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Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children

Primary Purpose

Fracture, Forearm, Midshaft

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
above or below elbow cast for the last 3 weeks of treatment
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, midshaft, child, treatment

Eligibility Criteria

undefined - 15 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • HAGA, location Juliana Children's HospitalRecruiting
  • Erasmus Medical Centre location Sophia Children's hospitalRecruiting

Outcomes

Primary Outcome Measures

pronation and supination

Secondary Outcome Measures

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
NCT00398242
Brief Title
Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children
Official Title
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 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 the treatment with above elbow armcast alone and the treatment of above elbow in combination with a short arm cast for stable midshaft both-bone forearm fractures.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture, Forearm, Midshaft, Child, Treatment
Keywords
fracture, forearm, midshaft, child, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
above or below elbow cast for the last 3 weeks of treatment
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 age < 16 years dislocation stable 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
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
00316-42220265
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

12. IPD Sharing Statement

Learn more about this trial

Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children

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