28 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement Study (NCT00208507) | Clinical Trial Compass
CompletedNot Applicable
28 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement Study
United States264 participantsStarted 2003-04-01
Plain-language summary
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.
Who can participate
Age range20 Years – 75 Years
SexALL
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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…
What they're measuring
1
Harris Hip Total Score
Timeframe: The Harris Hip Total Score evaluation took place at 6 weeks, 6 months, 12 months, and a final evaluation at 24 months or greater (up to 96 months)