Recruiting

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

Sponsor:

Canary Medical

Code:

NCT06040827

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Total Knee Arthroplasty

Study Details

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.

Conditions

Knee Osteoarthritis

Study ID

NCT06040827

Start date

Sep 12, 2023

Status verified date

Oct, 2024

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

626 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1 (Test)

Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension

Group 2 ( Control)

Group 2 (Control): Zimmer Persona® Personalized Knee System with 14 mm +30 mm stem extension

Interventions

Total 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.

Primary outcome measure

Safety - Adverse Events [ Time Frame: 5 years post TKA ]

Central Contacts and Locations

Central contacts

Nora C.R. York, BS

7604976115 nyork@canarymedical.com

Anne Maurer, BS

amaurer@canarymedical.com

Locations

Ozark Orthopaedics

Recruiting

Fayetteville, Arkansas, United States, 72703

Principal Investigator:

Charles Hanby, MD

Foundation For Orthopaedic Research and Education

Recruiting

Tampa, Florida, United States, 33607

Contacts

Kathy Kops

kkops@foreonline.org

Debbi Warren

dwarren@foreonline.org

Principal Investigator:

Steve Lyons, MD

Northside Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Principal Investigator:

Charles DeCook, MD

South Bend Orthopaedics

Recruiting

South Bend, Indiana, United States, 46544

Contacts

Derek Yocum

574-247-5199 dyocum@sbortho.com

Emma Householder

5742221822 ehouseholder@sbortho.com

Principal Investigator:

Jeffery Yergler, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Karen Schemmel

schemmk@ccf.org

Principal Investigator:

Nicolas s Piuzzi, MD

Carolina Orthopaedic & Neurosurgical Associates

Recruiting

Spartanburg, South Carolina, United States, 29303

Contacts

Susan Howard, RN

showard@carolinaona.com

Principal Investigator:

Daniel Gerscovich, MD

More Information

Sponsor

Canary Medical

Last update posted

Feb 5, 2025

Last verified

Oct, 2024

Keywords

total knee arthroplasty
Canary canturio™te
Zimmer Persona® Personalized Knee System
Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Canary Medical on 2025-02-05.