28mm Ceramic-on-Ceramic Total Hip Replacement Study (COC28)
This study is intended to gather medium (0-5 years) and long-term (6-10 years) information regarding the performance and safety of the commercially available Ceramax™ Ceramic on Ceramic Total Hip System. This is a two-phased study consisting of a clinical follow-up phase and a clinical outcomes phase.
In Phase One (0-5 years), diagnostic, demographic and operative information will be gathered for each subject enrolled in this study. In addition, Harris Hip Evaluations, subjective evaluations and radiographs will be completed annually.
In Phase Two (6 - 10 years), a subjective outcomes questionnaire and a SF-12 Health Survey will be mailed to subjects annually.
Non-inflammatory Degenerative Joint Disease (NIDJD)
Device: Ceramax Acetabular System
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prothesis System|
- Survivorship [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]The primary outcome measure is that the 10-year Kaplan-Meier survivorship estimate of the COC 28mm implanted hips will be a minimum of 90% (as recommended by National Institute of Clinical Excellence [NICE]). Based on an anticipated margin of error (ie. one-half the width of the confidence interval) of 7%, the lower 95% confidence interval will be no worse than 83%.
- Harris Hip Score [ Time Frame: 5 years ] [ Designated as safety issue: No ]At five years, the Harris Hip Score must be 80 points or higher and the Harris Hip pain assessment must be mild or no pain.
- Radiographic [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
At 5 years, secondary radiographic outcome measures will include:
- No radiolucencies >2mm in any zone in any post-operative interval;
- No acetabular cup migration >4mm;
- No change in cup inclination angle >4 degrees when compared to immediate post-operative angle; and
- No osteolysis.
- Survivorship [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]At 5 years, the secondary outcome measure will include no components removed for any reason.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||January 2024|
|Estimated Primary Completion Date:||January 2024 (Final data collection date for primary outcome measure)|
Ceramax COC 28mm Acetabular Cup
The 28 mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper. The Pinnacle acetabular shell is a hemispherical type acetabulum replacement prosthesis, is available in a range of outer diameter (OD) sizes, and is used with a 28mm femoral head. Pinnacle 100 shells will be used in this study. The BIOLOX® delta ceramic femoral head components are manufactured from the same ceramic material as the acetabular bearing insert components. The femoral head is secured to the femoral stem component with an interlocking taper.
Device: Ceramax Acetabular System
28mm Ceramic-on-ceramic Acetabular Cup System
Other Name: Ceramic-on-ceramic 28 mm Acetabular Cup
This is a prospective, non-randomized study of the 28mm Ceramic on Ceramic (COC) device. This study will follow each subject through 10 years postoperatively and will consist of:
- a clinical follow-up phase and
- a clinical outcomes phase.
Radiographic and clinical follow-up exams will take place at six-weeks, six-months and then annually through year 5 for each subject. For years 6 - 10, a communication will be sent to each subject in order to collect survivorship and general health information. This communication will ask whether the COC device is still in vivo and, if not, when the revision surgery took place, why, and which components were removed, if applicable. In addition, subjects will be asked to complete a SF-12 Health Survey at each 6 to 10-year follow-up interval. A self-addressed, stamped envelope will be provided to facilitate information return and privacy.
|Contact: Sam Himden, BA||574-372-7231||SHimden@its.jnj.com|
|United States, Colorado|
|Colorado Joint Replacement||Recruiting|
|Denver, Colorado, United States, 80210|
|Study Director:||Sam Himden, BA||DePuy Orthopaedics|