A Post Market Clinical Study Evaluating Clinical and Radiographic Outcomes of Total Knee Arthroplasty With Physica Porous KR or Physica Porous PS in Combination With Physica TT Tibial Plate in Cementless Configuration.
This clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate in combination with Physica Porous KR or Physica Porous PS up to 2 years after surgery, in order to assess the performance of the devices. Furthermore, ithe objective is to collect short-term survivorship of the implant and the incidence of early complications.
• Male or female of any race requiring a total knee replacement (TKR) and suitable for receiving Physica Porous KR or Physica Porous PS femoral component in combination with Physica TT Tibial Plate.
• Age ≥ 18 years old.
• Candidate for primary total knee replacement when clinical indications based on physical examination and medical history include one or more of the following conditions:
‣ Non-inflammatory degenerative joint disease like knee osteoarthritis, post traumatic knee arthritis
⁃ Inflammatory degenerative joint disease like rheumatoid arthritis
⁃ Any other medical reason for which the investigator deems the subject as a possible candidate for total knee replacement.
• Patient has well-preserved and well-functioning collateral ligaments and one of the following conditions:
‣ Absent or not-functioning posterior cruciate ligament and severe antero-posterior instability of the knee joint (for Physica Porous PS)
⁃ Undamaged and functional posterior cruciate ligament (for Physica Porous KR)
• Patient is able to understand the conditions of the study, to comply with the prescribed rehabilitation as well as willing to perform all scheduled follow-up visits.
• Patient signed the study-specific informed consent form approved by the ethics committee before study activities