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Clinical Trials/NCT01484366
NCT01484366
Terminated
Not Applicable

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

Florida Orthopaedic Institute2 sites in 1 country13 target enrollmentSeptember 2010
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ConditionsFractures of Radius and Ulna

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fractures of Radius and Ulna
Sponsor
Florida Orthopaedic Institute
Enrollment
13
Locations
2
Primary Endpoint
implant pain
Status
Terminated
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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:

  1. a lower rate of implant pain
  2. 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.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
February 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

implant pain

Time Frame: 1 year

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

Secondary Outcomes

  • re-operation rate to remove painful hardware(1 year)

Study Sites (2)

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