BACKGROUND Bovine bioinductive collagen implants (herein, "bovine collagen implant") can be used to augment rotator cuff repair. Concern exists that these bovine collagen implants may not yield clinical benefits and may actually increase postoperative stiffness and the need for reoperation. QUESTIONS/PURPOSES Among patients who underwent primary rotator cuff repair with or without a bovine collagen implant, we asked: (1) Did the proportion of patients undergoing reoperation for postoperative stiffness and inflammation differ between the bovine collagen implant and control groups? (2) Did short-term patient-reported outcomes differ between the two groups? (3) Did the proportion of patients receiving postoperative methylprednisolone prescriptions and corticosteroid injections differ between the two groups? METHODS We performed a retrospective, matched, comparative study of patients 18 years and older with minimum 2-year follow-up who underwent primary arthroscopic repair of partial or full-thickness rotator cuff tears diagnosed by MRI. All procedures were performed by one surgeonbetween February 2016 and December 2021. During the period in question, this surgeon broadly offered the bovine collagen implant to all patients who underwent rotator cuff repair and who (1) consented to xenograft use and (2) had surgery at a facility where the bovine collagen implant was available. The bovine collagen implant was used in rotator cuff tears of all sizes per the manufacturer's instructions. A total of 312 patients were considered for this study (243 control, 69 implant). Minimum 2-year clinical follow-up data were available for 83% (201 of 243) of patients in the control group and 90% (62 of 69) of patients in the bovine collagen implant group. After we applied the exclusion criteria, 163 control and 47 implant group patients remained and were eligible for matching. Propensity score matching was conducted to balance cohorts by age, gender, race (Black, White, other), ethnicity (Hispanic, non-Hispanic), health insurance status, Area Deprivation Index, BMI, American Society of Anesthesiologists physical status classification, diabetes, smoking, rotator cuff tear size, concomitant surgical procedures, preoperative American Shoulder and Elbow Surgeons (ASES) score, Subjective Shoulder Value (SSV), VAS score for pain, and shoulder ROM. We included 141 patients (47 in the implant group and 94 in the control group) after matching. Patients were categorized according to whether they received the bovine collagen implant. Before matching, the control cohort was older (mean ± SD 57 ± 10 years versus 52 ± 11 years; p = 0.004), more likely to be White (58% versus 23%; p < 0.001), with a smaller proportion of concomitant distal clavicle excisions (43% versus 21%; p = 0.003), and a smaller proportion of "other" concomitant procedures (17% versus 6%; p = 0.011) compared with the implant cohort. After matching, the cohorts were well matched in all demographic variables. The primary study outcome was reoperation for inflammation and stiffness, defined as a failure of nonoperative treatment for a minimum of 9 months, including physical therapy, NSAIDs, at least one course of oral methylprednisolone, and at least one cortisone injection (reoperations for traumatic retears were excluded). Secondary outcomes were patient-reported outcomes (SSV, ASES score, and VAS score for pain), receipt of methylprednisolone prescriptions, and receipt of corticosteroid injections. Chi-square, Fisher exact tests, and independent-samples t-tests were used to assess relationships between treatment group and study outcomes. RESULTS A greater proportion of patients in the bovine collagen implant group (9% [4 of 47]) underwent reoperation for inflammation and stiffness than in the control group (0% [0 of 94; p = 0.01]). At minimum 2-year follow-up, the cohorts did not differ by ASES score (mean ± SD 81 ± 24 implant versus 85 ±19 control; p = 0.24), SSV (79 ± 24 implant versus 85 ± 18 control; p = 0.30), or VAS score for pain (2.0 ± 2.9 implant versus 1.5 ± 2.3 control; p = 0.11). The cohorts did not differ in the proportion who received postoperative corticosteroid injections (15% implant versus 11% control; p = 0.46) or methylprednisolone prescriptions (49% implant versus 37% control; p = 0.18). CONCLUSION At minimum 2-year follow-up, patients undergoing primary arthroscopic rotator cuff repair with bovine collagen implant augmentation had a greater proportion of reoperation due to inflammation and stiffness compared with patients who did not receive the implant. Furthermore, the implant offered no benefit in patient-reported outcomes or need for postoperative corticosteroid injections or methylprednisolone prescriptions. Because of the lack of clinical benefit and potential increase in postoperative complications, we recommend against the use of these bovine collagen implants unless high-quality randomized controlled trials are able to demonstrate their clinical effectiveness, cost-effectiveness, and overall safety. LEVEL OF EVIDENCE Level III, therapeutic study.

