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Dislocated Stable Distal Both-Bone Forearm Fractures in Children

Treatment of Stable Dislocated Both-Bone Distal Forearm Fractures in Children: A Randomized Trial Between Treatment With en Without Kirschner-Wires

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00397852
Enrollment
110
Registered
2006-11-10
Start date
2006-01-31
Completion date
Unknown
Last updated
2006-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child, Distal, Forearm, Fracture, Treatment

Keywords

Fracture, Forearm, Distal, Child, Treatment

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.

Detailed 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.

Interventions

PROCEDUREKirschner-wires or not

Sponsors

Colaris, Joost, M.D.
Lead SponsorINDIV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 15 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
re-operations/ re-dislocations

Secondary

MeasureTime frame
pronation and supination
complications, function, esthetics, complains in daily living, X-rays

Countries

Netherlands

Contacts

Primary Contactjoost w colaris, drs
joostcolaris@hotmail.com0031642220265

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026