and without disease progression. No differences were found in clinical and imaging results between the 2 biological approaches.

中文翻译：

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微碎片脂肪组织与富含血小板的血浆治疗膝骨关节炎：一项为期 2 年随访的前瞻性随机对照试验

背景：

关节内微碎片脂肪组织 (MF-AT) 注射已被提议用于治疗膝骨关节炎 (OA)。

目的：

比较单次注射 MF-AT 或富血小板血浆 (PRP) 的临床结果和 OA 进展。

学习规划：

随机对照试验; 证据等级，1。

方法：

共有 118 名有症状的膝关节 OA 患者被随机分配接受单次关节内注射 MF-AT 或 PRP。患者在注射前和 1、3、6、12 和 24 个月时使用国际膝关节文献委员会 (IKDC) 主观评分、膝关节损伤和骨关节炎结果评分 (KOOS) 分量表、EuroQol 视觉模拟量表 (EQ-VAS) )、EuroQol 5 维度 (EQ-5D) 和疼痛视觉模拟量表 (VAS)。主要结果是 6 个月时的 IKDC 主观评分和 KOOS 疼痛子评分。在基线和第 6、12 和 24 个月时，使用全器官磁共振成像评分 (WORMS) 通过放射线照相术和高分辨率磁共振成像 (MRI) 评估膝关节。

结果：

MF-AT 和 PRP 都提供了长达 24 个月的统计和临床显着改善。MF-AT（41.1 ± 16.3 至 57.3 ± 18.8）和 PRP（44.8 ± 17.3 至 58.4 ± 18.1）组的 IKDC 主观评分从基线到 6 个月的改善相似（P < .0005 ）。MF-AT（58.4 ± 15.9 至 75.8 ± 17.4）和 PRP（63.5 ± 17.8 至 75.5 ± 16.1）组的 KOOS 疼痛子评分从基线到 6 个月的改善相似（P<.0005)。总体而言，MF-AT 和 PRP 组在临床结果、不良事件（分别为 18.9% 和 10.9%）和失败（分别为 15.1% 和 25.5%）方面没有差异。射线照相和 MRI 检查结果未显示注射后发生变化。作为次要结果，与 PRP 组相比，MF-AT 组有更多的中度/重度骨关节炎患者在 6 个月时达到 IKDC 评分的最小临床重要差异（分别为 75.0% 和 34.6%；P = .005） .

结论：

单次关节内注射 MF-AT 并不优于 PRP，失败和不良事件的数量相当低，并且没有疾病进展。两种生物学方法之间的临床和影像学结果没有发现差异。