A Prospective, Randomized Evaluation of Acellular Human Dermal Matrix Augmentation for Arthroscopic Rotator Cuff Repair
A Prospective, Randomized Evaluation of Acellular Human Dermal Matrix Augmentation for Arthroscopic Rotator Cuff Repair
复制标题
DOI：
10.1016/j.arthro.2011.06.038
复制
发表时间：
2012-01-01
影响因子：
4.7
通讯作者：
Litchfield, Robert B.
中科院分区：
文献类型：
--
作者：
Barber, F. Alan;Burns, Joseph P.;Litchfield, Robert B.
目的：前瞻性评估关节镜下脱细胞人体真皮基质增强大肩袖撕裂修复的安全性和有效性。方法：一项经机构审查委员会批准的前瞻性、多中心系列研究，接受关节镜下测量大于 3 cm 的 2 肌腱肩袖撕裂修复的患者，通过手术时打开的密封信封随机分配至采用 GraftJacket 脱细胞人真皮基质（Wright Medical Technology，阿灵顿，田纳西州）增强（组 1）或不增强（组 2）进行关节镜单排肩袖修复。术前和术后功能结果评估是通过使用美国肩肘外科医生 (ASES)、Constant 和加州大学洛杉矶分校量表获得的。平均 14.5 个月（范围：12 至 24 个月）对这些修复进行钆增强磁共振成像 (MRI) 评估。记录不良事件。结果：第1组有22名患者，第2组有20名患者，平均年龄56岁。平均随访时间为 24 个月（范围为 12 至 38 个月）。第 1 组的 ASES 评分从 48.5 提高到 98.9，第 2 组从 46.0 提高到 94.8。第 1 组的评分在统计学上优于第 2 组 (P = .035)。第 1 组的 Constant 评分从 41.0 提高到 91.9，第 2 组从 45.8 提高到 85.3。第 1 组的评分在统计上优于第 2 组 (P = .008)。加州大学洛杉矶分校第一组的分数从 13.3 提高到 28.2，第二组的分数从 15.9 提高到 28.3 (P = 0.43)。钆增强 MRI 扫描显示，第 1 组 85% 的修复袖带完好无损，第 2 组 40% 的修复袖带完好 (P < .01)。没有因基质移植物的存在而产生不良事件。结论：通过钆增强 MRI 确定，涉及 2 根肌腱的大（> 3 cm）袖带撕裂的脱细胞人真皮基质增强显示出更好的 ASES 和恒定分数，以及更常见的完整袖带。 85% 的增强组和 40% 的非增强组发现完整修复 (P < .01)。没有观察到与脱细胞人真皮基质相关的不良事件。证据级别：II 级，质量较低的随机对照试验。
Purpose: To prospectively evaluate the safety and effectiveness of arthroscopic acellular human dermal matrix augmentation of large rotator cuff tear repairs. Methods: A prospective, institutional review board-approved, multicenter series of patients undergoing arthroscopic repair of 2-tendon rotator cuff tears measuring greater than 3 cm were randomized by sealed envelopes opened at the time of surgery to arthroscopic single-row rotator cuff repair with GraftJacket acellular human dermal matrix (Wright Medical Technology, Arlington, TN) augmentation (group 1) or without augmentation (group 2). Preoperative and postoperative functional outcome assessments were obtained by use of the American Shoulder and Elbow Surgeons (ASES), Constant, and University of California, Los Angeles scales. Gadolinium-enhanced magnetic resonance imaging (MRI) evaluation of these repairs was obtained at a mean of 14.5 months (range, 12 to 24 months). Adverse events were recorded. Results: There were 22 patients in group 1 and 20 in group 2 with a mean age of 56 years. The mean follow-up was 24 months (range, 12 to 38 months). The ASES score improved from 48.5 to 98.9 in group 1 and from 46.0 to 94.8 in group 2. The scores in group 1 were statistically better than those in group 2 (P = .035). The Constant score improved from 41.0 to 91.9 in group 1 and from 45.8 to 85.3 in group 2. The scores in group 1 were statistically better than those in group 2 (P = .008). The University of California, Los Angeles score improved from 13.3 to 28.2 in group 1 and from 15.9 to 28.3 in group 2 (P = .43). Gadolinium-enhanced MRI scans showed intact cuffs in 85% of repairs in group 1 and 40% in group 2 (P < .01). No adverse events were attributed to the presence of the matrix grafts. Conclusions: Acellular human dermal matrix augmentation of large (>3 cm) cuff tears involving 2 tendons showed better ASES and Constant scores and more frequent intact cuffs as determined by gadolinium-enhanced MRI. Intact repairs were found in 85% of the augmented group and 40% of the nonaugmented group (P < .01). No adverse events related to the acellular human dermal matrix were observed. Level of Evidence: Level II, lesser-quality randomized controlled trial.