ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12606000126516

Ethics application status

Approved

Date submitted

4/04/2006

Date registered

6/04/2006

Date last updated

6/04/2006

Type of registration

Retrospectively registered

Titles & IDs

Public title

Comparison of two methods of immobilising torus fractures of the distal forearm

Scientific title

Randomised controlled trial to compare the difference in immobilisation of torus fractures of the distal forearm in plaster of paris casts and fibreglass slabs on pain and parental satisfaction.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Torus fractures of the distal forearm

Condition category

Condition code

Injuries and Accidents

Fractures

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

randomisation to immobilisation in below elbow encircling plaster of paris cast for 2 weeks. Clinical and radiological review at 2 weeks and further 2 weeks immobilisation in same treatment if needed.

Intervention code [1]

Treatment: Other

Comparator / control treatment

randomisation to immobilisation in a fibreglass volar slab for 2 weeks. Clinical and radiological review at 2 weeks and further 2 weeks immobilisation in same treatment if needed.

Control group

Active

Outcomes

Primary outcome [1]

Duration of pain measured daily by parental questionairre and by questioning

Timepoint [1]

At review at 2 weeks post immobilisation

Secondary outcome [1]

Ease of care

Timepoint [1]

Measured daily on a visual analogue scale in parental questionairre.

Secondary outcome [2]

Use immobilisation again

Timepoint [2]

Measured at structured interview on review at 2 weeks post immobilisation.

Eligibility

Key inclusion criteria

Presenting to the Emergency Department of the RCH And Minimally displaced greenstick fractures of the distal forearm.

Minimum age

Not stated

Maximum age

17 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Other associated fractures of the arm.Or Other injuries of the hand or wrist.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

opaque envelope

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

block sequences

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

2/03/2002

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Children's Hospital, Melbourne

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Children's Hospital, Melbourne

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Children's Hospital

Ethics committee address [1]

Melbourne

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

21126 A

Summary

Brief summary

AIM:  To determine patient and family preferences for immobilisation of undisplaced buckle (greenstick) type fractures of the forearm near to the wrist (distal forearm).
BACKGROUND: In the group of children who sustain fractures (breaks) of the forearm near to the wrist, which are undisplaced the mode and length of immobilisation in plaster has been variable. It has been shown that adequate treatment is to immobilize the arm for a two week period, remove the plaster cast then reassess the fracture site for tenderness. The treatment is then either to mobilise if there is minimal tenderness or to re-plaster for a further 1-2 weeks if there is still significant pain.
The method of immobilising these injuries has traditionally been in a full, encircling plaster cast, which requires splitting for removal.  Another method that has gained popularity recently is the plaster slab (half cast), fashioned and moulded to one side of the child’s forearm and wrist and held in place with a crepe bandage.  The functional outcome anecdotally appears to be the same with these two techniques, but the patient preference and comfort have never been investigated.
HYPOTHESIS: That plaster slab treatment of buckle fractures of the distal forearm is at least as acceptable to patients as full plaster casting, and that return to function will not be delayed.
PROJECT DESIGN: this is to be a prospective randomised study of two techniques of immobilisation of buckle fractures of the distal forearm in children.  
All children < 17 years of age, with an undisplaced fracture of the radius or ulna, presenting to the Emergency Department of the Royal Children’s Hospital will be enrolled into the study and randomised into either application of a full plaster cast or a plaster slab (half cast)
Parents will be asked to keep a daily diary of analgesia use, child complaints or perceived problems with the plaster.
Follow up will be in the Emergency Department by one of the two investigators at 2 weeks post injury.  At this time a patient and parent satisfaction questionnaire will be completed, the plaster will be removed and the forearm fracture reassessed.  If there is minimal or no tenderness the patient will be allowed to mobilise and return to normal function.  If there is pain the plaster, or plaster slab, will be replaced and review in a further 2 weeks will occur.
RELEVANCE: This research is relevant to current clinical management of patients with the described injuries as it will provide information as to the most acceptable immobilisation from the patients and families point of view.  It will also establish the time taken for different immobilisation techniques to return the children to full function.  These results should guide future treatment of these injuries, both in the hospital and in general practice clinics.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Ed Oakley

Address

Department of Emergency Medicine
Royal Children's Hospital
Flemington Rd
Parkville VIC 3052

Country

Australia

Phone

+61 3 93456592

Fax

+61 3 93455938

[email protected]

Contact person for scientific queries

Name

Ed Oakley

Address

Department of Emergency Medicine
Royal Children's Hospital
Flemington Rd
Parkville VIC 3052

Country

Australia

Phone

+61 3 93456592

Fax

+61 3 93455938

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically