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Prospective Biceps Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by West Penn Allegheny Health System.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01317719
First Posted: March 17, 2011
Last Update Posted: March 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
West Penn Allegheny Health System
  Purpose
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.

Condition Intervention
Biceps Tendon Rupture Procedure: Distal Biceps Re-Insertion Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Biceps Study

Resource links provided by NLM:


Further study details as provided by West Penn Allegheny Health System:

Groups/Cohorts Assigned Interventions
Distal Biceps Ruptures Procedure: Distal Biceps Re-Insertion Surgery
Surgical Repair of the Distal Biceps Tendon

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have received primary distal biceps repair by Dr. Schmidt
Criteria

Inclusion Criteria:

  • primary distal biceps repair with endobutton

Exclusion Criteria:

  • any ipsilateral wrist, forearm, or elbow condition
  • any contraindication to having an MRI
  Contacts and Locations
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): NCT01317719


Locations
United States, Pennsylvania
Allegheny Imaging of McCandless
Pittsburgh, Pennsylvania, United States
Sponsors and Collaborators
West Penn Allegheny Health System
Investigators
Principal Investigator: Christopher C Schmidt, MD WPAHS
  More Information

Responsible Party: Allegheny Singular Research Institute
ClinicalTrials.gov Identifier: NCT01317719     History of Changes
Other Study ID Numbers: RC-5159
First Submitted: March 16, 2011
First Posted: March 17, 2011
Last Update Posted: March 17, 2011
Last Verified: January 2011

Keywords provided by West Penn Allegheny Health System:
Rupture of Distal Bicep Tendon

Additional relevant MeSH terms:
Rupture
Wounds and Injuries