Clinical trial NCT05148104: Intra-Operative Evaluation of the Glenoid Implant Position With Structured Light
Official title: Intra-operative Evaluation of the Glenoid Implant Position With Structured Light
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shoulder Arthropathy Associated With Other Conditions
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Identify accuracy of the structured light computer vision system
timeFrame: Surgical timepoint
Secondary outcomes:
measure: Operative delay for imaging (seconds)
timeFrame: Surgical timepoint
measure: Computer vision system image processing time (seconds)
timeFrame: Surgical timepoint
measure: Intra-operative complications
timeFrame: Surgical timepoint
measure: Early post-operative complications (evaluated at 3 months follow-up from chart review)
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Appointed Orthopaedic Surgeon
name: Robin R Richards, MD
role: PRINCIPAL_INVESTIGATOR
References: