Evaluation of Cork Splint Materials Instead of Plaster Splint for Children

This study has been completed.

Sponsor:

Information provided by:

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT00285961

First received: February 1, 2006

Last updated: May 11, 2009

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 1, 2006

Last Updated Date

May 11, 2009

Start Date ^ICMJE

Not Provided

Primary Completion Date

April 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Functionality
Added value

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00285961 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluation of Cork Splint Materials Instead of Plaster Splint for Children

Official Title ^ICMJE

Evaluation of Cork Splint Materials Instead of Plaster Splint for Children

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

Device: Cork splint materials (instead of plaster splint)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

April 2004

Primary Completion Date

April 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Both

Ages

3 Years to 11 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT00285961

Other Study ID Numbers ^ICMJE

2003/364

Has Data Monitoring Committee

Responsible Party

René Verdonk, University Ghent

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Rene Verdonk, MD, PhD

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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