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Analysis of Suprapectoral and Subpectoral Biceps Tenodesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02192073
Recruitment Status : Withdrawn
First Posted : July 16, 2014
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Carla Edwards, Rush University Medical Center

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : September 1, 2020
Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Nikhil N Verma, MD Rush Univeristy Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Carla Edwards, Clinical Research Manger, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02192073    
Other Study ID Numbers: 13081402
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries