ClinicalTrials.gg
Status unknownNCT00314587Updated Feb 26, 2007

Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children

An interventional study of 1 or 2 elastic stable intramedullary nails in Fracture, 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 2007-02-26.

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has not verified this record recently (last verified Nov 2006), so the status shown — last known as Recruiting — may be out of date.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

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.

Read the 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.

02

Conditions studied

  • Fracture

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Keywords

  • fracture
  • forearm
  • midshaft
  • child
  • treatment
03

In context

Fractures, Bone

2,272 studies on the registry are indexed under Fractures, Bone; 321 are open to participants now.

This study's enrollment of 60 is below the median of 68 across 1,490 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Colaris, Joost, M.D. is the lead sponsor of 6 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Stable both-bone forearm fracture
  • Age \< 16 years old
  • Dislocation
  • Unstable

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
None (open label)
Enrollment
60 participants

Interventions

  • Procedure1 or 2 elastic stable intramedullary nails
06

What researchers measure

Primary outcomes

  1. pronation and supination

Secondary outcomes

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

07

Study locations

2 of 2 sites recruiting
  • Erasmus Medical Centre, Sophia Children's Hospital
    Rotterdam, South Holland 3015GJ, Netherlands
    • Joost W Colaris, M.D. · Contact · joostcolaris@hotmail.com · 0031-642220265
    • Joost W Colaris, M.D. · Principal investigator
    Recruiting
  • HAGA, Juliana Children's Hospital
    The Hague, South Holland 2566ER, Netherlands
    • Joost W Colaris, M.D. · Contact · joostcolaris@hotmail.com · 0031-642220265
    • Joost W Colaris, M.D. · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00314587
Lead sponsor
Colaris, Joost, M.D.
First posted
Apr 14, 2006
Start date
Jan 2006
Last update
Feb 26, 2007

Study contacts

Joost W Colaris, M.D.
Contact
joostcolaris@hotmail.com
0031-642220265
Joost W Colaris, M.D.
principal investigator · HAGA/Erasmus Medical Centre
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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