Dislocated Stable Distal Both-Bone Forearm Fractures in C... | NCT00397852

Studies
Dislocated Stable Distal Both-Bone Forearm Fractures in Children

NCT00397852

Sponsor

Colaris, Joost, M.D.

Status

Unknown status

Last Update Posted

Nov 10, 2006Estimated

Enrollment

110

Phase

Not Applicable

Conditions

Fracture
Forearm
Distal
Child
Treatment

Interventions

Kirschner-wires or not

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 8, 2006

First Submission Date that Met QC Criteria

Nov 8, 2006

First Posted Date

Nov 10, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2006

Last Update Posted Date

Nov 10, 2006Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110

Name	Type	Description	Arm Group Labels	Other Names
Kirschner-wires or not	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
re-operations/ re-dislocations

Secondary Outcomes

Measure	Description	Time Frame
pronation and supination
complications, function, esthetics, complains in daily living, X-rays

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
joost w colaris, drs	Contact	0031642220265		joostcolaris@hotmail.com

Overall Officials

Name	Affiliation	Role
joost w colaris, drs		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erasmus Medical Centre location Sophia Children's hospital	Recruiting	Rotterdam	South Holland		Netherlands

ID	Term
D050723	Fractures, Bone

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D001864	Bone Wires
D057126	Nuclear Receptor Subfamily 4, Group A, Member 2

Ancestor Terms

ID	Term
D016268	Internal Fixators
D019736	Prostheses and Implants
D004864	Equipment and Supplies
D009984	Orthopedic Fixation Devices

Browse Leaves

Not provided

Browse Branches

Not provided