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| ID | Type | Description | Link |
|---|---|---|---|
| P050009 | Other Identifier | FDA |
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The objective of this study is to gather clinical and survivorship information for the C2a-Taperâ„¢ Acetabular System, a ceramic-on-ceramic hip articulating system.
Study Design:
Phase 1
Sites will collect the following types of data:
Clinical-Total Harris Hip Score, Radiographic Evaluation- measurements on acetabular and femoral components Survivorship-removal/revision of one or more components (i.e. liner, head, shell and/or stem) Safety- All other adverse events
Follow-up Visit schedule
Phase 2:
Patients continue to be followed on an annual basis (Years 6-10) via mail. A self assessment form is sent directly to the subject on an annual basis starting in the 6th post-operative year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C2a Taper recipients | Patients who receive a THA with the C2a - Taperâ„¢ Acetabular System |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C2a - Taperâ„¢ Acetabular System | Device | The C2a-Taperâ„¢ Acetabular System is a ceramic on ceramic hip articulating system. The bearing surfaces consist of ceramic femoral heads and acetabular liners. |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score, Radiographic Evaluation | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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Multi-Center study conducted in the United states on patients who meed the inclusion / exclusion criteria identified in the protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Kara Mezger | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physician's Clinic of Iowa, PCI | Cedar Rapids | Iowa | 52401 | United States | ||
| Lexington Clinic |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| D006618 | Hip Dislocation, Congenital |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Lexington |
| Kentucky |
| 40504 |
| United States |
| D001847 |
| Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000082602 | Developmental Dysplasia of the Hip |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |