Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000861257
Ethics application status
Approved
Date submitted
17/05/2018
Date registered
22/05/2018
Date last updated
15/08/2022
Date data sharing statement initially provided
12/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual surgery pre-planning for paediatric lower limb deformities
Scientific title
Virtual surgery pre-planning to optimise bone geometry and gait kinematics for children with lower limb deformities
Secondary ID [1] 294884 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Slipped capital femoral epiphysis 307840 0
Cerebral palsy
 307925 0
Perthes disease 307926 0
Condition category
Condition code
Musculoskeletal 306883 306883 0 0
Other muscular and skeletal disorders
Injuries and Accidents 306962 306962 0 0
Fractures
Neurological 306963 306963 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Virtual surgery will be simulated to determine an optimal orthopaedic correction for patient’s waitlisted for proximal femoral bone deformity correction. Following virtual planning, which is estimated to take one week per patient (computational time and researcher time), personalised cutting guides will be designed, 3D printed and used in surgery to facilitate translation of the virtual plan to surgical execution. The surgical intervention is personalised and will be delivered on a single occasion. Face to face pre-operative motion capture and medical imaging assessment’s will be conducted within 6 months prior to surgery and post-operative motion capture and medical imaging assessment’s will be conducted 9-12 months post-surgery. Data management will be undertaken using REDCap and data fidelity will be supervised by Dr Carty, who has extensive experience in projects involving medical imaging and motion capture data.

Technology and experience: Virtual surgery will be informed by a fusion of motion capture data and medical imaging. Motion capture data will be collected and analysed by a biomechanist, and medical imaging data will be collected by a radiographer and viewed by a radiologist for incidental findings. Image fusion, virtual surgery and manufacture of cutting guides will be conducted by a team of biomedical and mechanical engineers in partnership with orthopaedic surgeons. Surgical execution will be conducted by an orthopaedic surgeon with extensive experience in paediatric lower limb deformities.
Intervention code [1] 301198 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305876 0
Bone geometry composite outcomes measured from MRI
Change in femoral anteversion
Change in femoral neck angle
Timepoint [1] 305876 0
A single assessment 1-4 months months prior to surgery and at a single assessment 9-12 months post-surgery
Primary outcome [2] 305877 0
Gait composite outcomes measured from motion capture
Change in transverse plane hip joint kinematics
Change in foot progression angle
Timepoint [2] 305877 0
A single assessment 1-4 months months prior to surgery and at a single assessment 9-12 months post-surgery
Secondary outcome [1] 346865 0
Change in hip joint contact force magnitude and direction calculated using neuromusculoskeletal modelling methods
Timepoint [1] 346865 0
A single assessment 1-4 months months prior to surgery and at a single assessment 9-12 months post-surgery
Secondary outcome [2] 346866 0
Change in gluteus medius muscle moment arm lengths across hip joint range of motion during gait calculated using neuromusculoskeletal modelling methods
Timepoint [2] 346866 0
A single assessment 1-4 months months prior to surgery and at a single assessment 9-12 months post-surgery

Eligibility
Key inclusion criteria
Children who are wait-listed for femoral deformity correction surgery at Lady Cilento Children's Hospital or Redcliffe Hospital
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non ambulant

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Outcome measures will include model shape indices (e.g., femoral anteversion) and gait kinematic (joint angles, muscle tendon lengths) and kinetic (joint moments, joint powers, muscle forces) waveforms. Shape indices will be compared using repeated measures t-tests. Gait waveforms will be compared using statistical parametric mapping, a statistical method able to perform hypothesis testing on one-dimensional (e.g. time series) kinematic and kinetic data in a continuous manner and takes into account the dependency between different time instances of the gait cycle and reduces post hoc regional focus bias and inter-component covariance bias in time series data.

Sample size estimates are based on meta-analysis data published by Principal Investigator Carty and Co-Investigator Walsh (refer to attachment). In this paper, an effect size of 1.07 was shown for change in hip rotation kinematics following femoral de-rotation osteotomy in children with cerebral palsy (i.e., combined estimate for unilateral and bilateral affected children). Considering the similar surgical procedure being conducted for the present study with 80% power (2-sided paired test at p<0.05) a sample size of seven participants is required. Given the innovative nature of this research we expect a 70% adherence rate from the orthopaedic surgeons to the implementation of the full virtual surgery plus cutting guide workflow and therefore a sample size of 10 will be necessary.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2018
Actual
5/01/2019
Date of last participant enrolment
Anticipated
31/12/2019
Actual
30/11/2020
Date of last data collection
Anticipated
30/09/2021
Actual
13/09/2021
Sample size
Target
15
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 10913 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [2] 10914 0
Redcliffe Hospital - Redcliffe
Recruitment postcode(s) [1] 22675 0
4101 - South Brisbane
Recruitment postcode(s) [2] 22676 0
4020 - Redcliffe

Funding & Sponsors
Funding source category [1] 299469 0
Government body
Name [1] 299469 0
Queensland Government
Country [1] 299469 0
Australia
Primary sponsor type
Hospital
Name
Children's Health Queensland Hospital and Health Service
Address
Level 5, Centre for Children’s Health Research
62 Graham Street
South Brisbane Qld 4101
Country
Australia
Secondary sponsor category [1] 298769 0
University
Name [1] 298769 0
Griffith University
Address [1] 298769 0
G02 Clinical Sciences 1
Room 1.04
Gold Coast campus
Parkwood Gold Coast QLD 4222
Country [1] 298769 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300376 0
Children’s Health Queensland Human Research Ethics Commitee
Ethics committee address [1] 300376 0
Ethics committee country [1] 300376 0
Australia
Date submitted for ethics approval [1] 300376 0
11/06/2018
Approval date [1] 300376 0
26/07/2018
Ethics approval number [1] 300376 0
HREC/18/QRCH/161

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2712 2712 0 0
/AnzctrAttachments/375100-Carty et al 2014.pdf (Publication)
Attachments [2] 2713 2713 0 0
/AnzctrAttachments/375100-Martinez Marquez et al 2018.pdf (Publication)

Contacts
Principal investigator
Name 83458 0
Dr Christopher Carty
Address 83458 0
Children’s Health Queensland Hospital and Health Service
Level 5, Centre for Children’s Health Research
62 Graham Street
South Brisbane Qld 4101
Country 83458 0
Australia
Phone 83458 0
+6173069 7193
Fax 83458 0
+6173068 3909
Email 83458 0
[email protected]
Contact person for public queries
Name 83459 0
Louise Durack
Address 83459 0
Office of Marketing and Communications
Building G34, Griffith University
Gold Coast Parkwood QLD 4222
Country 83459 0
Australia
Phone 83459 0
+61 7 5552 8654
Fax 83459 0
Email 83459 0
[email protected]
Contact person for scientific queries
Name 83460 0
Christopher Carty
Address 83460 0
Children’s Health Queensland Hospital and Health Service
Level 5, Centre for Children’s Health Research
62 Graham Street
South Brisbane Qld 4101
Country 83460 0
Australia
Phone 83460 0
+6173069 7193
Fax 83460 0
+6173068 3909
Email 83460 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data according to primary outcome measures for each de-identified participant
When will data be available (start and end dates)?
Start date - 01/0/2021
No end date determined
Available to whom?
Data will be provided by request from researchers
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
By emailing the principal investigator


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.