Titanium Knee Implant for Knee Arthritis
(TKA Trial)
Trial Summary
What is the purpose of this trial?
This trial evaluates the safety and effectiveness of the Persona Ti-Nidium implant in patients needing knee replacement surgery. The implant aims to improve movement and reduce pain by replacing damaged knee parts with an artificial joint. The study will follow patients for several years to assess long-term outcomes. The Persona® system is a newly launched implant designed for total knee replacement with innovations intended for better function and higher flexibility.
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 study team or your doctor.
What data supports the effectiveness of the Titanium Knee Implant for Knee Arthritis treatment?
Research shows that the Persona knee implant system, which is part of the Zimmer Biomet Persona Ti-Nidium Total Knee System, has promising outcomes. Studies report good patient satisfaction and implant durability up to five years after surgery, indicating its effectiveness in improving knee function and quality of life for patients with knee arthritis.12345
Is the Titanium Knee Implant (Zimmer Biomet Persona Ti-Nidium Total Knee System) safe for humans?
How does the Zimmer Biomet Persona Ti-Nidium Total Knee System treatment differ from other treatments for knee arthritis?
Research Team
Hillary Overholser
Principal Investigator
Zimmer Biomet Assoc Director
Eligibility Criteria
This trial is for adults with various knee conditions like osteoarthritis, rheumatoid arthritis, and chronic knee pain who need a total knee replacement. Participants must be able to consent and follow the study's procedures. Those with mental conditions affecting treatment adherence or at high risk as determined by the investigator are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Evaluation
Participants undergo preoperative clinical evaluations prior to their total knee arthroplasty
Treatment
Participants receive the Persona Ti-Nidium Total Knee System during total knee arthroplasty
Follow-up
Participants are monitored for safety and effectiveness after treatment with follow-up visits at Early Post-op, 6 months, 1 year, 2, 3, 5, 7, and 10 years post-operatively
Treatment Details
Interventions
- Zimmer Biomet Persona Ti-Nidium Total Knee System
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