Status:
RECRUITING
A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension
Lead Sponsor:
Canary Medical
Collaborating Sponsors:
NAMSA
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18+ years
Brief 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.
Detailed Description
Group 1 (Test): Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension Group 2 (Control): Zimmer Persona® Personalized Knee System with 14 mm +30 mm stem extension Safe...
Eligibility Criteria
Inclusion
- Inclusion
- 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
- 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
Exclusion
Key Trial Info
Start Date :
September 12 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
626 Patients enrolled
Trial Details
Trial ID
NCT06040827
Start Date
September 12 2023
End Date
December 1 2028
Last Update
February 5 2025
Active Locations (7)
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1
Ozark Orthopaedics
Fayetteville, Arkansas, United States, 72703
2
Foundation For Orthopaedic Research and Education
Tampa, Florida, United States, 33607
3
Northside Hospital
Atlanta, Georgia, United States, 30342
4
South Bend Orthopaedics
South Bend, Indiana, United States, 46544