Dislocated Stable Distal Both-Bone Forearm Fractures in Children
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by Colaris, Joost, M.D..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Colaris, Joost, M.D.
Information provided by:
Colaris, Joost, M.D.
ClinicalTrials.gov Identifier:
NCT00397852
First received: November 8, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
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Purpose
We create a randomized clinical trial between treatment with and without Kirschner wire fixation of a stable dislocated distal both-bone forearm fracture.
| Condition | Intervention |
|---|---|
|
Fracture Forearm Distal Child Treatment |
Procedure: Kirschner-wires or not |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Stable Dislocated Both-Bone Distal Forearm Fractures in Children: A Randomized Trial Between Treatment With en Without Kirschner-Wires |
Resource links provided by NLM:
Further study details as provided by Colaris, Joost, M.D.:
Primary Outcome Measures:
- re-operations/ re-dislocations
Secondary Outcome Measures:
- pronation and supination
- complications, function, esthetics, complains in daily living, X-rays
| Estimated Enrollment: | 110 |
| Study Start Date: | January 2006 |
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.
Eligibility| Ages Eligible for Study: | up to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00397852
Contacts
| Contact: joost w colaris, drs | 0031642220265 | joostcolaris@hotmail.com |
Locations
| Netherlands | |
| HAGA, location Juliana Children's Hospital | Recruiting |
| Den Haag, Zuid Holland, Netherlands | |
| Contact: joost w colaris, drs 0031642220265 joostcolaris@hotmail.com | |
| Erasmus Medical Centre location Sophia Children's hospital | Recruiting |
| Rotterdam, Zuid Holland, Netherlands | |
| Contact: joost w colaris, drs 0031642220265 joostcolaris@hotmail.com | |
Sponsors and Collaborators
Colaris, Joost, M.D.
Investigators
| Principal Investigator: | joost w colaris, drs |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00397852 History of Changes |
| Other Study ID Numbers: | colaris05 |
| Study First Received: | November 8, 2006 |
| Last Updated: | November 8, 2006 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by Colaris, Joost, M.D.:
|
Fracture Forearm Distal Child Treatment |
Additional relevant MeSH terms:
|
Fractures, Bone Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013