■生物技术可能会增强现有的关节镜肩袖修复,以改善再撕裂率和术后结局。这项研究的目的是评估使用生物诱导性牛胶原蛋白植入物增强的全厚度肩袖修复的治愈率和临床结果。
■在这项前瞻性多中心研究中,研究者招募了115名患者(平均年龄,60.4年),带有全厚度肩袖撕裂。有66个(57.4%)中等(1-3cm)撕裂和49个(42.6%)大(3-5cm)撕裂。符合条件的患者包括年龄≥21岁的慢性肩痛持续超过3个月且对保守治疗无反应的患者。患者接受了单行或双行修复,并使用了生物诱导性牛胶原蛋白植入物。在基线,3个月,一年,进行磁共振成像,并对患者进行美国肩肘外科医师(ASES)肩关节评分和Constant-Murley评分(CMS)评估.主要的失败终点是重新撕裂,分类为磁共振成像观察到的任何新的全厚度缺陷。
■在3个月时有13次再撕裂(11.3%),在1年内发现了另外6个(共19个[16.5%])。在巨大的眼泪中,与单排修复相比,双排修复在3个月(P=.0004)和1年(P=.0001)时的再撕裂率明显较低。对于中大泪液,ASES和CMS评分在基线和1年之间显着提高。在1年,91.7%(95%CI:84.9-96.1)和86.4%(95%CI:78.2-92.4)的患者符合ASES和CMS的最低临床重要差异,分别。没有再撕裂和年龄<65岁的患者在1年时的CMS评分明显优于有再撕裂和≥65岁的患者(P<0.05)。根据二头肌肌腱的治疗结果没有统计学上的显着差异。在9例报告的手术肩部再次手术中,仅2例被认为与胶原植入物潜在相关.
■这项前瞻性研究的中期结果表明,与文献相比,使用研究植入物增强标准关节镜修复技术的辅助治疗后1年的再撕裂率和临床功能改善。
UNASSIGNED: Biologic technologies can potentially augment existing arthroscopic rotator cuff repair to improve retear rates and postoperative outcomes. The purpose of this study was to evaluate healing rates and clinical outcomes of full-thickness rotator cuff repairs augmented with a bioinductive bovine collagen implant.
UNASSIGNED: In this prospective multicenter study, investigators enrolled 115 patients (mean age, 60.4 years) with full-thickness rotator cuff tears. There were 66 (57.4%) medium (1-3 cm) tears and 49 (42.6%) large (3-5 cm) tears. Eligible patients consisted of those ≥21 years of age with chronic shoulder pain lasting longer than 3 months and unresponsive to conservative therapy. Patients underwent single- or double-row repair augmented with a bioinductive bovine collagen implant. At the baseline, 3 months, and 1 year, magnetic resonance imaging was performed and patients were assessed for American Shoulder and Elbow Surgeons (ASES) Shoulder Score and Constant-Murley Score (CMS). The primary failure end point was retear, classified as any new full-thickness defect observed on magnetic resonance imaging.
UNASSIGNED: There were 13 retears (11.3%) at 3 months, with an additional 6 (19 total [16.5%]) found at 1 year. In large tears, double-row repair had a significantly lower rate of retear at 3 months (P = .0004) and 1 year (P = .0001) compared with single-row repair. ASES and CMS scores significantly improved between the baseline and 1 year for medium and large tears. At 1 year, the minimally clinically important difference for ASES and CMS was met by 91.7% (95% CI: 84.9-96.1) and 86.4% (95% CI: 78.2-92.4) of patients, respectively. Patients without retear and those <65 years of age had significantly better CMS scores at 1 year when compared with those with retear and those ≥65 years (P < .05). There was no statistically significant difference in outcomes based on treatment of the biceps tendon. Of 9 reported reoperations in the operative shoulder, only 2 were considered potentially related to the collagen implant.
UNASSIGNED: Interim results from this prospective study indicate a favorable rate of retear relative to the literature and improvement in clinical function at 1 year after adjunctive treatment with the study implant augmenting standard arthroscopic repair techniques.