Condition category
Injury, Occupational Diseases, Poisoning
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
17/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr E.R. Hammacher

ORCID ID

Contact details

Koekoekslaan 1
Nieuwegein
3430 EM
Netherlands
+31 (0)30 6092052
e.hammacher@antonius.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR393; 05.454

Study information

Scientific title

Acronym

Greenstick

Study hypothesis

Treatment of greenstick forearm fractures with bandages, as compared to cast therapy, will lead to a decrease of discomfort and no increase of pain complaints.

Ethics approval

Received from local medical ethics committee

Study design

Randomised open label active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Greenstick forearm fractures

Intervention

Patients are randomly assigned to be treated using either bandages or cast therapy.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Secondary dislocation of the fracture

Secondary outcome measures

1. Comfort
2. Pain
3. Function of the arm
4. Complications

Overall trial start date

26/09/2005

Overall trial end date

01/04/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with a greenstick forearm fracture which comprises 1/3 of the distal forearm
2. Patients with an age between 4 years old and 13 years old
3. Signed informed consent

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. Complicated fractures
2. The necessity to reposition the fracture

Recruitment start date

26/09/2005

Recruitment end date

01/04/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Koekoekslaan 1
Nieuwegein
3430 EM
Netherlands

Sponsor information

Organisation

St Antonius Hospital (Netherlands)

Sponsor details

P.O. Box 2500
Nieuwegein
3430 EM
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

St Antonius Hospital (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes