Arthroscopic Rotator Cuff Repair With Graft Augmentation of 3-Dimensional Biological Collagen for Moderate to Large Tears A Randomized Controlled Study
Arthroscopic Rotator Cuff Repair With Graft Augmentation of 3-Dimensional Biological Collagen for Moderate to Large Tears A Randomized Controlled Study
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DOI：
10.1177/0363546518756978
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发表时间：
2018-05-01
影响因子：
4.8
通讯作者：
Chen, Jian-De
中科院分区：
文献类型：
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作者：
Cai, You-Zhi;Zhang, Chi;Chen, Jian-De
背景：由于肩袖组织高度组织化和无血管性质，将肌腱直接重新插入肱骨大结节后，肩袖撕裂的愈合能力有限。因此，后遗症是肩袖修复后最常见的并发症之一。近年来，使用补片增强肩袖修复一直是降低再撕裂率的一个活跃研究领域。假设：使用 3D 胶原蛋白增强移植物可以防止修复肌腱的再撕裂，并改善中度至大度肩袖撕裂的肌腱骨愈合。研究设计：随机对照研究；证据水平，2.方法：对 112 名年龄 50 至 85 岁的患者进行了连续系列的前瞻性随机对照研究，这些患者接受了缝合桥技术（58 名患者，对照组）或采用 3 维 (3D) 胶原增强的缝合桥技术（54 名患者，研究组）进行肩袖修复。所有患者均随访 28.2 个月（范围：24-36 个月）。确定了疼痛的视觉模拟量表评分、加州大学洛杉矶分校 (UCLA) 肩部评分和 Constant 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撕裂率。每组3例患者在术后近24个月时进行活检，并进行组织学评估和透射电镜检查。结果：共有104例患者完成最终随访。 12 个月随访时，研究组 UCLA 肩部评分为 28.1 +/- 1.9，显着优于对照组（26.9 +/- 2.1，P = .002）。研究组的 Constant 评分 (87.1 +/- 3.2) 也显着优于对照组 (84.9 +/- 4.2，P = .003)。然而，在最终随访时，UCLA 肩部评分（对照组为 29.4 +/- 1.9，研究组为 30.0 +/- 1.6，P = .052）或 Constant 评分（对照组为 89.9 +/- 3.2，研究组为 90.8 +/- 3.5，P = .18）没有发现显着差异。就结构完整性而言，研究组中具有良好 I 型视网膜分级 (18/51) 的患者多于对照组 (10/53) (P = .06)。对照组术后复发率为 34.0%，研究组为 13.7%，表明研究组术后复发率显着较低 (P = .02)。 6 名患者的肌腱-骨界面活检标本显示，研究组比对照组有更多的骨形成和更多直径更大的排列纤维。两组均未出现术中或术后并发症。结论：3D 胶原蛋白增强术可以有效治疗中度至大度肩袖撕裂，显着改善功能，并降低再撕裂率。该技术还可以促进新的腱骨形成，从而对腱骨愈合产生显着的效果。
Background: 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.Hypothesis: Graft augmentation with 3D collagen could prevent retears of the repaired tendon and improve tendon-bone healing in moderate to large rotator cuff tears.Study Design: Randomized controlled study; Level of evidence, 2.Methods: 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.Results: 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.Conclusion: 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.