Because this is an FDA trial, I will be more restrictive and not admit patients who have complex cases or who have risk factors that I believe may increase the risk of failure. As soon as the implant is approved (in about 4 years) and I have learned more about the way this implant performs, I will ease these restrictions. The overriding goal at this point is to have excellent 2-year outcomes to assure FDA approval.

Summary of contraindications:

• Weak bone (DEXA T-score <-1.5)
• BMI>35
• Age > 64, Medicare insurance
• Osteonecrosis
• Moderate-severe dysplasia
• Legg-Perthes
• Large head or socket bone defects
• Patients with minor objective arthritis on XR (higher risk of dissatisfaction with a surgical outcome)
• Severe medical comorbidities