A Prospective Study to Evaluate the iTotal Knee and iPoly XE Tibial Inserts

Inclusion Criteria: 1. Clinical condition included in the approved Indications For Use for the iTotal® CR 2. Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment. 3. Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits 4. \> 18 years of age Exclusion Criteria: 1. Simultaneous bilateral procedure required 2. BMI \> 40 3. Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years 4. Poorly controlled diabetes 5. Neuromuscular conditions which prevent patient from participating in study activities 6. Active local or systemic infection 7. Immunocompromised 8. Fibromyalgia or other general body pain related condition 9. Rheumatoid arthritis or other forms of inflammatory joint disease 10. Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated on, to an extent that the procedure is unjustified 11. Diagnosed with or receiving treatment for Osteoporosis 12. Other physical disability affecting the hips, spine, or contralateral knee 13. Severe instability due to advanced loss of osteochondral structure 14. Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO) 15. Compromised PCL or collateral ligament 16. Severe fixed valgus or varus deformity of \>15º 17. Extensor lag \> 15º 18. Fixed flexion contracture ≥ 15º 19. Unwilling or unable to comply with study requirements 20. Participation in another clinical study which would confound results 21. Allergy to any of the implant materials