Total Knee Arthroplasty for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the safety and effectiveness of a specific knee implant for individuals undergoing total knee arthroplasty (also known as total knee replacement surgery). It tests various methods of attaching the implant, either with or without cement. Those considering knee replacement surgery due to issues like arthritis or previous surgical failures might be suitable candidates. Participants will aid researchers in understanding the benefits and performance of these implants in real-world scenarios. As a Phase 3 trial, this is the final step before FDA approval, providing participants an opportunity to contribute to the validation 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 implant and its instrumentation are safe for primary total knee arthroplasty?
Studies have shown that both cementless and cemented total knee replacements are similarly safe. Research indicates that cementless knee replacements provide strong, long-lasting results, with patients reporting outcomes similar to those with cemented replacements. However, recovery may be slower with cementless options. In contrast, cemented knee replacements carry a slightly higher risk of bone loss around the implant.
Short-term studies reveal that a combination of cementless parts in the knee is as safe and functional as cemented ones. Overall, both types of knee replacements are generally well-tolerated, with differences mainly in recovery time and specific risks.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the Persona OsseoTi Keel compatibility study because it explores innovative approaches to total knee arthroplasty (TKA) that could enhance patient outcomes. Unlike traditional knee replacements that often rely on cemented components for stability, this study investigates the use of cementless technology, which allows the bone to grow directly onto the implant, potentially leading to a more natural integration and longer-lasting joint. This method could reduce complications associated with cement, such as loosening over time, and promote quicker recovery. By examining different configurations of cementless and cemented options for the femur, tibia, and patella, researchers aim to pinpoint the most effective combination for improving the longevity and function of knee replacements.
What evidence suggests that this trial's treatments could be effective for total knee arthroplasty?
This trial will compare different methods of total knee replacement, including cemented and cementless approaches. Research has shown that both methods are highly effective. Cementless knee replacements, which allow bone to grow into the implant, have demonstrated long-term success and often result in quicker surgeries. Cemented knee replacements have been the standard for many years, with proven long-term success. While debate continues about which method is superior, both are effective. Some studies suggest that cementless implants might lead to a slower recovery in the initial months after surgery, but the long-term outcomes remain positive.26789
Who Is on the Research Team?
Hillary Overholser
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
Preoperative Evaluation
Participants undergo preoperative clinical evaluations prior to their total knee arthroplasty
Treatment
Participants receive the Persona Total Knee System during total knee arthroplasty
Follow-up
Participants are monitored for safety, performance, and clinical benefits of the Persona implant
What Are the Treatments Tested in This Trial?
Interventions
- Total Knee Arthroplasty
Total Knee Arthroplasty is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle
- Severe knee pain and disability due to degenerative joint disease, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle
- Severe knee pain and disability due to degenerative joint disease, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle
- Severe knee pain and disability due to degenerative joint disease, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle
- Severe knee pain and disability due to degenerative joint disease, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle
- Severe knee pain and disability due to degenerative joint disease, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle
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