Early Functional Recovery Is Improved in Patients Treated With Bioinductive Collagen Implant Augmentation Compared With Standard Arthroscopic Repair of High-grade Partial-Thickness Rotator Cuff Tears: A Prospective Randomized Trial

Abstract

Background: Arthroscopic surgical takedown and repair of symptomatic partial-thickness rotator cuff tears are commonly undertaken. An alternative approach is the use of a bioinductive collagen implant to augment the rotator cuff tear. Purpose: To investigate early function and rotator cuff tendon integrity in patients undergoing arthroscopic bioinductive collagen implant augmentation (REG group) versus rotator cuff takedown and repair (RCR group) for high-grade partial-thickness rotator cuff tears. Study Design: Randomized controlled clinical trial; Level of evidence, 2. Methods: Patients 35 to 75 years of age with symptoms >3 months and unresponsive to nonoperative treatment, with high-grade partial-thickness rotator cuff tears confirmed on 3-T magnetic resonance imaging (MRI), were randomly allocated to RCR or REG groups. Exclusion criteria included previous ipsilateral shoulder surgery, multitendon tears/pathology, and concomitant surgery including labral repair, long head of biceps tenodesis, or chondroplasty/microfracture. Patients were assessed preoperatively and at 6 weeks as well as 3, 6, and 12 months postoperatively. The primary study outcome was the Western Ontario Rotator Cuff Index (WORC) at 3 months after surgery. Secondary outcomes included the American Shoulder and Elbow Surgeons (ASES) and Constant scores, and the time taken to return to work and activities of daily living (ADLs). MRI-based rotator cuff repair integrity was assessed using the Sugaya grading system. Results: This study recruited 41 patients (REG n = 21; RCR n = 20). No group differences (P > .05) were observed in mean age (REG 57.1 years; RCR 57.8 years), preoperative duration of symptoms, and previous nonoperative treatments. The REG group reported superior outcomes for the WORC at 6 weeks (P = .001) and 3 months (P = .026) as well as the ASES at 6 weeks (P < .001) and WORC Work, Sport, and Emotions domains at 6 weeks and 3 months (P < .05). There were no group-based differences (P > .05) in patient-reported outcomes at 6 or 12 months after surgery. The REG group was faster (P < .05) to permanently remove the sling, drive a motor vehicle, and return to office duties and moderate-intensity chores. No MRI-based differences were observed, with 19 (90%) and 17 (85%) REG and RCR patients, respectively, graded Sugaya 1 to 2 at 12 months. Conclusion: For symptomatic high-grade partial-thickness rotator cuff tears, bioinductive collagen implant augmentation versus standard rotator cuff repair demonstrated improved early function with equivalent MRI-based healing rates. Registration: Australian New Zealand Clinical Trials Register (ACTRN12620000926932p).