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

NCT ID: NCT01484366

Last Updated: 2014-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-02-28

Brief Summary

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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

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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.

Conditions

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Fractures of Radius and Ulna

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intramedullary nailing and plating

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

Group Type ACTIVE_COMPARATOR

intramedullary nailing and plating

Intervention Type PROCEDURE

Surgical intramedullary nailing of the ulna and plating of the radius

plating

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

Group Type ACTIVE_COMPARATOR

plating

Intervention Type PROCEDURE

Surgical plating of both bonforearm fractures

Interventions

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intramedullary nailing and plating

Surgical intramedullary nailing of the ulna and plating of the radius

Intervention Type PROCEDURE

plating

Surgical plating of both bonforearm fractures

Intervention Type PROCEDURE

Other Intervention Names

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forearm fractures Forearm fractures

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Florida Orthopaedic Institute

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roy Sanders, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Orthopaedic Institute

Locations

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Tampa General Hospital

Tampa, Florida, United States

Site Status

St Josephs Hospital

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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BBFA

Identifier Type: -

Identifier Source: org_study_id