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

Sponsor
Xiros Ltd
Study ID
NCT05906004
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jun 15, 2023
Start date
May 31, 2026
Status verified
May 2026
Primary completion
Nov 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
37 participants (estimated)

Primary Outcome Measure

Constant Murley Score (CMS) [ Time Frame: 2 years ]

Central Contacts

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