A Multicenter Study to Evaluate Functional Outcome After Knee Replacement

For people ages 18 years and up

Inclusion:

• Clinical condition included in the approved Indications For Use for the iTotal CR
• 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
• Willingness to participate in the clinical study, to give informed consent and to attend all follow-up visits
• > 18 years of age

Exclusion:

• Subject will require a simultaneous bilateral procedure
• Other lower extremity surgery within 1 year
• Severe (> 15º) fixed valgus or varus deformity
• Severe (> 15º) extension deficit
• Severe instability due to advanced loss of osteochondral structure
• Loss of bone or musculature, osteoporosis, neuromuscular or vascular compromise in the area of the joint to be operated on to an extent that the procedure is unjustified
• Insufficient bone stock on the femoral or tibial surfaces
• Contralateral knee replacement surgery within the past 6 months
• BMI > 40
• 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
• Poorly controlled diabetes (defined as HbA1c >7 or surgeon discretion)
• Immunocompromised
• Other physical disability affecting the hips, spine, or contralateral knee that limits function
• Disabling chronic pain with narcotic dependence
• Compromised PCL or collateral ligament
• Prior history of failed implant surgery of the joint to be treated, including Unicompartmental Knee Arthroplasty (UKA), or Bicompartmental Knee Arthroplasty (BKA)
• Prior history of failed high tibial osteotomy (HTO)
• Participation in another clinical study which would confound results
• Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons