Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT06040827
Status:
RECRUITING
Last Update Posted:
2025-02-05
First Post:
2023-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension
Sponsor:
Canary Medical
Organization:
Study Overview
Official Title:
A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: