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| Name | Class |
|---|---|
| PrecisionOS Technology | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immersive Virtual Reality | Active Comparator | 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). |
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| Surgical Video | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immersive Virtual Reality | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Structured Assessment of Technical Skills (OSATS) | 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. | During surgery up until immediately after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Global Ratings Scale (GRS) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J Pollock, MD | The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Ottawa Skills and Simulation Centre | Ottawa | Ontario | K1Y 4M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33369660 | Result | Lohre R, Bois AJ, Pollock JW, Lapner P, McIlquham K, Athwal GS, Goel DP. Effectiveness of Immersive Virtual Reality on Orthopedic Surgical Skills and Knowledge Acquisition Among Senior Surgical Residents: A Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2031217. doi: 10.1001/jamanetworkopen.2020.31217. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Structured Assessment of Technical Skills (OSATS) | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | During surgery up until immediately after surgery. |
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1 day (duration of each participant's involvement in study)
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Danny P Goel | Precision OS Technology | 604-345-0401 | danny@precisionostech.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2020 | Jun 14, 2021 | Prot_SAP_000.pdf |
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| Surgical Technical Instructional Video | Other | 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. |
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| During surgery up until immediately after surgery. |
| Transfer of Training (ToT) | 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. | immediately after surgery. |
| Transfer Effectiveness Ratio (TER) | 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. | Immediately before surgery up immediately after surgery. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. |
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| Secondary | Global Ratings Scale (GRS) | 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. | Posted | Mean | Standard Deviation | Score on a scale | During surgery up until immediately after surgery. |
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| Secondary | Transfer of Training (ToT) | 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. | 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%. | Posted | Mean | Full Range | Percentage | immediately after surgery. |
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| Secondary | Transfer Effectiveness Ratio (TER) | 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. | 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)). | Posted | Mean | Full Range | Ratio Value | Immediately before surgery up immediately after surgery. |
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| EG001 | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
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