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

Florida Orthopaedic Institute

Status: Terminated

Conditions: Fractures of Radius and Ulna

Treatments: Procedure: plating; Procedure: intramedullary nailing and plating

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01484366

BBFA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

intramedullary nailing and plating

Active Comparator group

Description:

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

Treatment:

Procedure: intramedullary nailing and plating

plating

Active Comparator group

Description:

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

Treatment:

Procedure: plating