36 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement
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.
|Non-inflammatory Degenerative Joint Disease||Device: 36 mm ceramic head on a ceramic acetabular liner Device: 28 mm ceramic head on a polyethylene acetabular liner|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Delta Ceramax 36 mm Ceramic-on-Ceramic Acetabular Cup Prosthesis Study|
- Total Harris Hip Score [ Time Frame: At final follow-up visit, 24 months or later, up to 72 months ]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. The Total Harris Hip Score is a sum of its subscores (Pain, Function, Activities, Deformity, and Range of Motion).
- Harris Hip Subscale Score: Pain [ Time Frame: At final follow-up visit, 24 months or later, up to 72 months ]The Harris Hip's pain subscale is a numeric value from 0 to 44. A lower score indicates more pain; a score of 44 indicates no pain.
- Harris Hip Subscale Score: Function [ Time Frame: At final follow-up visit, 24 months or later, up to 72 months ]The Harris Hip's function subscale is a numeric value from 0 to 33. A lower score indicates less function; a score of 33 indicates no limitations in function level.
- Harris Hip Subscale Score: Activities [ Time Frame: At final follow-up visit, 24 months or later, up to 72 months ]The Harris Hip's Activities subscale is a numeric value from 0 to 14. A lower score indicates a lower ability to perform daily activities; a score of 14 indicates no limitations in daily activities.
- Harris Hip Subscale Score: Deformity [ Time Frame: At final follow-up visit, 24 months or later, up to 72 months ]The Harris Hip's Deformity subscale is a numeric value from 0 to 4. A lower score indicates more deformity; a score of 4 indicates no deformity.
- Harris Hip Subscale Score: Range of Motion [ Time Frame: At final follow-up visit, 24 months or later, up to 72 months ]The Harris Hip's Range of Motion subscale is a numeric value from 0 to 5. A lower score indicates a lower range of motion; a score of 5 indicates full range of motion.
- Harris Hip Score Longitudinal Analysis [ Time Frame: 6 week, 6 month, 12 month, 24 month, 36 month, and 48 months post-operatively ]The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon, with a range of 0 to 100. Lower scores indicate a worse outcome and a score of 100 is the best possible outcome. Longitudinal analysis (repeated measures) was performed to compare post-operative Harris Hip sores over time.
- Proportion of Composite Successes [ Time Frame: At final follow-up visit, 24 months or later, up to 72 months ]A subject was deemed to be a composite success at 24 months or greater if at the time of last clinical follow-up there had not been a revision of any THA components, the latest Harris Hip score was 80 or greater, and on the latest radiographic evaluation there were no radiolucencies greater than 2mm, no evidence of acetabular migration greater than 4mm, no change in acetabular shell inclination angle greater than 4 degrees, and no osteolysis.
|Study Start Date:||April 2003|
|Study Completion Date:||July 2013|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 36 mm
36 mm ceramic head on ceramic acetabular liner
Device: 36 mm ceramic head on a ceramic acetabular liner
Total hip replacement with a 36 mm ceramic head on a ceramic liner
Other Name: Delta Ceramax head on a ceramic liner.
28 mm ceramic-on-polyethylene
28 mm ceramic-on-polyethylene historical control
Device: 28 mm ceramic head on a polyethylene acetabular liner
Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
Other Name: Delta Ceramax head on a polyethylene liner
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953719
|United States, California|
|Sacramento, California, United States, 95816|
|United States, Colorado|
|Colorado Joint Replacement|
|Denver, Colorado, United States, 80210|
|United States, North Carolina|
|Winston-Salem, North Carolina, United States, 27103|
|United States, Ohio|
|Cardinal Orthopaedic Institute|
|Columbus, Ohio, United States, 43213|
|United States, Virginia|
|Alexandria, Virginia, United States, 22306|
|Principal Investigator:||Joel Politi, MD||Cardinal Orthopaedic Institute|
|Principal Investigator:||Douglas Dennis, MD||Colorado Joint Replacement|