Actively Recruiting
A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension
Led by Canary Medical · Updated on 2025-02-05
626
Participants Needed
7
Research Sites
272 weeks
Total Duration
On this page
Sponsors
C
Canary Medical
Lead Sponsor
N
NAMSA
Collaborating Sponsor
AI-Summary
What this Trial Is About
The objectives of this prospective observational cohort study are to evaluate the safety, reliability, reproducibility, and accuracy of the Canary canturioTM te post-TKA.
CONDITIONS
Official 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, 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
You will not qualify if you...
- Simultaneous bilateral total knee arthroplasty
- Staged bilateral total knee arthroplasty 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
AI-Screening
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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
CONTACT
A
Anne Maurer, BS
CONTACT
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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