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Persona IQ Cohort for Total Knee Replacement

N/A
Waitlist Available
Research Sponsored by Zimmer Biomet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

A prospective multicenter longitudinal cohort study of Zimmer Biomet (ZB) Persona IQ The Smart Knee which consists of the Persona Personalized Knee (PPK) System with mymobility® platform that is attempting to develop correlative measures to assist surgeons in understanding and managing risk in their patient populations. Specifically comparing four outcome measures captured via Remote Therapeutic Monitoring (RTM) utilizing the CANARY canturioTM Tibial Extension (CTE) sensors in combination with the mymobility® App. The primary objective of this prospective study is to systematically document the clinical outcomes of the Persona IQ Personalized Knee System with mymobility for primary total knee arthroplasty/replacement (TKA/TKR). This will be accomplished by monitoring subject activity trend patterns via the mymobility platform, evaluating smart system usability, monitoring short and long-term safety and effectiveness, and evaluating the value of the remote therapeutic monitoring platform. This data collection will be accomplished by the following: 1. The Canary Smart Tibial Stem comprised of the following subsystems: 1. Canary Cloud Data Management Platform (CDMP) 2. Canary Medical Gait Parameters (CMGP) Software Module 2. Persona IQ Personalized Knee System with mymobility Platform comprised of the following subsystems: 1. mymobility Platform for Patient Application 2. mymobility Care Team Dashboard 3. ZB Edge Artificial Intelligence Data Platform 3. Clinical Outcomes 1. Joint Motion: ROM and Deductions 2. Joint Stability: Medial/Lateral and Anterior/Posterior 3. Gait and Assistive Device Utilization 4. Surgical Incision Site 4. Objective Measurements: a. Timed Up \& Go (TUG) and Stair Climb Test 5. System Usability Evaluation 6. Patient Satisfaction 7. Health Care Provider Satisfaction Additionally, a data repository will be maintained for future secondary data analyses when data is transmitted and captured beyond the 1-year of follow-up.

Eligible Conditions
  • Total Knee Replacement
  • Knee Arthritis
  • Monitoring Orthopedic Devices
  • Osteoarthritis
  • Total Knee Arthroplasty

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Identify 14 to 30-days Persona IQ data points which correlate with 90-days post op full, arthrokinematic sagittal ROM data.
mymobility platform data combined with CTE data compared to patient satisfaction at various intervals post op.
mymobility platform data compared to CTE data.
+1 more
Secondary study objectives
Full patient clinical, mymobility platform data combined with CTE as it pertains to bearing variants at various intervals post op.
Full patient clinical, mymobility platform data combined with CTE data analysis for future product feature development.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Persona IQ CohortExperimental Treatment1 Intervention
The study device is intended to relieve pain and restore function in patients with adequate quality and quantity of bone stock to support the prosthesis. The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 58mm sized tibial stem extension. To qualify to receive the CTE with CHIRP System, the Patient must meet the following requirements in addition to any requirements for TKA surgery as determined by the patient's Health Care Professionals (HCPs): 1. The Patient's anatomy must be capable of accepting the Zimmer Biomet Persona Tibia Baseplate with canturio™te construct sizing. This assessment will be conducted pre-operatively by the HCP using a CTE Template supplied by Canary Medical. 2. The patient must have access to a computer with a USB connection to set up their Home Base Station. 3. The Patient must have wireless internet in their domicile.

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Who is running the clinical trial?

Zimmer BiometLead Sponsor
375 Previous Clinical Trials
66,533 Total Patients Enrolled
Erin OsbornStudy DirectorZimmer Biomet
13 Previous Clinical Trials
11,804 Total Patients Enrolled
~667 spots leftby Dec 2026