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Dislocated Stable 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-wires or not
Sponsored by
Colaris, Joost, M.D.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture focused on measuring Fracture, Forearm, Distal, Child, Treatment

Eligibility Criteria

undefined - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • both-bone forearm fracture
  • distal
  • dislocated
  • stable 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
  • Erasmus Medical Centre location Sophia Children's hospitalRecruiting

Outcomes

Primary Outcome Measures

re-operations/ re-dislocations

Secondary Outcome Measures

pronation and supination
complications, function, esthetics, complains in daily living, X-rays

Full Information

First Posted
November 8, 2006
Last Updated
November 8, 2006
Sponsor
Colaris, Joost, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT00397852
Brief Title
Dislocated Stable Distal Both-Bone Forearm Fractures in Children
Official Title
Treatment of Stable Dislocated Both-Bone Distal Forearm Fractures in Children: A Randomized Trial Between Treatment With en Without Kirschner-Wires
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 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.

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
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Kirschner-wires or not
Primary Outcome Measure Information:
Title
re-operations/ re-dislocations
Secondary Outcome Measure Information:
Title
pronation and supination
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 stable 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
joost w colaris, drs
Phone
0031642220265
Email
joostcolaris@hotmail.com
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
Facility Name
Erasmus Medical Centre location Sophia Children's hospital
City
Rotterdam
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 Stable Distal Both-Bone Forearm Fractures in Children

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