Forearm Position in Subpectoral Biceps Tenodesis

December 1, 2020 updated by: Bulent KARSLIOGLU, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Does Forearm Position Matter in Subpectoral Biceps Tenodesis? A Randomised Controlled Trial

The investigators aimed to compare two different forearm positions, extension-pronation (EP) or neutral, for fixation of the long head of the biceps tendon (LHB) in biceps tenodesis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Long head of biceps pathologies have been regarded as a source of anterior shoulder pain and disability. Tenodesis is preferable surgical choice for especially young patients to to eliminate anterior shoulder pain. The optimal position of the elbow and forearm during tenodesis is a debated topic. The investigators aimed to evaluate pain and strength loss after biceps tenodesis fixed at extension-pronation (EP) and neutral positions. The investigators aimed to find the most appropriate and anatomical arm position that gives better clinical and functional results.

Study Type

Interventional

Enrollment (Actual)

50

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

  • Turkey
      • Istanbul, Turkey
        • SBU Prof. Cemil Tascioglu City Hospital

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

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-Participants with diagnosis of chronic biceps tendinitis

Exclusion Criteria:

- Participants who had undergone rotator cuff repair surgery

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: Fixated in the EP position
Long head of biceps tenodesis was performed for 25 patients whose joints were fixated while forearm in the extension-pronation (EP) position
Procedure: Fixation while forearm in extension-pronation position
Fixation was performed after tenodesis in the extension-pronation position, which is the anatomically most suitable position of the biceps tendon.
No Intervention: Fixated in the neutral position
Long head of biceps tenodesis was performed for 25 patients whose joints were fixated while forearm in the neutral position (elbow 90 degrees flexed and hands positioned with the thump pointing up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the two groups in terms of functional score
Time Frame: 6 months
The investigators evaluated the functional results of the patients with the Ases score. 100 points is the best result in 17 questions.
6 months

Collaborators and Investigators

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

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Investigators

  • Study Chair: Bulent Karslıoğlu, SBU Prof Cemil Tascioglu City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 1, 2013

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

December 1, 2020

First Posted (Actual)

December 2, 2020

Study Record Updates

Last Update Posted (Actual)

December 2, 2020

Last Update Submitted That Met QC Criteria

December 1, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Forearm position in tenodesis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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