Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures

Hopital de l'Enfant-Jesus

Status and phase: Completed; Phase 3

Conditions: Radius Fractures

Treatments: Procedure: Percutaneous pinning; Procedure: Radio-radial fixator

Study type: Interventional

Funder types: Other

Identifiers

NCT00908895

PEJ-206

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Radio-radial fixator

Experimental group

Description:

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

Treatment:

Procedure: Radio-radial fixator

Percutaneous pinning

Active Comparator group

Description:

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

Treatment:

Procedure: Percutaneous pinning