Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff
Recruiting
Observational Study
Rotator Cuff Tear
Rotator Cuff Tears
Rotator Cuff Tears of the Shoulder
Rotator Cuff Injuries
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 16 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 37 (estimated)
- Sponsor
- Xiros Ltd · Industry
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About This Trial
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…
Trial Locations
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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 year…
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