Analysis of Suprapectoral and Subpectoral Biceps Tenodesis

Biceps Tendonitis Clinical Trial

Official title:

Prospective Analysis of Arthroscopic Suprapectoral and Open Subpectoral Biceps Tenodesis: 1 Year Follow-Up

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02192073
• Other study ID #: 13081402
• Status: Withdrawn
• Phase: N/A
• Start date: May 2014
• Est. completion date: September 1, 2020

Study information

• Verified date: September 2021
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Biceps Tendonitis
• Tendinopathy

Intervention

Procedure:
• Suprapectoral Biceps tenodesis

• Subpectoral biceps tenodesis

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Shoulder and Elbow Surgeons (ASES) Shoulder Score	Validated outcome score assessing pain and function of shoulder	1 year
Secondary	Constant Score	Validated score to assess shoulder pain and function	1 year