Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397852
Status:
UNKNOWN
Last Update Posted:
2006-11-10
First Post:
2006-11-08
Brief Title:
Dislocated Stable Distal Both-Bone Forearm Fractures in Children
Sponsor:
Colaris Joost MD
Organization:
Colaris Joost MD
Study Overview
Official Title:
Treatment of Stable Dislocated Both-Bone Distal Forearm Fractures in Children A Randomized Trial Between Treatment With en Without Kirschner-Wires
Status:
UNKNOWN
Status Verified Date:
2006-11
Last Known Status:
RECRUITING
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:
None
Brief Summary:
We create a randomized clinical trial between treatment with and without Kirschner wire fixation of a stable dislocated distal both-bone forearm fracture
Detailed Description:
children who arrive at the emergency unit with a dislocated both-bone distal forearm fracture will be asked to join the trial
After informed consent a randomization between 2 kinds of treatment will be done K-wire fixation or no K-wire fixation of the fracture after a stable reposition
Outpatient clinic visits till a follow-up of 6 months During these visits we will investigate the number of re-dislocations re-operations consolidation and dislocation on X-ray function of both arms complains in daily living and complications
After informed consent a randomization between 2 kinds of treatment will be done K-wire fixation or no K-wire fixation of the fracture after a stable reposition
Outpatient clinic visits till a follow-up of 6 months During these visits we will investigate the number of re-dislocations re-operations consolidation and dislocation on X-ray function of both arms complains in daily living and complications
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