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

November 10, 2014 updated by: Florida Orthopaedic Institute

Prospective Randomized Trial for Forearm Shaft Fractures: Plating of Radius and Ulna vs. Plating of Radius and Nailing of Ulna

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:

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
      • Tampa, Florida, United States, 33607
        • St Josephs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intramedullary nailing and plating
intramedullary nailing of the ulna and plating of the radius in the treatment of both bone forearm fractures
Procedure: intramedullary nailing and plating
Surgical intramedullary nailing of the ulna and plating of the radius
Other Names:
  • forearm fractures
Active Comparator: plating
plating of both the radius and ulna in the treatment of both bone forearm fractures
Procedure: plating
Surgical plating of both bonforearm fractures
Other Names:
  • Forearm fractures

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida Orthopaedic Institute

Investigators

  • Principal Investigator: Roy Sanders, MD, Florida Orthopaedic Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

November 30, 2011

First Submitted That Met QC Criteria

November 30, 2011

First Posted (Estimate)

December 2, 2011

Study Record Updates

Last Update Posted (Estimate)

November 11, 2014

Last Update Submitted That Met QC Criteria

November 10, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBFA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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