The primary objective of this study is to obtain long-term implant survivorship (out to 10 years) and to assess clinical, patient-reported outcome measures, and radiographic data for the commercially available Physica system. For ancillary arm, from baseline to 5-year follow-up.
Males and females of any race requiring a total knee replacement and suitable for the use of one of the configurations of the Physica system
Age> 22 (skeletally mature)
Suitable candidates for TKR who have undamaged and functional collateral ligaments
Suitable candidates for TKR with Physica KR, CR, who have an undamaged and functional posterior cruciate ligament; or Physica LMC with or without a functioning posterior cruciate ligament or Physica PS with an absent or not-functioning posterior cruciate ligament and/or severe antero-posterior instability of the knee joint
Patients with severe instability of the knee joint secondary to the absence of collateral ligament integrity and/or function
Patients with active or any suspected infection (on the affected knee or systemic)
Previous partial knee replacement (unicompartimental, bicompartimental or patellofemoral joint replacement), patellectomy, high tibial osteotomy
Patients with significant bone loss on femoral or tibial joint side
Single group
Physica Kinematic Retaining Knee System
DeviceModular total knee prosthesis with a Kinematic Retaining mechanism and posterior cruciate ligament (PCL) preservation
Physica Cruciate Retaining Knee System
DeviceTotal knee prosthesis with posterior cruciate ligament (PCL) preservation
Physica Posterior Stabilized Knee System
DeviceTotal knee prosthesis that sacrifices the posterior cruciate ligament (PCL) and replaces the functionality of the PCL with a post-cam mechanism.
Physica Cruciate Retaining Knee System with LMC Liner
DeviceTotal knee prosthesis with posterior cruciate ligament (PCL) preservation
Implant Survivorship
The primary endpoint is the definition of the implant survivorship of the study device to 10 years after the total knee replacement surgery.
American Knee Society Score (KSS) 2011
Clinical performance assessment measured by overall pain and functionality from baseline to 10-year follow-up
Patient-Reported Outcome Measures (PROMs)
Patient-Reported Outcome Measures (PROMs) including patient satisfaction achievement from baseline to 10-year follow-up
Radiographic Evaluation
• Radiographic implant evaluation and stability assessment from baseline to 10-year follow-up
Click on the lead sponsor to view all of their trials.
