Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension (NCT05693818) | Clinical Trial Compass
UnknownNot Applicable
Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension
United States88 participantsStarted 2023-01-31
Plain-language summary
The objective of this prospective study is to demonstrate accuracy of a limp detection model using a healthcare provider assessment as the non-reference standard.
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:
* • Patient must be 18 years of age or older
* Independent of study participation, patient is indicated for a commercially available PIQ TKA implant in accordance with product labeling
* Patient must be willing and able to complete the protocol required follow-up
* Patient has participated in the study-related informed consent process
* Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved informed consent
Exclusion Criteria:
* • Simultaneous bilateral TKA
* Staged bilateral TKA less than 6 months from indexed procedure
* Patient is a current alcohol or drug abuser
* Patient is known to be pregnant, breastfeeding, or considered a member of a protected class (e.g., prisoner, mentally incompetent, etc.)
* Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent and participation in follow-up program
* Patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions
* Patient with Neuropathic Arthropathy
* Patient with any loss of musculature or neuromuscular disease that compromises the affected limb
* Patients with known symptomatic foot, hip or spinal injuries and/or conditions that could affect gait
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.