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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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

Locations
United States
Arkansas
Ozark Orthopaedics
RECRUITING
Fayetteville
Florida
Foundation For Orthopaedic Research and Education
RECRUITING
Tampa
Georgia
Northside Hospital
RECRUITING
Atlanta
Indiana
South Bend Orthopaedics
RECRUITING
South Bend
Ohio
Cleveland Clinic
RECRUITING
Cleveland
JIS Research Institute
ENROLLING_BY_INVITATION
New Albany
South Carolina
Carolina Orthopaedic & Neurosurgical Associates
RECRUITING
Spartanburg
Contact Information
Primary
Nora C.R. York, BS
nyork@canarymedical.com
7604976115
Backup
Anne Maurer, BS
amaurer@canarymedical.com
Time Frame
Start Date: 2023-09-12
Estimated Completion Date: 2028-12
Participants
Target number of participants: 626
Treatments
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
Sponsors
Collaborators: NAMSA
Leads: Canary Medical

This content was sourced from clinicaltrials.gov