Treatment of Unstable Both-Bone Midshaft Forearm Fracture... | NCT00314587

Studies
Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children

NCT00314587

Sponsor

Colaris, Joost, M.D.

Status

Unknown status

Last Update Posted

Feb 26, 2007Estimated

Enrollment

Phase

Not Applicable

Conditions

Fracture

Interventions

1 or 2 elastic stable intramedullary nails

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

Apr 12, 2006

First Submission Date that Met QC Criteria

Apr 12, 2006

First Posted Date

Apr 14, 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

Feb 23, 2007

Last Update Posted Date

Feb 26, 2007Estimated

Description Module

Brief Summary

The investigators created a randomized clinical trial between 1 or 2 elastic stable intramedullary nails to find out what kind of treatment is optimal for unstable both-bone midshaft forearm fractures.

Detailed Description

Children who arrive at the emergency unit with an unstable both-bone midshaft forearm fracture will be asked to join the trial.

If the fracture will be unstable during reposition in the operating room, a randomization between 1 or 2 ESIN will be done.

The aftertreatment will be the same for both groups: above elbow plaster for 3 weeks. Outpatient clinic visits till a follow-up of 9 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complaints 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

Name	Type	Description	Arm Group Labels	Other Names
1 or 2 elastic stable intramedullary nails	Procedure

Measure	Description	Time Frame
pronation and supination

Measure	Description	Time Frame
complications, function, esthetics, complaints in daily living, X-rays

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stable both-bone forearm fracture
Age < 16 years old
Dislocation
Unstable

Exclusion Criteria:

Fracture older than 1 week
No informed consent
Refracture
Open fracture (Gustillo 2 and 3)

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, M.D.	Contact	0031-642220265		joostcolaris@hotmail.com

Overall Officials

Name	Affiliation	Role
Joost W Colaris, M.D.	HAGA/Erasmus Medical Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erasmus Medical Centre, Sophia Children's Hospital	Recruiting	Rotterdam	South Holland	3015GJ	Netherlands