Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00908895|
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : June 7, 2010
Last Update Posted : March 1, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Radius Fractures||Procedure: Radio-radial fixator Procedure: Percutaneous pinning||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Non-bridging Radio-radial Fixator Compared to Percutaneous Pinning for Unstable Distal Radius Fracture. A Prospective Randomized Trial.|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2007|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908895
|Département d'orthopédie, CHA-Pavillon Enfant-Jésus|
|Québec, Quebec, Canada, G1J1Z4|