Functional Review of Distal Biceps Re-Insertion NCT01278251

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Completed

Study information
Verified date	January 2011
Source	West Penn Allegheny Health System
Contact	n/a
Is FDA regulated	No
Health authority	United States: ASRI-WPAHS Institutional Review Board
Study type	Observational

This study seeks to test the hypothesis that endobutton repair of the ruptured distal biceps successfully restores elbow function.

Recruitment information / eligibility
Status	Completed
Enrollment	0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender	Both
Age group	20 Years to 80 Years
Eligibility	Inclusion Criteria: - primary distal biceps repair with endobutton - at least two years from date of surgery Exclusion Criteria: - any ipsilateral wrist, forearm, or elbow condition - any contraindication to having an MRI

Observational Model: Case-Only, Time Perspective: Retrospective

Procedure:
• Distal Biceps Re-Insertion

Locations
Country	Name	City	State
United States	Allegheny Imaging of McCandless	Pittsburgh	Pennsylvania

Sponsors *(1)*
Lead Sponsor	Collaborator
West Penn Allegheny Health System

United States,