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Recruiting NCT05693818

A Multicenter, Single- Arm Study of Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension

Conditions: Arthritis Knee

Sex: All
Ages: 18 Years – N/A
Enrollment: 88
Sponsor: Canary Medical

Location: United States

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.

Eligibility Criteria

Inclusion Criteria:• Patient must be 18 years of age or olderIndependent of study participation, patient is indicated for a commercially available PIQ TKA implant in accordance with product labelingPatient must be willing and able to complete the protocol required follow-upPatient has participated in the study-related informed consent processPatient is willing and able to provide written Informed Consent by signing and dating the IRB approved informed consentExclusion Criteria:• Simultaneous bilateral TKAStaged bilateral TKA less than 6 months from indexed procedurePatient is a current alcohol or drug abuserPatient 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 programPatient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructionsPatient with Neuropathic ArthropathyPatient with any loss of musculature or neuromuscular disease that compromises the affected limbPatients with known symptomatic foot, hip or spinal injuries and/or conditions that could affect gait

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05693818). StuddyBuddy aggregates publicly available trial information.