Virtual Reality vs Technical Video in Surgical Training

Sponsor
Ottawa Hospital Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT04404010
Collaborator
PrecisionOS Technology (Other)
20
Enrollment
1
Location
2
Arms
2
Actual Duration (Days)
304.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The use of instructional technical surgical videos is common in orthopaedic education. Many residents have used instructional technical surgical training videos prior to medical school, as well as during their residency program, and at instructional courses. The use of instructional technical surgical videos and multimedia is considered an adjunctive training method for orthopaedic residents to learn operative procedures.

Immersive virtual reality (iVR) is increasingly used in surgical education. Recently, iVR has shown transfer of skill training in orthopaedics. The continued study of the effectiveness of iVR training in orthopaedic education could benefit new competency based orthopaedics residency programs.

The purpose of this study is to compare the effectiveness of instructional technical surgical video training to immersive iVR training for teaching technical skills of reverse total shoulder arthroplasty. Our hypothesis was that iVR improved learning effectiveness compared to standard technical surgical video. Secondary objectives include validating a virtual reality ratings scale through correlation to real-world performance.

We proposed a randomized, blinded intervention-control trial directly comparing immersive iVR versus technical surgical instructional video training in the teaching of reverse shoulder arthroplasty in senior residents, learning at the 2020 annual Canadian Shoulder and Elbow Society meeting.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Immersive Virtual Reality
  • Other: Surgical Technical Instructional Video
N/A

Detailed Description

The use of instructional technical surgical videos is common in orthopaedic education. Many residents have used instructional technical surgical training videos prior to medical school, as well as during their residency program, and at instructional courses. The use of instructional technical surgical videos and multimedia is considered an adjunctive training method for orthopaedic residents to learn operative procedures.

Immersive virtual reality (iVR) is increasingly used in surgical education. Recently, iVR has shown transfer of skill training in orthopaedics. The continued study of the effectiveness of iVR training in orthopaedic education could benefit new competency based orthopaedics residency programs.

The purpose of this study is to compare the effectiveness of instructional technical surgical video training to immersive iVR training for teaching technical skills of reverse total shoulder arthroplasty. Our hypothesis was that iVR improved learning effectiveness compared to standard technical surgical video. Secondary objectives include validating a virtual reality ratings scale through correlation to real-world performance, and to determine efficiency of learning in both groups.

Currently, technical surgical instructional videos are pervasive in orthopaedic teaching education. Immersive VR, another form of teaching, is increasingly being used in surgical education. The production of an immersive VR suite with tactile and user metric feedback may be an advance over current bench top simulator technology, allowing for greater immersion and interaction, leading to better understanding of surgical planning and implementation. The development of this technology could provide trainees with immersive levels of training not previously seen, with improved learning of technical skills over media such as manufacturer technical documents. The effectiveness of training and efficiency of training of the novel immersive VR training systems need to be evaluated as they are increasingly incorporated into competency based, contemporary residency education.

We proposed a randomized, blinded intervention-control trial directly comparing immersive iVR versus technical surgical instructional video training in the teaching of reverse shoulder arthroplasty in senior (fourth and fifth year) residents, learning at the 2020 annual Canadian Shoulder and Elbow Society meeting.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Effectiveness of Immersive Virtual Reality Training Compared to Instructional Technical Surgical Video: A Randomized Controlled Trial
Actual Study Start Date :
Jan 30, 2020
Actual Primary Completion Date :
Feb 1, 2020
Actual Study Completion Date :
Feb 1, 2020

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Immersive Virtual Reality

Participants randomized to the immersive virtual reality (iVR) study arm, considered the "intervention group" will receive training on completion of a reverse shoulder arthroplasty using an iVR simulator (PrecisionOS Technology).

Other: Immersive Virtual Reality
Participants randomized to the iVR simulator utilizes a head-mounted display producing 3D visuals with haptic controllers for an immersive operating room experience. The module produced consists of the key steps in performing a reverse shoulder arthroplasty using virtual versions of the equipment used in the real procedure. Prior to initiation, participants will be provided with a safety and training demonstration on the use of the VR module by study personnel. Participants will be provided as much time as they require to watch the video, including repetition if desired, which they will be timed for completion.

Other: Surgical Video

Participants randomized to the standard video study arm, considered the "control group" will receive training on completion of reverse shoulder arthroplasty using a technical surgical instructional video.

Other: Surgical Technical Instructional Video
Participants will be provided as much time as they require to watch the instructional video, including repetition if desired, which they will be timed for completion.

