Non-inflammatory Degenerative Joint Disease Clinical Trial
Official title:
Delta Ceramax 36 mm Ceramic-on-Ceramic Acetabular Cup Prosthesis Study
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.
Total Hip Arthroplasty (THA) is the surgical reconstruction of the hip joint through
replacement of the femoral head and the acetabular articulating surfaces with fixed
prosthetic devices. The goals of THA are relief from pain, restoration of function, and
correction of deformity. THA is one of the most common adult reconstructive procedures. Over
the past 25 years, patients who have needed to have their hip joint replaced, either due to
trauma or arthritic disease, typically have had their hip joint bone articular surfaces
replaced with a metal hip stem, metal ball head (either stainless steel or chrome cobalt) and
a plastic acetabular cup (metal/metal/plastic). While the basic device has remained
essentially unchanged over that period, technological advancements in implant designs and
materials, and improvements in surgical technique and instrumentation have made THA one of
the most durable and successful procedures in medicine. Reproducible, high-quality,
short-term and mid-term results are attained regularly, and total hip replacements commonly
last 10 to 15 years and longer. The success of this procedure has allowed its expansion into
a wider, and often younger and more active population.
In spite of the improvements in THA, little change has occurred for the acetabular cup liner,
which is usually made out of Ultra High Molecular Weight Polyethylene plastic (UHMWPe).
Because it is plastic and inherently soft and somewhat pliable under load, the cup's
articular surface must inevitability wear and produce debris. This biologic response is now
thought to be a significant contributor to prosthetic component loosening, a primary failure
mode of THR. UHMWPe also degrades with time in the body. As concerns about polyethylene wear
and the associated untoward effects of the generated wear debris, and as THA continues to be
used in younger and higher-demand patients with increasing life expectancies, interest in
ceramic on ceramic total hip prosthesis has been renewed.
An alumina ceramic-on-ceramic acetabular coupling has been employed as an alternative to
metal/polyethylene couplings. This ceramic-on-ceramic coupling has many advantages, including
the elimination of polyethylene from the device system, wear rates that are appreciably less
than those experienced with metal/polyethylene couplings and reduced biologic reactivity. The
potential benefits of an alumina ceramic/ceramic bearing are significant.
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