Patch Study (Patch-augmented Rotator Cuff Repair)

NCT ID: NCT06076902

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-06
• Study Completion Date: 2027-04-30

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.

Conditions

Rotator Cuff Tears

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment group with patch augmentation

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Comparison group without patch augmentation

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Pitch-Patch Tissue Reinforcement Device (version model number 102-1090)

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spital Thurgau AG

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florian Hess, MD

Role: PRINCIPAL_INVESTIGATOR

Spital Thurgau AG

Locations

Spital Thurgau AG

Frauenfeld, Thurgau, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Florian Hess, MD

Role: CONTACT

florian.hess@stgag.ch

+41 58 144 8143

Facility Contacts

Florian Hess, MD

Role: primary

florian.hess@stgag.ch

+41 58 144 8143

Other Identifiers

ProjectID 2023-00238

Identifier Type: -

Identifier Source: org_study_id