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The Silent Hip has been rationalized for business reasons only
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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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The purpose of this study is to determine if the Silent™ hip is effective in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored
The purpose of this study is to determine if the Silent™ hip, when used as part of an artificial hip joint, is effective in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DePuy Silent™ Hip femoral prosthesis | Experimental | A short cementless, femoral component for use in total hip arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DePuy Silent™ Hip femoral prosthesis | Device | A short cementless, femoral component for use in total hip arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complications | 6mths post-surgery | |
| Harris Hip score change at 6mths post-surgery | 6mths post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score | 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery | |
| Oxford Hip Score | 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Newcastle Hospital | Broadmeadow | Australia | ||||
| Prince of Wales Private Hospital |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| UCLA Activity Rating |
| 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery |
| Incidence of post operative radiological signs | 7 days, 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery |
| Change in bone mineral density | 7days, 3mths, 6mths, 1yr and 2yrs post-surgery |
| Kaplan-Meier Survivorship Calculations | 3 months, 6 months, and Annually |
| Sydney |
| Australia |
| Sydney Adventist Hospital | Sydney | Australia |
| Hôpital Raymond Poincaré | Garches | France |
| Orthopädishe Universitätsklinik | Frankfurt | Germany |
| Ospedali Riuniti di Jesi | Iesi | Italy |
| Llandough Hospital | Cardiff | United Kingdom |