Back to resultsDislocated Unstable Distal Both-Bone Forearm Fractures in Children
Primary Purpose
Fracture, Forearm, Distal
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Kirschner-wire fixation
Sponsored by
About this trial
This is an interventional treatment trial for Fracture focused on measuring Fracture, Forearm, Distal, Child, Treatment
Eligibility Criteria
Inclusion Criteria:
- both-bone forearm fracture
- distal
- dislocated
- unstable after reposition
- age < 16 years
Exclusion Criteria:
- fracture older than 1 week
- no informed consent
- refracture
- open fracture (Gustillo 2 and 3)
- both fractures of type torus
Sites / Locations
- HAGA, location Juliana Children's HospitalRecruiting
Outcomes
Primary Outcome Measures
pronation and supination
Secondary Outcome Measures
complications, function, esthetics, complains in daily living, X-rays
Full Information
NCT ID
NCT00398268
First Posted
November 8, 2006
Last Updated
November 8, 2006
Sponsor
Colaris, Joost, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT00398268
Brief Title
Dislocated Unstable Distal Both-Bone Forearm Fractures in Children
Official Title
Treatment of Unstable Dislocated Both-Bone Distal Forearm Fractures in Children: A Follow-up Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Colaris, Joost, M.D.
4. Oversight
5. Study Description
Brief Summary
We create a follow-up study of Kirschner wire fixation of a unstable 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 an unstable reposition, the fracture will be fixated with 2 Kirschner-wires. The arm will be immobilised in above elbow cast during 4 weeks. Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complains in daily living and complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture, Forearm, Distal, Child, Treatment
Keywords
Fracture, Forearm, Distal, Child, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Kirschner-wire fixation
Primary Outcome Measure Information:
Title
pronation and supination
Secondary Outcome Measure Information:
Title
complications, function, esthetics, complains in daily living, X-rays
10. Eligibility
Sex
All
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
both-bone forearm fracture
distal
dislocated
unstable after reposition
age < 16 years
Exclusion Criteria:
fracture older than 1 week
no informed consent
refracture
open fracture (Gustillo 2 and 3)
both fractures of type torus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
joost w colaris, drs
Official's Role
Principal Investigator
Facility Information:
Facility Name
HAGA, location Juliana Children's Hospital
City
Den Haag
State/Province
Zuid Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
joost w colaris, drs
Phone
0031642220265
Email
joostcolaris@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Dislocated Unstable Distal Both-Bone Forearm Fractures in Children
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