膝关节骨关节炎患者关节镜清创后关节内注射微碎片脂肪组织：一项为期48个月的前瞻性临床研究的临床结果

IF 2 Q2 ORTHOPEDICS

Journal of Experimental Orthopaedics Pub Date : 2025-01-17 DOI:10.1002/jeo2.70144

Andrea Antonio Maria Bruno, Giuseppe Anzillotti, Massimo De Donato, Marco Basso, Jacopo Tamini, Paolo Dupplicato, Elizaveta Kon, Berardo Di Matteo, Enrico Arnaldi

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引用次数: 0

摘要

目的：微碎片化脂肪组织正在成为治疗包括膝骨关节炎（OA）在内的各种疾病的一种有希望的选择，尽管临床试验往往受到短随访期的限制。我们的目的是评估膝关节OA患者在关节镜下清创后单次注射微碎片脂肪组织的安全性和临床结果。方法：选取2016 - 2020年膝关节OA患者为研究对象。通过Lipogems®试剂盒获得微碎片化脂肪组织，并在关节镜清创后关节内注射。从基线到随访3、6、12、24和48个月，评估疼痛视觉模拟量表、Tegner评分、膝关节损伤和骨关节炎结局评分亚量表的变化。结果：41例患者随访6个月，39例随访24个月，38例随访48个月。其中三人在研究期间接受了膝关节置换手术。截至最后一次随访，所有临床评分均有统计学显著变化。结论：关节镜清创后单次膝关节内注射微碎片化脂肪组织能够为膝关节OA患者提供长达4年的临床疗效。本临床研究已在clinicaltrials.gov上注册(注册号：NCT06545266)。证据等级：四级病例系列。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Arthroscopic debridement followed by intra-articular injection of micro-fragmented adipose tissue in patients affected by knee osteoarthritis: Clinical results up to 48 months from a prospective clinical study

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Purpose

Micro-fragmented adipose tissue is emerging as a promising option for the treatment of various diseases including knee osteoarthritis (OA), though clinical trials are often limited by short follow-up periods. Our aim was to evaluate the safety and clinical outcomes of an arthroscopic debridement followed by a single injection of micro-fragmented adipose tissue in patients affected by knee OA.

Methods

From 2016 to 2020, patients affected by knee OA were enroled. Micro-fragmented adipose tissue was obtained through the Lipogems® kit and intraarticularly injected after an arthroscopic debridement. Visual analogue scale for pain, Tegner score, Knee Injury and Osteoarthritis Outcome score subscales variations were assessed from baseline to 3, 6, 12, 24 and 48 months of follow-up.

Results

Forty-one patients were evaluated up to 6 months of follow-up, 39 patients up to 24 months of follow-up and 38 patients up to 48 months of follow-up. Three underwent knee replacement surgery during the time of the study. All the clinical scores analyzed achieved statistically significant changes up to the last follow-up.

Conclusions

A single intra-articular knee injection of micro-fragmented adipose tissue following arthroscopic debridement is able to provide significant clinical benefits in patients affected by knee OA up to 4 years of follow-up.

The present clinical study was registered on clinicaltrials.gov (no. NCT06545266).