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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00397852
Other study ID # colaris05
Secondary ID
Status Recruiting
Phase N/A
First received November 8, 2006
Last updated November 8, 2006
Start date January 2006

Study information

Verified date November 2006
Source Colaris, Joost, M.D.
Contact joost w colaris, drs
Phone 0031642220265
Email joostcolaris@hotmail.com
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial Summary

We create a randomized clinical trial between treatment with and without Kirschner wire fixation of a stable dislocated distal both-bone forearm fracture.


Description:

children who arrive at the emergency unit with a dislocated both-bone distal forearm fracture will be asked to join the trial.

After informed consent, a randomization between 2 kinds of treatment will be done: K-wire fixation or no K-wire fixation of the fracture after a stable reposition.

Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: the number of re-dislocations, re-operations, consolidation and dislocation on X-ray, function of both arms, complains in daily living and complications.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 15 Years
Eligibility Inclusion Criteria:

- both-bone forearm fracture

- distal

- dislocated

- stable after reposition

- age < 16 years

Exclusion Criteria:

- fracture older than 1 week

- no informed consent

- refracture

- open fracture (Gustillo 2 and 3)

- both fractures of type torus

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Kirschner-wires or not


Locations

Country Name City State
Netherlands HAGA, location Juliana Children's Hospital Den Haag Zuid Holland
Netherlands Erasmus Medical Centre location Sophia Children's hospital Rotterdam Zuid Holland

Sponsors (1)

Lead Sponsor Collaborator
Colaris, Joost, M.D.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary re-operations/ re-dislocations
Secondary pronation and supination
Secondary complications, function, esthetics, complains in daily living, X-rays
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