NCT01317771

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

March 16, 2011

Last Update Submit

August 17, 2020

Conditions

Disorder of Tendon of Biceps

Keywords

Proximal Biceps Pathology

Study Arms (1)

Proximal Biceps Tendon Tenodesis

Procedure: Open proximal biceps tendon tenodesis with an EndoButton

Interventions

Open proximal biceps tendon tenodesis with an EndoButtonPROCEDURE

Surgical fixation for bicipital pathology

Proximal Biceps Tendon Tenodesis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Undergone open subpectoral proximal biceps tenodesis with the EndoButton

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allegheny Imaging of McCandless

Pittsburgh, Pennsylvania, United States

Location

Study Officials

  • Christopher C Schmidt, MD

    WPAHS

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 17, 2011

Study Start

March 11, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

August 19, 2020

Record last verified: 2020-08

Locations

US(1)