中文翻译：

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牛胶原蛋白植入增强术在初次肩袖修复中没有短期临床益处：一项匹配的回顾性研究。


背景技术牛生物诱导胶原植入物(本文中，“牛胶原植入物”)可用于增强肩袖修复。人们担心这些牛胶原蛋白植入物可能不会产生临床益处，实际上可能会增加术后僵硬和再次手术的需要。问题/目的在接受初次肩袖修复术（有或没有牛胶原蛋白植入物）的患者中，我们询问：（1）因术后僵硬和炎症而接受再次手术的患者比例在牛胶原蛋白植入物组和对照组之间是否有所不同？ (2) 两组患者报告的短期结果是否存在差异？ (3)术后接受甲泼尼龙处方和皮质类固醇注射的患者比例在两组之间是否存在差异？方法 我们对 18 岁及以上且接受至少 2 年随访的患者进行了一项回顾性、匹配、比较研究，这些患者接受了 MRI 诊断的部分或全层肩袖撕裂的初次关节镜修复术。所有手术均由一名外科医生在 2016 年 2 月至 2021 年 12 月期间完成。在此期间，该外科医生广泛向所有接受肩袖修复且 (1) 同意使用异种移植物且 (2) 接受手术的患者提供牛胶原蛋白植入物在可以进行牛胶原蛋白植入的设施中。根据制造商的说明，将牛胶原蛋白植入物用于各种尺寸的肩袖撕裂。本研究总共考虑了 312 名患者（243 名对照患者，69 名种植体）。对照组中 83%（243 名中的 201 名）患者和牛胶原蛋白植入组中 90%（69 名中的 62 名）患者可获得至少 2 年临床随访数据。 应用排除标准后，仍有 163 名对照组患者和 47 名种植体组患者符合匹配资格。进行倾向评分匹配，以按年龄、性别、种族（黑人、白人、其他）、种族（西班牙裔、非西班牙裔）、健康保险状况、面积剥夺指数、BMI、美国麻醉医师协会身体状况分类、糖尿病来平衡队列、吸烟、肩袖撕裂大小、伴随手术程序、术前美国肩肘外科医生 (ASES) 评分、主观肩关节值 (SSV)、疼痛 VAS 评分和肩关节活动度。匹配后我们纳入了 141 名患者（植入组 47 名，对照组 94 名）。根据患者是否接受牛胶原蛋白植入物对患者进行分类。在匹配之前，对照组年龄较大（平均值±SD 57±10岁对比52±11岁；p = 0.004），更有可能是白人（58%对比23%；p < 0.001），白人比例较小与植入组相比，伴随远端锁骨切除术（43% 对比 21%；p = 0.003），以及较小比例的“其他”伴随手术（17% 对比 6%；p = 0.011）。匹配后，队列在所有人口统计变量上都匹配良好。主要研究结果是因炎症和僵硬而再次手术，定义为至少 9 个月的非手术治疗失败，包括物理治疗、非甾体抗炎药、至少一个疗程的口服甲基强的松龙和至少一次可的松注射（创伤性后遗症的再次手术）被排除在外）。次要结局是患者报告的结局（SSV、ASES 评分和疼痛 VAS 评分）、接受甲基强的松龙处方以及接受皮质类固醇注射。 卡方、Fisher 精确检验和独立样本 t 检验用于评估治疗组与研究结果之间的关系。结果 牛胶原蛋白植入组中因炎症和僵硬而接受再次手术的患者比例（9% [47 中的 4]）高于对照组（0% [94 中的 0；p = 0.01]）。在至少 2 年的随访中，队列在 ASES 评分（平均值 ± SD 81 ± 24 种植体与 85 ± 19 对照；p = 0.24）、SSV（79 ± 24 种植体与 85 ± 18 对照；p = 0.30），或疼痛 VAS 评分（植入物为 2.0 ± 2.9，对照为 1.5 ± 2.3；p = 0.11）。这些队列在接受术后皮质类固醇注射（15% 植入剂 vs 11% 对照；p = 0.46）或甲基泼尼松龙处方（49% 植入剂 vs 37% 对照；p = 0.18）的比例上没有差异。结论 在至少 2 年的随访中，与未接受植入物的患者相比，接受初次关节镜下肩袖修复和牛胶原植入物增强的患者因炎症和僵硬而再次手术的比例更高。此外，植入物对患者报告的结果或术后皮质类固醇注射或甲泼尼龙处方的需要没有任何益处。由于缺乏临床益处且术后并发症可能增加，我们建议不要使用这些牛胶原蛋白植入物，除非高质量的随机对照试验能够证明其临床有效性、成本效益和整体安全性。证据级别 III 级，治疗研究。