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

Shoulder Arthropathy Associated With Other Conditions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05148104
• Other study ID #: Bullseye Glenoid
• Status: Recruiting
• Start date: November 19, 2021
• Est. completion date: November 2022

Study information

• Verified date: January 2022
• Source: Sunnybrook Health Sciences Centre
• Contact: Robin R Richards, MD
• Phone: 416-480-5051
• Email: robin.richards[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Shoulder Arthropathy Associated With Other Conditions

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

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