RePaReREGENETEN Bioinductive Implant System for Rotator Cuff Repair: Real World Post-Market Evaluation

This study focuses on individuals undergoing rotator cuff repair using the REGENETEN◊ Bioinductive Implant System. The main goal is to gather real-world data from up to 400 patients across 50 centers in the UK, Europe, and Australia. The study aims to understand the clinical and health economic outcomes following this specific type of rotator cuff repair. This research is important as it can provide valuable insights into the effectiveness and cost-efficiency of the REGENETEN◊ Bioinductive Implant System in real-world settings, potentially improving care for those with rotator cuff injuries. Patients participating in this study will receive treatment and evaluation according to standard medical care. The study will collect outcome data for up to 2 years post-surgery. The outcomes measured include the EuroQol 5 Dimension 5 Level (EQ-5D-5L) score, Oxford Shoulder Score (OSS), Pain Visual Analog Scale (VAS) score, Quick DASH (Disabilities of Arm, Shoulder and Hand) score, and Single Assessment Numeric Evaluation (SANE) score. These measures assess various aspects of a patient's health and quality of life, such as mobility, self-care, usual activities, pain, and overall shoulder condition. Higher scores in these measures generally indicate better outcomes.