Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures

Radius Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908895
• Other study ID #: PEJ-206
• Status: Completed
• Phase: Phase 3
• First received: May 26, 2009
• Last updated: February 25, 2011
• Start date: April 2003
• Est. completion date: May 2007

Study information

• Verified date: November 2009
• Source: Hopital de l'Enfant-Jesus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Radius Fractures

Intervention

Procedure:
• Radio-radial fixator
Using the Distal Radius Fixator from Synthes. A single splint for 5 days.
• 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.

Locations

Country	Name	City	State
Canada	Département d'orthopédie, CHA-Pavillon Enfant-Jésus	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Hopital de l'Enfant-Jesus

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No