28mm Ceramic-on-Ceramic Total Hip Replacement Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prothesis System

Conditions
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Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Post-traumatic Arthritis

Intervention / Treatment
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* Device: Ceramax Acetabular System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who were previously enrolled in the COC28 IDE study, or Newly recruited individuals who are qualified based on the approved labeling of the device, and; Individuals who are willing and able to provide informed patient consent for participation in the study; Individuals who are willing and able to return for follow-up as specified by the study protocol; and Individuals who are willing and able to complete the Hip Outcomes questionnaire and SF-12 Health Survey as specified by the study protocol Exclusion Criteria: In the opinion of the Investigator, the individual does not qualify based upon approved labeling requirements.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ceramax COC 28mm Acetabular Cup<br>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<br>* 28mm Ceramic-on-ceramic Acetabular Cup System<br>* Other names: Ceramic-on-ceramic 28 mm Acetabular Cup;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship | 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%. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score | 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. | 5 years | 
| Radiographic | 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. | 5 years | 
| Survivorship | At 5 years, the secondary outcome measure will include no components removed for any reason. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total hip arthroplasty, Total hip replacement, Hip joint replacement, Hip prosthesis replacement