背景:肩袖修复的高失败率需要开发出增强修复部位腱-骨连接处愈合的方法。
目的:详细评估术后1年随访患者开放性肩袖修补术中植入重组人骨形态发生蛋白-12(rhBMP-12)/可吸收胶原海绵(ACS)作为辅助治疗后的功能恢复和结构结果。
方法:随机对照试验;证据水平,2.
方法:将20例患者随机分为2组,rhBMP-12/ACS和标准护理(SOC)控制,有16名和4名患者,分别。患者接受了至少2至4厘米宽的肩袖撕裂的开放修复;在rhBMP-12/ACS组中,含有rhBMP-12的生物支架增强了这一点。使用100毫米视觉模拟量表(VAS)对疼痛以及包括前屈在内的主动和被动运动范围(ROM)进行随访评估。肩胛骨平面的高程,绑架,术后12、16、26、39和52周时的外旋转;16、26、39和52周时的肩胛骨外展和外旋转的等距强度;12和52周时的磁共振成像(MRI)。
结果:rhBMP-12/ACS组的平均VAS评分从术前的37.9mm下降至第52周的13.8mm,并且在第52周恢复了ROM和等距强度。在SOC对照组中,平均VAS评分从术前的48.3mm下降至第52周的1.5mm,并且到第52周恢复了ROM(不包括外部旋转)和等距强度。在rhBMP-12/ACS组的16例患者中,14在第12周显示完整的修复;由于伪影,其他2例患者的MRI扫描无法评估。在SOC控制组中,1例患者出现修复失败。在第52周,rhBMP-12/ACS组中的14次修复和SOC对照组中的2次使用可用MRI扫描的修复保持完整。
结论:将rhBMP-12/ACS用作肩袖修复辅助治疗的患者的功能恢复和结构结局证明了未来的发展,较大,多中心,前瞻性研究。
■NCT00936559,NCT01122498(ClinicalTrials.gov标识符)。
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.
OBJECTIVE: 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.
METHODS: 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.
CONCLUSIONS: 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.
UNASSIGNED: NCT00936559, NCT01122498 (ClinicalTrials.gov identifier).