Persona IQ for Total Knee Replacement
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new knee implant that uses smart technology to track recovery after surgery. The goal is to determine how effectively this implant relieves pain and restores function for those needing a knee replacement. Participants will use the mymobility app to send data, aiding doctors in understanding recovery patterns. This study suits individuals with a smartphone who are scheduled for a knee replacement with the Persona IQ system. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to the development of a potentially groundbreaking treatment.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.
What prior data suggests that the Persona IQ The Smart Knee is safe?
Research shows that the Persona IQ Personalized Knee System is a new type of smart knee implant. The FDA has approved it for use in total knee replacement surgeries, indicating it has undergone careful safety testing in people. The implant contains sensors that monitor knee movement, enabling doctors to track recovery remotely.
As an approved device, it meets specific safety standards. Although sources do not detail specific side effects or problems, FDA approval suggests it is generally safe for patients. However, patients should always discuss any concerns with their healthcare provider to ensure it is the right choice.12345Why are researchers excited about this trial?
Researchers are excited about the Persona IQ Personalized Knee System because it integrates advanced sensor technology directly into the knee implant. Unlike traditional knee replacements that primarily focus on structural support, Persona IQ provides real-time data on the knee's functionality, helping both patients and doctors monitor recovery and performance more closely. This innovative approach aims to improve post-surgery outcomes by offering personalized insights and potentially enhancing rehabilitation strategies.
What evidence suggests that the Persona IQ The Smart Knee is effective for post-operative recovery?
Studies have shown that the Persona IQ Knee implant, which participants in this trial may receive, is safe and effective, with positive results up to two years post-surgery. Sensors in the implant track key movement details, such as step count, knee range of motion, and walking speed. This data helps doctors assess knee performance and detect any issues early. Research also indicates that recipients report improved well-being and mobility after receiving the implant. Overall, this smart knee implant provides valuable information that can enhance recovery and knee function.16789
Who Is on the Research Team?
Erin Osborn
Principal Investigator
Zimmer Biomet
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo primary total knee arthroplasty/replacement (TKA/TKR) and are monitored using the Persona IQ Personalized Knee System with mymobility platform
Follow-up
Participants are monitored for safety and effectiveness after treatment, with data collection continuing for up to 1 year
Data Analysis and Reporting
Data collected is analyzed for clinical outcomes, patient satisfaction, and device usability
What Are the Treatments Tested in This Trial?
Interventions
- Persona IQ
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Zimmer Biomet
Lead Sponsor
Dr. Nitin Goyal
Zimmer Biomet
Chief Medical Officer since 2021
MD from Harvard Medical School
Ivan Tornos
Zimmer Biomet
Chief Executive Officer since 2023
MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business
Citations
Persona IQ® – Zimmer Biomet | Remote Patient Monitoring
Persona IQ is a first-to-world smart knee implant that captures patient-specific gait and range of motion metrics during the course of patient monitoring.
Study Details | NCT06089291 | Persona IQ Cohort Study
The study objective is to assess the seven kinematic metrics (step count, functional knee ROM, tibial ROM, distance walked, walking speed, cadence and stride ...
Patient reported outcomes and implant survivorship after ...
The Persona Knee implant is safe and effective and the clinical results up to two years after surgery are promising. PROMs results are very good ...
Patient reported outcomes do not correlate to functional ...
130 patients (75 female) received Persona IQ TKA (Zimmer Biomet, Warsaw, IN, USA) which includes a stem extension with embedded accelerometer and gyroscope.
Zimmer Biomet's Persona IQ Smart Knee
The Smart Knee™ implant offers patients and their healthcare team real-time insight into the knee's performance, highlighting potential issues even before ...
Study Details | NCT06089291 | Persona IQ Cohort Study
The study objective is to assess the seven kinematic metrics (step count, functional knee ROM, tibial ROM, distance walked, walking speed, cadence and stride ...
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hipandkneepittsburgh.com
hipandkneepittsburgh.com/smart-knee-implant-orthopaedic-hip-knee-replacement-surgeon-pittsburgh-pa/Smart Knee Implant (Persona IQ®) Pittsburgh, PA
Zimmer Biomet's Persona IQ smart knee implant is an innovative, FDA-approved medical device employed in total knee replacement surgery.
8.
zimmerbiomet.com
zimmerbiomet.com/content/dam/zb-corporate/en/patients/knee/persona-iq/3541.6-US-en%20Persona%20IQ%20Patient%20Brochure.Final.pdfA SmarterWay to Regain Mobility1,2*
This stem contains sensors that capture motion data allowing your surgeon and care team to monitor your knee's function after surgery. Your Persona IQ implant ...
9.
cabellhuntington.org
cabellhuntington.org/services/orthopedics/joint-replacement/smart-knee-implantSmart Knee Implant
The information collected by Persona IQ allows your physician to remotely view your knee data throughout your recovery. Through the latest implant technology, ...
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