Dislocated Stable Distal Both-Bone Forearm Fractures in Children

NCT ID: NCT00397852

Last Updated: 2006-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fracture Forearm Distal Child Treatment

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Fracture Forearm Distal Child Treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Kirschner-wires or not

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Colaris, Joost, M.D.

INDIV

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

joost w colaris, drs

Role: PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Erasmus Medical Centre location Sophia Children's hospital

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

HAGA, location Juliana Children's Hospital

The Hague, South Holland, Netherlands

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

joost w colaris, drs

Role: CONTACT

Phone: 0031642220265

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

joost w colaris, drs

Role: primary

joost w colaris, drs

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

colaris05

Identifier Type: -

Identifier Source: org_study_id