Clinical trial NCT06040827: A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension
Official title: A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Osteoarthritis
Keywords: total knee arthroplasty
Canary canturio™te
Zimmer Persona® Personalized Knee System
Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension
Lead sponsor: Canary Medical
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
First posted: 2023-09-18
Enrollment: 626
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients indicated for a total knee arthroplasty

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 Safety Endpoint The nature, severity, and frequency of safety risks 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.

The safety endpoint is the percentage of patients that meet any of the following criteria within 5 years post-TKA:

* Revision (tibia only)
* Aseptic loosening
* Instability (or unrecognized septic loosening)
* Intra-operative fracture of bone or device
* Post-operative fracture of bone or device
* Radiologic changes including:
* Lytic lines (radiolucency greater than 2 mm in 2 or more zones)
* Focal lysis(progressive osteolytic lesion)
* Osteolysis (3mm in more than 1 zone)
* Device fracture or failure (tibia only)
* Cortical thickening or periosteal reactions

Secondary Endpoints

The secondary endpoints (for 5 years post-TKA) are:

Successful Data Collection

* Percent of days with step-count data transmitted
* Percent of days with one or more gait bouts triggered and transmitted
* Percent of days with qualified gait cycles \>0 (applicable for walking speed, stride length, tibia ROM, functional knee ROM and cadence)
* Percent of days with step-count data transmitted and qualified gait cycles \>0 (applicable for distance) Pain and Functional Performance
* Knee Injury and Osteoarthritis Outcome Score (KOOS - JR)
* Numeric Pain Rating Scale (NPRS)
* Quality-of-life- EQ-5D-5L

Effectiveness Endpoints (Reliability, Reproducibility, and Accuracy) The reliability, precision and accuracy of walking speed using measurements at 1 year and 2 years post TKA will be assessed with a cohort of 75 patients from Group 1 (with the CTE). Additionally, the reliability, precision and accuracy of all 7 gait parameters (walking speed, cadence, stride length, functional knee ROM, tibia ROM, step count and distance) using measurements at 1 year with 3 different walking speeds, will be assessed with a consecutive cohort of 25 patients from Group 1 in a gait lab.

Eligibility criteria: 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

Primary outcomes:
measure: Safety - Adverse Events
timeFrame: 5 years post TKA
Secondary outcomes:
measure: Percent of days with step-count data transmitted
timeFrame: 5 years post TKA
measure: Percent of days with one or more gait bouts triggered and transmitted
timeFrame: 5 years post TKA
measure: Percent of days with qualified gait cycles >0 (applicable for walking speed meter/second, stride length meter, tibia ROM, functional knee ROM and cadence)
timeFrame: 5 years post TKA
measure: Percent of days with step-count data transmitted and qualified gait cycles >0 (applicable for distance in meters)
timeFrame: 5 years post TKA
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS - JR)
timeFrame: 5 years post TKA
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 5 years post TKA
measure: Quality-of-life- EQ-5D-5L
timeFrame: 5 years post TKA
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Ozark Orthopaedics
state: Arkansas
city: Tampa
country: United States
facility: Foundation For Orthopaedic Research and Education
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: South Bend
country: United States
facility: South Bend Orthopaedics
state: Indiana
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: New Albany
country: United States
facility: JIS Research Institute
state: Ohio
city: Spartanburg
country: United States
facility: Carolina Orthopaedic & Neurosurgical Associates
state: South Carolina
Study officials:
References: