Clinical trial NCT06089291: Persona IQ Cohort Study
Official title: Persona IQ Cohort Study: A Prospective Multicenter Longitudinal Cohort Study of the Persona IQ Personalized Knee System With Mymobility Platform
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Osteo Arthritis Knee
Knee Arthritis
Monitoring Orthopedic Devices
Total Knee Arthroplasty
Total Knee Replacement
Keywords: Cemented Primary Total Knee Arthroplasty
Medical Device
Performance
Safety
Persona IQ
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2023-10-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed description: 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. In addition to traditional data collection mechanisms, four passive outcome measures will be captured among all study subjects via the CTE sensors in combination with the mymobility App, attempting to develop correlative measures to assist surgeons in understanding and managing risk in their patient populations. These correlative outcomes will be measured using qualified step counts, average walking speed, Tibial and Functional range of motion (ROM), cadence, stride length, and distance traveled that will be statistically analyzed.

All the clinical outcomes and device safety data to be collected will be summarized by the applicable univariate statistics and analyzed by the appropriate statistical models. The logistic regressions for the categorical data point, especially binary data for rare events (i.e., revision, hospital readmission etc.) tend to require relatively large sample sizes to have enough power to perform conclusive analyses. 100 + 50i patients are needed to effectively use logistics regression in predicting outcomes, where i refers to the number of independent variables in the final model. It is expected between 15 and 20 independent variables will be available for the model. Assuming 18 independent variables, the sample size needs to be n = 1,000. Assuming 10% loss-to-follow-up, this study will enroll up to 1,112 patients.

Data collected in this study will be summarized descriptively. Categorical data will be summarized using counts and percentages over the time periods of interest. Continuous data will be summarized by using means, medians, standard deviation, minimum, maximum, and 95% CI over the time periods of interest. Appropriate linear regression and generalized linear regression models including logistic regression, cox regression, mixed model for repeated measurements will be applied for the primary, secondary and exploratory endpoints analysis per the data type and analysis goals. The applied statistical models will be used to evaluate and quantify the relationship among the differences in the episode of care data, patient pre-op physical condition and medical history, gait parameters, ROM, patient satisfaction, nine most common post TKR complication incident rates, patient reported outcomes (PROs), TUG test, etc. Implant survival will be evaluated using Kaplan-Meier product limit estimate and raw survival rates. In addition to inference models, the predictive models will also be built to predict the patient satisfaction and PROs using patient baseline status and early PIQ data.

Primary Endpoints: The four primary endpoints based on the clinical outcomes of the Canary CTE with CHIRP when used in conjunction with the ZB PPK system and mymobility® Platform for primary TKA will be analyzed by the appropriate linear and generalized linear regression models per the data type prospectively. The descriptive statistics will be provided as needed to individually describe the data points. The incidence of the nine most common post TKA medical complications will be analyzed by binary logistic regression model and time to event model such as cox regression. The relationship between pre-op, episode of care and post-operative gait recoveries will be evaluated by both binary logistic regression model and mixed model. The correlation between continuous 14 to 30-days Persona IQ data and 90-days post-operative sagittal ROM data will be evaluated by Pearson correlation, ICC with and without patient key baseline features adjusted. The relationship between categorical 14 to 30-days Persona IQ data and 90-days post-operative sagittal ROM data will be evaluated by either ANOVA or ANCOVA model per the analysis goal. The ordinary logistic regression will be applied to build predicting model for patient satisfaction at 42 and 90-days.

Secondary Endpoints: The relationship and correlation between the unique patient clinical data collected via mymobility® application and pre-operative and post-operative activity profiles, surgical techniques, patient attributes, etc. will be evaluated with the stratification of ZB bearing component variants (UC, CR, MC, PS \& CPS). Similar to the primary endpoint analyses, both descriptive statistics and the appropriate linear or generalized linear models will be selected to conduct the analysis based on the data type and the analysis goals. As needed, propensity score matching will be applied to select retrospective cohorts for ongoing exploratory analysis to support future product feature development and research.

Exploratory Endpoints: Implant survival and safety will be analyzed by Kaplan-Meier product limit estimate and raw survival rates with 95% CI. Patient functional performance, clinical benefit measurements and healthcare utilization with index procedure will be analyzed for the whole cohort and for varied subgroups stratified by important surgical or clinical or patient physical features via both appropriate statistical models and descriptive statistics. The continuous clinical outcome differences between the subjects utilizing ROSA and conventional implantation will be evaluated by ANCOVA model with baseline function score, patient key baseline features and visit time adjusted.

Persona IQ is a system comprised of the following subsystems:

1. RTM utilizing mymobility® patient application and care team dashboard,
2. PPK System with
3. CTE Extension Implant and Instrumentation,

   1. Surgical Base Station System,
   2. Home Base Station System,
   3. Canary CDMP,
   4. Canary CMGP software module, and
4. The ZBEdgeTM Connected Artificial Intelligence data platform.

The system combines physical components, electronics, software, and user interfaces to collect, store, analyze, transmit, and display patient data for use by both physicians and patients.

The CTE with CHIRP System is intended to provide objective kinematic data from the implanted medical device during a patient's TKA post-surgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized by the physician during the course of patient monitoring and treatment post-surgery. The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 58 mm sized tibial stem extension. The objective kinematic data generated by the CTE with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit. The CTE with CHIRP System is compatible with ZB PPK System.

ZB PPK components included in this study are commercially available, fixed bearing (FB) left and right-side configurations and various component sizes to accommodate anatomical variation. FB components may be configured for use in posterior cruciate-retaining, cruciate-sacrificing, or cruciate-substituting knee arthroplasty procedures. They are intended for long-term implantation in accordance with product labeling. Investigators should refer to the package insert for additional information on indications, contraindications, warnings, precautions, and compatibility with other ZB products.

The CTE with CHIRP System is a tibial extension implant containing electronics and software. Using internal motion sensors (3-D accelerometers and 3-D gyroscopes), the CTE collects kinematic data pertaining to a patient's gait and activity level following TKA. The kinematic data produced by the CTE implant is intended as an adjunct to the TKA post-procedure standard of care, as directed by the physician. The CTE implant is assembled with the ZB Persona Tibial Baseplate to form a total knee prosthesis. In addition to its data collection and reporting capabilities to the physician and patient, the CTE implant provides additional stability to the complete knee prosthesis in the same manner as a traditional tibial extension. The CTE with CHIRP System uses external OR and Home Base Station units to query the CTE implant (which has an internal radio and antenna) and upload the data collected by the CTE implant to the CDMP. Information from the implant is processed by the system's CMGP software, located in the Cloud, into clinically relevant metrics.

A list of functionally compatible ZB products may be located with the product instructions for use (IFU) and/or the Persona IQ The Smart Knee CANARY CTE with CHIRP TM System, ZB Persona CPS and PPK Surgical Techniques. ZB will make every attempt to update that reference regularly, but to ensure patient safety, please refer to the package insert or other accompanying product information that is provided with the implant. This device is compatible with ROSA Knee System. Investigators may reference the ROSA Knee System User Manual for further system details and IFU.

The devices used in the study are commercially available:

1. Canary CTE with CHIRP via FDA DeNovo # DEN200064.
2. ZB PPK System (compatible with CANARY CTE with CHIRP System).
3. mymobility® patient application and care team dashboard
4. ROSA Robotics ROSA Knee System
5. Other ZBEdgeTM Connected Intelligence Suite Technologies Device accountability is not required for this study if a commercial contract has been executed. In the event a commercial contract has not been executed, a "for research only" study agreement can be offered for a non-commercial user. If a "for research only" contract is executed, device accountability will be required for this study.

This is a post-market study that does not involve investigational products or procedures, and the physical risks to the patients for participation in the study are minimal. Many assessments are standard-of-care for these patient populations and do not require special training for their use in the study. Non-standard assessments, such as patient-reported outcome measures (PROMs), are used frequently in clinical research and instructions can easily be communicated by remote methods. As such, site initiation visits (SIV) may be conducted remotely for this study. During the course of the study, the Sponsor will conduct periodic central monitoring, remote monitoring, and maintain contact with the study staff to monitor compliance and evidence of adverse events, in accordance with the Sponsor's policies and procedures. The Sponsor will address any identified non-compliance with the executed CTA, study protocol, and applicable regulatory requirements. If onsite monitoring visit(s) are deemed appropriate by the Sponsor, the Investigator will permit representatives of the Sponsor's monitoring team to have direct access to inspect all source data/documents, study documents/binders, study subject case report forms, corresponding sections of study subject medical/hospital records, and any other documents relevant to the study. The Site Monitoring Visit Log will be maintained throughout the course of the study. The log will contain the visit date, monitor name/signature and the purpose of the visit (i.e., SIV, interim monitoring, site closeout, etc.). The site monitoring visit log will be filed in the site Regulatory Binder for the study.

Eligibility criteria: Inclusion Criteria:

* Patient must be 18 years of age or older.
* Patient qualifies for primary unilateral or simultaneous bilateral total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to osteoarthritis.
* Independent of study participation, patient is a candidate for commercially available Persona IQ Personalized Knee System implanted in accordance with product labeling.
* Patient has access to a platform-compatible computer with USB connection and appropriate home wireless internet access.
* Patient has access to the mymobility application via eligible smart phone.
* Patient must be willing and able to complete the protocol required follow-up.
* Patient is willing and able to provide written Informed Consent and Authorization by signing and dating the IRB approved Informed Consent and Authorization form.
* Patient is able to read and understand the language used in the mymobility App for their region.

Exclusion Criteria:

* Patient has undergone a contralateral knee replacement in the last 90 days or is scheduled for an upcoming contralateral knee replacement in the next 90 days.
* 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 is currently participating in any other surgical intervention study which would compromise the results of this study as determined by the Investigator.
* Patient has previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint.
* Patient has insufficient bone stock on femoral or tibial surfaces.
* Patient has skeletal immaturity.
* Patient has 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 gout, or a history of gout in the affected knee.
* Patient has a known or suspected sensitivity to one or more of the implant materials.
* Patient is undergoing procedures or treatments using ionizing radiation.
* Patient anticipates exposure to electrical currents conducted or induced into the body (e.g., electrical stimulation)

Primary outcomes:
measure: mymobility platform data compared to most common AEs.
timeFrame: 1 year
measure: mymobility platform data compared to CTE data.
timeFrame: 1 year
measure: Identify 14 to 30-days Persona IQ data points which correlate with 90-days post op full, arthrokinematic sagittal ROM data.
timeFrame: 90 days
measure: mymobility platform data combined with CTE data compared to patient satisfaction at various intervals post op.
timeFrame: 90 days
Secondary outcomes:
measure: Full patient clinical, mymobility platform data combined with CTE as it pertains to bearing variants at various intervals post op.
timeFrame: 1 year
measure: Full patient clinical, mymobility platform data combined with CTE data analysis for future product feature development.
timeFrame: 1 year
Other outcomes:
measure: Implant survival measured in years.
timeFrame: 1 year
measure: Implant safety measured in frequency of adverse events.
timeFrame: 1 year
measure: Functional performance measured through patient reported outcome measures total scores via Knee Injury and Osteoarthritis Outcome Score - Short Form (KOOS, JR).
timeFrame: 1 year
measure: Functional performance measured through patient reported outcome measures total scores via Lower Extremity Functional Scale (LEFS).
timeFrame: 1 year
measure: Functional performance measured through patient reported outcome measures total scores via Forgotten Joint Score (FJS-12).
timeFrame: 1 year
measure: Functional performance measured through patient reported outcome measures total scores via EuroQol-5 Dimensions-5 Levels - Health-Related Quality of Life Survey (EQ-5D-5L).
timeFrame: 1 year
measure: Rate of healthcare utilization in the form of non-standard of care surgeon office visits, post-operative physical therapy, emergency department visits and hospital readmissions associated with the index procedure.
timeFrame: 1 year
measure: Number of subjects implanted utilizing ROSA compared to the number of subjects that underwent conventional implantation.
timeFrame: 1 year
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute
state: North Carolina
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
affiliation: Zimmer Biomet
name: Erin Osborn
role: STUDY_DIRECTOR
References: