Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000637943
Ethics application status
Approved
Date submitted
3/06/2019
Date registered
29/05/2020
Date last updated
7/12/2022
Date data sharing statement initially provided
29/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the use of bedside ultrasound versus x-ray to diagnose forearm fractures in children; a randomised trial
Scientific title
Bedside Ultrasound Conducted in Kids with distal upper Limb fractures in the Emergency Department; an open diagnostic randomised-controlled trial and health economic analysis. (BUCKLED RCT)
Secondary ID [1] 298394 0
Nil known
Universal Trial Number (UTN)
U1111-1234-5856
Trial acronym
BUCKLED RCT
Linked study record
BUCKLED (diagnostic) - U1111-1205-3611, ACTRN12617001648314

Health condition
Health condition(s) or problem(s) studied:
Paediatric forearm fractures 313085 0
Condition category
Condition code
Injuries and Accidents 311571 311571 0 0
Fractures
Musculoskeletal 313976 313976 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible patients will be randomised to either bedside ultrasound, otherwise known as point-of-care ultrasound (POCUS), or x-ray imaging as the initial diagnostic approach.

POCUS Intervention:
POCUS will be performed by a health practitioner (nurse, doctor, allied health professional) who has undergone training and credentialing. This will involve application of gel on the affected forearm which is then interrogated with a high frequency linear probe for up to 10 minutes, using a 6-view protocol for evaluation of signs of a fracture.

Patients' fractures will be classified into 3 groups: 'no' fracture, 'buckle' fracture or 'other' fracture (i.e. cortical breach fracture, including incomplete, complete or physeal; bow deformity and fractures at other sites will also be included in this group). Both the radius and ulna bones will be individually classified, with the overall forearm classification based on the overarching fracture that determined the management of the patient. If a cortical breach or other signs of a cortical breach (e.g. periosteal haematoma) are identified on POCUS, they will receive an x-ray. 'Pain out of proportion' on physical examination, despite the findings on POCUS, will also mandate an x-ray. This will include patients who have uncontrolled pain, ongoing tenderness or reduced function despite adequate analgesia and is not felt to be in keeping with a soft tissue injury, as per treating clinician judgement. If either 'no' fracture or a 'buckle' fracture are identified on POCUS, they will not receive an x-ray prior to discharge. POCUS images will be later reviewed for correct interpretations.

All patients who are diagnosed with either a 'buckle' fracture or 'no' fracture will be given a tentative appointment for ED clinical review in 1 week (5-7 day convenience window).
Intervention code [1] 314638 0
Diagnosis / Prognosis
Intervention code [2] 316426 0
Treatment: Devices
Comparator / control treatment
Eligible patients randomised to x-ray imaging will have a minimum of 2-views performed (anteroposterior and lateral) by a radiographer, usually a process that takes 10 minutes if immediately available. Patients will receive routine care according to the interpretation of the x-ray, which will again be categorised into the 3 fracture groups. The 'no' fracture group will be managed at the clinician's discretion (documented), the 'buckle' fracture group will be managed in a wrist splint and the 'other' fracture group will be managed in a plaster cast.

All patients who are diagnosed in either the 'buckle' fracture or 'no' fracture groups will be given a tentative appointment for ED clinical review within 1 week (5-7 day convenience window).
Control group
Active

