Patch Study (Patch-augmented Rotator Cuff Repair)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Device: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device))
* Device: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group with patch augmentation<br>Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch | Device: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device))<br>* 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.<br>* Other names: Pitch-Patch Tissue Reinforcement Device (version model number 102-1090);|
| Active Comparator: Comparison group without patch augmentation<br>Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch | Device: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch<br>* Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rotator cuff retear rate | Occurence of retear following rotator cuff reconstruction to treat massive tear (measured using radiological imaging/ultrasound) | Up to two years postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate (adverse event greater than grade 2) | Development of postoperative complications following rotator cuff reconstruction to treat massive tear | Up to two years postoperative | 
| Pain levels | During clinical assessments, patient reported pain levels will be measured using visual analogue scale (VAS); scale 0 (low) to 15 (high) | Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits) | 
| Healing rate | Using radiological imaging (ultrasound), healing of the rotator cuff tear will be monitored over time | 6-week and 1-year exams (postoperative) | 
| Range of motion | Clinical assessments of healing using the range of motion will be compared over time | Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotator Cuff Repair