Department of Orthopaedic and Trauma Surgery, Ospedale Civile, Jesi, Italy.
Am J Sports Med. 2011 Feb;39(2):258-65. doi: 10.1177/0363546510390780. Epub 2010 Dec 15.
After reinsertion on the humerus, the rotator cuff has limited ability to heal. Growth factor augmentation has been proposed to enhance healing in such procedure.
This study was conducted to assess the efficacy and safety of growth factor augmentation during rotator cuff repair.
Randomized controlled trial; Level of evidence, 1.
Eighty-eight patients with a rotator cuff tear were randomly assigned by a computer-generated sequence to receive arthroscopic rotator cuff repair without (n = 45) or with (n = 43) augmentation with autologous platelet-rich fibrin matrix (PRFM). The primary end point was the postoperative difference in the Constant score between the 2 groups. The secondary end point was the integrity of the repaired rotator cuff, as evaluated by magnetic resonance imaging. Analysis was on an intention-to-treat basis.
All the patients completed follow-up at 16 months. There was no statistically significant difference in total Constant score when comparing the results of arthroscopic repair of the 2 groups (95% confidence interval, -3.43 to 3.9) (P = .44). There was no statistically significant difference in magnetic resonance imaging tendon score when comparing arthroscopic repair with or without PRFM (P = .07).
Our study does not support the use of autologous PRFM for augmentation of a double-row repair of a small or medium rotator cuff tear to improve the healing of the rotator cuff. Our results are applicable to small and medium rotator cuff tears; it is possible that PRFM may be beneficial for large and massive rotator cuff tears. Also, given the heterogeneity of PRFM preparation products available on the market, it is possible that other preparations may be more effective.
肩袖在重新固定于肱骨后,其愈合能力有限。已提出使用生长因子增强来增强此类手术中的愈合效果。
本研究旨在评估生长因子增强在肩袖修复中的疗效和安全性。
随机对照试验;证据等级,1 级。
88 例肩袖撕裂患者通过计算机生成的序列随机分为两组,一组接受关节镜下肩袖修复(n = 45),另一组接受富血小板纤维蛋白基质(PRFM)自体增强修复(n = 43)。主要终点是两组术后 Constant 评分的差异。次要终点是通过磁共振成像评估修复后的肩袖完整性。分析基于意向治疗。
所有患者均在 16 个月时完成随访。两组关节镜修复的总 Constant 评分无统计学差异(95%置信区间,-3.43 至 3.9)(P =.44)。两组关节镜修复与 PRFM 修复相比,磁共振成像肌腱评分无统计学差异(P =.07)。
本研究不支持使用自体 PRFM 增强双排修复小或中等肩袖撕裂以改善肩袖愈合。我们的结果适用于小和中等肩袖撕裂;PRFM 可能对大的和巨大的肩袖撕裂有益。此外,鉴于市场上 PRFM 准备产品的异质性,其他制剂可能更有效。