Outcomes
Primary outcome [1] 320277 0
The difference in functional outcome between the two diagnostic modality arms will be determined using a PROMIS tool. The PROMIS Pediatric Upper Extremity Short questionnaire is a validated tool that assesses the physical function, including activities of daily living, for patients 5-15 years of age.
Timepoint [1] 320277 0
The PROMIS tool scores will be determined at baseline (premorbid), 1 week, 4 weeks and 8 weeks.. The primary outcome of the study will be the PROMIS score at 28 days (+/- 3 day window).
Secondary outcome [1] 371056 0
Health economic analysis will be conducted to determine the cost-effectiveness of both imaging modalities in the diagnosis of paediatric distal forearm injuries. The CHU9D instrument will be utilised, alongside the PROMIS, to enable a complete cost-utility analysis. The analysis will also take into account any change in the total length of stay in the ED, as well as any change in the number of x-rays conducted. Detailed resource utilisation (labour, consumables, imaging) will be reported for both the POCUS and x-ray (routine care) trial arms for each site. The sum cost of resources, including implementation, staff labour, equipment and ED length of stay, will then be estimated per patient for both models of care.
Timepoint [1] 371056 0
CHU9D data collected at baseline (prior to randomisation), 1 week, 4 weeks and 8 weeks. Overall analysis will be conducted at the end of the recruitment period.
Secondary outcome [2] 371057 0
Patient (child) and parent satisfaction
Timepoint [2] 371057 0
Satisfaction scores based on a 5-point Likert scale will be collected at 4 weeks and 8 weeks post recruitment for each patient
Secondary outcome [3] 371058 0
Complications related to the injury. For example, loss of function, growth disturbance, unexpected surgical intervention
Timepoint [3] 371058 0
All patients enrolled in the study will also be contacted at 8 weeks post recruitment to determine.
Secondary outcome [4] 371059 0
ED length of stay will be determined from the clinical records.
Timepoint [4] 371059 0
Length of stay will be defined from the time the patient was triaged to the time of discharge (home or admission to the ward).
Secondary outcome [5] 378297 0
Pain scores will be recorded using the Faces Pain Scale Revised for each child.
Timepoint [5] 378297 0
Baseline (prior to randomisation), 1 week, 4 weeks and 8 weeks.
Secondary outcome [6] 382371 0
The diagnostic accuracy of POCUS and x-ray imaging will be determined against the gold standard final diagnosis, as determined by the consensus from an expert panel based on the clinical course, investigations and final management. Diagnostic accuracy will be determined for 'any' fracture ('buckle' and 'other' fractures combined) and 'other' fractures alone ('buckle' and 'no' fractures combined as the comparator)
Timepoint [6] 382371 0
Diagnostic accuracy will be determined after their8 weeks contact.
Secondary outcome [7] 382372 0
The rate of avoidance of x-ray imaging in the POCUS group for the 'no' fracture and 'buckle' fracture groups will be determined from review of hospital records and parent survey.
Timepoint [7] 382372 0
4 weeks and 8 weeks.
Secondary outcome [8] 383152 0
Treatment time in ED will be determined from the clinical records.
Timepoint [8] 383152 0
Time from clinical review of the patient until time of discharge from ED

Eligibility
Key inclusion criteria
• Children aged 5-15 years presenting to the ED
• Isolated, non-angulated distal third forearm injury being evaluated for suspected fracture
Minimum age
5 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Injury sustained >48 hour at time of ED presentation
• External imaging has already been performed
• Known metabolic bone disease, such as osteogenesis imperfecta
• Suspicion of non-accidental injury
• Congenital bone malformation, such as radius hypoplasia
• Compound fracture
• Neurovascular compromise
• Distracting injury (e.g. elbow)
• Suspicion for hand fracture (e.g. scaphoid)
• Inability to perform an accurate clinical assessment e.g. severe developmental delay or behavioural difficulties
• Inability to perform ultrasound due to unavailability of a credentialed practitioner
• Inability to obtain informed consent from parent

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation via computer program (Griffith University). Patients will be randomised after agreeing to participate in study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation to either the POCUS or x-ray imaging as the initial diagnostic approach will occur after stratification by site and age (5-9 years and 10-15 years). Randomisation will be in a 1:1 ratio within blocks of size 6-8 (size randomly selected).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Child, parent and treating clinician(s) not masked. Radiographer and reporting radiologist masked to the initial diagnostic allocation and any POCUS findings.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations were based on a non-inferiority hypothesis comparing POCUS with x-ray (routine care) for the primary outcome of upper limb function assessed using the PROMIS score at 4 weeks. Previous studies suggest the true between-group difference was assumed to be zero with the non-inferiority margin defined as an absolute difference of 5 points and the standard deviation of PROMIS assumed to be 11.5 points. To achieve 90% power with a one-sided a of 0.025, we require primary outcome data for 224 children (112 per arm).

