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微片段化脂肪组织在治疗后12个月对膝关节骨关节炎的疗效等同于富血小板血浆:一项随机对照试验

Microfragmented Adipose Tissue Is Equivalent to Platelet-Rich Plasma for Knee Osteoarthritis at 12 Months Posttreatment: A Randomized Controlled Trial.

作者信息

Baria Michael, Barker Tyler, Durgam Sushmitha, Pedroza Angela, Flanigan David, Jia Liuqing, Kaeding Christopher, Magnussen Robert

机构信息

Department of Physical Medicine and Rehabilitation, The Ohio State University, Columbus, Ohio, USA.

Sports Medicine Research Institute, The Ohio State University, Columbus, Ohio, USA.

出版信息

Orthop J Sports Med. 2024 Mar 18;12(3):23259671241233916. doi: 10.1177/23259671241233916. eCollection 2024 Mar.

Abstract

BACKGROUND

Platelet-rich plasma (PRP) is an effective treatment for knee osteoarthritis (OA). Microfragmented adipose tissue (MFAT) is another orthobiologic that holds promise, but data supporting its use are limited. Previous studies showed that MFAT created using the Lipogems device was equivalent to PRP created via noncommercial laboratory-based processes.

PURPOSE

To perform a comparison of commercially available MFAT and PRP systems for treatment of knee OA.

STUDY DESIGN

Randomized controlled trial; Level of evidence, 2.

METHODS

A total of 71 patients with symptomatic knee OA (Kellgren-Lawrence grades 1-4) were randomized to receive a single injection of either leukocyte-rich PRP (Angel; Arthrex) or MFAT (Lipogems) under ultrasound guidance. Patient-reported outcomes (Knee injury and Osteoarthritis Outcome Score [KOOS], visual analog scale for pain with activities of daily living [VAS pain], and Tegner activity level) were recorded at baseline and at 1, 3, 6, and 12 months after injection. The primary outcome was the KOOS-Pain subscale score at 12 months after injection.

RESULTS

Overall, 49 patients completed their 12-month follow-up (PRP group, n = 23; MFAT group, n = 26). All demographic features were similar between groups, except that more men were randomized to the PRP group and more women to the MFAT group. At 12 months posttreatment, KOOS-Pain scores improved in both groups, with no significant group difference (PRP, 78 ± 17.9 vs MFAT, 77.8 ± 19.3; = .69). Similarly, other KOOS subscales, VAS pain scores, and Tegner scores improved at 12 months, with no differences between treatment groups.

CONCLUSION

Both PRP and MFAT injections for knee OA resulted in improved patient-reported outcomes at 12 months posttreatment, with no differences found between treatments.

REGISTRATION

NCT04351087 (ClinicalTrials.gov identifier).

摘要

背景

富血小板血浆(PRP)是治疗膝关节骨关节炎(OA)的一种有效方法。微片段化脂肪组织(MFAT)是另一种有前景的生物治疗方法,但支持其应用的数据有限。先前的研究表明,使用Lipogems设备制备的MFAT等同于通过非商业性实验室方法制备的PRP。

目的

比较市售的MFAT和PRP系统治疗膝关节OA的效果。

研究设计

随机对照试验;证据等级:2级。

方法

总共71例有症状的膝关节OA患者(Kellgren-Lawrence分级为1-4级)被随机分为两组,在超声引导下分别接受单次注射富含白细胞的PRP(Angel;Arthrex公司)或MFAT(Lipogems)。在基线以及注射后1、3、6和12个月记录患者报告的结局指标(膝关节损伤和骨关节炎结局评分[KOOS]、日常生活活动疼痛视觉模拟量表[VAS疼痛]以及Tegner活动水平)。主要结局指标是注射后12个月时的KOOS-疼痛子量表评分。

结果

总体而言,49例患者完成了12个月的随访(PRP组,n = 23;MFAT组,n = 26)。两组之间所有人口统计学特征相似,只是随机分配到PRP组的男性更多,随机分配到MFAT组的女性更多。治疗后12个月时,两组的KOOS-疼痛评分均有所改善,组间无显著差异(PRP组为78 ± 17.9,MFAT组为77.8 ± 19.3;P = 0.69)。同样,在12个月时,其他KOOS子量表、VAS疼痛评分和Tegner评分也有所改善,治疗组之间无差异。

结论

PRP和MFAT注射治疗膝关节OA在治疗后12个月时均使患者报告的结局得到改善,两种治疗方法之间未发现差异。

注册信息

NCT04351087(ClinicalTrials.gov标识符)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bf07/10953019/2b4f31bdacdf/10.1177_23259671241233916-fig1.jpg

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