UnknownNot Applicable

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

Canada14 participantsStarted 2021-11-19

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Identify accuracy of the structured light computer vision system

Timeframe: Surgical timepoint

Trial details

NCT IDNCT05148104

SponsorSunnybrook Health Sciences Centre

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-11

Contact for this trial

Robin R Richards, MD

416-480-5051 robin.richards@sunnybrook.ca

View on ClinicalTrials.gov More Shoulder Arthropathy Associated With Other Conditions trials