Patch Study (Patch-augmented Rotator Cuff Repair)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device)), Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Tears. Basic parameters: 30 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Rotator cuff retear rate [Time frame: Up to two years postoperative]
Secondary outcome measures (4)
- Complication rate (adverse event greater than grade 2) [Time frame: Up to two years postoperative]
- Pain levels [Time frame: Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits)]
- Healing rate [Time frame: 6-week and 1-year exams (postoperative)]
- Range of motion [Time frame: Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- Spital Thurgau AG — Frauenfeld
Identifiers
NCT: NCT06076902 · ProjectID 2023-00238