NCT04404010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2020

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 5, 2021

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

2 days

First QC Date

May 22, 2020

Results QC Date

May 18, 2021

Last Update Submit

September 21, 2022

Conditions

Keywords

Immersive Virtual RealityTechnical Training Video

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (3)

  • Global Ratings Scale (GRS)

    During surgery up until immediately after surgery.

  • Transfer of Training (ToT)

    immediately after surgery.

  • Transfer Effectiveness Ratio (TER)

    Immediately before surgery up immediately after surgery.

Study Arms (2)

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).

Other: Immersive Virtual Reality

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.

Other: Surgical Technical Instructional Video

Interventions

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.

Immersive Virtual Reality

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.

Surgical Video

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Senior residents (4th and 5th year residents) attending 2020 CSES course

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Ottawa Skills and Simulation Centre

Ottawa, Ontario, K1Y 4M9, Canada

Location

Related Publications (1)

  • 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.

Results Point of Contact

Title
Dr. Danny P Goel
Organization
Precision OS Technology

Study Officials

  • J Pollock, MD

    The Ottawa Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2020

First Posted

May 27, 2020

Study Start

January 30, 2020

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

September 28, 2022

Results First Posted

September 5, 2021

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations