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Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff

NCT05906004 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 37

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

  • Rotator Cuff Tear
  • Rotator Cuff Tears
  • Rotator Cuff Tears of the Shoulder
  • Rotator Cuff Injuries

Interventions

DEVICE

Pitch-Patch

Pitch-Patch device used for rotator cuff augmentation/ reinforcement.

Sponsors & Collaborators

  • Xiros Ltd

    lead INDUSTRY

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2029-11-30
Completion
2029-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05906004 on ClinicalTrials.gov