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The purpose of this study is to evaluate early fixation and stability of the Tritanium cup. It is expected that the Tritanium® cup will be equal to or better than conventional cementless cups in early fixation/stability and meet the expectations of Japanese surgeons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tritanium® cup |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tritanium® cup | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in implantation position(angle) of the cup | Baseline, intraoperative, 3 months, 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Japanese Orthopaedic Association (JOA) score | Baseline, 3 months, 6months and 12 months | |
| Change in Quality of Life as assessed by Euro QOL 5 Dimension (EQ-5D) | Pre-operation, 3 months, 6months and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patient who has diagnosis of secondary osteoarthritis, avascular necrosis and rheumatoid arthritis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ysuyuki Inatsugu | Contact | +81-3-6894-8394 | yasuyuki.inatsugu@stryker.com |
| Name | Affiliation | Role |
|---|---|---|
| Yasuyuki Inatsugu | Stryker Japan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RINKU General Medical Center | Recruiting | Izumisano | Osaka | 598-8577 | Japan |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D005271 | Femur Head Necrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |