Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2007-05-31

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.

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Detailed Description

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Conditions

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Radius Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Radio-radial fixator

Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)

Group Type EXPERIMENTAL

Radio-radial fixator

Intervention Type PROCEDURE

Using the Distal Radius Fixator from Synthes. A single splint for 5 days.

Percutaneous pinning

Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks

Group Type ACTIVE_COMPARATOR

Percutaneous pinning

Intervention Type PROCEDURE

Insert two K-wires in the distal radius, one in the fracture line dorsally and one from the styloid. A cast for 6 weeks.

Interventions

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Radio-radial fixator

Using the Distal Radius Fixator from Synthes. A single splint for 5 days.

Intervention Type 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.

Intervention Type PROCEDURE

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