NCT05148104

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 14 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2021-11-19
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2021-12-08
• Last updated: 2022-01-24

Locations

1 site across 1 country: Canada