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Analysis of the Fixation of the Proximal Biceps Tendon

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ClinicalTrials.gov Identifier: NCT01317771
Recruitment Status : Unknown
Verified March 2011 by West Penn Allegheny Health System.
Recruitment status was:  Not yet recruiting
First Posted : March 17, 2011
Last Update Posted : March 17, 2011
Sponsor:
Information provided by:
West Penn Allegheny Health System

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Disorder of Tendon of Biceps Procedure: Open proximal biceps tendon tenodesis with an EndoButton

Study Design
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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Analysis of the Fixation of the Proximal Long Head of the Biceps Tendon
Groups and Cohorts
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Group/Cohort Intervention/treatment
Proximal Biceps Tendon Tenodesis Procedure: Open proximal biceps tendon tenodesis with an EndoButton
Surgical fixation for bicipital pathology


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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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
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Responsible Party: Allegheny Singular Research Institute
ClinicalTrials.gov Identifier: NCT01317771     History of Changes
Other Study ID Numbers: RC-5202
First Posted: March 17, 2011    Key Record Dates
Last Update Posted: March 17, 2011
Last Verified: March 2011

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

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries