Condition category
Surgery
Date applied
21/11/2018
Date assigned
23/11/2018
Last edited
23/11/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Surgical procedures are becoming increasingly complex, but there are fewer training opportunities for junior doctors. This is due to restrictions in working hours, as well as an improved focus on patient safety. Novel methods of training surgeons to perform complex procedures are required to safely and effectively educate the next generation.
Total hip replacement (THR) was heralded as the operation of the 20th Century, but is a complex skill. Errors during this surgery are a result of technical mistakes and failures in decision-making, communication and behaviours (non-technical skills). Currently, training surgeons learn to perform hip replacement initially from lectures, textbooks and workshops on sawbone materials, before learning on real patients in surgery. Practicing on human donors may also contribute to education, but this is expensive and thus poorly accessible. For over twenty years, keyhole surgery has been practiced by surgeons on simulators – computers with controllers which can train for the technical and non-technical skills. However, simulators have been unable to simulate open procedures, such as total hip replacement.
Our group has developed a cognitive training tool and a novel virtual reality (VR) simulator to train for total hip replacement surgery with the latest commercially-available technology. We aim to see if surgical trainees are able to prepare for surgery using cognitive training tools, as compared to conventional videos and texts. We aim to then see if they can learn technical and non-technical skills for this performing hip replacement from VR as effectively as from current training methods from expert surgeons.

Who can participate?
Junior surgeons with no independent experience of performing hip replacement

What does the study involve?
Participants will be randomly selected to receive cognitive training and then VR or conventional training in a syllabus. They will be assessed in a written exam as well as during performing a real total hip replacement procedure on a human donor.

What are the possible benefits and risks of participating?
The possible benefits of participating are threefold. Junior surgeons will receive structured training and practice regarding an important and common procedure (THR), half will be exposed to new forms of training (cognitive and virtual), and thirdly they will contribute towards research to improve the next generation of surgical education. There are no significant risks from participating, and a full risk-analysis has been performed to mitigate all risks during performing hip replacement on the human donors.

Where is the study run from?
1. Imperial College London (UK)
2. Chelsea & Westminster Hospital NHS Trust (UK)

When is the study starting and how long is it expected to run for?
February 2018 to October 2019

Who is funding the study?
1. Royal College of Surgeons of England (UK)
2. The Michael Uren Foundation (UK)
3. Johnson & Johnson (USA)
4. CW+ Trust (UK)

Who is the main contact?
Kartik Logishetty
k.logishetty@ic.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Logishetty Logishetty

ORCID ID

http://orcid.org/0000-0002-0469-9539

Contact details

MSk Lab
Imperial College London
London
W6 8RP
United Kingdom
+447734218425
k.logishetty@ic.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

237607

Study information

Scientific title

The THRiVR study: a randomized controlled trial comparing Virtual Reality to conventional training for surgeons learning Total Hip Replacement

Acronym

THRiVR

Study hypothesis

The primary hypothesis is:
1. Surgical trainees learning with virtual reality (VR) can perform simulated total hip arthroplasty to the higher technical levels than those trained with conventional training

The secondary hypotheses are:
2. Compared to the control, VR-trained surgeons develop higher levels of non-technical skills
3. The skills developed in VR training for hip arthroplasty are gained over time on a learning curve
4. VR is an acceptable form of surgical training
5. Cognitive training enhances development of knowledge related to total hip replacement, prior to conventional and VR training

Ethics approval

Imperial College London and Imperial College Healthcare Health Research Authority, 10/04/2018, In18/HRA/2085

Study design

Interventional single-blinded two-stage paralle design randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Total hip replacement

Intervention

Participants will be randomly allocated to either the intervention or the control group through stratified block randomisation, using blocks of equal size with stratification to balance surgical experience of total hip arthroplasty through any approach.
For stage 1, participants in the intervention group will undergo cognitive-task based training, and participants in the control group will undergo video and text-based training.
For stage 2, participants in the intervention group will receive a fully-immersive virtual reality total hip arthroplasty training program over 5 60 minute sessions administed by a technician. Participants in the control group will undergo conventional surgical training, involving 1-to-1 dry-bone and anatomical practicals with expert hip surgeons for 5 60 minute sessions.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Technical and non-technical skills in total hip replacement, assessed using the ISCP Total Hip Arthroplasty Procedure Based Assessment from cadaveric total hip arthroplasty at the end of the 6 week program.

Secondary outcome measures

1. Behavioural related to safety and teamwork, assessed using the NOTECHS score at the cadaveric assessment (after the end of the 6 week program)
2. Knowledge of basic science and procedural steps related to THR, assessed using a postgraduate level exam in the 5 weekly VR sessions
3. Time-to-complete VR THR, measured in the 5 weekly VR sessions by the virtual reality platform from the point when the surgeon begins the first step of the procedure
4. Errors in task performance, measured in the 5 weekly VR sessions by the virtual reality platform by recording the number of errors in instrument selection
5. Accuracy in implant orientation in dry-bone, cadaver and VR sessions, measured in the 5 weekly VR sessions by the virtual reality platform by recording degrees of deviation from an assigned target, in cup inclination, cup anteversion, height of femoral neck osteotomy in millimetres from the less trochanter, and angle of femoral neck osteotomy in degrees
6. Feasibility and usability, assessed using Technology Acceptance Model-based and Realism surveys after the end of the 6 week program

Overall trial start date

01/02/2018

Overall trial end date

01/10/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Surgeons in training
2. Aged 18 years or older
3. Able to read and speak English
4. Able to provide informed consent

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

72

Participant exclusion criteria

1. Unable to speak or read English at a sufficient level to give informed consent
2. Retired from surgical practice
3. Suffers from a psychiatric illness that limits informed consent
4. Unwilling or unable to receive or access emails for study questionnaires
5. Medical history of headaches or epilepsy
6. Registered as partial sighted
7. Injuries or deformity preventing full function of both upper limbs
8. Performed more than 25 THRs under supervision or independently

Recruitment start date

22/11/2018

Recruitment end date

01/01/2019

Locations

Countries of recruitment

Canada, United Kingdom

Trial participating centre

MSk Lab, Imperial College London
Fulham Palace Road
London
W6 8RF
United Kingdom

Trial participating centre

University of Ottawa Orthopaedics
The Ottawa Hospital - General Campus 501 Smyth Rd, Ottawa, ON
Ottawa
K1H 8L6
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

South Kensington Campus
London
SW7 2AZ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Royal College of Surgeons of England

Alternative name(s)

RCS

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Funder name

Chelsea and Westminster Health Charity

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Johnson and Johnson

Alternative name(s)

Johnson & Johnson, JNJ

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

The research outputs from this project will be disseminated in peer-reviewed scientific journals, in internal reports to Imperial College and funding bodies, by presentation at conferences, and by publication of results on public-access websites.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available. The data will be stored on a secure lab server at Imperial College London, and we do not plan to share individual data sets, video-recordings or analyses unless directly contacted by another academic researcher or institution for their non-commercial use.

Intention to publish date

01/04/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes