NCT00397852

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2006

Completed
Last Updated

November 10, 2006

Status Verified

November 1, 2006

First QC Date

November 8, 2006

Last Update Submit

November 8, 2006

Conditions

FractureForearmDistalChildTreatment

Keywords

FractureForearmDistalChildTreatment

Outcome Measures

Primary Outcomes (1)

  • re-operations/ re-dislocations

Secondary Outcomes (2)

  • pronation and supination

  • complications, function, esthetics, complains in daily living, X-rays

Interventions

Kirschner-wires or notPROCEDURE

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • both-bone forearm fracture
  • distal
  • dislocated
  • stable after reposition
  • age \< 16 years

You may not qualify if:

  • fracture older than 1 week
  • no informed consent
  • refracture
  • open fracture (Gustillo 2 and 3)
  • both fractures of type torus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Erasmus Medical Centre location Sophia Children's hospital

Rotterdam, South Holland, Netherlands

RECRUITING

HAGA, location Juliana Children's Hospital

The Hague, South Holland, Netherlands

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Interventions

Bone WiresNuclear Receptor Subfamily 4, Group A, Member 2

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Internal FixatorsProstheses and ImplantsEquipment and SuppliesOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentSurgical Fixation DevicesOrphan Nuclear ReceptorsDNA-Binding ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Cytoplasmic and Nuclear

Study Officials

  • joost w colaris, drs

    PRINCIPAL INVESTIGATOR

Central Study Contacts

joost w colaris, drs

CONTACT

0031642220265joostcolaris@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDIV

Study Record Dates

First Submitted

November 8, 2006

First Posted

November 10, 2006

Study Start

January 1, 2006

Last Updated

November 10, 2006

Record last verified: 2006-11

Locations

NL(2)