Safety and accuracy of the canturio te device after knee replacement
Checks the canturio te device after knee replacement for osteoarthritis.
Key facts
- Who runs it
- Canary Medical
- Where
- Atlanta, Cleveland, Fayetteville, New Albany, South Bend, Spartanburg, and Tampa, United StatesSee the 7 sites
- Trial code
- Registry title
- A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension
- Status
- Recruiting
- People taking part
- 626 people, planned
- Started
- 12 Sept 2023
- Expected to end
- Dec 2028
- Type of study
- Observational, 2 groups
- Treatments tested
- Total Knee Arthroplasty
- Record updated
- 5 February 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with severe knee pain and disability from osteoarthritis who are going to have a first total knee replacement. It follows people who get a knee implant with a sensor in the shin-bone part.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Severe knee pain and disability due to osteoarthritis, with only mild or moderate bending of the knee inward, outward or in flexion. The person needs a 58mm or 30mm tibial stem extension.
- Earlier treatment
- This must be a first (primary) total knee replacement. People who had the other knee replaced less than 6 months before cannot join.
Main reasons for not taking part
- Both knees replaced at the same time
- Past infection in the knee, or an infection that could affect the new joint
- Pregnancy or breastfeeding
- Osteoporosis, weak bone, or muscle or nerve disease affecting the leg
- Current alcohol or drug abuse
The registry criteria, word for word
Show all 27 criteriaShow less
Other 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 in United States
- Northside HospitalAtlanta, United StatesContact: Katie MooreTaking people
- Cleveland ClinicCleveland, United StatesContact: Karen SchemmelTaking people
- Ozark OrthopaedicsFayetteville, United StatesContact: Robert SandersonTaking people
- JIS Research InstituteNew Albany, United StatesContact: Nora C.R. York, BSEnrolling by invitation
- South Bend OrthopaedicsSouth Bend, United StatesContact: Derek YocumTaking people
- Carolina Orthopaedic & Neurosurgical AssociatesSpartanburg, United StatesContact: Susan Howard, RNTaking people
- Foundation For Orthopaedic Research and EducationTampa, United StatesContact: Kathy KopsTaking people
About the trial
What the trial wants to find out
The objectives of this prospective observational cohort study are to evaluate the safety, reliability, reproducibility, and accuracy of the Canary canturioTM te post-TKA.
The 2 groups in the trial
- Group 1 (Test)
Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension
Treatment: Total Knee Arthroplasty
- Group 2 ( Control)
Group 2 (Control): Zimmer Persona® Personalized Knee System with 14 mm +30 mm stem extension
Treatment: Total Knee Arthroplasty
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension
- Plain-language title
- Safety and accuracy of the canturio te device after knee replacementGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 5 February 2025