Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant

Exclusion Criteria

• •Age less than 40 years or greater than 80 years at time of surgery
• •Patients templated to receive an acetabular component smaller than 52mm in diameter
• •Presence of a previous prosthetic hip replacement device in the hip joint to be operated
• •Previous girdlestone procedure or surgical fusion of the hip to be operated
• •Acute femoral neck fracture
• •Above knee amputation of the contralateral and/or ipsilateral leg
• •Patients with a diagnosis of inflammatory degenerative arthritis
• •Skeletally immature
• •Evidence of active infections that may spread to other areas of the body
• •The presence of a highly communicable disease that may limit follow-up
• •Presence of known active metastatic or neoplastic disease
• •Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weightbearing
• •Any previous hip surgery or conditions that may interfere with the total hip replacement's survival or outcome
• •Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or indicates difficulty to return for follow-up
• •Patient is know to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser
• •Any patient who qualifies for inclusion in the study but refuses consent to participate in the study
• •Any steroid therapy, local or systemic, within three months prior to surgery
• •Patient requiring structural bone grafts in order to support the prosthetic components or to shape the bone to receive the implants
• •Patient has known allergies to metal, e.g., jewelry
• •Any patient not meeting all radiographic and clinical parameters for inclusion