Arthroscopic Rotator Cuff Repair Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorJoseph W. Galvin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients > 18 years of age who speak English, indicated for arthroscopic rotator cuff repair and open subpectoral biceps tenodesis.

Supraspinatus (+/- anterior infraspinatus tendon) full thickness tears.

Medium (1-3cm) and large (3-5) cm tears. Classification according to anterior to posterior dimensions: small <1cm, medium 1-3 cm, large 3-5 cm, massive >5cm or 2 tendons.

Patte Grade 1 and 2. Patte Classification: grade 1, tear at insertion; grade 2, retracted to humeral head; grade 3, retracted to glenoid or medial to glenoid.

Disqualifiers

Pregnant women, non-English speakers and prisoners.

Patients with prior surgery on the ipsilateral shoulder.

Worker's compensation status.

Adhesive capsulitis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rotator cuff repair with biceps patch augmentation

    Procedure/Surgery

    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/Surgery

    Standard of care technique. Active comparator

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Cuff repair without patch autograftActive comparator 1 intervention
Group B: Cuff repair with patch augmentationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ASES Score

American Shoulder and Elbow Surgeons Score. From 0-100. Higher is better

Time frame
1 year post-operative

Secondary outcomes

1

Rotator cuff healing

Signs of cuff healing in MRI

Time frame
6 months post-operative

Other outcomes

1

SANE Score

From 0-100, how good the shoulder feels. Higher is better

Time frame
1 year post-operative
2

VAS Pain Score

0-10. Higher is worse

Time frame
1 year post-operative
3

ROM

Range of motion

Time frame
1 year post-operative

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Joseph W. Galvin

Lead sponsor

University of Iowa

Sponsor institution

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