Shoulder Arthropathy Associated With Other ConditionsNCT05148104
Intra-Operative Evaluation of the Glenoid Implant Position With Structured Light
An observational study of Shoulder Arthropathy Associated With Other Conditions, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Arthropathy Associated With Other Conditions
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 19 Nov 2021to Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: To be an eligible participant in this study, the patient must be about to undergo a total shoulder replacement.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Cari Whyne, PhD, 416-480-6100 ext. 5056, cari.whyne@sunnybrook.ca
About this study
Official title: Intra-operative Evaluation of the Glenoid Implant Position With Structured Light
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Surgical timepoint
Secondary outcomes (4)
Operative delay for imaging (seconds)
seconds
Measured: Surgical timepoint
Computer vision system image processing time (seconds)
seconds
Measured: Surgical timepoint
Intra-operative complications
from chart review
Measured: Surgical timepoint
Early post-operative complications (evaluated at 3 months follow-up from chart review)
from chart review
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start19 Nov 2021
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Arthropathy Associated With Other ConditionsStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Robin Richards, Sunnybrook Health Sciences Centre
- Investigators
- Robin R Richards, MD, Principal investigator, Appointed Orthopaedic Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148104
- Sponsor's protocol ID
- Bullseye Glenoid
- Status last verified
- Jan 2022
- First submitted
- 24 Nov 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-operative Evaluation of the Glenoid Implant Position With Structured Light
- ClinicalTrials.gov ID
- NCT05148104
- Acronym / sponsor ID
- Bullseye Glenoid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To be an eligible participant in this study, the patient must be about to undergo a total shoulder replacement.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify accuracy of the structured light computer vision system
Time frame: Surgical timepoint
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).
4 secondary outcomes
Operative delay for imaging (seconds)
Time frame: Surgical timepoint
Computer vision system image processing time (seconds)
Time frame: Surgical timepoint
Intra-operative complications
Time frame: Surgical timepoint
Early post-operative complications (evaluated at 3 months follow-up from chart review)
Time frame: 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin R Richards, MD principal investigator
Appointed Orthopaedic Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Arthropathy Associated With Other Conditions, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robin R Richards, MD (416-480-5051, robin.richards@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify accuracy of the structured light computer vision system (time frame: Surgical timepoint). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.