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

Completed · Not applicable

Conditions studied: Non-inflammatory Degenerative Joint Disease

In brief

This study is a supplement to the 28 mm Ceramic-on-Ceramic study which was designed to evaluate artificial hips with a 28 mm ceramic head and liner to determine whether they perform as well as artificial hips with a 28 mm ceramic head and a polyethylene liner. This arm of the study is designed to compare a 36 mm ceramic head and sleeve with a subset of the control (28mm ceramic head and a polyethylene sleeve) from the original study (G030075) (NCT#00208507) with additional follow-up, to determine if they perform as well.

Key facts

Study ID

NCT00953719

Run by

DePuy Orthopaedics

People needed

243

Starts

2003-04-01

Expected to finish

2013-07-01

Last updated by the study team

2019-04-10

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.
• Surgical replacement requires the use of an acetabular liner and femoral head greater or smaller than a 36mm diameter

Where it is running

• Study site — Sacramento, California, United States
• Colorado Joint Replacement — Denver, Colorado, United States
• Study site — Winston-Salem, North Carolina, United States
• Cardinal Orthopaedic Institute — Columbus, Ohio, United States
• Study site — Alexandria, Virginia, United States

Full record on ClinicalTrials.gov

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