Patch Study (Patch-augmented Rotator Cuff Repair)

Sponsor
Spital Thurgau AG
Study ID
NCT06076902
Status
Recruiting
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Conditions

  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device)) — DEVICE
    The Pitch-Patch is a single-use device intended to reinforce the rotator cuff following or during repair by sutures or suture anchors where weakness exists in the soft tissue.
  • Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch — DEVICE
    Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch.

Study Details

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.

Key Dates

First listed
Oct 11, 2023
Start date
Apr 6, 2023
Status verified
Oct 2023
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group with patch augmentation
    Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch
  • Active Comparator: Comparison group without patch augmentation
    Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch

Primary Outcome Measure

Rotator cuff retear rate [ Time Frame: Up to two years postoperative ]

Central Contacts

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