Actively Recruiting
A Multicenter, Postmarket Surveillance Study of the Canary canturioTM Tibial Extension Compared to Standard Stem Extension in Patients Undergoing Total Knee Arthroplasty for Knee Osteoarthritis
Led by Canary Medical · Updated on 2025-02-05
626
Participants Needed
7
Research Sites
26 weeks
Total Duration
On this page
Sponsors
C
Canary Medical
Lead Sponsor
N
NAMSA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, reliability, reproducibility, and accuracy of the Canary canturioTM tibial extension in patients who have undergone total knee arthroplasty (TKA) due to knee osteoarthritis. This observational study compares outcomes between patients receiving the Zimmer Persona Personalized Knee System with the Canary canturioTM tibial extension and those receiving the Zimmer Persona system with a standard 14 mm +30 mm stem extension. The study aims to monitor safety risks and gait performance over five years post-TKA. Participants are divided into two groups: one with the Canary canturioTM tibial extension and one with a standard stem extension. Safety endpoints include revision surgeries, loosening, fractures, and radiologic changes within five years after surgery. Secondary endpoints assess data collection on step counts and gait parameters, as well as patient-reported pain, knee function, and quality of life. A subgroup of patients will have detailed gait lab assessments at one and two years post-TKA. During the study, participants will be monitored for adverse events and their gait will be tracked using wearable technology to collect step count and walking data. Patient-reported outcomes such as pain scores and quality of life questionnaires will be completed regularly. The study lasts five years from the time of knee replacement surgery, with continuous data collection and periodic evaluations to assess the performance and safety of the knee systems.
CONDITIONS
Brief Title
A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- 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
- Patient has a platform-compatible personal computer with wireless internet and USB port
- Patient is a candidate for commercially available Persona Personalized Knee System implanted according to product labeling
You will not qualify if you...
- Simultaneous bilateral total knee arthroplasty
- Staged bilateral total knee arthroplasty less than 6 months from indexed procedure
- Current alcohol or drug abuse
- Known pregnancy, breastfeeding, or member of a protected class (e.g., prisoner, mentally incompetent)
- Psychiatric illness or cognitive deficit preventing informed consent or follow-up participation
- Previous infection in the affected joint or infection that may affect prosthetic joint
- Mental or neurologic conditions unwilling or incapable of following postoperative care instructions
- Skeletal immaturity
- Insufficient bone stock on femoral or tibial surfaces
- Neuropathic arthropathy
- Osteoporosis or neuromuscular disease compromising affected limb
- Severe instability due to absent collateral ligament integrity
- Stable, painless arthrodesis in functional position
- Rheumatoid arthritis with skin ulcer or recurrent skin breakdown
- Known or suspected sensitivity to implant materials
- Undergoing ionizing radiation treatments
- Symptomatic foot, hip, or spinal injuries affecting gait or walking ability
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo total knee arthroplasty with either the Canary canturioTM tibial extension or the standard Zimmer Persona® Personalized Knee System stem extension.
1 visit (in-person)
Duration - Up to 5 years post-surgery
Participants are monitored for safety outcomes, functional performance, and device effectiveness for up to 5 years after total knee arthroplasty.
Visits and assessments occur periodically over 5 years
Trial Site Locations
Total: 7 locations
1
Ozark Orthopaedics
Fayetteville, Arkansas, United States, 72703
Actively Recruiting
2
Foundation For Orthopaedic Research and Education
Tampa, Florida, United States, 33607
Actively Recruiting
3
Northside Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
4
South Bend Orthopaedics
South Bend, Indiana, United States, 46544
Actively Recruiting
5
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
6
JIS Research Institute
New Albany, Ohio, United States, 43054
Enrolling by Invitation
7
Carolina Orthopaedic & Neurosurgical Associates
Spartanburg, South Carolina, United States, 29303
Actively Recruiting
Research Team
N
Nora C.R. York, BS
A
Anne Maurer, BS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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