Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001311246
Ethics application status
Approved
Date submitted
5/07/2018
Date registered
6/08/2018
Date last updated
29/09/2020
Date data sharing statement initially provided
29/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Toddler Fracture Immobilisation Study
Scientific title
A randomised controlled trial to compare two different immobilisation techniques (above knee plaster of Paris (AKPOP) and Controlled Ankle Movement (CAM) boot used for children, aged 1-5 years with a toddler’s fracture and its effect on activities of daily living.
Secondary ID [1] 295447 0
Nil
Universal Trial Number (UTN)
Trial acronym
ToFI Study
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Undisplaced spiral tibial fractures 308701 0
Condition category
Condition code
Injuries and Accidents 307639 307639 0 0
Fractures
Musculoskeletal 308001 308001 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Procedure and Assessments
Demographic and Relevant Clinical Information
Emergency department doctors will assess and diagnose the toddler’s fracture during the initial presentation to the ED.

Following informed consent, CRF #1 will be completed, containing demographic information for example, participant’s date of birth and gender. In addition, relevant clinical information will be collected including details of the injury, relevant past medical history, and medical evaluations/contacts prior to the ED visit.

Patients are then randomised to either CAM boot or AK-POP and the relevant immobilisation device applied prior to discharge from ED. Information regarding care and maintenance of the immobilisation device is given to parents prior to discharge.

Prior to discharge from the ED, all patients will receive an appointment and X-ray form for a follow-up review in one week. All patients who are placed in an AK POP will return the following day to the ED for a plaster check as per usual practice (Time Point 2). All parents will be asked to complete a diary on day 2 (CRF 2), recording their child’s pain score on the visual analogue scale (VAS) and an Activities of Daily Living (ADL) questionnaire.

The questionnaire used is modified, to be relevant to this study, from the validated Care and Comfort Hypertonicity Questionnaire (CCHQ) and will be known as the Care and Comfort Questionnaire (CCQ).

Follow Up Assessment at 7-10 Days (Time Point 3)
At Time Point 3 all patients will have a repeat X-ray prior to their ED review clinic and then be seen by an ED consultant or ED nurse practitioner (NP) who will review the X-ray and assess the child clinically. AK POP will be assessed and removed and replaced if there is any concern regarding pressure areas. All POPs will be reinforced with fibreglass wrap and advice given to weight bear as tolerated as per normal practice at this visit.

All patients will receive a fracture clinic appointment prior to discharge from the ED review clinic. A CRF # 3 will be completed documenting details of the visit and a pain score from both doctor/NP and parent, as well as completing a CCQ. Weight bearing status of the patient will be clearly documented as full, partial or non-weight bearing.

Comparison between the initial x-ray and radiograph at FUA-1 will be formally assessed by the hospital radiology department.

Patients will be given a fracture clinic appointment prior to leaving and a CRF will be placed in the notes for completion at the 4 week review.

Follow Up Assessment at 4-5 Weeks (Time Point 4)
At Time Point 4 post injury, all patients will be reviewed in the orthopaedic fracture clinic and a clinical assessment of fracture healing will be made as well as ability to weight bear.

A CRF #4 will be completed documenting a pain score from both the orthopaedic doctor and parent. A CCQ will also be completed by the parent at this appointment. Whether or not the child is weight-bearing, partially weight bearing or not weight bearing will be documented. Any complications encountered during the study period including unscheduled hospital attendances will be documented. Any further investigations or on-going treatment deemed necessary by the orthopaedic surgeon will be documented.

Follow Up Assessment At 6 Weeks (Time Point 5)
A Time Point 5 a follow-up phone interview will be conducted by the study management team at 6 weeks post study enrolment. A CRF #5 will be completed over the phone documenting pain, ability to weight bearing and any parental concerns. A CCQ will also be completed and the parent will be asked if they would be happy for their child to be immobilised with this technique if required again.
Intervention code [1] 301755 0
Treatment: Devices
Comparator / control treatment
A Controlled ankle movement boot is being directly compared with an above knee Plaster of Paris for Toddler fracture immobilisation.

An above knee plaster covers the leg from toes to mid thigh. A CAM boot is a walking boot that covers the foot and leg below the knee.

There are no direct strategies used to assess adherence to the CAM boot except for informing the parents that they must keep the boot on at all times except when non-weight bearing in a bath. Parents seem to understand the importance of immobilising a fracture and we have had no problems with children removing them themselves.
Control group
Active

Outcomes
Primary outcome [1] 306624 0
The Care and Comfort Questionnaire (CCQ) will be used to assess the activities of daily living for each immobilisation technique.

Timepoint [1] 306624 0
Parents will complete the questionnaire on day 1 (primary time point) and 2 and at clinical review at 1 week and 4 weeks and finally at 6 weeks by phone interview.

In total 5 CCQ assessments are completed.
Secondary outcome [1] 349044 0
1. Assessment of healing by X-ray at 1-2 weeks post injury, assessed by presence or absence of a periosteal reaction or callous formation and presence of fracture widening or displacement.
Timepoint [1] 349044 0
At 1 week review
Secondary outcome [2] 349045 0
2. Complications of treatment which will include any adverse events related to the immobilisation technique such as pressure sores, rashes, broken casts and other unscheduled hospital reviews as well as any complications of fracture healing.

This outcome is captured using a study specific questionnaire completed at time point 3 after review of follow-up radiograph.
Timepoint [2] 349045 0
This outcome is captured using a study specific questionnaire completed at time point 2, 3,4 and 5 on day 2 (for AKPOP only), week 1, 4 and 6 respectively.
Secondary outcome [3] 349046 0
3. Assessment of weight bearing at 1 and 4 weeks. Documented as non-weight bearing, partially weight bearing or fully weight-bearing. on study specific questionnaire CRF 3,4 and 5 at time points 3, 4 and 5.
Timepoint [3] 349046 0
At 1 week and 4 week review
Secondary outcome [4] 349047 0
4. Assessment of pain control daily for the first week and then at each subsequent visit using a parent and doctor reported visual analogue scale (VAS).
Timepoint [4] 349047 0
Day 1, 2, and weeks 1, 4 and 6
Secondary outcome [5] 349048 0
5. Need for analgesia during the first week and a 1, 4 and 6 weeks. Documented as No, Yes and if Yes how many times in the past 24 hours.
Timepoint [5] 349048 0
Week 1, 4 and 6
Secondary outcome [6] 349049 0
6. Time taken off work for parents in days recorded on study specific questionnaire at time point 3,4 and 5.
Timepoint [6] 349049 0
Ongoing throughout trial at time points 3,4 and 5 at 1,4 and 6 weeks respectively.
Secondary outcome [7] 349050 0
7. Time taken off school or day-care for children in days recorded on study specific questionnaire at time point 3,4 and 5.
Timepoint [7] 349050 0
Ongoing throughout trial at time points 3,4 and 5 at 1,4 and 6 weeks respectively.
Secondary outcome [8] 349051 0
8. Cost analysis of treatment received via capture of cost information from the parent/guardian/participant related to in-patient, out-patient, or ED visits and to any other health facilities including general practitioner attendance for treatment or investigation during the 6 weeks following randomisation recorded on study specific questionnaire at time point 3,4 and 5.
Timepoint [8] 349051 0
Ongoing throughout trial at time points 3,4 and 5 at 1,4 and 6 weeks respectively.

Eligibility
Key inclusion criteria
Children aged 1 year and less than 5 years old with clinical suspicion of a toddler’s fracture.
Minimum age
1 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Concern regarding non-accidental injury (NAI).
• Underlying bone abnormality e.g. osteogenesis imperfecta, bone cysts.
• Chronic disease affecting bone development e.g. chronic steroid use, Cerebral Palsy (CP), chronic renal disease.
• Previous fracture on same leg within the past 6 months.
• Fractures of both the tibia and fibula.
• Inability to attend follow-up at PMH/PCH.
• Other types of tibial fractures e.g. transverse or buckle fracture.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be block randomized in a 1:1 ratio to one of the two treatment arms: CAM boot or AK POP. An independent statistician will generate a randomisation schedule using variable block sizes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical Analysis Plan
Power/Sample Size
Sample size is determined using the primary outcome measure of activities of daily living (ADLs).

We propose a sample size of 60 (30 per group). Using ANOVA: repeated measures between factors (G*power), power of 80%, alpha of 0.05 and allowing for 6 drop outs an effect size of 0.31 would be required. This is considered a medium to large effect size, which is deemed clinically suitable by the investigators. A clinically meaningful difference of 2, would translate to a standard deviation of 3.2 (to find an effect size of 0.31). The researchers feel this would represent reasonable standard deviation for the data.

Given that we do not have prior data or literature to base our sample size / power we plan to review the sample size calculation using data from the study once 50% of participants have completed the 6 week assessment. This will be performed in conjunction with the analysis from the DSMB. This is not a review of efficacy of the CAM vs above knee plaster, but a review of the sample size requirements through examining variation (given we have no prior variation data). We do not plan to cease the study early for sample size reasons, but will use this information to determine if greater number of participants are needed if our estimated effect size / standard deviation is inaccurate. The criteria for power/sample size review includes:
- Clinical significant difference of 2 (mean difference grp1= 5 and grp 2 =3)
- Power 80%
- Alpha 0.05
- 2 groups
- 3 measurements
- Correlation among rep measures 0.5
- Standard deviation determined by the data from this study once 50% participants have completed the 6 week assessment.

Statistical Analysis
Pain and activity scales are measured at all time points and will be reported at each time point (time points 1,2 , 3, 4, 5) as means and standard deviations or medians and interquartile ranges depending on the data distribution. The C&C is divided into 4 sections; personal care, positioning/transferring, comfort and interaction/communication. Caregivers rate each item on a scale of 1-7 with 1 being very easy/no problem and 7 being extremely difficult impossible and mean or median score will be calculated for each section. The C&C summary score is the mean of the section mean scores. The distribution of the data will be considered when determining if the mean scores can be used to determine the C&C summary score.

Repeated measures linear mixed models will be used to determine differences between the groups at each time points (1, 2, 3, 4 and 5). Time will be entered into the model as a factor (categorical) variable. Time point 1 represents pre fracture baseline score and may be added to the model as a predictor. A mixed model is chosen as it allows for correlation between time points, and enables all subjects to be included even if there is missing data. Model assumptions will be checked and data transformed if required. If transformation is unsuccessful then non-parametric methods will be chosen.

Secondary outcomes are collected at varying times. Each outcome will be reported using a comparative table. Healing (on x-ray), weight bearing status and complications will be reported using frequencies and proportions. Time taken off school and work reported using means and standard deviations or medians and interquartile ranges depending on the data distribution

All adverse events will be collated and the proportion of children with any adverse events recorded for each group. A difference in proportions for all adverse (fracture complications, weight bearing, pressure, cast changes) will be calculated along with the corresponding 95% confidence intervals.

Cost-analysis comparing the two immobilisation techniques will be performed. Both direct (such as ED and GP visits, resource items) and indirect costs (time off work) will be included. Unit costs will be assigned to each item. Mean cost per individual (representing cost burden) and median costs per individual (reflecting expected cost per individual) will be compared between the two groups. Independent t tests may be performed to assess the statistical significance of the difference in mean costs between groups.
Alpha will be set as 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/03/2018
Date of last participant enrolment
Anticipated
31/12/2019
Actual
2/02/2020
Date of last data collection
Anticipated
16/02/2020
Actual
17/03/2020
Sample size
Target
60
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 11323 0
Perth Children's Hospital - Nedlands
Recruitment hospital [2] 11324 0
Princess Margaret Hospital - Subiaco
Recruitment postcode(s) [1] 23220 0
6009 - Nedlands
Recruitment postcode(s) [2] 23221 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 300036 0
Charities/Societies/Foundations
Name [1] 300036 0
Perth Children's Hospital Foundation
Country [1] 300036 0
Australia
Primary sponsor type
Hospital
Name
Perth Children's Hospital
Address
15 Hospital Avenue, Nedlands 6909 WA
Country
Australia
Secondary sponsor category [1] 299426 0
None
Name [1] 299426 0
Address [1] 299426 0
Country [1] 299426 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300886 0
Child and Adolescent Health Service Human Research Ethics Committee [EC00268]
Ethics committee address [1] 300886 0
Ethics committee country [1] 300886 0
Australia
Date submitted for ethics approval [1] 300886 0
10/11/2017
Approval date [1] 300886 0
10/01/2018
Ethics approval number [1] 300886 0
RGS0000000595

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

Contacts
Principal investigator
Name 85158 0
Dr Kate Bradman
Address 85158 0
Emergency Department
Perth Children's Hospital
15 Hospital Avenue
Nedlands 6909
WA
Country 85158 0
Australia
Phone 85158 0
+61 8 6456 2222
Fax 85158 0
Email 85158 0
[email protected]
Contact person for public queries
Name 85159 0
Sharon O'Brien
Address 85159 0
Emergency Department
Perth Children's Hospital
15 Hospital Avenue
Nedlands 6909
WA
Country 85159 0
Australia
Phone 85159 0
+61 8 6456 2222
Fax 85159 0
Email 85159 0
[email protected]
Contact person for scientific queries
Name 85160 0
Kate Bradman
Address 85160 0
Emergency Department
Perth Children's Hospital
15 Hospital Avenue
Nedlands 6909
WA
Country 85160 0
Australia
Phone 85160 0
+61 8 6456 2222
Fax 85160 0
Email 85160 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
SourceTitleYear of PublicationDOI
EmbaseRandomised controlled trial comparing immobilisation in above-knee plaster of Paris to controlled ankle motion boots in undisplaced paediatric spiral tibial fractures.2021https://dx.doi.org/10.1136/emermed-2020-210299
N.B. These documents automatically identified may not have been verified by the study sponsor.