Persona IQ Cohort Study: A Multicentric Prospective Cohort Study of the Persona IQ® Personalized Knee System With the Mymobility® Care Management Application
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Identify 14 to 30-days Persona IQ data points which correlate with 90-days post op full, arthrokinematic sagittal ROM data.
研究概览
简要总结
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 kinematic metrics captured via Remote Therapeutic Monitoring (RTM) utilizing the CANARY canturio te (CTE) and canturio se (CSE) sensors in combination with the mymobility® App.
The purpose of this study is to evaluate safety, functional performance, and effectiveness of the implant.
Primary Objective:
Assess Persona IQ kinematic metrics captured via the CTE/CSE sensor to assist surgeons in understanding and managing recovery through post-operative gait metrics.
Secondary Objective:
Evaluate the value of Remote Therapeutic Monitoring (RTM) and healthcare utilization.
Exploratory Objective:
Exploratory analyses will be performed using these data to direct future product feature development, data algorithm products, and research. This includes but is not limited to participants implanted utilizing ROSA® Robotics and other ZBEdge technologies.
详细描述
The Canary Tibial Extension (CTE)/canturio Smart Extension (CSE) with Canary Health Implanted Reporting Processor (CHIRP) System are intended to provide objective kinematic data from the implanted medical device during a patient's total knee arthroplasty (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 30 mm sized tibial stem extension and/or normally indicated for at least a 58mm sized tibial stem extension. The objective kinematic data generated by the CTE/CSE with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit. The CTE/CSE with CHIRP System is compatible with Zimmer Persona® Personalized Knee System
The CTE/CSE with CHIRP System uses external OR and Home Base Station units to query the CTE/CSE implant (which has an internal radio and antenna) and upload the data collected by the CTE/CSE implant to the Canary Cloud data management platform (CDMP). Information from the implant is processed by the system's Canary Medical Gait Parameter (CMGP) software, located in the Cloud, into clinically relevant metrics.
Follow-up Procedures:
Follow-up evaluations will be conducted at 1 month (± 14 days), and 3 months (± 30 days) after surgery. At every follow-up visit, pain and function of the study knee will be evaluated, and subject's quality of life will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be 18 years of age or older.
- •Patient qualifies for primary unilateral, staged bilateral or simultaneous bilateral total knee arthroplasty.
- •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 appropriate technology to ensure full functionality for the home base station used as a part of their study procedure.
- •Patient has access to the mymobility platform via eligible smart device.
- •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.
排除标准
- •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 Neuropathic Arthropathy.
- •Patient has osteoporosis, or any loss of musculature or neuromuscular disease that compromises the affected limb, as determined by the Investigator.
- •Patient has gout, or a history of gout in the affected knee.
- •Patient is undergoing procedures or treatments using ionizing radiation at or in the proximity of the CTE/CSE.
- •Off-label use or not according to the approved instructions for use (IFU) of study devices.
研究组 & 干预措施
Persona IQ Cohort
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 that are normally indicated for at least a 30 mm sized tibial stem extension and/or normally indicated for at least a 58mm sized tibial stem.
To qualify to receive the CTE/CSE with CHIRP System, the patient must be a candidate for commercially available Persona IQ Personalized Knee System implanted in accordance with product labeling.
干预措施: Persona IQ (Device)
结局指标
主要结局
Identify 14 to 30-days Persona IQ data points which correlate with 90-days post op full, arthrokinematic sagittal ROM data.
时间窗: 90 days
Functional ROM during a qualified gait cycle. Calculated from tibia ROM. Mean sagittal plane functional ROM when walking. Difference between maximum and minimum knee joint flexion.
mymobility platform data compared to most common AEs.
时间窗: 6 months
Assess the differences in episode of care, data compiled, collected, and delivered in the mymobility platform to correlate the incidence of nine most common post TKR medical complications. Nine most common post TKR medical complications: wound complication, thromboembolic disease, neural deficit, vascular injury, medial collateral ligament injury, instability, malalignment, stiffness, deep periprosthetic joint infection.
mymobility platform data compared to CTE/CSE data.
时间窗: 6 months
Comparison of mymobility platform data gait analysis to CTE data gait analysis.
mymobility platform data combined with CTE/CSE data compared to patient satisfaction at various intervals post op.
时间窗: 6 months
Assess the ability of post-op data compiled, collected, and delivered in the mymobility application (from, among other sources, the patient's smartphone sensors and Persona IQ implant data) collected during PODs 0-90 to predict which subjects will have a "very satisfied" or "satisfied" score on the Patient Satisfaction at 42 and 90-days. Potential Sources of Data: Smartphone Agnostic (iPhone or Android).Captures Google Fit steps from Android phone (and Fitbit, if data is imported to Google Fit app in Android application) as well as HealthKit Mobility Metrics from qualified iOS devices (steps, stairs, gait speed, asymmetry, etc.). Smartphone, Smartwatch, and PIQ activity dashboards displayed in surgeon/care team dashboard (Web or Mobile) and in patient app experience (Web or Mobile). Modular functionality allows care team to select content and management feature customization.
次要结局
- Full patient clinical, mymobility platform data combined with CTE as it pertains to bearing variants at various intervals post op.(6 months)
- Full patient clinical, mymobility platform data combined with CTE data analysis for future product feature development.(6 months)