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Analysis of Suprapectoral and Subpectoral Biceps Tenodesis

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ClinicalTrials.gov Identifier: NCT02192073
Recruitment Status : Recruiting
First Posted : July 16, 2014
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Biceps Tendonitis Procedure: Suprapectoral Biceps tenodesis Procedure: Subpectoral biceps tenodesis Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Analysis of Arthroscopic Suprapectoral and Open Subpectoral Biceps Tenodesis: 1 Year Follow-Up
Study Start Date : May 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Active Comparator: 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
Procedure: Suprapectoral Biceps tenodesis
Active Comparator: 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
Procedure: Subpectoral biceps tenodesis



Primary Outcome Measures :
  1. American Shoulder and Elbow Surgeons (ASES) Shoulder Score [ Time Frame: 1 year ]
    Validated outcome score assessing pain and function of shoulder


Secondary Outcome Measures :
  1. Constant Score [ Time Frame: 1 year ]
    Validated score to assess shoulder pain and function



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192073


Contacts
Contact: Mukesh Ahuja, MBBS 312-563-2214

Locations
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Barb L Ramsey, RN    312-563-2883      
Principal Investigator: Nikhil N Verma, MD         
Sub-Investigator: Brian Forsythe, MD         
Sub-Investigator: Anthony Romeo, MD         
Sub-Investigator: Gregory Nicholson, MD         
Sub-Investigator: Brian J Cole, MD         
Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: Nikhil N Verma, MD Rush Univeristy Medical Center

Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02192073     History of Changes
Other Study ID Numbers: 13081402
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: October 2017

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries