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
ACTRN12623000816651
Ethics application status
Approved
Date submitted
15/02/2023
Date registered
28/07/2023
Date last updated
28/07/2023
Date data sharing statement initially provided
28/07/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of simulated pin placement practice on in-theatre performance by orthopaedic trainees
Scientific title
Transfer validity of paediatric supracondylar humeral fracture pin placement practice on in-theatre performance by orthopaedic trainees using an augmented reality simulator
Secondary ID [1] 309003 0
None
Universal Trial Number (UTN)
U1111-1271-2730
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric supracondylar humeral fracture 329040 0
Surgical Performance 329130 0
Condition category
Condition code
Musculoskeletal 326026 326026 0 0
Other muscular and skeletal disorders
Surgery 326108 326108 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The BoneDoc simulator is an augmented reality surgical simulator composed of a tangible silicone/3D printed bone arm, and an iPad C-arm simulator. Participants are able to use the simulator to practice pinning of paediatric supracondylar humeral fractures.
The simulator will be first administered at the November training weekends for each intervention cohort of orthopaedic trainees. We will use these training weekends to test participants at baseline on the simulator and collect demographic data. The simulator will be setup as one of the 15-minute assessment stations in the training weekend. Simulator sets will be distributed to individual trainees at this point following consent.

It is then expected that trainees will undertake at minimum, monthly 15-minute practices on the simulator for the next six months of training. Note that the simulator training will be in addition to any routine training they will be receiving at their respective hospitals. Their simulator performance will be assessed again in a controlled environment at the March training weekend to establish learning effects on pin accuracy and number of X-ray images taken.
Simulator intervention is entirely self-administered and self-regulated. There is no maximum number of times the trainee can practice using the simulator. Adherence will be assessed at the end of follow-up.
Intervention code [1] 325448 0
Treatment: Devices
Comparator / control treatment
Comparator data will be retrospectively audited from trainees who undertook traditional training and have no exposure to the simulator during their six months to three-years of follow-up (only traditional orthopaedic training).

Surgical data of supracondylar fracture reductions performed by trainees will be collected from hospital PACS systems (picture archiving and communication systems) and routinely collected operation reports from 01 February 2019 to 31 Dec 2021.
Control group
Historical

Outcomes
Primary outcome [1] 333882 0

Theatre time and radiation time (Composite Primary)
Assessed by patient hospital records of operation time and radiology time
Timepoint [1] 333882 0
For each supracondylar case undertaken by a trainee over the follow-up period of 6 months.
Primary outcome [2] 333883 0
Accuracy of Pinning based on number of accurate vs inaccurate pin placements. Accuracy is defined based on procedural recommendation literature and assessed using patient intraoperative X-rays.
Timepoint [2] 333883 0
For each supracondylar case undertaken by a trainee over the follow-up period of 6 months.
Primary outcome [3] 333886 0
Number of fluoroscopy shots from patient hospital radiology records.
Timepoint [3] 333886 0
For each supracondylar case undertaken by a trainee over the follow-up period of 6 months
Secondary outcome [1] 418618 0
Adverse event: stratified for types of complications (nerve injury, vascular injury, loss of reduction, compartment syndrome). Assessed by patient hospital records indicating a complication needing hospital level care.
Timepoint [1] 418618 0
Within 1 week of each case undertaken by a trainee during the 6 month follow-up period.
Secondary outcome [2] 418619 0
Total number of times using the simulator through accessing the simulator logs on the device
Timepoint [2] 418619 0
Over the follow-up period of 6 months.
Secondary outcome [3] 418620 0
Frequency of using the simulator – which options best describe your regularity of using the simulator: monthly, fortnightly, weekly, just prior to case. Assessed by self report from the trainees.
Timepoint [3] 418620 0
Over the follow-up period of 6 months
Secondary outcome [4] 418621 0
Perceived familiarity with SCHF by the end of the follow-up (Likert scale)
Timepoint [4] 418621 0
At the end of the 6 month follow-up period
Secondary outcome [5] 418622 0
Number of mistakes while using the simulator - defined by number of times trainee reconsiders pin. Assessed by the simulator application.
Timepoint [5] 418622 0
At the final training weekend where the simulator is administered under controlled conditions one last time 6 months after enrolment
Secondary outcome [6] 418624 0
Total number of SCHF treatments undertaken during the follow up period. Assessed by recorded SCHF cases on trainee logbooks
Timepoint [6] 418624 0
Collated at the end of 6 months follow-up
Secondary outcome [7] 418625 0
Qualitative experiences of using the simulator via one-on-one recorded zoom interviews
Timepoint [7] 418625 0
At the end of 6 months follow-up

Eligibility
Key inclusion criteria
Inclusion criteria: Full-time registered orthopaedic trainees in New Zealand over the years 2019 – 2024
Minimum age
25 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Trainees planning to undertake part time work or withdraw from the program at any point during follow-up will not be eligible.

Study design
Purpose of the study
Educational / counselling / training
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is an interventional cohort study of simulated training given to orthopaedic trainees over a year. The intervention cohort is composed of prospective trainees using the simulator at least once per month over six months (November to April). The comparator cohort data is composed of a retrospective audit of matched trainees in the years 2019, 2020, and 2021.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Comparisons will be performed using Student’s t-tests or Wilcoxon Rank Sum tests (depending on the distribution of the data) for theatre time and X^2 or Fischer’s exact tests (depending on the count of the outcome) for number of complications, number of accurate pin placements, and number of mistakes.

Primary endpoints will be plotted on separate cumulative sum curves to show trends in performance over the course of follow-up by individuals and aggregated according to pre- and post-one-year simulator training. Control limits will be determined based on values identified in the literature and consultation with senior orthopaedic consultants,
Univariable ordinary least squares (OLS) regression analyses will be used to examine the association of theatre time, number of complications (including non-ideal unions), and number of x-ray shoots with independent variables. Logistic regression will be used to examine the association of accurate pin placement (yes/no) with independent variables. Independent variables will be the number of times the simulator is used, number of SCHF procedures performed prior to intervention, Gartland classification, scores on tests of spatial awareness, and number of SCHF procedures performed during intervention. Independent variables that are significantly associated with a primary endpoint (p<0.05) will be included as co-variates in multivariable analyses. Appropriate model diagnostics, and where required, data transformations will be used.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
19/08/2022
Date of last participant enrolment
Anticipated
Actual
19/02/2023
Date of last data collection
Anticipated
31/07/2023
Actual
Sample size
Target
65
Accrual to date
Final
14
Recruitment outside Australia
Country [1] 25269 0
New Zealand
State/province [1] 25269 0

Funding & Sponsors
Funding source category [1] 313216 0
University
Name [1] 313216 0
University of Otago, Dunedin School of Medicine Research Student Support Committee
Country [1] 313216 0
New Zealand
Funding source category [2] 313219 0
Charities/Societies/Foundations
Name [2] 313219 0
Wishbone Research Foundation
Country [2] 313219 0
New Zealand
Primary sponsor type
Individual
Name
Phil Blyth
Address
University of Otago, Otago Medical School, Department of the Dean. 201 Great King Street, Central Dunedin, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 314938 0
Individual
Name [1] 314938 0
Kari Clifford
Address [1] 314938 0
University of Otago, Otago Medical School, Department of Surgical Sciences (Dunedin), 201 Great King Street, Central Dunedin, Dunedin 9016
Country [1] 314938 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312447 0
University of Otago Human Ethics Committee
Ethics committee address [1] 312447 0
Ethics committee country [1] 312447 0
New Zealand
Date submitted for ethics approval [1] 312447 0
02/11/2021
Approval date [1] 312447 0
11/11/2021
Ethics approval number [1] 312447 0
HD21/087

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

Contacts
Principal investigator
Name 124702 0
Dr Phil Blyth
Address 124702 0
University of Otago, Otago Medical School, Department of the Dean. 290 Great King Street, Central Dunedin, Dunedin 9016
Country 124702 0
New Zealand
Phone 124702 0
+64 212992237
Fax 124702 0
Email 124702 0
[email protected]
Contact person for public queries
Name 124703 0
Phil Blyth
Address 124703 0
University of Otago, Otago Medical School, Department of the Dean. 290 Great King Street, Central Dunedin, Dunedin 9016
Country 124703 0
New Zealand
Phone 124703 0
+64 212992237
Fax 124703 0
Email 124703 0
[email protected]
Contact person for scientific queries
Name 124704 0
Phil Blyth
Address 124704 0
University of Otago, Otago Medical School, Department of the Dean. 290 Great King Street, Central Dunedin, Dunedin 9016
Country 124704 0
New Zealand
Phone 124704 0
+64 212992237
Fax 124704 0
Email 124704 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
Participants partake on the premise that their data will not be individualised as it is a small cohort with high risk of confidentiality breach.


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.