28 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement Study

Completed · Not applicable

Conditions studied: Joint Diseases

In brief

The study is designed to evaluate artificial hips with a 28 mm ceramic head and a ceramic liner to determine whether they perform as well as artificial hips with a 28 mm ceramic head and a polyethylene liner.

Key facts

Study ID

NCT00208507

Run by

DePuy Orthopaedics

People needed

264

Starts

2003-04-01

Expected to finish

2012-01-05

Last updated by the study team

2023-11-07

Who can join

Age: 20 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Colorado Joint Replacement — Denver, Colorado, United States
• Cardinal Orthopaedic Institute — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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