Center for Sport Medicine, the First Affiliated Hospital, College of Medicine Zhejiang University, Hangzhou, China.
Dr. Li Dak Sum & Yip Yio Chin Center for Stem Cell and Regenerative Medicine School of Medicine, Zhejiang University, Hangzhou, China.
Am J Sports Med. 2018 May;46(6):1424-1431. doi: 10.1177/0363546518756978. Epub 2018 Mar 13.
Due to the highly organized tissue and avascular nature of the rotator cuff, rotator cuff tears have limited ability to heal after the tendon is reinserted directly on the greater tubercle of the humerus. Consequently, retears are among the most common complications after rotator cuff repair. Augmentation of rotator cuff repairs with patches has been an active area of research in recent years to reduce retear rate.
Graft augmentation with 3D collagen could prevent retears of the repaired tendon and improve tendon-bone healing in moderate to large rotator cuff tears.
Randomized controlled study; Level of evidence, 2.
A prospective, randomized controlled study was performed in a consecutive series of 112 patients age 50 to 85 years who underwent rotator cuff repair with the suture-bridge technique (58 patients, control group) or the suture-bridge technique augmented with 3-dimensional (3D) collagen (54 patients, study group). All patients were followed for 28.2 months (range, 24-36 months). Visual analog scale score for pain, University of California Los Angeles (UCLA) shoulder score, and Constant score were determined. Magnetic resonance imaging was performed pre- and postoperatively (at a minimum of 24 months) to evaluate the integrity of the rotator cuff and the retear rate of the repaired tendon. Three patients in each group had biopsies at nearly 24 months after surgery with histological assessment and transmission electron microscopy.
A total of 104 patients completed the final follow-up. At the 12-month follow-up, the UCLA shoulder score was 28.1 ± 1.9 in the study group, which was significantly better than that in the control group (26.9 ± 2.1, P = .002). The Constant score was also significantly better in the study group (87.1 ± 3.2) than in the control group (84.9 ± 4.2, P = .003). However, at the final follow-up, no significant differences were found in the UCLA shoulder scores (29.4 ± 1.9 in the control group and 30.0 ± 1.6 in the study group, P = .052) or Constant scores (89.9 ± 3.2 in the control group and 90.8 ± 3.5 in the study group, P = .18). In terms of structural integrity, more patients in the study group had a favorable type I retear grade (18/51) than in the control group (10/53) ( P = .06). The postoperative retear rate was 34.0% in the control group and 13.7% in the study group, thus indicating a significantly lower retear rate in the study group ( P = .02). Biopsy specimens of the tendon-bone interface in 6 patients revealed more bone formation and more aligned fibers with larger diameters in the study group than in the control group. No intraoperative or postoperative complications were noted in either group.
3D collagen augmentation could provide effective treatment of moderate to large rotator cuff tears, providing substantial functional improvement, and could reduce the retear rate. This technique could also promote new tendon-bone formation, thus exerting a prominent effect on tendon-bone healing.
由于肩袖组织高度有序且无血管，因此当肌腱直接重新插入肱骨大结节时，肩袖撕裂的愈合能力有限。因此，肩袖修复后的再撕裂是最常见的并发症之一。近年来，使用补片增强肩袖修复以降低再撕裂率是一个活跃的研究领域。
用 3D 胶原进行移植物增强可以防止修复肌腱的再撕裂，并改善中到大的肩袖撕裂的肌腱-骨愈合。
前瞻性随机对照研究；证据水平，2。
对连续的 112 例年龄在 50 至 85 岁的患者进行了前瞻性、随机对照研究，这些患者接受了肩袖修复缝合桥技术（58 例，对照组）或缝合桥技术加 3D 胶原增强（54 例，研究组）。所有患者均随访 28.2 个月（范围，24-36 个月）。评估疼痛的视觉模拟评分、加州大学洛杉矶分校（UCLA）肩部评分和常数评分。在术前和术后（至少 24 个月）进行磁共振成像，以评估肩袖的完整性和修复肌腱的再撕裂率。每组中有 3 名患者在手术后将近 24 个月时进行了活检，进行组织学评估和透射电子显微镜检查。
共有 104 例患者完成了最终随访。在 12 个月的随访中，研究组的 UCLA 肩部评分（28.1 ± 1.9）明显优于对照组（26.9 ± 2.1，P =.002）。研究组的常数评分（87.1 ± 3.2）也明显优于对照组（84.9 ± 4.2，P =.003）。然而，在最终随访时，对照组和研究组的 UCLA 肩部评分（对照组 29.4 ± 1.9，研究组 30.0 ± 1.6，P =.052）或常数评分（对照组 89.9 ± 3.2，研究组 90.8 ± 3.5，P =.18）均无显著差异。在结构完整性方面，研究组中更多的患者（18/51）具有较好的 I 型再撕裂分级，而对照组中（10/53）则较少（P =.06）。对照组的术后再撕裂率为 34.0%，研究组为 13.7%，因此研究组的再撕裂率明显较低（P =.02）。6 名患者的肌腱-骨界面活检标本显示，研究组的骨形成和直径较大的纤维排列更整齐。两组均未发生术中或术后并发症。
3D 胶原增强可有效治疗中到大的肩袖撕裂，提供实质性的功能改善，并降低再撕裂率。该技术还可以促进新的肌腱-骨形成，从而对肌腱-骨愈合产生显著影响。
