Patch Study (Patch-augmented Rotator Cuff Repair)

Recruiting now · Not applicable

Conditions studied: Rotator Cuff Tears

In brief

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.

Key facts

Study ID

NCT06076902

Run by

Spital Thurgau AG

People needed

300

Starts

2023-04-06

Expected to finish

2027-04-30

Last updated by the study team

2023-10-11

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Spital Thurgau AG — Frauenfeld, Thurgau, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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