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.
