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

April 24, 2023 updated by: University of Chicago

Biceps Tenotomy or Tenodesis in Treating Long Head of the Biceps Pathology: a Prospective Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patient with chronic refractive bicipital pain

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Lewis L Shi, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2013

Primary Completion (Actual)

April 8, 2014

Study Completion (Actual)

April 8, 2014

Study Registration Dates

First Submitted

April 4, 2014

First Submitted That Met QC Criteria

April 7, 2014

First Posted (Estimate)

April 8, 2014

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB13-0117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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