Trial Outcomes & Findings for Virtual Reality vs Technical Video in Surgical Training (NCT NCT04404010)
NCT ID: NCT04404010
Last Updated: 2022-09-28
Results Overview
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.
COMPLETED
NA
20 participants
During surgery up until immediately after surgery.
2022-09-28
Participant Flow
1 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.
Participant milestones
| Measure |
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).
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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).
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
Mistakenly enrolled, withdrawn after randomization (did not meet eligibility criteria)
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Immersive Virtual Reality
n=9 Participants
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).
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.
|
Surgical Video
n=9 Participants
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
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
18 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
4 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=9 Participants
|
6 Participants
n=9 Participants
|
14 Participants
n=18 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
9 participants
n=9 Participants
|
9 participants
n=9 Participants
|
18 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Immersive Virtual Reality
n=9 Participants
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).
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.
|
Surgical Video
n=9 Participants
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.
|
|---|---|---|
|
Objective Structured Assessment of Technical Skills (OSATS)
|
15.9 score on a scale
Interval 14.3 to 17.5
|
9.4 score on a scale
Interval 7.4 to 11.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Immersive Virtual Reality
n=9 Participants
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).
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.
|
Surgical Video
n=9 Participants
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.
|
|---|---|---|
|
Global Ratings Scale (GRS)
|
22.8 Score on a scale
Standard Deviation 8.2
|
22.4 Score on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: immediately after surgery.Population: 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%.
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.
Outcome measures
| Measure |
Immersive Virtual Reality
n=18 Participants
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).
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.
|
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.
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.
|
|---|---|---|
|
Transfer of Training (ToT)
|
59.4 Percentage
Interval 0.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Immediately before surgery up immediately after surgery.Population: 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)).
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.
Outcome measures
| Measure |
Immersive Virtual Reality
n=18 Participants
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).
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.
|
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.
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.
|
|---|---|---|
|
Transfer Effectiveness Ratio (TER)
|
0.79 Ratio Value
Interval 0.0 to 1.0
|
—
|
Adverse Events
Immersive Virtual Reality
Surgical Video
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place