首页> 外文期刊>Orthopaedic Journal of Sports Medicine >Treatment of Partial-Thickness Rotator Cuff Tears With a Resorbable Bioinductive Bovine Collagen Implant: 1-Year Results From a Prospective Multicenter Registry
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Treatment of Partial-Thickness Rotator Cuff Tears With a Resorbable Bioinductive Bovine Collagen Implant: 1-Year Results From a Prospective Multicenter Registry

机译:用可再吸收的生物诱导牛胶原植入物的部分厚度旋转器袖口撕裂:潜在多中心注册表的1年结果

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Background: Surgical treatment of partial-thickness rotator cuff tears remains challenging and controversial, with several traditional options including debridement with acromioplasty, transtendon or in situ repair, and take-down and repair. A resorbable bioinductive bovine collagen implant has shown promise as an alternative treatment option for partial-thickness tears. Purpose: Data from a registry were analyzed to further establish that the implant contributes to improved patient-reported outcome (PRO) scores across a large number of patients treated for partial-thickness rotator cuff tears. Study Design: Case series; Level of evidence, 4. Methods: A total of 19 centers in the United States enrolled patients &21 years old with partial-thickness tears of the rotator cuff in a comprehensive prospective multicenter registry. PRO scores were recorded preoperatively and postoperatively at 2 and 6 weeks, 3 and 6 months, and 1 year: American Shoulder and Elbow Surgeons, Single Assessment Numeric Evaluation, Veterans RAND 12-Item Health Survey (physical and mental component scores), and Western Ontario Rotator Cuff scores. Revisions were reported throughout the study. Results: The registry included 272 patients with partial-thickness tears (49 grade 1 tears, 101 grade 2 tears, and 122 grade 3 tears), 241 who underwent isolated bioinductive repair (IBR; collagen implant placed after bursectomy without a traditional rotator cuff repair), and 31 who had take-down and repair with bioinductive augmentation. Patients experienced statistically significant and sustained improvement from baseline for all PRO scores beginning at 3 months. Among patients with grade ≥2 tears, those with take-down and repair had significantly inferior scores at 2 and 6 weeks for most PRO scores as compared with those who underwent IBR, but the difference was no longer significant at 1 year for all but the physical component score of the Veterans RAND 12-Item Health Survey. There were 11 revisions, which occurred at a mean ± SD of 188.7 ± 88.0 days after the index surgery. There were no infections. Conclusion: This registry analysis further establishes across a large data set that this resorbable bioinductive bovine collagen implant improves PROs in all grades of partial-thickness tears, whether used as IBR or in conjunction with take-down and repair. IBR may offer improved early clinical outcomes (≤6 weeks) and comparable outcomes at 1 year when compared with a more invasive “take-down and repair” approach.
机译:背景:部分厚度旋转器袖口撕裂的手术处理仍然具有挑战性和争议,具有几种传统选择,包括清创肩塑料,扭朗或原位修复,以及降低和修复。可再吸收的生物诱导牛胶原植入物已显示出作为部分厚度撕裂的替代治疗选择。目的:分析来自登记处的数据,进一步确定植入物有助于改善患者报告的患者报告的结果(Pro)分数,横跨用于部分厚度转子箍撕裂的大量患者。研究设计:案例系列;证据级别,4.方法:美国共有19个中心招募患者& GT; 21岁,旋转垫的部分厚度撕裂在综合性潜在的多中心注册表中。 Pro分数在2和6周,3和6个月,3和6个月,以及1年:美国肩部和肘部外科医生,单一评估数字评估,退伍军人兰特12项健康调查(身体和精神成分分数)和西方安大略省转子袖带分数。在整个研究中报道了修订。结果:注册处包括272名患有部分厚度撕裂的患者(49级泪液,101级泪液和122级泪液),241人接受了孤立的生物阻雷(IBR;胶原蛋白植入后塞切除术,没有传统的旋转袖口修复)和31谁在生物InciCuctive增强中进行了降低和修复。患者从3个月开始的所有Pro评分的基线有统计学显着和持续改善。在≥2级泪液的患者中,与接受IBR的人相比,大多数职业比分的2和6周具有显着劣等的分数,但除了退伍军人兰特12项健康调查的物理成分分数。有11个修订,在指数手术后的平均±SD为188.7±88.0天。没有感染。结论:该注册表分析进一步建立了大量数据集,即这种可再吸收的生物诱导牛胶原植入物在所有等级的部分厚度撕裂中提高了优势,无论是IBR还是与降低和修复结合。与更具侵入性的“降低和修复”方法相比,IBR可以提高早期临床结果(≤6周)和1年的可比结果。

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