NCT01317719

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2013

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

3 years

First QC Date

March 16, 2011

Last Update Submit

September 17, 2020

Conditions

Biceps Tendon Rupture

Keywords

Rupture of Distal Bicep Tendon

Study Arms (1)

Distal Biceps Ruptures

Procedure: Distal Biceps Re-Insertion Surgery

Interventions

Distal Biceps Re-Insertion SurgeryPROCEDURE

Surgical Repair of the Distal Biceps Tendon

Distal Biceps Ruptures

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have received primary distal biceps repair by Dr. Schmidt

You may qualify if:

  • primary distal biceps repair with endobutton

You may not qualify if:

  • any ipsilateral wrist, forearm, or elbow condition
  • any contraindication to having an MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allegheny Imaging of McCandless

Pittsburgh, Pennsylvania, United States

Location

Study Officials

  • Christopher C Schmidt, MD

    WPAHS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 17, 2011

Study Start

January 14, 2011

Primary Completion

December 30, 2013

Study Completion

December 30, 2013

Last Updated

September 18, 2020

Record last verified: 2020-09

Locations

US(1)