Clinical Study Evaluating the Outcomes of a New Knee System with a Physiological Rollback Mechanism

Exclusion Criteria

• •1. Obese patients with BMI above 35 kg/m2 (severe obesity)
• •2. Previous partial knee replacement (unilateral, bicompartimental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or femoral osteotomy in the affected knee
• •3. Primary Total Knee Replacement (TKR) in the affected knee
• •4. Varus or Valgus deformity greater than 20°
• •5. Patients with a fixed flexion contracture greater than 10°
• •6. Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS\< 70 points
• •7. Patients with symptomatic OA of the hips, spine, ankles, if it can interfere with the evaluation of the target knee
• •8. Patients with active or any suspected infection (on the affected knee or systemic)
• •9. Muscular insufficiency or absence of muscoligamentous supporting structures required for adequate soft tissue balance
• •10. Patients with known or suspicious metal hypersensitivity
• •11. Recurrent medical history of severe allergic or immune-mediated reactions
• •12. Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation
• •13. Current treatment or treatment within the previous 2 years before the screening visit for malignant and life-threatening non-malignant disorders
• •14. Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation
• •15. Any intercurrent chronic disease or condition that may interfere with the completion of the 5-year follow-up, such as liver disease, severe coronary disease, alcohol or drug abuse, disordered mental state, or other clinically significant condition
• •16. Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation
• •17. Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device
• •18. Patients with systemic or metabolic disorders leading to progressive bone deterioration
• •19. Patients who have a medical condition with less 5 years of life expectancy
• •20. Previous organ transplant surgery
• •21. Any psychiatric illness that would prevent comprehension of the details and nature of the study
• •22. Participation in any experimental drug/device study within the 6 months prior to the screening visit
• •23. Female patients who are pregnant, nursing, or planning a pregnancy