Treatement of Extension Fractures of the Distal Radius (fradius)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00492492
First received: June 26, 2007
Last updated: December 29, 2008
Last verified: December 2008

June 26, 2007
December 29, 2008
May 2007
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00492492 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Treatement of Extension Fractures of the Distal Radius
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.

Treatment of extension fractures of the distal radius : prospective randomized postoperative comparison between trans-styloid and intrafocal pinning on the one side and volar fixed-angle plating on the other side.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fracture of Distal Radius
  • Procedure: trans-styloid and intrafocal pinning on the one side
  • Procedure: volar fixed-angle plating on the other side
Not Provided
Marcheix PS, Dotzis A, Benkö PE, Siegler J, Arnaud JP, Charissoux JL. Extension fractures of the distal radius in patients older than 50: a prospective randomized study comparing fixation using mixed pins or a palmar fixed-angle plate. J Hand Surg Eur Vol. 2010 Oct;35(8):646-51. doi: 10.1177/1753193410364179. Epub 2010 Mar 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
July 2008
Not Provided

Inclusion Criteria:

  • patient who is affiliated to the NHS (National Health Service)
  • patient who has officially given his consent
  • on over 50 year old patient
  • Patient with an extension fracture of the distal radius
  • patient who is in no condition to express his consent

Exclusion Criteria:

  • patient who is under the protection of justice
  • Patient with an open fracture
  • Patient with an flexion fracture of the distal radius
  • Patient with a metastasis localized in the distal radius
  • traumatised patient
  • patient who is liable not to profit by medical follow-up in Limoges hospital after he has been operated on
  • A pregnant woman / a parturient / a breast-feeding mother
  • patient who is serving a sentence .
  • patient sent to hospital without his consent
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00492492
I06029
Yes
Not Provided
University Hospital, Limoges
Not Provided
Principal Investigator: Jean-Louis CHARISSOUX, MD CHU LIMOGES
University Hospital, Limoges
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP