Actively Recruiting
Post-Market Clinical Follow-up Study of the Pitch-Patch Device for Rotator Cuff Tear Repair
Led by Xiros Ltd · Updated on 2026-05-15
37
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
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 device's performance and safety through both retrospective record review and prospective follow-up visits lasting up to three years.
CONDITIONS
Brief Title
Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has been treated using a Pitch-Patch device for augmentation or reinforcement of the rotator cuff 2-2.5 years prior to enrolment.
- Patient has a baseline Constant Murley Score (CMS), assessed within 30 days prior to implantation of the device.
- Patient must be 16 years old or above.
- Patient is willing to participate in the study and has provided written informed consent as approved by the Ethics Committee.
You will not qualify if you...
- The Pitch-Patch has been used outside its intended use.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 months
Participants who have previously received the Pitch-Patch device are followed up to assess long-term safety and performance of the device.
1 to 2 visits depending on cohort assignment
Trial Site Locations
Total: 1 location
1
Reading Shoulder Unit
Reading, United Kingdom, RG1 6UZ
Actively Recruiting
Research Team
L
Lisa Cook
V
Vikki Adams
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here