Analysis of Suprapectoral and Subpectoral Biceps Tenodesis

NCT ID: NCT02192073

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2020-09-01

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.

Conditions

Biceps Tendonitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Suprapectoral Biceps tenodesis

Intervention Type: PROCEDURE

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

Group Type: ACTIVE_COMPARATOR

Subpectoral biceps tenodesis

Intervention Type: PROCEDURE

Interventions

Suprapectoral Biceps tenodesis

Intervention Type: PROCEDURE

Subpectoral biceps tenodesis

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Carla Edwards

Clinical Research Manger

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nikhil N Verma, MD

Role: PRINCIPAL_INVESTIGATOR

Rush Univeristy Medical Center

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

References

Forsythe B, Berlinberg EJ, Diaz CC, Korrapati A, Agarwalla A, Patel HH, Cole BJ, Cvetanovich GL, Yanke AB, Romeo AA, Verma NN. No Difference in Clinical Outcomes for Arthroscopic Suprapectoral Versus Open Subpectoral Biceps Tenodesis at Midterm Follow-up: A Randomized Prospective Analysis. Am J Sports Med. 2022 May;50(6):1486-1494. doi: 10.1177/03635465221084731.

Reference Type: DERIVED

PMID: 35507468 (View on PubMed)

Other Identifiers

13081402

Identifier Type: -

Identifier Source: org_study_id