Bushnell Brandon D, Bishai Shariff K, Krupp Ryan J, McMillan Sean, Schofield Brian A, Trenhaile Scott W, McIntyre Louis F
Department of Orthopedic Surgery, Harbin Clinic, Rome, Georgia, USA.
Associated Orthopedists of Detroit, Detroit, Michigan, USA.
Orthop J Sports Med. 2021 Aug 13;9(8):23259671211027850. doi: 10.1177/23259671211027850. eCollection 2021 Aug.
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.
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.
Case series; Level of evidence, 4.
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.
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.
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.
部分厚度肩袖撕裂的手术治疗仍然具有挑战性且存在争议，有几种传统选择，包括清创加肩峰成形术、经肌腱或原位修复以及切除并修复。一种可吸收的生物诱导牛胶原蛋白植入物已显示出作为部分厚度撕裂替代治疗选择的前景。
分析来自登记处的数据，以进一步证实该植入物有助于改善大量接受部分厚度肩袖撕裂治疗患者的患者报告结局（PRO）评分。
病例系列；证据级别，4级。
美国的19个中心在一项全面的前瞻性多中心登记中纳入了年龄大于21岁的肩袖部分厚度撕裂患者。在术前以及术后2周和6周、3个月和6个月以及1年记录PRO评分：美国肩肘外科医师协会评分、单评估数字评价、退伍军人兰德12项健康调查（身体和心理成分评分）以及西安大略肩袖评分。在整个研究过程中报告翻修情况。
该登记包括272例部分厚度撕裂患者（49例1级撕裂、101例2级撕裂和122例3级撕裂），241例接受单纯生物诱导修复（IBR；在切除滑囊后植入胶原蛋白植入物，未进行传统肩袖修复），31例进行切除并采用生物诱导增强修复。从3个月开始，所有PRO评分患者均从基线水平出现统计学上显著且持续的改善。在≥2级撕裂患者中，与接受IBR的患者相比，进行切除并修复的患者在2周和6周时大多数PRO评分显著较低，但除退伍军人兰德12项健康调查的身体成分评分外，在1年时差异不再显著。有11例翻修，发生在初次手术后平均±标准差188.7±88.0天。无感染发生。
该登记分析在一个大的数据集上进一步证实，这种可吸收的生物诱导牛胶原蛋白植入物可改善所有等级部分厚度撕裂的PRO，无论作为IBR使用还是与切除并修复联合使用。与更具侵入性的“切除并修复”方法相比，IBR可能在早期（≤6周）提供更好的临床结局，且在1年时结局相当。
