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Treatment of Non-Dislocated Midshaft Both-Bone Fractures

Primary Purpose

Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
above and below elbow cast
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, Cast

Eligibility Criteria

undefined - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Both-bone midshaft forearm fracture Age < 16 years old Exclusion Criteria: Dislocation Fracture older than 1 week No informed consent Refracture Open fracture (Gustillo 2 and 3) Torus fractures of both ulna and radius

Sites / Locations

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

Outcomes

Primary Outcome Measures

pronation and supination

Secondary Outcome Measures

complications, function, esthetics, complaints in daily living, X-rays

Full Information

First Posted
April 12, 2006
Last Updated
February 23, 2007
Sponsor
Colaris, Joost, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT00314600
Brief Title
Treatment of Non-Dislocated Midshaft Both-Bone Fractures
Official Title
Above Elbow Cast in Non-Dislocated Both-Bone Midshaft Forearm Fractures in Children: Necessity or Needless Cruelty? A Randomized Trial
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 to find out what kind of treatment is optimal for non-dislocated both-bone midshaft forearm fractures.
Detailed Description
Children who arrive at the emergency unit with a non-dislocated both-bone midshaft forearm fracture will be asked to join the trial. After informed consent we will do a randomization between 6 weeks above elbow cast and 3 weeks above elbow cast in combination with 3 weeks under elbow cast. 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, 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, Cast

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
Device
Intervention Name(s)
above and below elbow cast
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: Both-bone midshaft forearm fracture Age < 16 years old Exclusion Criteria: Dislocation Fracture older than 1 week No informed consent Refracture Open fracture (Gustillo 2 and 3) Torus fractures of both ulna and radius
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
Not yet 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

Citations:
PubMed Identifier
23860674
Citation
Colaris JW, Reijman M, Allema JH, Biter LU, Bloem RM, van de Ven CP, de Vries MR, Kerver AJ, Verhaar JA. Early conversion to below-elbow cast for non-reduced diaphyseal both-bone forearm fractures in children is safe: preliminary results of a multicentre randomised controlled trial. Arch Orthop Trauma Surg. 2013 Oct;133(10):1407-14. doi: 10.1007/s00402-013-1812-8. Epub 2013 Jul 17.
Results Reference
derived

Learn more about this trial

Treatment of Non-Dislocated Midshaft Both-Bone Fractures

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