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
Limacorporate S.p.a
Lead sponsor