Patch Study: a Single-center, Prospective, Single-blind, Randomized, Two-arm Controlled Study of Outcomes Following Synthetic Polyester Patch-augmented Rotator Cuff Repair
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Spital Thurgau AG
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Rotator cuff retear rate
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Single blind study in which only patients will not be aware of treatment (with or without rotator cuff augmentation with polyester patch)
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment group with patch augmentation
Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch
Intervention: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device)) (Device)
Comparison group without patch augmentation
Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch
Intervention: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch (Device)
Outcomes
Primary Outcomes
Rotator cuff retear rate
Time Frame: Up to two years postoperative
Occurence of retear following rotator cuff reconstruction to treat massive tear (measured using radiological imaging/ultrasound)
Secondary Outcomes
- Complication rate (adverse event greater than grade 2)(Up to two years postoperative)
- Pain levels(Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits))
- Healing rate(6-week and 1-year exams (postoperative))
- Range of motion(Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits))