Cristina Delgado, Gia Rodríguez, Carmen Ortega, Vanesa López, Jordi Ardévol, Emilio Calvo
Shoulder and Elbow Reconstructive Surgery Unit, Department of Orthopaedic Surgery and Traumatology. IIS-Fundación Jiménez Díaz, Madrid (Spain).
Hospital Universitario Rey Juan Carlos, Madrid (Spain).
J Shoulder Elbow Surg. 2025 Sep 10. doi: 10.1016/j.jse.2025.07.031.
Biologic augmentation with a bioinductive collagen patch has been proposed as an alternative to improve the healing rate of rotator cuff tears (RCT). Several studies have reported promising results when treating partial, full-thickness, and even massive tears. However, the effect of the patch on the repair of rotator cuff retears remains unclear.
To analyze the effect of the collagen patch on tendon integrity in patients with rotator cuff retear and a previous rotator cuff repair, and to evaluate the effects of the bioinductive implant on functional outcomes and pain levels at the first 24-months postoperatively.
Observational, prospective multicenter study of patients diagnosed with rotator cuff retear after prior arthroscopic rotator cuff repair, scheduled for a new arthroscopic repair with the addition of a bioinductive collagen implant (REGENETEN, Smith&Nephew, Andover, MA, USA). The primary outcome was integrity of the repaired tendon evaluated at 12-months follow-up in an MRI study using Sugaya classification. Repairs graded as Sugaya IV and V were defined as retear. Secondary outcome measures included pain levels measured with visual analog score (VAS) and functional outcomes, evaluated with the Constant Murley (CS), American Shoulder and Elbow Surgeons (ASES), and single Assessment Numeric Evaluation scores at 24-months follow-up.
Twenty-one patients, 57.1% male, median age at surgery 59 years (range 46-67), with a median follow-up of 25.9 months (range 24-34) were included. No intraoperative or immediate postoperative complications occurred. MR imaging revealed an overall retear rate of 28.6% (6/21). Of these, in 3 cases, the identified retear size was smaller than the initial tear. Only one patient underwent revision surgery. VAS score significantly decreased from preoperative, median 8 (range 4-10), to postoperative, median 5 (range 0-8) (p=0.001). Regarding functional outcomes, Constant and ASES scores significantly improved from 44 and 20 respectively to 63 and 59.2 at 24 months follow-up (p=0.004; p=0.0001). The mean subjective shoulder value score after revision surgery was 60 points (range 10-100).
Biologic augmentation with a bioinductive collagen patch provides clinical and functional improvement in patients undergoing revision rotator cuff tear repair, with over 70% of the revision repairs remaining intact at 1-year follow-up.
使用生物诱导性胶原蛋白贴片进行生物增强已被提议作为提高肩袖撕裂（RCT）愈合率的一种替代方法。几项研究报告了在治疗部分、全层甚至巨大撕裂时取得的有前景的结果。然而，该贴片对肩袖再撕裂修复的效果仍不清楚。
分析胶原蛋白贴片对肩袖再撕裂且之前有过肩袖修复的患者肌腱完整性的影响，并评估生物诱导性植入物在术后前24个月对功能结果和疼痛水平的影响。
对先前接受关节镜下肩袖修复后被诊断为肩袖再撕裂的患者进行观察性、前瞻性多中心研究，这些患者计划进行新的关节镜修复并添加生物诱导性胶原蛋白植入物（REGENETEN，美国马萨诸塞州安多弗市的施乐辉公司）。主要结局是在12个月随访时通过MRI研究使用 Sugaya分类评估修复肌腱的完整性。被评为Sugaya IV和V级的修复被定义为再撕裂。次要结局指标包括在24个月随访时用视觉模拟评分（VAS）测量的疼痛水平以及用Constant Murley（CS）、美国肩肘外科医师协会（ASES）和单项评估数值评分评估的功能结果。
纳入21例患者，男性占57.1%，手术时的中位年龄为59岁（范围46 - 67岁），中位随访时间为25.9个月（范围24 - 34个月）。术中及术后即刻均未发生并发症。MRI成像显示总体再撕裂率为28.6%（6/21）。其中，3例中确定的再撕裂尺寸小于初始撕裂。只有1例患者接受了翻修手术。VAS评分从术前的中位8分（范围4 - 10分）显著降至术后的中位5分（范围0 - 8分）（p = 0.001）。关于功能结果，Constant和ASES评分在24个月随访时分别从44分和20分显著提高至63分和59.2分（p = 0.004；p = 0.0001）。翻修手术后的平均主观肩部价值评分为60分（范围10 - 100分）。
使用生物诱导性胶原蛋白贴片进行生物增强可使接受翻修性肩袖撕裂修复的患者在临床和功能上得到改善，超过70%的翻修修复在1年随访时保持完整。
