Abstract
Background/Objectives: Rotator cuff repair (RCR) is a common orthopedic procedure, with healing outcomes strongly influenced by patient-specific factors such as tissue quality, tear characteristics, and biological healing potential. Bioinductive collagen implants have shown great results in enhancing tendon healing and reducing retear rate. This study aimed to evaluate the clinical and imaging outcomes of RCR augmented with a xeno-derived collagen membrane over 24 months and to assess complications or implant failures. Methods: Patients underwent arthroscopic RCR using anchors (single or double-row) with additional xeno-derived matrix augmentation. The study included patients older than 40 years with full-thickness supraspinatus and/or infraspinatus tendon tears (DeOrio-Cofield grade 3-4) who were candidates for arthroscopic rotator cuff repair and provided informed consent. Clinical outcomes were assessed using the Constant-Murley Score (CMS), Disabilities of the Arm, Shoulder and Hand score (DASH), and Visual Analogue Score (VAS) at baseline, 3, 6, 12, and 24 months. MRI was performed preoperatively and at 24 months to assess tendon thickness. Results: All scores improved significantly. CMS increased from 16.3 ± 4.1 to 82.9 ± 5.8, VAS decreased from 7.8 ± 1.0 to 1.5 ± 0.8, and DASH improved from 70.3 ± 6.4 to 12.4 ± 4.5 (p < 0.05). Tendon thickness in the supraspinatus (T3) increased from 4.2 ± 0.9 mm to 6.8 ± 1.2 mm (p < 0.05). Retear rate was 7.55%, with no major complications. Conclusions: The bioinductive collagen implant showed notable results in improving tendon thickness, healing, and excellent clinical outcomes in RCR, without membrane-related complications. The study was designed as a prospective single-arm case series without a control group and that was the main limitation; The absence of adverse reactions in this cohort further supports the favorable safety profile of this implant in the present study population.