Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000892819p
Ethics application status
Submitted, not yet approved
Date submitted
10/03/2021
Date registered
8/07/2021
Date last updated
8/07/2021
Date data sharing statement initially provided
8/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial of adults and children comparing longevity of Plaster of Paris and synthetic casts in people with undisplaced forearm fractures.
Scientific title
A randomized controlled trial of adults and children comparing longevity of Plaster of Paris and synthetic casts in people with undisplaced forearm fractures.
Secondary ID [1] 303658 0
Nil know
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fracture
 321051 0
Condition category
Condition code
Injuries and Accidents 318853 318853 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group
A synthetic cast will be applied to patients who are admitted into the study and allocated to the intervention group. This will be applied on the initial ED presentation and the patient will be discharged with a referral for Fracture clinic follow-up as per normal Monash Health protocol. At this appointment the Fracture clinic doctors will review the plaster and monitor the progress of the fracture healing as per standard care. The synthetic cast will be changed if any issues arise with it, or it will remain in-situ for the duration of the immobilisation period (generally 6 weeks).

We plan to work out the average time it takes to apply the cast when we do the training of their applications (approximately 20 casts). We would estimate it would take about 10 min
Intervention code [1] 319960 0
Treatment: Devices
Comparator / control treatment
A Plaster of Paris cast (POP) will be applied to patients who are admitted into the study and allocated to the control group. This will be applied on the initial ED presentation and be discharged with a referral for Fracture clinic follow-up as per normal Monash Health protocol. At this appointment, the Fracture clinic doctors will review the plaster and monitor the progress of the fracture healing as per standard practice. The POP cast will be changed if any issues arise with it, or it will remain in-situ for the duration of the immobilisation period (generally 6 weeks).

We plan to work out the average time it takes to apply the POP in the ED (approx. 20 plasters) before the start the trail.. We would estimate it would take about 10 min
Control group
Active

Outcomes
Primary outcome [1] 326800 0
The primary outcome measure in this study will be the number of cast used in the immobilization of a fracture.

This information will be obtained from the medical records from the hospital as well as data collected at the fracture clinic reviews. The plaster technicians will fill in an Interim Case Report which will gather data on why the cast was changed, where it was changed. This will be cross referenced to the medical records
Timepoint [1] 326800 0
This will be calculated from the initial Emergency Department cast until the final cast is removed at the fracture clinic (usually around 6 weeks)
Secondary outcome [1] 392708 0
1. Average costs of current pathway vs Synthetic cast applied in the Emergency Department. By calculating the number of casts used in the management of the fracture. The cost of the cast will be determined as an average prior to trial commencing i.e average cost of material and time to apply.

This will be calculated by averaging the number of casts used in each patients care through data collection from the hospital medical records
Timepoint [1] 392708 0
Average cost will be determined approximetely 6 weeks post initial ED presentation
Secondary outcome [2] 392709 0
The length of time the initial cast will remain in situ, until it is removed.

This will be calculated by auditing the hospital medical records for the individual patient
Timepoint [2] 392709 0
The length of time the initial cast which was applied in the Emergency Department remains insitu until it is removed either in the Emergency Department or fracture clinic.
Secondary outcome [3] 392710 0
Number of fracture clinic / Emergency Department visits for management of wrist fractures

This will be calculated by auditing the hospital medical records for the individual patient
Timepoint [3] 392710 0
Data will be collected after the final fracture clinic appointment (usually around 6 week)
Secondary outcome [4] 392711 0
Patient satisfaction questionnaire
This will be administered at the time of the removal of the initial plaster in either the Emergency department or fracture clinic

This questionnaire is based on the questionnaire used by Ingliss et al (2013) in their synthetic cast study. This has been modified to be able to be easier to interpret by patients who are required to complete it
Timepoint [4] 392711 0
This will be administered at the time of the removal of the initial plaster in either the Emergency department or fracture clinic

Eligibility
Key inclusion criteria
Patients to be included must meet the following criteria:

1. Paediatric including and over the age of 5 years of age and adults
2. Fracture acutely sustained (previous 72 hours), undisplaced forearm fracture (including distal radius and/or ulna [epiphysis/metaphysis]
3. Below elbow circumferential casting is the management in accordance to Monash Health Orthopaedic recommendations.
4. Ongoing conservative management is planned
5. Ongoing management expected to take place within Monash Health (Monash Emergency and Monash Orthopaedic units)
6. Able to give informed consent.
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they have any of the following conditions:

1. Compound (open) fracture
2. Significant swelling and/or neurovascular compromise such that initial backslab (rather than circumferential casting) is recommended.
3. Isolated proximal forearm fractures such as radial head/neck, olecranon or coronoid process fractures of ulna(displaced or undisplaced).
4. Any forearm fracture or fracture-dislocation for which operative management is recommended (acute or delayed).
5. Inability to understand the study explanation/requirements for any reason (e.g. language difficulties, abnormal/reduced cognitive state).
6.Adequate circumferential cast already in place (from GP or non-Monash referring hospital).
7.Fracture requiring surgical stabilisation

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2021
Actual
Date of last participant enrolment
Anticipated
28/02/2022
Actual
Date of last data collection
Anticipated
2/03/2022
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 308077 0
Hospital
Name [1] 308077 0
Casey Hospital
Country [1] 308077 0
Australia
Primary sponsor type
Hospital
Name
Casey Hospital
Address
62-70 Kangan Drive,
Berwick, Victoria,
Australia, 3806
Country
Australia
Secondary sponsor category [1] 308814 0
None
Name [1] 308814 0
Address [1] 308814 0
Country [1] 308814 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308066 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 308066 0
Ethics committee country [1] 308066 0
Australia
Date submitted for ethics approval [1] 308066 0
24/03/2021
Approval date [1] 308066 0
Ethics approval number [1] 308066 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109406 0
Mr Scott Anderson
Address 109406 0
Casey Hospital
62-70 Kangan Dr,
Berwick, Victoria,
Australia, 3806
Country 109406 0
Australia
Phone 109406 0
+61 387682057
Fax 109406 0
Email 109406 0
[email protected]
Contact person for public queries
Name 109407 0
Scott Anderson
Address 109407 0
Casey Hospital
62-70 Kangan Dr,
Berwick, Victoria,
Australia, 3806
Country 109407 0
Australia
Phone 109407 0
+61387682057
Fax 109407 0
Email 109407 0
[email protected]
Contact person for scientific queries
Name 109408 0
Robert meek
Address 109408 0
Casey Hospital
62-70 Kangan Dr,
Berwick, Victoria,
Australia, 3806
Country 109408 0
Australia
Phone 109408 0
+61387682057
Fax 109408 0
Email 109408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.