Long-term Safety Study of the Pitch-Patch Device for Repairing Rotator Cuff Tears Using a Polyester Patch to Support Partial Rotator Cuff Repairs

What this Trial Is About

This research aims to verify the long-term safety and performance of the Pitch-Patch device when used to reinforce partially repairable rotator cuff tears. The study focuses on patients who have already received this device, which is a polyester prosthesis designed to provide strength and stability to rotator cuff repairs. The device is manufactured by Xiros Ltd and is already available on the market. Participants in this single-armed study will all have had the Pitch-Patch implanted as part of their rotator cuff repair. The device comes in two sizes, and the study will collect data over a total of three years. Patients will be enrolled during a follow-up visit occurring between 2 and 2.5 years after their implant surgery. Data from earlier time points, including 3 months, 6 months, and 1 year after surgery, will be gathered retrospectively from medical records if available. Throughout the study, participants will be monitored using assessments such as the Constant Murley Score and evaluations of device-related or procedure-related adverse events at the 2-year mark. Additional measures include re-tear rates, shoulder function scores, activity levels, and tissue integration into the patch. The study is designed to track the devices performance and safety through both retrospective record review and prospective follow-up visits lasting up to three years.

Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff