A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
Canary Medical
Study ID
NCT06040827
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Total Knee Arthroplasty — DEVICE
    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.

Study Details

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

Key Dates

Start date
Sep 12, 2023
Status verified
Oct 2024
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
626 participants (estimated)

Arms

  • Arm: Group 1 (Test)
    Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension
  • Arm: Group 2 ( Control)
    Group 2 (Control): Zimmer Persona® Personalized Knee System with 14 mm +30 mm stem extension

Primary Outcome Measure

Safety - Adverse Events [ Time Frame: 5 years post TKA ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Ozark OrthopaedicsFayettevilleArkansas72703
Robert Sanderson
Charles Hanby, MD (PRINCIPAL_INVESTIGATOR)
Foundation For Orthopaedic Research and EducationTampaFlorida33607
Debbi Warren
[email protected]
Steve Lyons, MD (PRINCIPAL_INVESTIGATOR)
Northside HospitalAtlantaGeorgia30342
Katie Moore
Charles DeCook, MD (PRINCIPAL_INVESTIGATOR)
South Bend OrthopaedicsSouth BendIndiana46544
Derek Yocum
[email protected]
574-247-5199
Emma Householder
[email protected]
5742221822
Jeffery Yergler, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Karen Schemmel
[email protected]
Nicolas s Piuzzi, MD (PRINCIPAL_INVESTIGATOR)
JIS Research InstituteNew AlbanyOhio43054-
Carolina Orthopaedic & Neurosurgical AssociatesSpartanburgSouth Carolina29303
Susan Howard, RN
[email protected]
Daniel Gerscovich, MD (PRINCIPAL_INVESTIGATOR)

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Ozark Orthopaedics· Fayetteville, ARFoundation For Orthopaedic Research and Education· Tampa, FLNorthside Hospital· Atlanta, GASouth Bend Orthopaedics· South Bend, INCleveland Clinic· Cleveland, OHJIS Research Institute· New Albany, OH

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