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terminated for business reasons; study closed.
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To demonstrate the safety and efficacy of the Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System using a composite clinical success (CCS) primary endpoint.
The results from the Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System cohort will be compared to the historical results from a ceramic on ceramic (CoC) hip system cohort. The primary endpoint clinical composite success (CCS) criterion at 24 months postoperative is based on a Harris Hip Score ≥ 80 and the absence of any revision,replacement, or modification of any study component.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Large Diameter Metal on Metal | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Large Diameter Metal on Metal | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite clinical criterion | Based on Harris Hip Score ≥ 80, and absence of any revision, replacement, or modification of any study component | 24-months postoperative |
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INCLUSION CRITERIA:
Patient:
EXCLUSION CRITERIA:
Patient:
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| Name | Affiliation | Role |
|---|---|---|
| Giulia Carli | Corin Ltd | Study Director |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D010020 | Osteonecrosis |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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| 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 |