Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00492492
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2007-06-26
Brief Title:
Treatement of Extension Fractures of the Distal Radius
Sponsor:
University Hospital Limoges
Organization:
University Hospital Limoges
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
fradius
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None