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.
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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…
Contacts

Lisa Cook

+44 (0) 113 238 7200

lisa.cook@xiros.co.uk

CONTACT

Vikki Adams

07825626018

vikki.adams@xiros.co.uk

CONTACT