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

NCT05148104 | Unknown

• 1 other identifier: Bullseye Glenoid
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Operative delay for imaging (seconds)

  Surgical timepoint

• Computer vision system image processing time (seconds)

  Surgical timepoint

• Intra-operative complications

  Surgical timepoint

• Early post-operative complications (evaluated at 3 months follow-up from chart review)

  3 months after surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Study Officials

• Robin R Richards, MD

  Appointed Orthopaedic Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin R Richards, MD

CONTACT

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

Cari Whyne, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon, Division of Orthopaedic Surgery

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 8, 2021
• Study Start: November 19, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)