Cementless Alumina-Alumina Total Hip and Hybrid

Study Overview
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Brief Summary
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Evaluate the safety and efficacy of the CeramTec Acetabular Alumina Insert and CeramTec Alumina head when used with the Foundation Porous Coated Acetabular Shell and an Encore hip stem.

Official Title
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Keramos Ceramic/Ceramic Total Hip System

Conditions
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Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Avascular Necrosis

Intervention / Treatment
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* Device: Alumina/Alumina
* Device: Standard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with inflammatory tissue disorders (e.g. rheumatoid arthritis, lupus, etc), osteoarthritis, post-traumatic arthritis or secondary arthritis, or avascular necrosis. Less than 70 on preoperative HHS score Primary total hip replacement Patient is likely to be available for evaluation for the duration of the study. Exclusion Criteria: Patients with physical conditions that would eliminate adequate implant support or prevent the use of an appropriately sized implant (e.g., tumor) Previous surgery that has adversely affected bone stock (such as some hip pinning or some osteotomies) or prior total hip replacement. Insufficient quality or quantity of bone resulting from conditions such as: Cancer, where radiation has destroyed the available bonestock Congenital dislocation Metabolic bone disease of the upper femur or pelvis Femoral osteotomy revision Girdlestone revision Active infection of the hip joint Old or remote infection Other conditions that lead to inadequate skeletal fixation Neurological conditions that might hinder patient's ability to follow study procedures, e.g., to restrict physical activities (e.g., Severe Parkinson's, CVA on affected side) Patient's mental condition that may interfere with his ability to give an informed consent or willingness to fulfill the required follow-up of the study Mental illness Senility Drug Abuse Alcoholism Conditions that place excessive demands on the implant Charcot's joints Muscle deficiencies Multiple joint disabilities Refusal to modify postoperative physical activities Skeletal immaturity Obesity (50% over recorded body weight mass index) Greater than or equal to 70 on preoperative HHS score

Ages Eligible for Study
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Minimum Age: 18 Years

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational<br>CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell. | Device: Alumina/Alumina<br>* CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell<br>|
| Active Comparator: Control Device<br>Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head. | Device: Standard<br>* Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alumina/Alumina articulation will perform as well as the alumina/polyethylene. |  | 5 year |