NCT05906004 Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff
| NCT ID | NCT05906004 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xiros Ltd |
| Condition | Rotator Cuff Tear |
| Study Type | OBSERVATIONAL |
| Enrollment | 37 participants |
| Start Date | 2026-05 |
| Primary Completion | 2029-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 37 participants in total. It began in 2026-05 with a primary completion date of 2029-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a clinical investigation study. It will verify the long-term safety and performance of the Pitch-Patch when implanted to reinforce partially repairable rotator cuff tears and used as described by the manufacturer's instructions. The medical device in this study is already on the market and is manufactured by Xiros Ltd. The Pitch-Patch is a single-use polyester prosthesis available in two sizes (30x20mm and 35x25mm). It is reinforced around the perimeter and around each eyelet to provide strength and stability to the device and repair. The study will collect data on patients who meet the entry criteria and have received the device. This is a single-armed study, meaning all patients will have a Pitch-Patch. The total length of the study is expected to be 3 years. A minimum of 37 patients will be enrolled into the study. Patients will be enrolled at a study specific follow up visit 2-2.5 years after implant, and data for baseline, procedure, and other time points prior to 2 years (3month, 6month, and 1 year post surgery) will be collected retrospectively from medical records if available.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05906004 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Rotator Cuff Tear. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05906004 currently recruiting?
Yes, NCT05906004 is actively recruiting participants. Contact the research team at lisa.cook@xiros.co.uk for enrollment information.
Where is the NCT05906004 trial being conducted?
This trial is being conducted at Reading, United Kingdom.
Who is sponsoring the NCT05906004 clinical trial?
NCT05906004 is sponsored by Xiros Ltd. The trial plans to enroll 37 participants.