Back to resultsTreatment of Unstable Both-Bone Midshaft Forearm Fractures in Children
Primary Purpose
Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
1 or 2 elastic stable intramedullary nails
Sponsored by
About this trial
This is an interventional treatment trial for Fracture focused on measuring fracture, forearm, midshaft, child, treatment
Eligibility Criteria
Inclusion Criteria: Stable both-bone forearm fracture Age < 16 years old Dislocation Unstable Exclusion Criteria: Fracture older than 1 week No informed consent Refracture Open fracture (Gustillo 2 and 3)
Sites / Locations
- HAGA, Juliana Children's HospitalRecruiting
- Erasmus Medical Centre, Sophia Children's HospitalRecruiting
Outcomes
Primary Outcome Measures
pronation and supination
Secondary Outcome Measures
complications, function, esthetics, complaints in daily living, X-rays
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00314587
Brief Title
Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children
Official Title
Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children: A Randomized Trial Between 1 and 2 Elastic Stable Intramedullary Nails
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
The investigators created a randomized clinical trial between 1 or 2 elastic stable intramedullary nails to find out what kind of treatment is optimal for unstable both-bone midshaft forearm fractures.
Detailed Description
Children who arrive at the emergency unit with an unstable both-bone midshaft forearm fracture will be asked to join the trial.
If the fracture will be unstable during reposition in the operating room, a randomization between 1 or 2 ESIN will be done.
The aftertreatment will be the same for both groups: above elbow plaster for 3 weeks. Outpatient clinic visits till a follow-up of 9 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complaints 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
Keywords
fracture, forearm, midshaft, child, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
1 or 2 elastic stable intramedullary nails
Primary Outcome Measure Information:
Title
pronation and supination
Secondary Outcome Measure Information:
Title
complications, function, esthetics, complaints 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:
Stable both-bone forearm fracture
Age < 16 years old
Dislocation
Unstable
Exclusion Criteria:
Fracture older than 1 week
No informed consent
Refracture
Open fracture (Gustillo 2 and 3)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joost W Colaris, M.D.
Phone
0031-642220265
Email
joostcolaris@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joost W Colaris, M.D.
Organizational Affiliation
HAGA/Erasmus Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
HAGA, Juliana Children's Hospital
City
Den Haag
State/Province
Zuid Holland
ZIP/Postal Code
2566ER
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joost W Colaris, M.D.
Phone
0031-642220265
Email
joostcolaris@hotmail.com
First Name & Middle Initial & Last Name & Degree
Joost W Colaris, M.D.
Facility Name
Erasmus Medical Centre, Sophia Children's Hospital
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3015GJ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joost W Colaris, M.D.
Phone
0031-642220265
Email
joostcolaris@hotmail.com
First Name & Middle Initial & Last Name & Degree
Joost W Colaris, M.D.
12. IPD Sharing Statement
Learn more about this trial
Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children
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