Prospective Biceps Study
This study is enrolling participants by invitation only.
Sponsor:
West Penn Allegheny Health System
Information provided by:
West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT01317719
First received: March 16, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
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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 |
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Allegheny Singular Research Institute |
| ClinicalTrials.gov Identifier: | NCT01317719 History of Changes |
| Other Study ID Numbers: | RC-5159 |
| Study First Received: | March 16, 2011 |
| Last Updated: | March 16, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by West Penn Allegheny Health System:
|
Rupture of Distal Bicep Tendon |
Additional relevant MeSH terms:
|
Tendon Injuries Rupture, Spontaneous Rupture Wounds and Injuries Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 23, 2013