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Patch Study (Patch-augmented Rotator Cuff Repair)
Sponsor: Spital Thurgau AG
Summary
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.
Official title: Patch Study: a Single-center, Prospective, Single-blind, Randomized, Two-arm Controlled Study of Outcomes Following Synthetic Polyester Patch-augmented Rotator Cuff Repair
Key Details
Gender
All
Age Range
30 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2023-04-06
Completion Date
2027-04-30
Last Updated
2023-10-11
Healthy Volunteers
No
Conditions
Interventions
Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement 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
Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch.
Locations (1)
Spital Thurgau AG
Frauenfeld, Thurgau, Switzerland