A Study to Evaluate the Conformis iTotal Identity Knee Replacement System

Exclusion Criteria

• •Simultaneous bilateral procedure required
• •BMI \> 40
• •Active malignancy (defined as a history of any invasive malignancy - except nonmelanoma skin cancer), unless subject has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
• •Poorly controlled diabetes (defined as HbA1c \>7 or Investigator discretion)
• •Neuromuscular conditions which prevent subject from participating in study activities
• •Active local or systemic infection which precludes TKR procedure
• •Immunocompromised in the opinion of the Investigator
• •Medically diagnosed fibromyalgia or similar conditions that might impact the subject's ability to differentiate source of pain
• •Rheumatoid arthritis or other forms of inflammatory joint disease
• •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
• •Diagnosed with or receiving treatment for osteoporosis that is likely to confound results in the opinion of the Investigator
• •Other physical disability affecting the hips, spine, or contralateral knee that is likely to confound results in the opinion of the Investigator
• •Severe instability due to advanced loss of osteochondral structure
• •Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO)
• •Compromised PCL or collateral ligament
• •Severe fixed valgus or varus deformity of \>15º
• •Extensor lag \> 15º
• •Fixed flexion contracture ≥ 15º
• •Unwilling or unable to comply with study requirements
• •Participation in another clinical study which would confound results
• •Allergy to any of the implant materials
• •Pregnant or planning to become pregnant prior to study TKR procedure (in case of pregnancy after study TKR procedure, eligibility to continue with the protocol will be reviewed)