A Prospective Study Comparing Suture Anchor and Soft Tissue Pectoralis Major Tendon Techniques for Biceps Tenodesis

Stopped early · Not applicable

Conditions studied: Bicep Tendinitis, Biceps; Tenosynovitis, Biceps Tendon Disorder

In brief

This is a prospective randomized controlled trial comparing two common techniques of long head of biceps tendon tenodesis in shoulder surgery. Numerous techniques of biceps tenodesis currently exist and are commonly performed. We will be comparing the tenodesis procedure using a suture anchor device versus a technique where the tendon is simply sutured to the pectoralis major tendon.

Key facts

Study ID

NCT03529162

Run by

St. Louis University

People needed

4

Starts

2018-10-19

Expected to finish

2020-01-27

Last updated by the study team

2021-04-29

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18 - 100 years
• Able to provide written informed consent
• Has: (a) partial- or full-thickness rotator cuff tear verified by preoperative magnetic resonance imaging (MRI) and arthroscopy; (b) concomitant biceps lesions (LHBT partial tear>50%, SLAP type II lesion, pulley lesion, or subluxation/dislocation of LHBT) that were diagnosed arthroscopically with concomitant symptoms; and (c) arthroscopic rotator cuff repair.

You may not qualify if…

• Any medical illness that adversely impacts the patient's ability to complete the study procedures
• Isolated glenohumeral pathological conditions
• Any prior surgery on the same shoulder
• Complete rupture of the LHBT assessed by MRI or at time of procedure
• Incomplete repair of the rotator cuff

Where it is running

• Saint Louis University — St Louis, Missouri, United States
• SSM Health - Saint Louis University Hospital — St Louis, Missouri, United States
• SSM Health - St. Mary's Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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