- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01317719
Prospective Biceps Study
September 17, 2020 updated by: Carmen Latona, West Penn Allegheny Health System
The primary goal of this study is to determine if surgical repair of the distal biceps fully restores the supination strength of the forearm.
Secondarily, the investigators want to examine the insertion site location of the tendon and determine if it correlates with the patients' functional outcome as determined by Disabilities of the Arm, Shoulder, and Hand (DASH), Visual Analog Pain Scale (VAPS), and isometric supination torque testing.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
15
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
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States
- Allegheny Imaging of McCandless
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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 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who have received primary distal biceps repair by Dr. Schmidt
Description
Inclusion Criteria:
- primary distal biceps repair with endobutton
Exclusion Criteria:
- any ipsilateral wrist, forearm, or elbow condition
- any contraindication to having an 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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Distal Biceps Ruptures
|
Surgical Repair of the Distal Biceps Tendon
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 14, 2011
Primary Completion (ACTUAL)
December 30, 2013
Study Completion (ACTUAL)
December 30, 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)
September 18, 2020
Last Update Submitted That Met QC Criteria
September 17, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC-5159
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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