Physica TT Tibial Plate Follow up Study

Exclusion Criteria22

• Severe instability of the knee joint secondary to the absence of collateral ligament integrity and/or function. Only for Physica Porous KR: important joint instability and deficiency of posterior cruciate ligament.
• Any active or suspected infection (local or systemic) or previous history of infection that may affect the prosthetic joint.
• Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy.
• Significant bone loss on femoral or tibial joint side.
• Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course.
• Known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials.
• Septicaemia.
• Persistent acute or chronic osteomyelitis.
• Open epiphyses (immature patient with active bone growth).
• Necrotic bone
• Arterial vascular insufficiency or nerve diseases of the lower limbs severe enough to interfere with the study evaluation.
• Compromised bone stock due to disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis.
• Systemic or metabolic disorders leading to progressive bone deterioration, which may impair fixation and stability of the implant.
• Any concomitant disease and dependency that might affect the performance of the implanted prosthesis.
• Any clinically major pathology based on clinical medical history or any medical intervention or reason that the Investigator feels may affect the study evaluation.
• Neurological or musculoskeletal disorder or disease that may adversely affect gait, functional recovery and evaluation.
• Neuromuscular or neurosensory deficit that would hamper the performance assessment of the device.
• Any psychiatric illness that would prevent comprehension of the details and nature of the study.
• Simultaneously taking part in another surgical intervention study or pain management study that may affect with clinical study outcomes.
• Female patient who is pregnant, nursing, or planning a pregnancy.
• Important osteoporosis, haemophilic disease.
• Internistic problems with high risk for surgery.