Pitch-Patch Rotator Cuff Augmentation: Post-Market Follow-Up
Official title: Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff
Run by Xiros Ltd · NCT05906004 · Data updated 2026-11-12
This study follows patients who received the Pitch-Patch to reinforce partially repairable rotator cuff tears to see how well it performs and stays safe over the long term.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 37 (estimated) |
| Sponsor | Xiros Ltd Industry-sponsored |
| Locations | 1 site (Reading) |
| Status | Recruiting |
| Started | June 16, 2026 |
| Main results expected | November 2029 |
| Study ends | December 2029 |
| Registry record updated | September 4, 2026 |
| Trial ID | NCT05906004 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Individuals 16 years or older who were treated with a Pitch-Patch for augmentation or reinforcement of a rotator cuff tear 2–2.5 years ago and have a recent baseline Constant Murley Score within 30 days prior to implantation.
✕Probably not a fit
Patients whose rotator cuff condition does not rely on Pitch-Patch augmentation or whose injuries are outside the intended use may not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects long-term safety and performance data on the Pitch-Patch prosthesis used to reinforce partially repairable rotator cuff tears. It uses a prospective and retrospective design over about three years, enrolling at least 37 patients who received the device and assessing baseline, procedure details, and follow-up data up to 2 years post-implant (with retrospective collection when available). The device is a single-use polyester patch available in two sizes, and it is implanted according to the manufacturer's instructions. Data will come from medical records and study follow-up visits at 2–2.5 years after implantation. No control group is involved; all participants receive the Pitch-Patch as part of standard care.
Why it matters
Potential benefit: If successful, the study could confirm the Pitch-Patch’s long-term safety and support its continued use to reinforce rotator cuff repairs.
How similar studies have gone: Past data on similar augmentation devices have shown variable but notable benefits; this specific post-market follow-up may be one of the first to assess long-term outcomes for the Pitch-Patch.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient has been treated using a Pitch-Patch device for augmentation or reinforcement of the rotator cuff 2-2.5years 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 having been informed of the nature of the study, has provided written informed consent as approved by the Ethics Committee (EC). Exclusion Criteria: \- The Pitch-Patch has been used outside its intended use.
Where it's running
-
Reading Shoulder Unit
Reading, United Kingdom Recruiting
Study contacts
- Study coordinator: Lisa Cook
- Email: lisa.cook@xiros.co.uk
- Phone: +44 (0) 113 238 7200
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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FiberLocker® augmentation for rotator cuff repair
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This study is testing whether a slower or faster rehabilitation program after shoulder surgery helps people with severe rotator cuff tears recover better.
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Evaluating hemidiaphragmatic paralysis after shoulder surgery with nerve blocks
This study is testing how often patients having shoulder surgery with a specific nerve block experience breathing issues and how it affects their pain and use of pain medication afterward.
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Biomarkers to see if rotator cuff repairs will heal after surgery
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.