Evaluating the safety and effectiveness of a new knee implant extension
A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension
This study is testing a new knee implant extension to see if it is safe and works better than a standard knee system for people getting knee replacement surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 626 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Canary Medical Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 7 sites (Fayetteville, Arkansas and 6 other locations) |
| Trial ID | NCT06040827 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to assess the safety, reliability, reproducibility, and accuracy of the Canary canturioTM te tibial extension in patients undergoing total knee arthroplasty (TKA). Participants will be divided into two groups: one receiving the new tibial extension and the other receiving a standard Zimmer Persona® knee system. The study will monitor various safety endpoints over a five-year period, including revision rates and radiologic changes. Additionally, secondary endpoints will focus on data collection related to patient mobility and gait metrics.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require primary total knee arthroplasty due to severe knee pain and disability from osteoarthritis.
Not a fit: Patients undergoing simultaneous bilateral total knee arthroplasty or those with staged bilateral procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and safety for patients receiving total knee arthroplasty with the new tibial extension.
How similar studies have performed: While this approach is observational, similar studies evaluating new orthopedic implants have shown promising results in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion * 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 Exclusion * 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
Where this trial is running
Fayetteville, Arkansas and 6 other locations
- Ozark Orthopaedics — Fayetteville, Arkansas, United States (Recruiting)
- Foundation For Orthopaedic Research and Education — Tampa, Florida, United States (Recruiting)
- Northside Hospital — Atlanta, Georgia, United States (Recruiting)
- South Bend Orthopaedics — South Bend, Indiana, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- JIS Research Institute — New Albany, Ohio, United States (Enrolling_by_invitation)
- Carolina Orthopaedic & Neurosurgical Associates — Spartanburg, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Nora C.R. York, BS
- Email: nyork@canarymedical.com
- Phone: 7604976115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.