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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]

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

Condition category

Condition code

Injuries and Accidents

Fractures

Musculoskeletal

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]

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]

The Care and Comfort Questionnaire (CCQ) will be used to assess the activities of daily living for each immobilisation technique.

Timepoint [1]

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]

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]

At 1 week review

Secondary outcome [2]

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]

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]

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]

At 1 week and 4 week review

Secondary outcome [4]

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]

Day 1, 2, and weeks 1, 4 and 6

Secondary outcome [5]

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]

Week 1, 4 and 6

Secondary outcome [6]

6. Time taken off work for parents in days recorded on study specific questionnaire at time point 3,4 and 5.

Timepoint [6]

Ongoing throughout trial at time points 3,4 and 5 at 1,4 and 6 weeks respectively.

Secondary outcome [7]

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]

Ongoing throughout trial at time points 3,4 and 5 at 1,4 and 6 weeks respectively.

Secondary outcome [8]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Perth Children's Hospital - Nedlands

Recruitment hospital [2]

Princess Margaret Hospital - Subiaco

Recruitment postcode(s) [1]

6009 - Nedlands

Recruitment postcode(s) [2]

6008 - Subiaco

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Perth Children's Hospital Foundation

Address [1]

15 Hospital Avenue, Nedlands 6909 WA,

Country [1]

Australia

Primary sponsor type

Hospital

Name

Perth Children's Hospital

Address

15 Hospital Avenue, Nedlands 6909 WA

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Child and Adolescent Health Service Human Research Ethics Committee [EC00268]

Ethics committee address [1]

Perth Children's Hospital
15 Hospital Avenue, Nedlands 6909
WA

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/11/2017

Approval date [1]

10/01/2018

Ethics approval number [1]

RGS0000000595

Summary

Brief summary

A Toddler’s Fracture is a fracture of the lower part of the ‘shin’ bone (tibia) in toddler’s or young children aged less than 8 years.  The fracture is usually found in the lower 2/3 of the tibia in most cases and is undisplaced and has a spiral pattern.  It often occurs after minimal trauma or a twisting injury.  Most often, children with these injuries present to an emergency department with refusal to weight bear or walk, but have few other clinical signs.
Historically, an above knee plaster of Paris (AK POP) is applied for 4-6 weeks to treat these injuries.  An above knee plaster can cause significant disruption to the lives of the child and family as it not only affects bathing and mobility but also requires multiple visits to the hospital. These may be for complications such as broken casts and pressure areas or for routine fracture clinic appointments with the orthopaedic team.
A controlled ankle motion walking boot or CAM boot is an orthopaedic device prescribed for the treatment and stabilization of severe sprains, fractures, and tendon or ligament tears and acts like a plaster cast to provide stability to a fractured bone or unstable joint, or to immobilise soft tissue injuries.  CAM boot immobilisation would, theoretically, be preferential to parents and children and would allow bathing and regular prams and strollers to be used instead of the required modifications needed for above knee plaster casts.
We aim to show that children have improved activities of daily living when immobilised in a CAM boot compared to an AK POP, without any detrimental effect on healing. We will also be looking at the amount of pain children experience in the two groups and parental satisfaction with the immobilisation technique used. Finally, we will assess and compare the cost of the two treatments, including time taken off work or school/day-care, and the number of hospital visits required.

Trial website

n/a

Trial related presentations / publications

n/a

Public notes

Contacts

Principal investigator

Name

Dr Kate Bradman

Address

Emergency Department
Perth Children's Hospital
15 Hospital Avenue
Nedlands 6909
WA

Country

Australia

Phone

+61 8 6456 2222

Fax

kate.bradman@health.wa.gov.au

Contact person for public queries

Name

Sharon O'Brien

Address

Emergency Department
Perth Children's Hospital
15 Hospital Avenue
Nedlands 6909
WA

Country

Australia

Phone

+61 8 6456 2222

Fax

sharon.obrien@health.wa.gov.au

Contact person for scientific queries

Name

Kate Bradman

Address

Emergency Department
Perth Children's Hospital
15 Hospital Avenue
Nedlands 6909
WA

Country

Australia

Phone

+61 8 6456 2222

Fax

kate.bradman@health.wa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Randomised controlled trial comparing immobilisation in above-knee plaster of Paris to controlled ankle motion boots in undisplaced paediatric spiral tibial fractures.	2021	https://dx.doi.org/10.1136/emermed-2020-210299

N.B. These documents automatically identified may not have been verified by the study sponsor.

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