Evaluate the Safety and Effectiveness of the Polymotion Hip Resurfacing (PHR) System Compared to Total Hip Arthroplasty

Egyéb feltételek

• In order to be eligible to participate in this study, subjects must meet all of the following criteria:
• Requires primary hip resurfacing arthroplasty due to:; non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, or; mild dysplasia/developmental dislocation of the hip (DDH) up to Crowe Grade 1
• Harris Hip Score < 70 points
• Skeletally mature, age ≥21 and <65 years
• Physically and mentally able and willing to comply with the Protocol, including the ability to read and complete required forms and willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol; Subjects who meet any of the following criteria will be excluded from participating in this study:
• Inadequate bone stock or bone quality to support the device based on a Canal-Bone Ratio (CBR-7) of >0.45.0F
• Severe osteopenia, a medical history or increased risk of severe osteoporosis or severe osteopenia, a history of fragility fracture, and other conditions that lead to increased bone resorption
• Osteonecrosis or avascular necrosis (AVN)
• Multiple cysts of the femoral head (> 1cm) or cysts crossing the head-neck junction
• Metabolic disorders which may impair bone formation (e.g., osteomalacia, osteogenesis imperfecta, parathyroid disease, rickets, etc.)
• Severe femoral head deformities that will prevent fixation of the prosthetic resurfacing femoral head
• Inflammatory arthritis such as rheumatoid arthritis (RA)
• Severe proximal femoral rotational deformity in whom appropriate combined anteversion of femoral-acetabular construct is unachievable
• Severe acetabular dysplasia/development dislocation of the hip, defined as Crowe Grade ≥ 2
• Previous surgical intervention on index hip (e.g., treatment of hip fracture, arthroscopy)
• Severe medical comorbidities, including:; severe cardiopulmonary disease,; congestive heart failure,; severe liver or kidney dysfunction,; end-stage renal disease,; severe uncontrolled diabetes,; history of IV drug use,; history of hypercoagulable state or pulmonary embolism,; severe lumbar spinal stenosis,; vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or post-operative recovery,; neuropathic arthropathy (Charcot joint),; immunosuppression or other immunodeficiency disorders, e.g., diseases such as Acquired Immune Deficiency Syndrome (AIDS) or post-organ transplant and on high doses of corticosteroids
• Incompetent or deficient soft tissue surrounding the joint (e.g., hip abductor muscle deficiency)
• BMI > 40
• Active or suspected infection in or around the hip joint
• Known or suspected metal sensitivity (e.g., jewelry) or allergy to any implant materials
• Pregnant or plan to become pregnant during the study duration
• Current smoker