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

Fractures of Radius and Ulna Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01484366
• Other study ID #: BBFA
• Status: Terminated
• Phase: N/A
• First received: November 30, 2011
• Last updated: November 10, 2014
• Start date: September 2010
• Est. completion date: February 2013

Study information

• Verified date: November 2014
• Source: Florida Orthopaedic Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures of Radius and Ulna
• Fractures, Bone
• Radius Fractures
• Ulna Fractures

Intervention

Procedure:
• intramedullary nailing and plating
Surgical intramedullary nailing of the ulna and plating of the radius
• plating
Surgical plating of both bonforearm fractures

Locations

Country	Name	City	State
United States	St Josephs Hospital	Tampa	Florida
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Orthopaedic Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	implant pain	a visual analog scale (VAS) will be used to assess pain in the forearm	1 year	No
Secondary	re-operation rate to remove painful hardware	repeat surgical intervention will be captured	1 year	No