CompletedNot Applicable

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

United States243 participantsStarted 2003-04-01

Plain-language summary

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.

Who can participate

Age range

20 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 withi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total Harris Hip Score

Timeframe: At final follow-up visit, 24 months or later, up to 72 months

Trial details

NCT IDNCT00953719

SponsorDePuy Orthopaedics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-08-01

Results submitted2014-05-13

View on ClinicalTrials.gov More Non-inflammatory Degenerative Joint Disease trials