Intra-Operative Evaluation of the Glenoid Implant Position With Structured Light

NCT ID: NCT05148104

Last Updated: 2022-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-19
• Study Completion Date: 2022-11-30

Brief Summary

Positioning of the glenoid component is one of the most challenging steps in shoulder replacement surgery. Prosthesis longevity and functional outcomes are considered highly dependent on accurate positioning. Currently, there are no adequate means to verify the position of the glenoid component during surgery which is a significant impediment to accurate positioning. We propose a non-interventional study to validate a novel technology for verifying the position of the glenoid component during shoulder replacement surgery.

Detailed Description

Positioning of the glenoid component is one of the most challenging steps in shoulder replacement surgery. In this study, we are testing a new method of checking the glenoid component position using an optical light 3D scanner for both total and reverse total shoulder replacements. Currently, the position of the glenoid component is verified by the operating surgeon visually and there is no routine imaging to verify the position of the glenoid component during surgery.

Participants in this study will have a 3D optical image of their glenoid bone taken during the surgical procedure. Taking this image will require less than 3 minutes and the image will only include their surgical wound (no facial features or other identifying features will be taken in the images). Two to six weeks after the surgery, the study participants will have CT scan of their replaced shoulder. This will allow the researchers to measure the accuracy of the new imaging system.

It is anticipated that about 14 people will participate in this study at Sunnybrook. The length of this study for participants is 6 weeks. The entire study is expected to take about 1 year to complete and the results should be known 6 months after study completion.

Conditions

Shoulder Arthropathy Associated With Other Conditions

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients receiving shoulder arthroplasty

Patients receiving shoulder arthroplasty that have an intact glenoid prior to the procedure. Ideally the glenoid surface should be visible and intact during imaging.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Greater than 18 years of age.
• Scheduled to undergo total shoulder arthroplasty surgery.
• Scheduled pre-operative CT imaging of the shoulder and the surgical plan includes open exposure of the glenoid.

Exclusion Criteria

• Previous shoulder surgery involving the glenoid.
• No clinically indicated pre-operative CT imaging.
• Pregnancy (current or planned).
• Current or planned participation in other research, or having a clinical condition that would result in cumulative annual radiation exposure exceeding the regulatory limit (30 mSv) from all sources.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Robin Richards

Orthopaedic Surgeon, Division of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robin R Richards, MD

Role: PRINCIPAL_INVESTIGATOR

Appointed Orthopaedic Surgeon

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Robin R Richards, MD

Role: CONTACT

robin.richards@sunnybrook.ca

416-480-5051

Cari Whyne, PhD

Role: CONTACT

cari.whyne@sunnybrook.ca

416-480-6100 ext. 5056

Facility Contacts

Cari Whyne, PhD

Role: primary

cari.whyne@sunnybrook.ca

416-480-6100 ext. 5056

Other Identifiers

Bullseye Glenoid

Identifier Type: -

Identifier Source: org_study_id