Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures

Phase 3

Completed

• Conditions: Radius Fractures
• Interventions: Procedure: Radio-radial fixator; Procedure: Percutaneous pinning

• Registration Number: NCT00908895
• Lead Sponsor: Hopital de l'Enfant-Jesus

Brief Summary

The treatment of extra-articular distal radius fractures is still controversial. In Canada, most patients with unstable fractures are treated with pinning and cast. Results are often associated with shortening and lack of function.

The purpose of the study is to compare stabilization with a radio-radial fixator to the usual method, suggesting that the radio-radial fixator will provide more strength at 6 months follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Study First Submitted: 2009-05-26
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-27
• Status Verified: 2009-11
• Results First Submitted: 2009-11-12
• Results First Submitted QC: 2010-05-12
• Results First Posted: 2010-06-07
• Last Update Submitted: 2011-02-25
• Last Update Posted: 2011-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Distal radius fracture Frykman I or II
• Unstable fracture according to Lafontaine's criteria
• Fracture line more than 1cm form the joint line
• Closed fracture
• Age > 18 years
• Surgery performed between 72 hours from the trauma
• Monotrauma
• Patient signed the informed consent

Exclusion Criteria

• Distal radius fracture Frykman III-VI (intra-articular fracture)
• Open fracture
• Polytraumatism
• Stable or non-displaced fracture

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radio-radial fixator	Radio-radial fixator	Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
Percutaneous pinning	Percutaneous pinning	Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks

Primary Outcome Measures

Name	Time	Method
The Grip Strength	6 months	Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance.

Secondary Outcome Measures

Name	Time	Method
Range of Movement of Wrist	6 months	Range of motion were divided in subgroups: dorsal flexion, volar flexion, pronation, supination, radial inclination, cubital inclination.; Motion is described as a percentage of the opposite side.

Trial Locations

Locations (1)

Département d'orthopédie, CHA-Pavillon Enfant-Jésus; 🇨🇦 Québec, Quebec, Canada