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Patch Study (Patch-augmented Rotator Cuff Repair)

RecruitingNAAges 30 Years - 75 YearsAllSpital Thurgau AG
NCT06076902 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This single-center, prospective, randomized controlled study will compare patients allocated to two treatment arms who are undergoing surgery to repair rotator cuff tears: (1) arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch, and (2) arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch. The primary objective is to compare complications (primarily retear rates) and the secondary objective is to compare mid- and long-term clinical and radiological outcomes using standard orthopedic assessments, such as the subjective shoulder value and the Constant-Murley score.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults with massive rotator cuff tear * Tear must affect at least two tendons * Primary surgery only * Origin of tear can be either degenerative or traumatic * German language speaking Exclusion Criteria: * Fatty infiltration grade 4 (according to Goutallier) * Bilateral tears * Cases of arthritis or severe osteoarthritis * Structural or pathological condition of the bone or soft tissue that could impair healing * Unable or unwilling to restrict activities to prescribed levels or follow rehabilitation guidelines * Unable or unwilling to give consent (language barrier or cognitive impairment) * Unwilling or unable to be assessed at 1- and 2-year follow-up assessment visits
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What it tests

  • Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device))
  • Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch
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Where

1 site
Spital Thurgau AG
Frauenfeld, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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