Total Knee Replacement for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the long-term performance of different knee replacement systems for individuals with osteoarthritis, a condition causing joint pain and stiffness. It evaluates how well these knee implants perform over time, focusing on patient experiences and X-ray results. Participants may receive one of four knee systems, including the Physica Cruciate Retaining Knee System, each designed to meet various needs during total knee replacement surgery. Suitable candidates have osteoarthritis or similar joint issues and are considering a total knee replacement. As an unphased trial, this study offers patients the chance to contribute to valuable research that could enhance future knee replacement options.
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 coordinators or your doctor.
What prior data suggests that the Physica system is safe for total knee replacement?
Research shows that the Physica knee systems are safe and achieve high patient satisfaction. Studies on the Physica Kinematic Retaining Knee System report a 99.4% success rate, indicating that almost all implants functioned well without needing replacement. Patients experienced significant improvements in knee function and pain relief.
The Physica Cruciate Retaining Knee System and its version with an LMC Liner have demonstrated similar positive outcomes. Patients reported less pain and improved movement after receiving the implant.
Early studies on the Physica Posterior Stabilized Knee System indicate good performance, with many patients returning to activities they enjoyed before their knee issues. The research suggests these systems are well-tolerated, with no major safety concerns.
Overall, studies have positively received these treatments, and the evidence suggests they are safe options for those considering knee replacement surgery.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these Physica knee systems because they offer tailored solutions for total knee replacement in osteoarthritis patients. Unlike traditional knee implants, the Physica Cruciate Retaining (CR) System and its variant with LMC Liner are designed to preserve the knee's natural ligaments, potentially enhancing stability and function. The Physica Kinematic Retaining (KR) System aims to mimic the natural movement of the knee, providing a more natural feel for patients. Meanwhile, the Physica Posterior Stabilized (PS) System offers increased stability for those who need it. Each option provides a unique approach to addressing the specific needs of patients, potentially leading to better outcomes and greater satisfaction.
What evidence suggests that this trial's treatments could be effective for osteoarthritis?
Research shows that the different Physica knee systems studied in this trial hold promise for people with osteoarthritis. Participants may receive the Physica Cruciate Retaining Knee System, which studies reveal significantly improves knee function, leading to better patient outcomes. Another option is the Physica Kinematic Retaining Knee System, which also demonstrates impressive improvements and a 99.4% success rate, indicating that most implants last long without needing replacement. Participants may also receive the Physica Posterior Stabilized Knee System, for which results indicate good patient-reported outcomes and functional performance. Overall, these systems receive positive feedback for enhancing knee function and patient satisfaction.12467
Who Is on the Research Team?
Fabiana Pavan
Principal Investigator
Limacorporate S.p.a
Are You a Good Fit for This Trial?
This trial is for adults over 22 with knee issues like osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or deformities needing a total knee replacement. Candidates must be able to follow the study's rehab program and attend all visits. Exclusions include poor bone quality, active infections, certain past surgeries or conditions affecting bone health, pregnancy, and severe instability of the knee.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Subjects are implanted with one of the configurations of the Physica system: Physica KR, Physica CR, or Physica PS
Follow-up
Participants are monitored for implant survivorship, clinical performance, and patient-reported outcomes
Ancillary Follow-up
Ancillary subgroup follow-up for clinical and radiographic assessments
What Are the Treatments Tested in This Trial?
Interventions
- Physica Cruciate Retaining Knee System
- Physica Cruciate Retaining Knee System with LMC Liner
- Physica Kinematic Retaining Knee System
- Physica Posterior Stabilized Knee System
Physica Cruciate Retaining Knee System is already approved in European Union, United States, Canada for the following indications:
- Primary osteoarthritis
- Post-traumatic arthritis
- Rheumatoid arthritis
- Degenerative joint disease
- Post-traumatic arthritis
- Rheumatoid arthritis
- Primary osteoarthritis
- Post-traumatic arthritis
- Rheumatoid arthritis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Limacorporate S.p.a
Lead Sponsor