Study of the ConforMIS iDuo(R) G2

Exclusion Criteria

• •1. BMI \> 40
• •2. 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
• •3. Poorly controlled diabetes
• •4. Neuromuscular conditions which prevent patient from participating in study activities
• •5. Active local or systemic infection
• •6. Immunocompromised
• •7. Fibromyalgia or other general body pain related condition
• •8. Rheumatoid arthritis or other forms of inflammatory joint disease
• •9. 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
• •10. Diagnosed or receiving treatment for Osteoporosis
• •11. Other physical disability affecting the hips, spine, or contralateral knee
• •12. Severe instability due to advanced loss of osteochondral structure
• •13. Prior arthroplasty of the affected knee
• •14. Compromised ACL, PCL or collateral ligament
• •15. Severe fixed valgus or varus deformity of \>15º
• •16. Extensor lag \> 15 º
• •17. Fixed flexion contracture ≥ 10 º
• •18. Prior history of failed implant surgery of the joint to be treated, including high tibial osteotomy (HTO)
• •19. Unwilling or unable to comply with study requirements
• •20. Participation in another clinical study which would confound results
• •21. If during intra-op, it is noted that the patient has tri-compartmental disease, then the patient is considered a screen fail