Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures
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.
|Radius Fractures||Procedure: Radio-radial fixator Procedure: Percutaneous pinning||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Non-bridging Radio-radial Fixator Compared to Percutaneous Pinning for Unstable Distal Radius Fracture. A Prospective Randomized Trial.|
- The Grip Strength [ Time Frame: 6 months ]Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance.
- Range of Movement of Wrist [ Time Frame: 6 months ]
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.
|Study Start Date:||April 2003|
|Study Completion Date:||May 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908895
|Département d'orthopédie, CHA-Pavillon Enfant-Jésus|
|Québec, Quebec, Canada, G1J1Z4|