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Comparison of Outcomes Between Biceps Tenotomy and Tenodesis in the Treatment of the Long Head of the Biceps Pathology

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ClinicalTrials.gov Identifier: NCT02107586
Recruitment Status : Unknown
Verified December 2016 by University of Chicago.
Recruitment status was:  Recruiting
First Posted : April 8, 2014
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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Brief Summary:
The purpose of the study is to determine what the different outcomes are for biceps tenodesis and tenotomy in the treatment of the long head of the biceps pathology.

Condition or disease Intervention/treatment Phase
Chronic Refractive Bicipital Pain Procedure: Biceps tenotomy Procedure: Biceps tenodesis Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biceps Tenotomy or Tenodesis in Treating Long Head of the Biceps Pathology: a Prospective Randomized Controlled Trial
Study Start Date : January 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Biceps tenodesis
32 subjects in the study will receive biceps tenodesis as a surgical intervention
 Procedure: Biceps tenodesis
Biceps tenodesis involves detaching the long head of the biceps from it's superior labrum in the shoulder and reattaching it to the humerus bone just below the shoulder.
Active Comparator: Biceps tenotomy
32 subjects in the study will receive biceps tenotomy as a surgical intervention
 Procedure: Biceps tenotomy
A biceps tenotomy procedure involves cutting of the long head of the biceps just prior to its insertion on the superior labrum of the glenoid.


Outcome Measures
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Primary Outcome Measures :
  1. American Shoulder and Elbow Surgeons (ASES) Shoulder Score [ Time Frame: one year ]
    The scale measures pain from 0 to 10 and also includes a questionnaire for assessing the activity of daily living.


Secondary Outcome Measures :
  1. EuroQol EQ-5D [ Time Frame: one year ]
    The questionnaire measures mobility, ability to care for self, ability to perform usual activities, pain/discomfort, and anxiety/depression


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient with chronic refractive bicipital pain

Exclusion Criteria:

-

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): NCT02107586


Contacts
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Contact: Lewis L Shi, MD 773-795-3583 lshi@bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Lewis L Shi, MD         
Sub-Investigator: Mohammed Hussain, BS         
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Lewis L Shi, MD University of Chicago
More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02107586    
Other Study ID Numbers: IRB13-0117
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Chicago:
biceps tenodesis
biceps tenotomy
biceps tendonitis
biceps inflammation
shoulder surgery