TerminatedNot Applicable

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

Stopped: COVID-19, followed by PI leaving institution.

United States4 participantsStarted 2018-10-19

Plain-language summary

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.

Who can participate

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

What they're measuring

Change in Long Head of the Biceps Tendon Score (LHB)

Timeframe: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.

Trial details

NCT IDNCT03529162

SponsorSt. Louis University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-27

Results submitted2021-01-27