Treatement of Extension Fractures of the Distal Radius (fradius)
Fracture of Distal Radius
Procedure: trans-styloid and intrafocal pinning on the one side
Procedure: volar fixed-angle plating on the other side
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatement of Extension Fractures of the Distal Radius : Prospective Randomized Postoperative Comparison Between Trans-Styloid and Intrafical Pinning on the One Side and Volar Fixed-Angle Plating on the Other Side.|
- The main judging criterion will lay on an X-ray assessment of the distal radius, we will try to find a loss of reduction at tree month.
- The secondary criteria will lay on fonctional scores (quickDASH and Herzberg score) at 6 weeks, 3 months and 6 months, as well as on post-operative X-ray assessments in order to compare post-operative reduction of the distal radius fracture.
|Study Start Date:||May 2007|
|Study Completion Date:||July 2008|
Distal radius fractures are more and more numerous. Most of the time, the people concerned are elderly or old with an osteoporotic bone, and an important dorsal metaphysal comminution. The French reference treatment of the extension distal radius fracture, the Kapandji method, turns out to be less and less performing to treat such complicated fractures. At the moment, two points of view are in opposition in France. On the one side, the point of view of those who are in favour of the treatment by intrafocal pinning: they think they will be able to improve their technique if they add a trans-styloid pinning of stabilisation. On the other side, those who are in favour of a treatment using a volar fixed-angle plating.
The purpose of the study is to compare these two types of treatment by using a prospective and randomized analysis.
The main judging criterion will lay on an X-ray assessment of the distal radius, we will try to find a loss of reduction at tree month.
The secondary criteria will lay on fonctional scores (quickDASH and Herzberg score) at 6 weeks, 3 months and 6 months, as well as on post-operative X-ray assessments in order to compare post-operative reduction of the distal radius fracture.
All the patients taken to the emergency ward of Limoges Hospital, and suffering from an extension distal radius fracture (intra or extra articular according to Kapandji classification) will have the possibility to participate in this study, if they want to.
The patients will be X-rayed before and after the operation, they will have an immobilization for 3 weeks. Then the cast will be removed, and new X-rays will be taken. Then the patients will be allowed to perform their daily activities. A new follow-up control will take place 6 week later, it will include a new series X-rays and functional scores. At this point, people will be able to start physiotherapy. New functional scores and X-ray assessments will still be taken 3 and 6 months later.
All the X-rays will be analyzed by an orthopaedist, a radiologist, and by a radiological software.
- Fonctional scores (quickDASH and Herzberg score) at 6 weeks, 3 months and 6 months.
- X-ray assessment after the operation and at 3 weeks, 6 weeks, 3 months and 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492492
|Department of Bone Surgery|
|Limoges,, France, 87000|
|Principal Investigator:||Jean-Louis CHARISSOUX, MD||CHU LIMOGES|