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

Sponsor

Canary Medical (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06040827

Collaborator

(none)

600

Enrollment

Location

62.7

Anticipated Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Device: Total Knee Arthroplasty

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 12, 2023

Anticipated Primary Completion Date :

Jun 1, 2028

Anticipated Study Completion Date :

Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Group 1 (Test) Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension	Device: 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.
Group 2 ( Control) Group 2 (Control): Zimmer Persona® Personalized Knee System with 14 mm +30 mm stem extension	Device: 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.

Arm

Intervention/Treatment

Group 1 (Test)

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

Device: 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.

Group 2 ( Control)

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

Device: Total Knee Arthroplasty

Outcome Measures

Primary Outcome Measures

Safety - Adverse Events [5 years post TKA]
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.

Secondary Outcome Measures

Percent of days with step-count data transmitted [5 years post TKA]
Successful Data Collection
Percent of days with one or more gait bouts triggered and transmitted [5 years post TKA]
Successful Data Collection
Percent of days with qualified gait cycles >0 (applicable for walking speed meter/second, stride length meter, tibia ROM, functional knee ROM and cadence) [5 years post TKA]
Successful Data Collection
Percent of days with step-count data transmitted and qualified gait cycles >0 (applicable for distance in meters) [5 years post TKA]
Successful Data Collection
Knee Injury and Osteoarthritis Outcome Score (KOOS - JR) [5 years post TKA]
Pain and Functional Performance
Numeric Pain Rating Scale (NPRS) [5 years post TKA]
Pain and Functional Performance
Quality-of-life- EQ-5D-5L [5 years post TKA]
Pain and Functional Performance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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:

o 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 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 Criteria:

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