Analysis of the Fixation of the Proximal Biceps Tendon

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by West Penn Allegheny Health System.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT01317771
First received: March 16, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Allegheny Singular Research Institute
ClinicalTrials.gov Identifier: NCT01317771     History of Changes
Other Study ID Numbers: RC-5202
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:
Proximal Biceps Pathology

ClinicalTrials.gov processed this record on September 30, 2014