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

Not Applicable

Terminated

• Conditions: Fractures of Radius and Ulna
• Interventions: Procedure: intramedullary nailing and plating; Procedure: plating

• Registration Number: NCT01484366
• Lead Sponsor: Florida Orthopaedic Institute

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-11-30
• Study First Submitted QC: 2011-11-30
• Study First Posted: 2011-12-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-10
• Last Update Posted: 2014-11-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
re-operation rate to remove painful hardware	1 year	repeat surgical intervention will be captured

Trial Locations

Locations (2)

St Josephs Hospital; 🇺🇸 Tampa, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States