CRE 031 Pitch-Patch Prospective Clinical Investigation
Research type
Research Study
Full title
Retrospective data collection and prospective clinical investigation for the augmentation or reinforcement of the rotator cuff using the Pitch-Patch
IRAS ID
321390
Contact name
Ofer Levy
Contact email
Sponsor organisation
Xiros Ltd
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
This post-market study will collect retrospective and prospective clinical data over at least the performance lifetime (i.e. 2 years) of the Pitch-Patch device to understand the long-term safety and performance of the device in the intended patient population when indicated for augmentation (strengthened) or reinforcement of the rotator cuff.
The aim is to collect data on both patch sizes (30 x 20 mm and 35 x 25mm) and both surgical techniques (open and key hole). The study also aims to collect data on the safety and performance of the device when implanted to reinforce partially repairable tears.
The study will include a minimum of 32 patients with Constant Murley Score (CMS) data at baseline and at least 2 years follow-up after surgery.
All patients in the study will be or have been recipients of the Pitch-Patch device, as part of their standard of (routine) care.
Maximum of 5 years follow-up data (if available) will be collected for the purposes of this study even if the site conducts longer follow-ups. Data is being collected at a longer follow-up (i.e. longer than the 2 years performance lifetime) to assess safety.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
23/EE/0039
Date of REC Opinion
21 Apr 2023
REC opinion
Further Information Favourable Opinion