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.
