Evaluation of Cork Splint Materials Instead of Plaster Sp... | NCT00285961

Studies
Evaluation of Cork Splint Materials Instead of Plaster Splint for Children

NCT00285961

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

May 12, 2009Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Wrist Fractures
Forearm Fractures
Elbow Fractures
Ankle Fractures
Foot Fractures
Wounds and Injuries

Interventions

Cork splint materials (instead of plaster splint)

Countries

Belgium

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

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Apr 2004Actual

Completion Date

Apr 2004Actual

First Submitted Date

Feb 1, 2006

First Submission Date that Met QC Criteria

Feb 1, 2006

First Posted Date

Feb 2, 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

May 11, 2009

Last Update Posted Date

May 12, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an evaluation of the functionality and added value of cork splint materials instead of a plaster splint for children (3-11 years old).

Detailed Description

Not provided

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

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
Cork splint materials (instead of plaster splint)	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fractures of the wrist, forearm, elbow, ankle, foot
Distortions of the wrist, elbow, ankle
Wounds without tendon injuries

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rene Verdonk, MD, PhD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium

Label	URL
Website University Hospital Ghent	View source

Condition Browse Module

MeSH Terms

ID	Term
D000092503	Wrist Fractures
D000092482	Elbow Fractures
D064386	Ankle Fractures
D014947	Wounds and Injuries

Ancestor Terms

ID	Term
D014954	Wrist Injuries
D001134	Arm Injuries
D050723	Fractures, Bone
D000092464	Elbow Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Functionality
Added value