Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components

Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components

MicroPort Orthopedics (MPO) is conducting this study to investigate the primary stability of its PROFEMUR® Preserve Femoral Components using radiostereometric analysis (RSA). RSA allows precise measurement of micromotion around orthopedic implants and hence, may estimate long-term fixation to bone.

Inclusion Criteria:

• Subject is a candidate for primary THA for osteoarthritis
• Subject is able to undergo primary THA procedure
• Subject is a candidate to be implanted with the specified combination of components
• Subject is willing and able to complete required study visits and assessments
• Subject is willing to sign the approved Informed Consent document

Exclusion Criteria:

• Subject has any of the following contraindications at the time of the implantation:
• Overt infection;
• Distant foci of infections (which may cause hematogenous spread to the implant site);
• Rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram;
• Skeletally immature (less than 21 years of age at time of surgery);
• Inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable;
• Subjects 76 years of age or older
• Subjects with post-traumatic arthritis in the affected hip
• Subjects with rheumatoid arthritis in the affected hip
• Subjects with hip dysplasia in the affected hip
• Subjects with prior arthroplasty of the affected hip
• Subjects that are morbidly obese (BMI > 35)
• Subjects that are immuno-suppressed
• Subjects with known or tested-positive allergy to metals
• Subjects currently enrolled in another clinical investigation which could affect the endpoints of this protocol
• Subjects unwilling or unable to sign the Informed Consent document
• Subjects with substance abuse issues
• Subjects who are incarcerated or have pending incarceration