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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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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