A key secondary endpoint is to assess the non-inferiority of POCUS compared with x-ray as the initial imaging strategy for children who are later confirmed by the expert panel to have buckle fractures. Previous studies suggest that the standard deviation of PROMIS for children with buckle fractures is approximately 7.5 points. Assuming the true between-group difference is 0 and defining the non-inferiority margin as 5 points, then with 90% power and one-sided a=0.025, we require primary outcome data on 96 children with buckle fractures (48 per arm). We assume 35-45% of participants will be diagnosed with buckle fractures by the expert panel.

Recruitment will continue until primary outcome data has been collected on both at least 112 children per arm and at least 48 buckle fractures per arm. Allowing for approximately 25% attrition and variation in buckle fracture prevalence, we expect to recruit up to 300 patients to achieve the required sample size.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2020
Actual
1/09/2020
Date of last participant enrolment
Anticipated
2/03/2023
Actual
11/11/2021
Date of last data collection
Anticipated
2/06/2023
Actual
31/05/2022
Sample size
Target
300
Accrual to date
Final
270
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13886 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 13887 0
Robina Hospital - Robina
Recruitment hospital [3] 13888 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [4] 13891 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 26659 0
4215 - Southport
Recruitment postcode(s) [2] 26660 0
4226 - Robina
Recruitment postcode(s) [3] 26661 0
4575 - Birtinya
Recruitment postcode(s) [4] 26664 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 302936 0
Charities/Societies/Foundations
Name [1] 302936 0
Emergency Medicine Foundation
Country [1] 302936 0
Australia
Funding source category [2] 304592 0
Charities/Societies/Foundations
Name [2] 304592 0
Wishlist Sunshine Coast Hospital Foundation
Country [2] 304592 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
1 Hospital Bvld
Southport
Qld 4215
Country
Australia
Secondary sponsor category [1] 302897 0
University
Name [1] 302897 0
Griffith University
Address [1] 302897 0
Gold Coast campus Griffith University
G40 Griffith Health Centre
Level 8.86 Southport
QLD 4215 Australia
Country [1] 302897 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303498 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 303498 0
Ethics committee country [1] 303498 0
Australia
Date submitted for ethics approval [1] 303498 0
06/06/2019
Approval date [1] 303498 0
07/08/2019
Ethics approval number [1] 303498 0
HREC/19/QCHQ/53306

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

Contacts
Principal investigator
Name 93870 0
Dr Peter James Snelling
Address 93870 0
Gold Coast University Hospital
Emergency Department
1 Hospital Blvd
Southport, Qld
4215
Country 93870 0
Australia
Phone 93870 0
+61 07 5687 0000
Fax 93870 0
Email 93870 0
[email protected]
Contact person for public queries
Name 93871 0
Peter James Snelling
Address 93871 0
Gold Coast University Hospital
Emergency Department
1 Hospital Blvd
Southport, Qld
4215
Country 93871 0
Australia
Phone 93871 0
+61 1300 744 284
Fax 93871 0
Email 93871 0
[email protected]
Contact person for scientific queries
Name 93872 0
Peter James Snelling
Address 93872 0
Gold Coast University Hospital
Emergency Department
1 Hospital Blvd
Southport, Qld
4215
Country 93872 0
Australia
Phone 93872 0
+61 1300 744 284
Fax 93872 0
Email 93872 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
EmbaseBedside Ultrasound Conducted in Kids with distal upper Limb fractures in the Emergency Department (BUCKLED): a protocol for an open-label non-inferiority diagnostic randomised controlled trial.2021https://dx.doi.org/10.1186/s13063-021-05239-z
EmbaseUltrasonography or Radiography for Suspected Pediatric Distal Forearm Fractures.2023https://dx.doi.org/10.1056/NEJMoa2213883
N.B. These documents automatically identified may not have been verified by the study sponsor.