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首页> 外文期刊>Orthopaedic Journal of Sports Medicine >Local rhBMP-12 on an Absorbable Collagen Sponge as an Adjuvant Therapy for Rotator Cuff Repair—A Phase 1, Randomized, Standard of Care Control, Multicenter Study: Part 2—A Pilot Study of Functional Recovery and Structural Outcomes
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Local rhBMP-12 on an Absorbable Collagen Sponge as an Adjuvant Therapy for Rotator Cuff Repair—A Phase 1, Randomized, Standard of Care Control, Multicenter Study: Part 2—A Pilot Study of Functional Recovery and Structural Outcomes

机译：可吸收胶原蛋白海绵上的局部rhBMP-12作为辅助治疗肩袖的辅助疗法-1期，随机，护理控制标准，多中心研究：第2部分-功能恢复和结构结果的初步研究

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Background: The high failure rate of rotator cuff repairs requires the development of methods to enhance healing at the tendon-bone junction of the repair site. Purpose: To assess functional recovery and structural outcomes in detail after implanting recombinant human bone morphogenetic protein–12 (rhBMP-12)/absorbable collagen sponge (ACS) as adjuvant treatment during open rotator cuff repair in patients over a 1-year postoperative follow-up. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: A total of 20 patients were randomized into 2 groups, rhBMP-12/ACS and standard-of-care (SOC) control, with 16 and 4 patients, respectively. The patients underwent open repair of a rotator cuff tear at least 2 to 4 cm wide; in the rhBMP-12/ACS group, this was augmented with a bioscaffold containing rhBMP-12. Follow-up assessments were conducted with a 100-mm visual analog scale (VAS) for pain and active and passive ranges of motion (ROMs) including forward flexion, elevation in the scapular plane, abduction, and external rotation at 12, 16, 26, 39, and 52 weeks after surgery; isometric strength in scapular abduction and external rotation at 16, 26, 39, and 52 weeks; and magnetic resonance imaging (MRI) at 12 and 52 weeks. Results: The mean VAS score decreased from 37.9 mm preoperatively to 13.8 mm at week 52, and ROM and isometric strength recovered at week 52 in the rhBMP-12/ACS group. The mean VAS score decreased from 48.3 mm preoperatively to 1.5 mm at week 52, and ROM (excluding external rotation) and isometric strength recovered by week 52 in the SOC control group. Of the 16 patients in the rhBMP-12/ACS group, 14 showed an intact repair at week 12; the MRI scans of the other 2 patients could not be evaluated because of artifacts. In the SOC control group, 1 patient showed repair failure. At week 52, 14 repairs in the rhBMP-12/ACS group and 2 repairs with available MRI scans in the SOC control group remained intact. Conclusion: Functional recovery and structural outcomes in patients in whom rhBMP-12/ACS was used as adjuvant therapy in rotator cuff repair justify conducting future, larger, multicenter, prospective studies. Registration: NCT00936559, NCT01122498 ( ClinicalTrials.gov identifier).
机译：背景：肩袖修复的高失败率要求开发方法以增强修复部位的腱-骨连接处的愈合。目的：在术后1年随访中，植入重组人骨形态发生蛋白12（rhBMP-12）/可吸收胶原海绵（ACS）作为辅助治疗开放性肩袖修复期间的辅助治疗，以详细评估功能恢复和结构结局。向上。研究设计：随机对照试验;证据级别：2。方法：总共将20例患者随机分为2组，分别是rhBMP-12 / ACS和护理标准（SOC）对照，分别为16例和4例。患者接受了至少2至4厘米宽的肩袖撕裂的开放式修复;在rhBMP-12 / ACS组中，增加了包含rhBMP-12的生物支架。使用100毫米视觉模拟量表（VAS）对疼痛以及主动和被动运动范围（ROM）进行随访评估，包括向前弯曲，肩cap骨平面抬高，外展以及12、16、26时的外旋术后39、52周;在16、26、39和52周时，肩骨外展和外旋的等距强度;在第12周和第52周进行磁共振成像（MRI）。结果：rhBMP-12 / ACS组的平均VAS评分从术前的37.9 mm降低至第52周的13.8 mm，并且ROM和等距强度在52周时恢复。 VAS平均评分从术前的48.3 mm降低到第52周的1.5 mm，SOC对照组的ROM（不包括外旋）和等轴测强度在52周时恢复。 rhBMP-12 / ACS组的16例患者中，有14例在第12周表现出完整的修复;而在第12周时，该修复未见任何改变。其他2例患者的MRI扫描由于伪影而无法评估。在SOC对照组中，有1例表现出修复失败。在第52周，rhBMP-12 / ACS组进行了14次修复，而SOC对照组进行了MRI扫描，进行了2次修复。结论：在将rhBMP-12 / ACS用作肩袖修复辅助治疗的患者中，其功能恢复和结构结局证明了进行未来，大型，多中心，前瞻性研究的合理性。注册：NCT00936559，NCT01122498（ClinicalTrials.gov标识符）。

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