Retrospective Data Collection and Prospective Clinical Investigation for the Augmentation or Reinforcement of the Rotator Cuff Using the Pitch-Patch

Launched by XIROS LTD · Jun 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a device called the Pitch-Patch, which is used to help repair rotator cuff tears in the shoulder. The goal is to see how safe and effective the Pitch-Patch is over a long period after it has been implanted. The Pitch-Patch is a polyester device that helps reinforce partially repairable tears in the rotator cuff. This study will involve collecting information from patients who have received this device since 2012, and it aims to understand how well it works in real-life situations.

To participate in this study, patients must have been treated with the Pitch-Patch for their rotator cuff injuries. Anyone who agrees to join will be asked to provide consent after understanding the study's purpose. The study will last for four years, including two years of recruiting patients and two years of follow-up to gather data on their recovery at different points, such as three months, six months, and up to five years after the procedure. This is a great opportunity for patients to contribute to research that could improve shoulder injury treatments in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Treated using Pitch-Patch device for augmentation or reinforcement of the rotator cuff since 2012.
• • If applicable, patient is willing to participate in the study (beyond standard of (routine) care) and have been informed of the nature of the study, agree to its follow-up and have provided written informed consent as approved by the Ethics Committee (EC).
• Exclusion Criteria:
• • There are no exclusion criteria; the aim of this study is to collect all data to see how the device is used in the real world setting.