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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 1091 0
Condition category
Condition code
Injuries and Accidents 1172 1172 0 0
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] 968 0
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] 1576 0
Duration of pain measured daily by parental questionairre and by questioning
Timepoint [1] 1576 0
At review at 2 weeks post immobilisation
Secondary outcome [1] 2858 0
Ease of care
Timepoint [1] 2858 0
Measured daily on a visual analogue scale in parental questionairre.
Secondary outcome [2] 2859 0
Use immobilisation again
Timepoint [2] 2859 0
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?
No
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
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1281 0
Hospital
Name [1] 1281 0
Royal Children's Hospital, Melbourne
Country [1] 1281 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital, Melbourne
Address
Country
Australia
Secondary sponsor category [1] 1134 0
None
Name [1] 1134 0
nil
Address [1] 1134 0
Country [1] 1134 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2617 0
Royal Children's Hospital
Ethics committee address [1] 2617 0
Melbourne
Ethics committee country [1] 2617 0
Australia
Date submitted for ethics approval [1] 2617 0
Approval date [1] 2617 0
Ethics approval number [1] 2617 0
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 36002 0
Address 36002 0
Country 36002 0
Phone 36002 0
Fax 36002 0
Email 36002 0
Contact person for public queries
Name 10157 0
Ed Oakley
Address 10157 0
Department of Emergency Medicine
Royal Children's Hospital
Flemington Rd
Parkville VIC 3052
Country 10157 0
Australia
Phone 10157 0
+61 3 93456592
Fax 10157 0
+61 3 93455938
Email 10157 0
[email protected]
Contact person for scientific queries
Name 1085 0
Ed Oakley
Address 1085 0
Department of Emergency Medicine
Royal Children's Hospital
Flemington Rd
Parkville VIC 3052
Country 1085 0
Australia
Phone 1085 0
+61 3 93456592
Fax 1085 0
+61 3 93455938
Email 1085 0
[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
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