Analysis of the Fixation of the Proximal Biceps Tendon | NCT01317771

Studies
Analysis of the Fixation of the Proximal Biceps Tendon

NCT01317771

Sponsor

West Penn Allegheny Health System

Status

Withdrawn

Last Update Posted

Aug 19, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Disorder of Tendon of Biceps

Interventions

Open proximal biceps tendon tenodesis with an EndoButton

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI decided to not activate

Expanded Access Info

Start Date

Mar 11, 2011Actual

Primary Completion Date

Mar 1, 2013Actual

Completion Date

Mar 1, 2013Actual

First Submitted Date

Mar 16, 2011

First Submission Date that Met QC Criteria

Mar 16, 2011

First Posted Date

Mar 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2020

Last Update Posted Date

Aug 19, 2020Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Proximal Biceps Tendon Tenodesis			Procedure: Open proximal biceps tendon tenodesis with an EndoButton

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Open proximal biceps tendon tenodesis with an EndoButton	Procedure	Surgical fixation for bicipital pathology	Proximal Biceps Tendon Tenodesis

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher C Schmidt, MD	WPAHS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Allegheny Imaging of McCandless		Pittsburgh	Pennsylvania		United States