36 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement

This is an interventional treatment trial for Non-inflammatory Degenerative Joint Disease focused on measuring Hip arthroplasty, Acetabular cup, Ceramic-on-polyethylene Read More

Inclusion Criteria:

• Non-inflammatory degenerative joint disease. Composite diagnoses of NIDJD include osteoarthritis, avascular necrosis, post-traumatic arthritis, slipped capital femoral epiphysis (SCFE), fracture of the pelvis, and developmental dysplasia.
• X-ray evaluation confirms the presence of NIDJD
• Femoral and acetabular bone stock is sufficient, regarding strength and shape, and is suitable to receive the implants.
• Individuals 20 to 75 years of age at the time of surgery
• Patients with a previous total hip replacement of the contralateral leg who have a pain rating of none or slight and who are at least one year post arthroplasty are eligible for participation in the study.
• Harris Hip Score of 70 or lower
• Pain at least Moderate

Exclusion Criteria:

• Presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the hip joint to be operated.
• Previous Girdlestone procedure (resection arthroplasty) 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 bilateral degenerative joint disease requiring staged or simultaneous hip replacements.
• Patients with an existing total hip arthroplasty in the contralateral hip with a Harris Hip pain rating of mild, moderate, marked or totally disabled.
• Patients who have undergone total hip arthroplasties in their contralateral hips within the past 12 months.
• Patients with a known allergy to metal (e.g. jewelry).
• Skeletally immature patients (tibial and femoral epiphyses are not closed).
• Evidence of active infections that may spread to other areas of the body (e.g., osteomyelitis, pyogenic infection of the hip joint, overt infection, urinary tract infection, etc.).
• The presence of highly communicable disease or diseases that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.).
• Presence of known metastatic or neoplastic disease.
• Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weight bearing, (e.g., muscular dystrophy, multiple sclerosis).
• Conditions that may interfere with the total hip arthroplasty's survival or outcome, (e.g., Paget's disease, Charcot's disease).
• Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or who indicates difficulty or inability to return for follow-up visits prescribed by the study protocol.
• Patient is known to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser.
• Any systemic steroid therapy, excluding inhalers, within three months prior to surgery.
• Patients carrying the diagnosis of inflammatory degenerative arthritis (IDJD) to include the following composite diagnoses: rheumatoid arthritis, systemic lupus erythematosus, pigmented villonodular synovitis, juvenile rheumatory arthritis and other arthritic processes of inflammatory or autoimmune etiology.
• Patients requiring structural bone grafts in order to support the prosthetic component(s) or to shape the bone to receive the implant(s).
• Patients who refuse to provide consent to participate in the clinical investigation.
• Surgical replacement requires the use of an acetabular liner and femoral head greater or smaller than a 36mm diameter