We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Analysis of the Fixation of the Proximal Biceps Tendon

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 March 2011 by West Penn Allegheny Health System.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01317771
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
Ten randomly selected patients that have undergone an open proximal biceps tendon tenodesis with an EndoButton for bicipital pathology with Christopher Schmidt, MD, will be asked to participate in the study. The study will assess the tendon healing to bone through magnetic resonance imaging (MRI). Individuals will also be asked to fill a visual analog scale (VAS) pain and disability of the arm shoulder and hand (DASH) assessment tools. The variables for our objective will include age, hand dominance, gender and chronicity of symptoms prior to surgery, and other related surgical procedures.

Condition Intervention
Disorder of Tendon of Biceps Procedure: Open proximal biceps tendon tenodesis with an EndoButton

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Analysis of the Fixation of the Proximal Long Head of the Biceps Tendon

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

Estimated Enrollment: 10
Groups/Cohorts Assigned Interventions
Proximal Biceps Tendon Tenodesis Procedure: Open proximal biceps tendon tenodesis with an EndoButton
Surgical fixation for bicipital pathology

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This research study will collect the MRI and questionnaire data from 10 subjects that have undergone a subpectoral proximal biceps tendon tenodesis using the EndoButton.
Criteria

Inclusion Criteria:

  • Undergone open subpectoral proximal biceps tenodesis with the EndoButton

Exclusion Criteria:

  • No history of surgery or disability in the contra-lateral extremity
  • Not a member of a legally restricted group or protected population
  • No prior surgery or further surgery on the extremity of interest
  • No condition preventing the individual from undergoing a 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): NCT01317771


Contacts
Contact: David M Weir, MS 412-359-4310 dweir@wpahs.org

Locations
United States, Pennsylvania
Allegheny Imaging of McCandless Not yet recruiting
Pittsburgh, Pennsylvania, United States
Contact: David M Weir, MS       dweir@wpahs.org   
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: NCT01317771     History of Changes
Other Study ID Numbers: RC-5202
First Submitted: March 16, 2011
First Posted: March 17, 2011
Last Update Posted: March 17, 2011
Last Verified: March 2011

Keywords provided by West Penn Allegheny Health System:
Proximal Biceps Pathology