NCT06076902

Patch Study (Patch-augmented Rotator Cuff Repair)

Patch Study: a Single-center, Prospective, Single-blind, Randomized, Two-arm Controlled Study of Outcomes Following Synthetic Polyester Patch-augmented Rotator Cuff Repair

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Spital Thurgau AG · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The Pitch-Patch is a single-use synthetic polyester patch (Pitch-Patch, neoligamentsTM, Leeds, UK) intended to reinforce the rotator cuff following or during repair by sutures or suture anchors where weakness exists in the soft tissue. The surgical group will be randomly assigned, and each group will include 150 patients. After surgery, patients will be followed for two years and undergo clinical and radiological assessments. The main research question to be answered by this investigation is whether synthetic patch augmentation can significantly improve outcomes in patients with rotator cuff tears from either degenerative or traumatic origins versus patients with no patch augmentation.

Conditions

• Rotator Cuff Tears

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2023-04-06
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2023-10-11
• Last updated: 2023-10-11

Locations

1 site across 1 country: Switzerland