Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures

Study Overview
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Brief Summary
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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.

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

Conditions
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Radius Fractures

Intervention / Treatment
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* Procedure: Radio-radial fixator
* Procedure: Percutaneous pinning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radius fractures, Radio-radial fixator, Percutaneous pinning, Grip strength