Tritanium® Primary Acetabular Shell Study

Ki vehet részt

• A. Patient has signed an IRB approved, study specific Informed Patient Consent Form
• B. Patient is a male or non-pregnant female age 18 years or older at time of study device implantation
• C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD)
• D. Patient is a candidate for a primary cementless total hip replacement
• E. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation

Ki nem vehet részt

• J. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days)
• K. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint
• G. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation
• I. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration
• F. Patient has a Body Mass Index (BMI) ≥ 40
• H. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device
• L. Patient has a known sensitivity to device materials
• M. Patient is a prisoner