Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures

Non-bridging Radio-radial Fixator Compared to Percutaneous Pinning for Unstable Distal Radius Fracture. A Prospective Randomized Trial.

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.

Study Overview

• Status: Completed
• Conditions: Radius Fractures
• Intervention / Treatment: Procedure: Radio-radial fixator; Procedure: Percutaneous pinning

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1J1Z4
      • Département d'orthopédie, CHA-Pavillon Enfant-Jésus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radio-radial fixator; Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)	Procedure: Radio-radial fixator; Using the Distal Radius Fixator from Synthes. A single splint for 5 days.
Active Comparator: Percutaneous pinning; Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks	Procedure: Percutaneous pinning; Insert two K-wires in the distal radius, one in the fracture line dorsally and one from the styloid. A cast for 6 weeks.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Movement of Wrist	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.	6 months

Collaborators and Investigators

• Sponsor: Hopital de l'Enfant-Jesus

Study record dates

Study Major Dates

• Study Start: April 1, 2003
• Primary Completion (Actual): May 1, 2007
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: May 26, 2009
• First Submitted That Met QC Criteria: May 26, 2009
• First Posted (Estimate): May 27, 2009

Study Record Updates

• Last Update Posted (Estimate): March 1, 2011
• Last Update Submitted That Met QC Criteria: February 25, 2011
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Grip strength; Radius fractures; Radio-radial fixator; Percutaneous pinning
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: PEJ-206