RecruitingNCT06040827

A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension

Sponsor

Canary Medical

Enrollment

626 participants

Start Date

Sep 12, 2023

Study Type

OBSERVATIONAL

Conditions

Knee Osteoarthritis

Summary

The objectives of this prospective observational cohort study are to evaluate the safety, reliability, reproducibility, and accuracy of the Canary canturioTM te post-TKA.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

Patient must be 18 years of age or older
Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to osteoarthritis, limited to:
Mild or Moderate valgus, varus, or flexion deformities
Patient must be willing and able to complete the protocol required follow-up
Patient is indicated for a 58mm or 30mm tibial stem extension
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
Patient has a platform-compatible personal computer located in their dwelling with appropriate wireless internet access and a USB port
Independent of study participation, patient is a candidate for commercially available Persona Personalized Knee System implanted in accordance with product labeling

Exclusion Criteria17

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 has previous history of infection in the affected joint and/or a local or systemic infection that may affect the prosthetic joint
Patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions
Patient with skeletal immaturity
Patient has insufficient bone stock on femoral or tibial surfaces
Patient with Neuropathic Arthropathy
Patient has osteoporosis, or any loss of musculature or neuromuscular disease that compromises the affected limb
Patient has severe instability secondary to the absence of collateral ligament integrity.
Patient has a stable, painless arthrodesis in a satisfactory functional position
Patient has rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
Patient has a known or suspected sensitivity to one or more of the implant materials
Patient is undergoing procedures or treatments using ionizing radiation
Patients with known symptomatic foot, hip, or spinal injuries and/or conditions that could affect gait

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICETotal Knee Arthroplasty

The nature, severity, and frequency of safety risks (Adverse Events) in subjects with the Canary canturioTM te will be compared to those subjects with the legally marketed Zimmer Persona® Personalized Knee System with 14 mm x +30 mm stem extension within 5 years post-TKA.