- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00398242
Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children
Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children: A Randomized Trial Between Treatment With Above Elbow Cast and a Combination of Above- and Below Elbow Armcast.
Study Overview
Status
Intervention / Treatment
Detailed Description
children who arrive at the emergency unit with a stable both-bone midshaft forearm fracture will be asked to join the trial.
If the fracture will be stable during reposition in the operating room, a randomization between 2 kinds of plaster treatment will be done.
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Joost W Colaris
- Phone Number: 0031642220265
- Email: joostcolaris@hotmail.com
Study Locations
-
-
Zuid Holland
-
Den Haag, Zuid Holland, Netherlands
- Recruiting
- HAGA, location Juliana Children's Hospital
-
Contact:
- Joost W Colaris, Drs
- Phone Number: 00316-42220265
- Email: joostcolaris@hotmail.com
-
Rotterdam, Zuid Holland, Netherlands
- Recruiting
- Erasmus Medical Centre location Sophia Children's hospital
-
Contact:
- Joost W Colaris
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- both-bone forearm fracture
- age < 16 years
- dislocation
- stable
Exclusion Criteria:
- fracture older than 1 week
- no informed consent
- refracture
- open fracture (Gustillo 2 and 3)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
pronation and supination
|
Secondary Outcome Measures
Outcome Measure |
---|
complications, function, esthetics, complains in daily living, X-rays
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: joost w colaris, drs
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Colaris03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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