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

• Conditions: Shoulder Arthropathy Associated With Other Conditions

• Registration Number: NCT05148104
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Study Timeline

• Study Start: 2021-11-19
• Study First Submitted: 2021-11-24
• Study First Submitted QC: 2021-11-24
• Study First Posted: 2021-12-08
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-07
• Last Update Posted: 2022-01-24
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify accuracy of the structured light computer vision system	Surgical timepoint	The primary study outcome will be the accuracy of the structured light computer vision system. The outcome is a single measure quantified by the difference in predicted and actual position of the glenoid implant. The measure of the difference is a combination of version error (degrees), inclination error (degrees), and offset error (mm).

Secondary Outcome Measures

Name	Time	Method
Early post-operative complications (evaluated at 3 months follow-up from chart review)	3 months after surgery	from chart review
Operative delay for imaging (seconds)	Surgical timepoint	seconds
Computer vision system image processing time (seconds)	Surgical timepoint	seconds
Intra-operative complications	Surgical timepoint	from chart review

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada