背景:用隔离的生物诱导修复(IBR)代替完成修复治疗的部分厚度肩袖撕裂已显示出完全愈合。该治疗方案由剩余肌腱的结构完整性提供,这与旋转器电缆保持完整时在小/中等全厚度撕裂(FTT)中存在的类似。这项随机对照试验(RCT)研究了与缝合修复相比,小/中FTT的IBR是否具有更好的愈合和患者报告的结果(PRO)。
方法:这种前瞻性,双盲(患者和结果评估者),单中心RCT纳入年龄≥18岁的患者,患者有小/中(≤2.5cm)全厚度冈上肌撕裂和完整的旋转电缆.患者被随机分组,不知道关节镜下等效修复(对照,n=30)或IBR(n=30)。主要结果是6个月时活检的肌腱质量。次要结果是PROs(美国肩肘外科医生[ASES],Constant-MurleyShoulder[CMS],和疼痛视觉模拟评分)以及在6、12和24个月时通过MRI测量的肌腱厚度和愈合;在12和24个月时的满意度;以及恢复工作的时间。
结果:基线人口统计,眼泪,和手术特征在两组之间具有可比性(IBR:平均年龄,54.2年,14名男性;对照:平均年龄,56.4年,16男)。通过6个月活检测量,高度有组织,平行的胶原蛋白束,没有炎症,存在于所有IBR患者中,虽然组织不善,非平行胶原纤维存在于24/30(80%)的对照组患者(P<0.0001),28/30有轻微的炎症。IBR组(2.0mm)在基线6个月时通过MRI测量的肌腱厚度增加大于对照组(0.8mm)(P<0.0001)。所有IBR患者在12个月和24个月时MRI均有100%愈合。与对照组相比,IBR组在每次评估时都有较高的ASES和CMS评分,6个月和12个月时疼痛减轻,在12个月和24个月时满意度更高(P<.0003)。IBR组显着更快地恢复工作(中位数90天[IQR,25]vs.中位数163.5天[IQR,24];P<.0001)比对照组。
结论:与缝合修复相比,IBR治疗导致优越的肌腱质量,患者结果,满意,并返回工作。通过MRI和活检评估,IBR能够实现明显的强劲愈合反应。表现出优越的肌腱质量和愈合。
BACKGROUND: Partial-thickness rotator cuff tears treated with an isolated bioinductive repair (IBR) in lieu of a completion-and-repair have shown complete healing. This treatment option is afforded by the remaining tendon\'s structural integrity, which is similar to that present in small/medium full-thickness tears (FTTs) when the rotator cable remains intact. This randomized controlled trial (RCT) investigated whether an IBR for small/medium full-thickness tears resulted in superior healing and patient-reported outcomes (PROs) compared with a sutured repair.
METHODS: This prospective, double blinded (patients and outcome assessors), single-center randomized controlled trial enrolled patients ≥18 years with a small/medium (≤2.5 cm) full thickness supraspinatus tear and intact rotator cable. Patients were randomized and blinded to arthroscopic transosseous-equivalent repair (control, n = 30) or IBR (n = 30). The primary outcome was tendon quality on biopsy at 6 months. Secondary outcomes were PROs (American Shoulder and Elbow Surgeons [ASES], Constant-Murley Shoulder [CMS], and pain visual analogue scale scores) and tendon thickness and healing measured via MRI at 6, 12, and 24 months; satisfaction at 12 and 24 months; and time to return to work.
RESULTS: Baseline demographic, tear, and surgical characteristics were comparable between the groups (IBR: mean age, 54.2 years, 14 male; control: mean age, 56.4 years, 16 male). Measured via a 6-month biopsy, highly organized, parallel bundles of collagen, without inflammation, were present in all IBR patients, whereas poorly organized, nonparallel collagen fibers were present in 24/30 (80%) of control patients (P < .0001), with 28/30 having minimal to mild inflammation. The increase in tendon thickness measured via MRI at 6 months from baseline was greater in the IBR group (2.0 mm) than in the control group (0.8 mm) (P < .0001). All IBR patients had 100% healing on MRI at 12 and 24 months. Compared with the control group, the IBR group had higher American Shoulder and Elbow Surgeons and Constant-Murley Shoulder scores at each evaluation, less pain at 6 and 12 months, and greater satisfaction at 12 and 24 months (P < .0003). The IBR group returned to work significantly faster (median 90 days [IQR, 25] vs. median 163.5 days [IQR, 24]; P < .0001) than the control group.
CONCLUSIONS: Compared with a sutured repair, the IBR treatment resulted in superior tendon quality, patient outcomes, satisfaction, and return to work. The IBR enabled a robust healing response evident through MRI and biopsy evaluation, demonstrating superior tendon quality and healing.