Forearm Shaft Fractures: Plating of Radius and Ulna Versu... | NCT01484366

Studies
Forearm Shaft Fractures: Plating of Radius and Ulna Versus Plating of Radius and Nailing of Ulna

NCT01484366

Sponsor

Florida Orthopaedic Institute

Status

Terminated

Last Update Posted

Nov 11, 2014Estimated

Enrollment

13Actual

Phase

Not Applicable

Conditions

Fractures of Radius and Ulna

Interventions

intramedullary nailing and plating
plating

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

Nov 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low enrollment. Treament no longer used by researchers.

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Feb 2013Actual

Completion Date

Feb 2013Actual

First Submitted Date

Nov 30, 2011

First Submission Date that Met QC Criteria

Nov 30, 2011

First Posted Date

Dec 2, 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

Nov 10, 2014

Last Update Posted Date

Nov 11, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The hypothesis is that intramedullary nailing of the ulna and plating of the radius will result in a superior outcome as evidenced by two primary end points:

a lower rate of implant pain
a lower re-operation rate to remove painful hardware.

Detailed Description

This is a prospective, randomized study to determine if intramedullary nailing of the ulna and plating of the radius is equal to, or superior to plating of both the radius and ulna for the treatment of both bone forearm fractures.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intramedullary nailing and plating	Active Comparator	intramedullary nailing of the ulna and plating of the radius in the treatment of both bone forearm fractures	Procedure: intramedullary nailing and plating
plating	Active Comparator	plating of both the radius and ulna in the treatment of both bone forearm fractures	Procedure: plating

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intramedullary nailing and plating	Procedure	Surgical intramedullary nailing of the ulna and plating of the radius	intramedullary nailing and plating

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
implant pain	a visual analog scale (VAS) will be used to assess pain in the forearm	1 year

Secondary Outcomes

Measure	Description	Time Frame
re-operation rate to remove painful hardware	repeat surgical intervention will be captured	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diaphyseal fractures of both radius and ulna
Ulna fractures that are oblique or transverse
Fractures may be closed or Grade I-IIIA open
Patients must be over 18 and skeletally mature

Exclusion Criteria:

Children under the age of 18
Pregnancy
Comminuted ulna fractures
Those with associated bony elbow or wrist trauma
Elbow dislocation
Subjects with bone pathology (osteoporosis, OI, Paget's disease, bone cancer)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roy Sanders, MD	Florida Orthopaedic Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampa General Hospital		Tampa	Florida	33606	United States
St Josephs Hospital

Intervention Browse Module

MeSH Terms

ID	Term
D005594	Fracture Fixation, Intramedullary
D004595	Electroplating

Ancestor Terms

ID	Term
D005593	Fracture Fixation, Internal
D005592	Fracture Fixation
D019637	Orthopedic Procedures
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided