Analysis of the Fixation of the Proximal Biceps Tendon

Disorder of Tendon of Biceps Clinical Trial

Official title:

Analysis of the Fixation of the Proximal Long Head of the Biceps Tendon

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01317771
• Other study ID #: RC-5202
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Disorder of Tendon of Biceps
• Tendinopathy

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,