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 range18 Years
SexALL
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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