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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01317771
Other study ID # RC-5202
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date March 11, 2011
Est. completion date March 1, 2013

Study information

Verified date August 2020
Source West Penn Allegheny Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 1, 2013
Est. primary completion date March 1, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Open proximal biceps tendon tenodesis with an EndoButton
Surgical fixation for bicipital pathology

Locations

Country Name City State
United States Allegheny Imaging of McCandless Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
West Penn Allegheny Health System

Country where clinical trial is conducted

United States, 

See also
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