Analysis of Suprapectoral and Subpectoral Biceps Tenodesis

NCT02192073 | Withdrawn

• 1 other identifier: 13081402
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• American Shoulder and Elbow Surgeons (ASES) Shoulder Score

  Validated outcome score assessing pain and function of shoulder

  1 year

Secondary Outcomes (1)

• Constant Score

  1 year

Study Arms (2)

Suprapectoral Biceps Tenodesis

ACTIVE COMPARATOR

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

Procedure: Suprapectoral Biceps tenodesis

Subpectoral Biceps Tenodesis

ACTIVE COMPARATOR

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

Procedure: Subpectoral biceps tenodesis

Interventions

Suprapectoral Biceps tenodesis PROCEDURE

Suprapectoral Biceps Tenodesis

Subpectoral biceps tenodesis PROCEDURE

Subpectoral Biceps Tenodesis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• 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.

  PMID: 35507468 DERIVED

Study Officials

• Nikhil N Verma, MD

  Rush Univeristy Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Manger

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: July 16, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2020
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

US (1)