Arthroscopic Rotator Cuff Repair Trial

Sponsor
Joseph W. Galvin
Study ID
NCT07568392
Status
Not Yet Recruiting

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Conditions

  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Rotator cuff repair with biceps patch augmentation — PROCEDURE
    This is a standard of care practice surgical technique. This arm will undergo arthroscopic rotator cuff repair with the use of called "Biceps Smash" technique which may provide improved tendon thickness and biology with limited morbidity and in a cost effective approach
  • Rotator cuff repair without biceps patch augmentation — PROCEDURE
    Standard of care technique. Active comparator

Study Details

This study aims to assess post-operative outcomes and healing rates following arthroscopic rotator cuff repair with and without biceps tendon autograft patch augmentation in patients with medium to large rotator cuff tears. This will be a single center, parallel arm randomized trial within the Orthopedics Shoulder Surgery Department at University of Iowa Hospitals and Clinics (UIHC). Eligible patients indicated for arthroscopic rotator cuff repair and open subpectoral biceps tenodesis will be enrolled, consented and randomized, in a 1:1 scheme, into 2 study arms. Arm 1 will consist of arthroscopic rotator cuff repair without biceps tendon autograft. Arm 2 will consist of arthroscopic rotator cuff repair with biceps tendon autograft patch augmentation. Outcomes of interest are American Shoulder and Elbow Surgeons Score (ASES), at 1 year and 2 years postoperatively. Exploratory outcomes are SANE, VAS Pain and active shoulder range of motion, and healing signs on MRI imaging studies at minimum 6-months postoperatively.

Key Dates

First listed
May 5, 2026
Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cuff repair without patch autograft
    Arthroscopic rotator cuff repair without patch augmentation
  • Experimental: Cuff repair with patch augmentation
    Arthroscopic rotator cuff repair with patch augmentation

Primary Outcome Measure

ASES Score [ Time Frame: 1 year post-operative ]

Central Contacts

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