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Status unknownNCT00398242Updated Nov 10, 2006

Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children

An interventional study of above or below elbow cast for the last 3 weeks of treatment in Fracture, Forearm and Midshaft, sponsored by Colaris, Joost, M.D.. Status unknown at 2 sites in Netherlands. Open to participants aged Up to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-11-10.

Sponsored by Colaris, Joost, M.D. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2006), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
Up to 15 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Fracture
  • Forearm
  • Midshaft
  • Child
  • Treatment

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Keywords

  • fracture
  • forearm
  • midshaft
  • child
  • treatment
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 60 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Colaris, Joost, M.D. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • both-bone forearm fracture
  • age \< 16 years
  • dislocation
  • stable

Exclusion criteria

Exclusion Criteria:

  • fracture older than 1 week
  • no informed consent
  • refracture
  • open fracture (Gustillo 2 and 3)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single
Enrollment
60 participants

Interventions

  • Deviceabove or below elbow cast for the last 3 weeks of treatment
06

What researchers measure

Primary outcomes

  1. pronation and supination

Secondary outcomes

  1. complications, function, esthetics, complains in daily living, X-rays

07

Study locations

2 of 2 sites recruiting
  • HAGA, location Juliana Children's Hospital
    Den Haag, Zuid Holland, Netherlands
    Recruiting
  • Erasmus Medical Centre location Sophia Children's hospital
    Rotterdam, Zuid Holland, Netherlands
    • Joost W Colaris · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00398242
Lead sponsor
Colaris, Joost, M.D.
First posted
Nov 10, 2006
Start date
Jan 2006
Last update
Nov 10, 2006

Study contacts

Joost W Colaris
Contact
joostcolaris@hotmail.com
0031642220265
Joost W Colaris, Drs
principal investigator
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.

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