Recruiting

Glenoid Implant Position

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05148104

Conditions

Shoulder Arthropathy Associated With Other Conditions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Shoulder Arthropathy Associated With Other Conditions

Study ID

NCT05148104

Start date

Nov 19, 2021

Status verified date

Jan, 2022

Completion date

Nov, 2022

Anticipated

Primary completion date

Nov, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

14 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Identify accuracy of the structured light computer vision system [ Time Frame: Surgical timepoint ]

Central Contacts and Locations

Central contacts

Robin R Richards, MD

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

Cari Whyne, PhD

416-480-6100cari.whyne@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Cari Whyne, PhD

416-480-6100cari.whyne@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Jan 24, 2022

Last verified

Jan, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2022-01-24.