Prospective Biceps Study | NCT01317719

Studies
Prospective Biceps Study

NCT01317719

Sponsor

West Penn Allegheny Health System

Status

Completed

Last Update Posted

Sep 18, 2020Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Biceps Tendon Rupture

Interventions

Distal Biceps Re-Insertion Surgery

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

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2011Actual

Primary Completion Date

Dec 30, 2013Actual

Completion Date

Dec 30, 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

Sep 17, 2020

Last Update Posted Date

Sep 18, 2020Actual

Description Module

Brief Summary

The primary goal of this study is to determine if surgical repair of the distal biceps fully restores the supination strength of the forearm. Secondarily, the investigators want to examine the insertion site location of the tendon and determine if it correlates with the patients' functional outcome as determined by Disabilities of the Arm, Shoulder, and Hand (DASH), Visual Analog Pain Scale (VAPS), and isometric supination torque testing.

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

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Distal Biceps Ruptures			Procedure: Distal Biceps Re-Insertion Surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Distal Biceps Re-Insertion Surgery	Procedure	Surgical Repair of the Distal Biceps Tendon	Distal Biceps Ruptures

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

primary distal biceps repair with endobutton

Exclusion Criteria:

any ipsilateral wrist, forearm, or elbow condition
any contraindication to having an MRI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who have received primary distal biceps repair by Dr. Schmidt

Sampling Method

Non-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