Analysis of the Fixation of the Proximal Biceps Tendon

August 17, 2020 updated by: Carmen Latona, West Penn Allegheny Health System

Analysis of the Fixation of the Proximal Long Head of the Biceps Tendon

Ten randomly selected patients that have undergone an open proximal biceps tendon tenodesis with an EndoButton for bicipital pathology with Christopher Schmidt, MD, will be asked to participate in the study. The study will assess the tendon healing to bone through magnetic resonance imaging (MRI). Individuals will also be asked to fill a visual analog scale (VAS) pain and disability of the arm shoulder and hand (DASH) assessment tools. The variables for our objective will include age, hand dominance, gender and chronicity of symptoms prior to surgery, and other related surgical procedures.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

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
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Allegheny Imaging of McCandless

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This research study will collect the MRI and questionnaire data from 10 subjects that have undergone a subpectoral proximal biceps tendon tenodesis using the EndoButton.

Description

Inclusion Criteria:

  • Undergone open subpectoral proximal biceps tenodesis with the EndoButton

Exclusion Criteria:

  • No history of surgery or disability in the contra-lateral extremity
  • Not a member of a legally restricted group or protected population
  • No prior surgery or further surgery on the extremity of interest
  • No condition preventing the individual from undergoing a MRI

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Proximal Biceps Tendon Tenodesis
Procedure: Open proximal biceps tendon tenodesis with an EndoButton
Surgical fixation for bicipital pathology

Collaborators and Investigators

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

Sponsor

West Penn Allegheny Health System

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)

March 11, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

March 16, 2011

First Submitted That Met QC Criteria

March 16, 2011

First Posted (Estimate)

March 17, 2011

Study Record Updates

Last Update Posted (Actual)

August 19, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-5202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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