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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational | Experimental | CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell. |
|
| Control Device | Active Comparator | Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alumina/Alumina | Device | CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alumina/Alumina articulation will perform as well as the alumina/polyethylene. | 5 year |
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Inclusion Criteria:
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:
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
Conditions that place excessive demands on the implant
Greater than or equal to 70 on preoperative HHS score
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mark Newman, Inc. | Newport Beach | California | 92663 | United States | ||
| Charleston Orthopaedic Assoc. |
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| Label | URL |
|---|---|
| Sponsor company home page | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 8, 2021 | |
| Reset | Mar 31, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 8, 2021 | Mar 31, 2021 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D012015 | Reference Standards |
| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| D008919 | Investigative Techniques |
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| Standard | Device | Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head |
|
| Charleston |
| South Carolina |
| 29414 |
| United States |
| Advanced Orthopaedic Centers | Richmond | Virginia | 23294 | United States |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |