A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System

Exclusion Criteria

• •Simultaneous bilateral procedure required
• •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
• •Neuromuscular conditions which prevent patient from participating in study activities
• •Active local or systemic infection
• •Immunocompromised
• •Fibromyalgia or other general body pain related condition
• •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 to an extent that the procedure is unjustified
• •Diagnosed with or receiving treatment for Osteoporosis
• •Other physical disability affecting the hips, spine, or contralateral knee.
• •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 \> 15 º
• •Fixed flexion contracture ≥ 15 º
• •Unwilling or unable to comply with study requirements
• •Participation in another clinical study which would confound results
• •Allergy to any of the implant materials