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
  Purpose

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.


Condition Intervention
Fracture of Distal Radius
Procedure: trans-styloid and intrafocal pinning on the one side
Procedure: volar fixed-angle plating on the other side

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 110
Study Start Date: May 2007
Study Completion Date: July 2008
Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492492

Locations
France
Department of Bone Surgery
Limoges,, France, 87000
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Jean-Louis CHARISSOUX, MD CHU LIMOGES
  More Information

No publications provided by University Hospital, Limoges

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00492492     History of Changes
Other Study ID Numbers: I06029
Study First Received: June 26, 2007
Last Updated: December 29, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Limoges:
radius,
pinning,
fixed-angle plate,
quick-DASH,
HERZBERG-score.

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014