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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Arthropathy Associated With Other Conditions

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 Type: Observational
• Enrollment (Anticipated): 14

Contacts and Locations

• Study Contact: Name: Robin R Richards, MD; Phone Number: 416-480-5051; Email: robin.richards@sunnybrook.ca
• Study Contact Backup: Name: Cari Whyne, PhD; Phone Number: 5056 416-480-6100; Email: cari.whyne@sunnybrook.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Health Sciences Centre
      • Contact: Cari Whyne, PhD; Phone Number: 5056 416-480-6100; Email: cari.whyne@sunnybrook.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

To be an eligible participant in this study, the patient must be about to undergo a total shoulder replacement.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify accuracy of the structured light computer vision system	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).	Surgical timepoint

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Robin R Richards, MD, Appointed Orthopaedic Surgeon

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: Bullseye Glenoid

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No