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

Primary Purpose

Fractures of Radius and Ulna

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
intramedullary nailing and plating
plating
Sponsored by
Florida Orthopaedic Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fractures of Radius and Ulna focused on measuring fractures of both radius and ulna

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Tampa General Hospital
  • St Josephs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

intramedullary nailing and plating

plating

Arm Description

intramedullary nailing of the ulna and plating of the radius in the treatment of both bone forearm fractures

plating of both the radius and ulna in the treatment of both bone forearm fractures

Outcomes

Primary Outcome Measures

implant pain
a visual analog scale (VAS) will be used to assess pain in the forearm

Secondary Outcome Measures

re-operation rate to remove painful hardware
repeat surgical intervention will be captured

Full Information

First Posted
November 30, 2011
Last Updated
November 10, 2014
Sponsor
Florida Orthopaedic Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01484366
Brief Title
Forearm Shaft Fractures: Plating of Radius and Ulna Versus Plating of Radius and Nailing of Ulna
Official Title
Prospective Randomized Trial for Forearm Shaft Fractures: Plating of Radius and Ulna vs. Plating of Radius and Nailing of Ulna
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment. Treament no longer used by researchers.
Study Start Date
September 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida Orthopaedic Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures of Radius and Ulna
Keywords
fractures of both radius and ulna

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intramedullary nailing and plating
Arm Type
Active Comparator
Arm Description
intramedullary nailing of the ulna and plating of the radius in the treatment of both bone forearm fractures
Arm Title
plating
Arm Type
Active Comparator
Arm Description
plating of both the radius and ulna in the treatment of both bone forearm fractures
Intervention Type
Procedure
Intervention Name(s)
intramedullary nailing and plating
Other Intervention Name(s)
forearm fractures
Intervention Description
Surgical intramedullary nailing of the ulna and plating of the radius
Intervention Type
Procedure
Intervention Name(s)
plating
Other Intervention Name(s)
Forearm fractures
Intervention Description
Surgical plating of both bonforearm fractures
Primary Outcome Measure Information:
Title
implant pain
Description
a visual analog scale (VAS) will be used to assess pain in the forearm
Time Frame
1 year
Secondary Outcome Measure Information:
Title
re-operation rate to remove painful hardware
Description
repeat surgical intervention will be captured
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Sanders, MD
Organizational Affiliation
Florida Orthopaedic Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
St Josephs Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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