NCT06040827

Brief Summary

The objectives of this prospective observational cohort study are to evaluate the safety, reliability, reproducibility, and accuracy of the Canary canturioTM te post-TKA.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
626

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Sep 2023Dec 2028

First Submitted

Initial submission to the registry

July 20, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 12, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

February 5, 2025

Status Verified

October 1, 2024

Enrollment Period

4.7 years

First QC Date

July 20, 2023

Last Update Submit

February 3, 2025

Conditions

Knee Osteoarthritis

Keywords

total knee arthroplastyCanary canturio™teZimmer Persona® Personalized Knee SystemZimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension

Outcome Measures

Primary Outcomes (1)

  • Safety - Adverse Events

    The nature, severity, and frequency of safety risks (Adverse Events) in subjects with the Canary canturioTM te will be compared to those subjects with the legally marketed Zimmer Persona® Personalized Knee System with 14 mm x +30 mm stem extension within 5 years post-TKA.

    5 years post TKA

Secondary Outcomes (7)

  • Percent of days with step-count data transmitted

    5 years post TKA

  • Percent of days with one or more gait bouts triggered and transmitted

    5 years post TKA

  • Percent of days with qualified gait cycles >0 (applicable for walking speed meter/second, stride length meter, tibia ROM, functional knee ROM and cadence)

    5 years post TKA

  • Percent of days with step-count data transmitted and qualified gait cycles >0 (applicable for distance in meters)

    5 years post TKA

  • Knee Injury and Osteoarthritis Outcome Score (KOOS - JR)

    5 years post TKA

  • +2 more secondary outcomes

Study Arms (2)

Group 1 (Test)

Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension

Device: Total Knee Arthroplasty

Group 2 ( Control)

Group 2 (Control): Zimmer Persona® Personalized Knee System with 14 mm +30 mm stem extension

Device: Total Knee Arthroplasty

Interventions

Total Knee ArthroplastyDEVICE

The nature, severity, and frequency of safety risks (Adverse Events) in subjects with the Canary canturioTM te will be compared to those subjects with the legally marketed Zimmer Persona® Personalized Knee System with 14 mm x +30 mm stem extension within 5 years post-TKA.

Group 1 (Test)Group 2 ( Control)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients indicated for a total knee arthroplasty

You may qualify if:

  • 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 may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Ozark Orthopaedics

Fayetteville, Arkansas, 72703, United States

RECRUITING

Foundation For Orthopaedic Research and Education

Tampa, Florida, 33607, United States

RECRUITING

Northside Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

South Bend Orthopaedics

South Bend, Indiana, 46544, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

JIS Research Institute

New Albany, Ohio, 43054, United States

ENROLLING BY INVITATION

Carolina Orthopaedic & Neurosurgical Associates

Spartanburg, South Carolina, 29303, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Central Study Contacts

Nora C.R. York, BS

CONTACT

7604976115nyork@canarymedical.com

Anne Maurer, BS

CONTACT

amaurer@canarymedical.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2023

First Posted

September 18, 2023

Study Start

September 12, 2023

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

February 5, 2025

Record last verified: 2024-10

Locations

US(7)