Patch Study (Patch-augmented Rotator Cuff Repair)

Spital Thurgau AG

Status: Enrolling

Conditions: Rotator Cuff Tears

Treatments: Device: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch; Device: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device))

Study type: Interventional

Funder types: Other

Identifiers

NCT06076902

ProjectID 2023-00238

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Treatment group with patch augmentation

Experimental group

Description:

Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch

Treatment:

Device: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device))

Comparison group without patch augmentation

Active Comparator group

Description:

Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch

Treatment:

Device: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch