Analysis of Suprapectoral and Subpectoral Biceps Tenodesis

Not Applicable

Withdrawn

• Conditions: Biceps Tendonitis
• Interventions: Procedure: Suprapectoral Biceps tenodesis; Procedure: Subpectoral biceps tenodesis

• Registration Number: NCT02192073
• Lead Sponsor: Rush University Medical Center

Brief Summary

Biceps pathology typically includes pain in the anterior shoulder that is reproduced with provocative maneuvers. However, optimal treatment of patient with this diagnosis is not clear and can include tenotomy (cutting the biceps) or various forms of tenodesis (cutting then reattaching). As tenotomy can lead to cosmetic deformity and anterior humeral discomfort from spasms, many surgeons perform tenodesis. There are various techniques for tenodesis. This study will compare 2 methods: suprapectoral (doing the surgery using an incision higher in the shoulder) versus subpectoral fixation (surgery which involves making an incision lower in the shoulder).

Purpose of the study is to prospectively determine whether arthroscopic suprapectoral or open subpectoral biceps tenodesis results in better function.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-16
• Primary Completion: 2018-09-01
• Study Completion: 2020-09-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Scheduled to undergo biceps tenodesis
• Pain at intertubercular groove
• Anterior Humeral pain
• Patient agrees to follow up and consent

Exclusion Criteria

• Biceps Tenotomy
• Revision biceps procedure
• Prior SLAP or labral repair
• Concomitant subscapularis repair
• More than 1 rotator cuff repair at time of surgery
• Concomitant arthroplasty
• Prior infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suprapectoral Biceps Tenodesis	Suprapectoral Biceps tenodesis	Suprapectoral Biceps Tenodesis involves detaching the long head of biceps from it's origin and reattaching it to humerus in the superior border of the pectoralis major insertion
Subpectoral Biceps Tenodesis	Subpectoral biceps tenodesis	Subpectoral Biceps Tenodesis involves detaching the long head of biceps from it's origin and reattaching it to humerus in the inferior border of the pectoralis major insertion

Primary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons (ASES) Shoulder Score	1 year	Validated outcome score assessing pain and function of shoulder

Secondary Outcome Measures

Name	Time	Method
Constant Score	1 year	Validated score to assess shoulder pain and function

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States