[Comparative study on effectiveness of bioinductive patch-augmented arthroscopic rotator cuff repair]

To evaluate the effectiveness of using a bioinductive patch on tendon healing, functional recovery, and safety in arthroscopic rotator cuff repair.

A non-concurrent controlled study with prospective enrollment of the intervention group and retrospective collection of the control group was conducted. Patients with rotator cuff injuries admitted between June 2024 and March 2025 were enrolled. The sample size was calculated using G*Power software. A total of 60 patients meeting the selection criteria were enrolled, including 30 patients in the patch group (receiving arthroscopic rotator cuff repair combined with bioinductive patch implantation) and 30 patients in the control group (receiving arthroscopic rotator cuff repair only). There was no significant difference between groups ( P>0.05) in baseline data, including age, gender, affected side, disease duration, DeOrio-Cofield classification, degree of fatty infiltration, proportion involving the subscapularis, proportion of revision surgeries, and preoperative visual analogue scale (VAS) score, Constant-Murley score, American Shoulder and Elbow Surgeons (ASES) score, and University of California, Los Angeles (UCLA) score. The following indicators were compared between groups: the tendon healing rate at 6 months postoperatively and postoperative pain VAS score, functional scores (Constant-Murley, ASES, UCLA), imaging indicators (tendon thickness, footprint coverage, effusion), and patient-reported outcomes [12-Item Short-Form Health Survey (SF-12) physical/mental component score, SF-36 overall score, simple shoulder test (SST), satisfaction]. Additionally, subgroup analyses were performed based on whether the tear involved the subscapularis preoperatively, the degree of fatty infiltration (Goutallier grades Ⅰ, Ⅱ/Ⅲ, Ⅳ), and primary/revision surgery to compare tendon healing outcomes. A multiple linear regression model was used to analyze independent influencing factors of Constant-Murley score improvement at 6 months postoperatively.

Incisions in both groups healed by first intention. All patients were followed up, with follow-up time of (13.0±1.8) months in the patch group and (12.8±1.9) months in the control group, showing no significant difference ( t=0.415, P=0.680). The pain and shoulder joint function of the two groups gradually improved over time, and the corresponding scores showed significant differences between different time points ( P<0.05). The pain relief and functional recovery improvement in the patch group was better than that in the control group, and there were significant differences in all scores between groups at 1 and 6 months ( P<0.05). At 6 months postoperatively, the patch group had significantly better SF-12 physical component scores, SF-36 overall scores, and SST scores than the control group ( P<0.05), while the SF-12 mental component score and patient's satisfaction showed no significant difference between groups ( P>0.05). At 12 months postoperatively, the surgical success rate was significantly higher in the patch group than in the control group ( P<0.05). Imaging review showed no significant difference between groups in tendon healing rate, retear rate, complete footprint coverage rate, or effusion degree at 6 months postoperatively ( P>0.05), but the increase in tendon thickness was significantly greater in the patch group than in the control group ( P<0.05). Subgroup analysis showed that for revision surgery patients, there was no significant difference in retear rate based on patch use ( P>0.05); however, primary surgery patients had a significantly higher tendon healing rate with patch use ( P<0.05). For patients with Goutallier grade Ⅰ, Ⅱ fatty infiltration, patch use resulted in a significantly higher tendon healing rate ( P<0.05), while for those with grade Ⅲ, Ⅳ fatty infiltration, the difference was not significant ( P>0.05). For patients with or without involvement of the subscapularis, there was no significant difference in tendon healing rate based on patch use ( P>0.05). Multiple linear regression analysis showed that independent influencing factors of Constant-Murley score improvement at 6 months postoperatively included the use of bioinductive patch, age, and fatty infiltration degree ( P<0.05).

The bioinductive patch can effectively promote joint functional recovery and structural improvement after rotator cuff repair with good safety.