Outcome Measures

Primary Outcome Measures

  1. Objective Structured Assessment of Technical Skills (OSATS) [During surgery up until immediately after surgery.]

    The Objective Structured Assessment of Technical Skills (OSATS) outcome measure is a validated assessment tool used for grading overall technical ability during surgery. This checklist contains 27 items, in which an assessor will mark off whether the task was completed successfully or not. For each item done correctly, it is worth 1 point. For each item done incorrectly, no point is awarded. All points are totalled for a maximum possible score of 27 points (minimum score of 0 and maximum score of 27). A higher score indicates a better outcome.

Secondary Outcome Measures

  1. Global Ratings Scale (GRS) [During surgery up until immediately after surgery.]

    The Global Ratings Scale (GRS) is a validated assessment tool used for grading operative performance. The GRS contains 7 categories: respect for tissue, time and motion, instrument handling, knowledge of instruments, flow of operation, use of assistants, and knowledge of specific procedure. Each category is graded using a 5-point Likert type scale, a higher number indicates a better outcome, with a maximum of 5 points per category. Each categorical score is totalled for a maximum overall score of 35 points (minimum score of 0 and maximum score of 35). A higher score indicates a better outcome.

  2. Transfer of Training (ToT) [immediately after surgery.]

    Transfer of Training (ToT) outcome informs how much skill is gained in the iVR group compared to the control performance. This is measured using an equation. ToT equals the average time to complete surgical procedure (for those in instructional video group) minus the average time to complete the surgical procedure (for those in the iVR training group), divided by the average time to complete surgical procedure (for those in instructional video group). The outcome is presented as a cumulative ratio, and a numerical value is provided. A higher number indicates a better outcome. For the purpose of this project, there is not a spread of data for a single instance of training as we did not complete multiple repetitions, otherwise we would have incremental values for each.

  3. Transfer Effectiveness Ratio (TER) [Immediately before surgery up immediately after surgery.]

    Transfer Effectiveness Ratio (TER) outcomes informs on the skill comparison relative to the control, on real world training reduction times. TER equals the average time to complete surgical procedure (for those in instructional video group) minus the average time to complete the surgical procedure (for those in the iVR training group), divided by the average time to complete the iVR training. The outcome is presented as a cumulative ratio, and a numerical value is provided. A higher number, indicates a better outcome. For the purpose of this project, there is not a spread of data for a single instance of training as we did not complete multiple repetitions, otherwise we would have incremental values for each.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Senior residents (4th and 5th year residents) attending 2020 CSES course
Exclusion Criteria:
  • N/A

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1The University of Ottawa Skills and Simulation CentreOttawaOntarioCanadaK1Y 4M9

Sponsors and Collaborators

  • Ottawa Hospital Research Institute
  • PrecisionOS Technology

Investigators

  • Principal Investigator: J Pollock, MD, The Ottawa Hospital

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT04404010
Other Study ID Numbers:
  • 20200008-01H
First Posted:
May 27, 2020
Last Update Posted:
Sep 5, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ottawa Hospital Research Institute

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail1 participant was mistakenly consented (error in screening - participant was not a PGY4 or 5) and randomized to immersive virtual reality arm as part of study. After randomization, but prior to study testing we realized the participant was not eligible, therefore they were excluded prior to any further study procedures commenced. 1 additional participant was mistakenly consented (error in screening - participant was not a PGY4 or 5), therefore excluded PRIOR to randomization.
Arm/Group TitleImmersive Virtual RealitySurgical Video
Arm/Group DescriptionParticipants randomized to the immersive virtual reality (iVR) study arm, considered the "intervention group" will receive training on completion of a reverse shoulder arthroplasty using an iVR simulator (PrecisionOS Technology). Immersive Virtual Reality: Participants randomized to the iVR simulator utilizes a head-mounted display producing 3D visuals with haptic controllers for an immersive operating room experience. The module produced consists of the key steps in performing a reverse shoulder arthroplasty using virtual versions of the equipment used in the real procedure. Prior to initiation, participants will be provided with a safety and training demonstration on the use of the VR module by study personnel. Participants will be provided as much time as they require to watch the video, including repetition if desired, which they will be timed for completion.Participants randomized to the standard video study arm, considered the "control group" will receive training on completion of reverse shoulder arthroplasty using a technical surgical instructional video. Surgical Technical Instructional Video: Participants will be provided as much time as they require to watch the instructional video, including repetition if desired, which they will be timed for completion.
Period Title: Overall Study
STARTED109
COMPLETED99
NOT COMPLETED10

Baseline Characteristics

Arm/Group TitleImmersive Virtual RealitySurgical VideoTotal
Arm/Group DescriptionParticipants randomized to the immersive virtual reality (iVR) study arm, considered the "intervention group" will receive training on completion of a reverse shoulder arthroplasty using an iVR simulator (PrecisionOS Technology). Immersive Virtual Reality: Participants randomized to the iVR simulator utilizes a head-mounted display producing 3D visuals with haptic controllers for an immersive operating room experience. The module produced consists of the key steps in performing a reverse shoulder arthroplasty using virtual versions of the equipment used in the real procedure. Prior to initiation, participants will be provided with a safety and training demonstration on the use of the VR module by study personnel. Participants will be provided as much time as they require to watch the video, including repetition if desired, which they will be timed for completion.Participants randomized to the standard video study arm, considered the "control group" will receive training on completion of reverse shoulder arthroplasty using a technical surgical instructional video. Surgical Technical Instructional Video: Participants will be provided as much time as they require to watch the instructional video, including repetition if desired, which they will be timed for completion.Total of all reporting groups
Overall Participants9918
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
9
100%
9
100%
18
100%
>=65 years
0
0%
0
0%
0
0%
Sex: Female, Male (Count of Participants)
Female
1
11.1%
3
33.3%
4
22.2%
Male
8
88.9%
6
66.7%
14
77.8%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%
Region of Enrollment (participants) [Number]
Canada
9
100%
9
100%
18
100%

Outcome Measures

1. Primary Outcome
TitleObjective Structured Assessment of Technical Skills (OSATS)
DescriptionThe Objective Structured Assessment of Technical Skills (OSATS) outcome measure is a validated assessment tool used for grading overall technical ability during surgery. This checklist contains 27 items, in which an assessor will mark off whether the task was completed successfully or not. For each item done correctly, it is worth 1 point. For each item done incorrectly, no point is awarded. All points are totalled for a maximum possible score of 27 points (minimum score of 0 and maximum score of 27). A higher score indicates a better outcome.
Time FrameDuring surgery up until immediately after surgery.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleImmersive Virtual RealitySurgical Video
Arm/Group DescriptionParticipants randomized to the immersive virtual reality (iVR) study arm, considered the "intervention group" will receive training on completion of a reverse shoulder arthroplasty using an iVR simulator (PrecisionOS Technology). Immersive Virtual Reality: Participants randomized to the iVR simulator utilizes a head-mounted display producing 3D visuals with haptic controllers for an immersive operating room experience. The module produced consists of the key steps in performing a reverse shoulder arthroplasty using virtual versions of the equipment used in the real procedure. Prior to initiation, participants will be provided with a safety and training demonstration on the use of the VR module by study personnel. Participants will be provided as much time as they require to watch the video, including repetition if desired, which they will be timed for completion.Participants randomized to the standard video study arm, considered the "control group" will receive training on completion of reverse shoulder arthroplasty using a technical surgical instructional video. Surgical Technical Instructional Video: Participants will be provided as much time as they require to watch the instructional video, including repetition if desired, which they will be timed for completion.
Measure Participants99
Mean (95% Confidence Interval) [score on a scale]
15.9
9.4
2. Secondary Outcome
TitleGlobal Ratings Scale (GRS)
DescriptionThe Global Ratings Scale (GRS) is a validated assessment tool used for grading operative performance. The GRS contains 7 categories: respect for tissue, time and motion, instrument handling, knowledge of instruments, flow of operation, use of assistants, and knowledge of specific procedure. Each category is graded using a 5-point Likert type scale, a higher number indicates a better outcome, with a maximum of 5 points per category. Each categorical score is totalled for a maximum overall score of 35 points (minimum score of 0 and maximum score of 35). A higher score indicates a better outcome.
Time FrameDuring surgery up until immediately after surgery.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleImmersive Virtual RealitySurgical Video
Arm/Group DescriptionParticipants randomized to the immersive virtual reality (iVR) study arm, considered the "intervention group" will receive training on completion of a reverse shoulder arthroplasty using an iVR simulator (PrecisionOS Technology). Immersive Virtual Reality: Participants randomized to the iVR simulator utilizes a head-mounted display producing 3D visuals with haptic controllers for an immersive operating room experience. The module produced consists of the key steps in performing a reverse shoulder arthroplasty using virtual versions of the equipment used in the real procedure. Prior to initiation, participants will be provided with a safety and training demonstration on the use of the VR module by study personnel. Participants will be provided as much time as they require to watch the video, including repetition if desired, which they will be timed for completion.Participants randomized to the standard video study arm, considered the "control group" will receive training on completion of reverse shoulder arthroplasty using a technical surgical instructional video. Surgical Technical Instructional Video: Participants will be provided as much time as they require to watch the instructional video, including repetition if desired, which they will be timed for completion.
Measure Participants99
Mean (Standard Deviation) [Score on a scale]
22.8
(8.2)
22.4
(9.0)
3. Secondary Outcome
TitleTransfer of Training (ToT)
DescriptionTransfer of Training (ToT) outcome informs how much skill is gained in the iVR group compared to the control performance. This is measured using an equation. ToT equals the average time to complete surgical procedure (for those in instructional video group) minus the average time to complete the surgical procedure (for those in the iVR training group), divided by the average time to complete surgical procedure (for those in instructional video group). The outcome is presented as a cumulative ratio, and a numerical value is provided. A higher number indicates a better outcome. For the purpose of this project, there is not a spread of data for a single instance of training as we did not complete multiple repetitions, otherwise we would have incremental values for each.
Time Frameimmediately after surgery.

Outcome Measure Data

Analysis Population Description
The ToT is calculated as a cumulative ratio. There isn't a spread of data for a single instance of training, however, if we had done more repetitions then we would have incremental values for each. Therefore, the single numerical value of ToT is 0.594 or 59.4%. Answer is based off of the following calculation: (Time (surgical video) - Time (immersive virtual reality) divided by the Time (surgical video)) multiplied by 100%.
Arm/Group TitleTransfer of Training Ratio
Arm/Group DescriptionA comparison of skill achievement compared to control performance. This informs how much skill is gained by training.
Measure Participants18
Mean (Full Range) [Percentage]
59.4
4. Secondary Outcome
TitleTransfer Effectiveness Ratio (TER)
DescriptionTransfer Effectiveness Ratio (TER) outcomes informs on the skill comparison relative to the control, on real world training reduction times. TER equals the average time to complete surgical procedure (for those in instructional video group) minus the average time to complete the surgical procedure (for those in the iVR training group), divided by the average time to complete the iVR training. The outcome is presented as a cumulative ratio, and a numerical value is provided. A higher number, indicates a better outcome. For the purpose of this project, there is not a spread of data for a single instance of training as we did not complete multiple repetitions, otherwise we would have incremental values for each.
Time FrameImmediately before surgery up immediately after surgery.

Outcome Measure Data

Analysis Population Description
The TER is calculated as a cumulative ratio. There isn't a spread of data for a single instance of training, however, if we had done more repetitions then we would have incremental values for each. Therefore, the single numerical value of TER is 0.79. Answer is based off of the following calculation: (Time (surgical video) - Time (immersive virtual reality) divided by Time (simulated immersive virtual reality)).
Arm/Group TitleTransfer Effectiveness Ratio
Arm/Group DescriptionSkill comparison relative to control, incorporating improvements in task time. This informs real world training reduction times.
Measure Participants18
Mean (Full Range) [Ratio Value]
0.79

Adverse Events

Time Frame1 day (duration of each participant's involvement in study)
Adverse Event Reporting Description There are no serious risks associated with this study. The purpose of this study was to compare training methods to determine which one is most effective among orthopaedic surgical residents. There was a possibility for those in the virtual reality group to experience dizziness or nausea, however is considered mild and rare. Trained personnel were available to assist throughout the duration of training as well.
Arm/Group TitleImmersive Virtual RealitySurgical Video
Arm/Group DescriptionParticipants randomized to the immersive virtual reality (iVR) study arm, considered the "intervention group" will receive training on completion of a reverse shoulder arthroplasty using an iVR simulator (PrecisionOS Technology). Immersive Virtual Reality: Participants randomized to the iVR simulator utilizes a head-mounted display producing 3D visuals with haptic controllers for an immersive operating room experience. The module produced consists of the key steps in performing a reverse shoulder arthroplasty using virtual versions of the equipment used in the real procedure. Prior to initiation, participants will be provided with a safety and training demonstration on the use of the VR module by study personnel. Participants will be provided as much time as they require to watch the video, including repetition if desired, which they will be timed for completion.Participants randomized to the standard video study arm, considered the "control group" will receive training on completion of reverse shoulder arthroplasty using a technical surgical instructional video. Surgical Technical Instructional Video: Participants will be provided as much time as they require to watch the instructional video, including repetition if desired, which they will be timed for completion.
All Cause Mortality
Immersive Virtual RealitySurgical Video
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/9 (0%) 0/9 (0%)
Serious Adverse Events
Immersive Virtual RealitySurgical Video
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/9 (0%) 0/9 (0%)
Other (Not Including Serious) Adverse Events
Immersive Virtual RealitySurgical Video
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/9 (0%) 0/9 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleDr. Danny P Goel
OrganizationPrecision OS Technology
Phone604-345-0401
Emaildanny@precisionostech.com
Responsible Party:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT04404010
Other Study ID Numbers:
  • 20200008-01H
First Posted:
May 27, 2020
Last Update Posted:
Sep 5, 2021
Last Verified:
Aug 1, 2021