Treatement of Extension Fractures of the Distal Radius (fradius)
Primary Purpose
Fracture of Distal Radius
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
trans-styloid and intrafocal pinning on the one side
volar fixed-angle plating on the other side
Sponsored by
About this trial
This is an interventional treatment trial for Fracture of Distal Radius focused on measuring radius,, pinning,, fixed-angle plate,, quick-DASH,, HERZBERG-score.
Eligibility 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
Sites / Locations
- Department of Bone Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
trans-styloid and intrafocal pinning on the one side
volar fixed-angle plating on the other side
Arm Description
trans-styloid and intrafocal pinning on the one side
volar fixed-angle plating on the other side
Outcomes
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.
Secondary Outcome Measures
The secondary criteria will lay on fonctional scores (quickDASH and Herzberg score), as well as on post-operative X-ray assessments in order to compare post-operative reduction of the distal radius fracture.
Full Information
NCT ID
NCT00492492
First Posted
June 26, 2007
Last Updated
September 6, 2016
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT00492492
Brief Title
Treatement of Extension Fractures of the Distal Radius
Acronym
fradius
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Distal Radius
Keywords
radius,, pinning,, fixed-angle plate,, quick-DASH,, HERZBERG-score.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
trans-styloid and intrafocal pinning on the one side
Arm Type
Other
Arm Description
trans-styloid and intrafocal pinning on the one side
Arm Title
volar fixed-angle plating on the other side
Arm Type
Other
Arm Description
volar fixed-angle plating on the other side
Intervention Type
Procedure
Intervention Name(s)
trans-styloid and intrafocal pinning on the one side
Intervention Type
Procedure
Intervention Name(s)
volar fixed-angle plating on the other side
Primary Outcome Measure Information:
Title
The main judging criterion will lay on an X-ray assessment of the distal radius, we will try to find a loss of reduction.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The secondary criteria will lay on fonctional scores (quickDASH and Herzberg score), as well as on post-operative X-ray assessments in order to compare post-operative reduction of the distal radius fracture.
Time Frame
6 weeks, 3 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis CHARISSOUX, MD
Organizational Affiliation
CHU LIMOGES
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Bone Surgery
City
Limoges,
ZIP/Postal Code
87000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
20237186
Citation
Marcheix PS, Dotzis A, Benko 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.
Results Reference
derived
Learn more about this trial
Treatement of Extension Fractures of the Distal Radius
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