Knee OsteoarthritisNCT06040827
A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension
An observational study of Knee Osteoarthritis, run by Canary Medical at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Total Knee Arthroplasty
- Type of treatment
- Medical device
- How many people
- 626 participants
- Where
- 7 sitesUnited States
- Study dates
- 12 Sep 2023to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients indicated for a total knee arthroplasty
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anne Maurer, BS contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Northside Hospital
Atlanta, Georgia, 30342
Katie Moore
Charles DeCook, MD
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Karen Schemmel, schemmk@ccf.org
Nicolas s Piuzzi, MD
- Recruiting
Ozark Orthopaedics
Fayetteville, Arkansas, 72703
Robert Sanderson
Charles Hanby, MD
- Enrolling by invitation
JIS Research Institute
New Albany, Ohio, 43054
- Recruiting
South Bend Orthopaedics
South Bend, Indiana, 46544
Derek Yocum, 574-247-5199, dyocum@sbortho.com
Emma Householder, 5742221822, ehouseholder@sbortho.com
- Recruiting
Carolina Orthopaedic & Neurosurgical Associates
Spartanburg, South Carolina, 29303
Susan Howard, RN, showard@carolinaona.com
Daniel Gerscovich, MD
- Recruiting
Foundation For Orthopaedic Research and Education
Tampa, Florida, 33607
Kathy Kops, kkops@foreonline.org
Debbi Warren, dwarren@foreonline.org
About this study
The objectives of this prospective observational cohort study are to evaluate the safety, reliability, reproducibility, and accuracy of the Canary canturioTM te post-TKA.
Read the detailed description
Group 1 (Test): Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension Group 2 (Control): Zimmer Persona® Personalized Knee System with 14 mm +30 mm stem extension Safety Endpoint The nature, severity, and frequency of safety risks 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.
The safety endpoint is the percentage of patients that meet any of the following criteria within 5 years post-TKA:
- Revision (tibia only)
- Aseptic loosening
- Instability (or unrecognized septic loosening)
- Intra-operative fracture of bone or device
- Post-operative fracture of bone or device
- Radiologic changes including:
- Lytic lines (radiolucency greater than 2 mm in 2 or more zones)
- Focal lysis(progressive osteolytic lesion)
- Osteolysis (3mm in more than 1 zone)
- Device fracture or failure (tibia only)
- Cortical thickening or periosteal reactions
Secondary Endpoints
The secondary endpoints (for 5 years post-TKA) are:
Successful Data Collection
- Percent of days with step-count data transmitted
- Percent of days with one or more gait bouts triggered and transmitted
- Percent of days with qualified gait cycles >0 (applicable for walking speed, stride length, tibia ROM, functional knee ROM and cadence)
- Percent of days with step-count data transmitted and qualified gait cycles >0 (applicable for distance) Pain and Functional Performance
- Knee Injury and Osteoarthritis Outcome Score (KOOS - JR)
- Numeric Pain Rating Scale (NPRS)
- Quality-of-life- EQ-5D-5L
Effectiveness Endpoints (Reliability, Reproducibility, and Accuracy) The reliability, precision and accuracy of walking speed using measurements at 1 year and 2 years post TKA will be assessed with a cohort of 75 patients from Group 1 (with the CTE). Additionally, the reliability, precision and accuracy of all 7 gait parameters (walking speed, cadence, stride length, functional knee ROM, tibia ROM, step count and distance) using measurements at 1 year with 3 different walking speeds, will be assessed with a consecutive cohort of 25 patients from Group 1 in a gait lab.
- Conditions
- Knee Osteoarthritis
- Being tested
- Total Knee Arthroplasty
- Keywords
- total knee arthroplasty, Canary canturio™te, Zimmer Persona® Personalized Knee System, Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Test) | Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension Receives: Device: Total Knee Arthroplasty | |
| Group 2 ( Control) | Group 2 (Control): Zimmer Persona® Personalized Knee System with 14 mm +30 mm stem extension Receives: Device: Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years post TKA
Secondary outcomes (7)
Percent of days with step-count data transmitted
Successful Data Collection
Measured: 5 years post TKA
Percent of days with one or more gait bouts triggered and transmitted
Successful Data Collection
Measured: 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)
Successful Data Collection
Measured: 5 years post TKA
Percent of days with step-count data transmitted and qualified gait cycles >0 (applicable for distance in meters)
Successful Data Collection
Measured: 5 years post TKA
Knee Injury and Osteoarthritis Outcome Score (KOOS - JR)
Pain and Functional Performance
Measured: 5 years post TKA
Numeric Pain Rating Scale (NPRS)
Pain and Functional Performance
Measured: 5 years post TKA
Quality-of-life- EQ-5D-5L
Pain and Functional Performance
Measured: 5 years post TKA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start12 Sep 2023
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 626 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canary Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040827
- Sponsor's protocol ID
- PS220001
- Status last verified
- Oct 2024
- First submitted
- 20 Jul 2023
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension
- ClinicalTrials.gov ID
- NCT06040827
- Acronym / sponsor ID
- PS220001
- Conditions
- Knee Osteoarthritis
- Keywords
- total knee arthroplasty, Canary canturio™te, Zimmer Persona® Personalized Knee System, Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 626 participants (estimated)
- Lead sponsor
- Canary MedicalIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this prospective observational cohort study are to evaluate the safety, reliability, reproducibility, and accuracy of the Canary canturioTM te post-TKA.
Detailed description
Group 1 (Test): Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension Group 2 (Control): Zimmer Persona® Personalized Knee System with 14 mm +30 mm stem extension Safety Endpoint The nature, severity, and frequency of safety risks 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.
The safety endpoint is the percentage of patients that meet any of the following criteria within 5 years post-TKA:
- Revision (tibia only)
- Aseptic loosening
- Instability (or unrecognized septic loosening)
- Intra-operative fracture of bone or device
- Post-operative fracture of bone or device
- Radiologic changes including:
- Lytic lines (radiolucency greater than 2 mm in 2 or more zones)
- Focal lysis(progressive osteolytic lesion)
- Osteolysis (3mm in more than 1 zone)
- Device fracture or failure (tibia only)
- Cortical thickening or periosteal reactions
Secondary Endpoints
The secondary endpoints (for 5 years post-TKA) are:
Successful Data Collection
- Percent of days with step-count data transmitted
- Percent of days with one or more gait bouts triggered and transmitted
- Percent of days with qualified gait cycles >0 (applicable for walking speed, stride length, tibia ROM, functional knee ROM and cadence)
- Percent of days with step-count data transmitted and qualified gait cycles >0 (applicable for distance) Pain and Functional Performance
- Knee Injury and Osteoarthritis Outcome Score (KOOS - JR)
- Numeric Pain Rating Scale (NPRS)
- Quality-of-life- EQ-5D-5L
Effectiveness Endpoints (Reliability, Reproducibility, and Accuracy) The reliability, precision and accuracy of walking speed using measurements at 1 year and 2 years post TKA will be assessed with a cohort of 75 patients from Group 1 (with the CTE). Additionally, the reliability, precision and accuracy of all 7 gait parameters (walking speed, cadence, stride length, functional knee ROM, tibia ROM, step count and distance) using measurements at 1 year with 3 different walking speeds, will be assessed with a consecutive cohort of 25 patients from Group 1 in a gait lab.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Test) | – | Device: Total Knee ArthroplastyZimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension |
| Group 2 ( Control) | – | Device: Total Knee ArthroplastyGroup 2 (Control): Zimmer Persona® Personalized Knee System with 14 mm +30 mm stem extension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients indicated for a total knee arthroplasty
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Knee ArthroplastyThe 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. | Device | Group 1 (Test), Group 2 ( Control) |
Primary outcome
Safety - Adverse Events
Time frame: 5 years post TKA
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.
7 secondary outcomes
Percent of days with step-count data transmitted
Time frame: 5 years post TKA
Percent of days with one or more gait bouts triggered and transmitted
Time frame: 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)
Time frame: 5 years post TKA
Percent of days with step-count data transmitted and qualified gait cycles >0 (applicable for distance in meters)
Time frame: 5 years post TKA
Knee Injury and Osteoarthritis Outcome Score (KOOS - JR)
Time frame: 5 years post TKA
Numeric Pain Rating Scale (NPRS)
Time frame: 5 years post TKA
Quality-of-life- EQ-5D-5L
Time frame: 5 years post TKA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne Maurer, BS contact
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Canary Medical at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nora C.R. York, BS (7604976115, nyork@canarymedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Adverse Events (time frame: 5 years post TKA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.