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Evaluation of Cork Splint Materials Instead of Plaster Splint for Children

Primary Purpose

Wrist Fractures, Forearm Fractures, Elbow Fractures

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Cork splint materials (instead of plaster splint)

About this trial

This is an interventional treatment trial for Wrist Fractures focused on measuring Fractures of the wrist, forearm, elbow, ankle, foot, Distortions of the wrist, elbow, ankle, Wounds without tendon injuries

Eligibility Criteria

3 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital Ghent

Outcomes

Primary Outcome Measures

Functionality

Added value

Secondary Outcome Measures

Full Information

NCT ID

NCT00285961

First Posted

February 1, 2006

Last Updated

May 11, 2009

Sponsor

University Hospital, Ghent

1. Study Identification

Unique Protocol Identification Number

NCT00285961

Brief Title

Evaluation of Cork Splint Materials Instead of Plaster Splint for Children

Official Title

Evaluation of Cork Splint Materials Instead of Plaster Splint for Children

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

April 2004 (Actual)

Study Completion Date

April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Ghent

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Cork splint materials (instead of plaster splint)

Primary Outcome Measure Information:

Title

Functionality

Title

Added value

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rene Verdonk, MD, PhD

Organizational Affiliation

University Hospital, Ghent

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Ghent

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Links:

URL

http://www.uzgent.be

Description

Website University Hospital Ghent

Learn more about this trial

Evaluation of Cork Splint Materials Instead of Plaster Splint for Children

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