28 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement Study
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|ClinicalTrials.gov Identifier: NCT00208507|
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : February 16, 2011
Last Update Posted : January 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Joint Diseases||Device: 28 mm ceramic head on ceramic acetabular liner. Device: 28 mm ceramic head on polyethylene liner||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||264 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis Study (28mm)|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||December 2010|
Active Comparator: Delta Ceramax Ceramic-on-Ceramic Acetabular Cup System
Total hip replacement with a 28 mm ceramic head and liner.
Device: 28 mm ceramic head on ceramic acetabular liner.
Total hip replacement with 28 mm ceramic head on ceramic liner articulation
Other Name: Delta Ceramax™ 28 mm Ceramic-on-Ceramic Acetabular Cup
Active Comparator: Pinnacle™ Acetabular Cup with Marathon® Polyethylene
Total hip replacement with 28 mm ceramic head with a polyethylene liner.
Device: 28 mm ceramic head on polyethylene liner
Total hip replacement with 28 mm ceramic head on a polyethylene liner articulation.
Other Name: Detla Ceramax 28 mm ceramic femoral head and Marathon polyethylene liner.
- Harris Hip Total Score [ Time Frame: 6 weeks, 6, 12 months and last follow up at 24 months or greater ]The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored.
- Complication Rates [ Time Frame: On-going to end of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208507
|United States, Colorado|
|Colorado Joint Replacement|
|Denver, Colorado, United States, 80210|
|United States, Ohio|
|Cardinal Orthopaedic Institute|
|Columbus, Ohio, United States, 43213|
|Principal Investigator:||Joel Politi, MD||Cardinal Orthopaedic Institute|
|Principal Investigator:||Douglas Dennis, MD||Colorado Joint Replacement|