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| Name | Class |
|---|---|
| Johnson and Johnson Medical | UNKNOWN |
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The purpose of this study is to determine if the Silentâ„¢ hip, when used as part of an artificial hip joint, is stable and effective in treatment of patients with joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical, standard and special x-rays (RSA) to allow the position of the Silent Hip within the bone to be accurately monitored.
The Primary Objective of this study was to evaluate the short-term stability of the Silent Hip, implanted using a manual or navigated technique, using radiostereometric analysis (RSA). The study was also intended to provide the clinical data necessary to demonstrate conformance with the essential requirements of the Medical Device Directive. Secondary objectives were to determine the efficacy of the Silentâ„¢ Hip femoral prosthesis from a clinical and radiological prospective, to assess the safety of the device and to evaluate the impact of the procedure on the Subjects' Quality of Life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DePuy Silentâ„¢ Hip femoral prosthesis | Other | A short cementless, femoral component for use in total hip arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DePuy Silentâ„¢ Hip femoral prosthesis | Device | A short cementless, femoral component for use in total hip arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| The translational and rotational movements of the Silentâ„¢ hip in the 3 dimensions from the baseline position (determined from the 7 day post-operative RSA x-rays) to the 1 year follow-up visit. | 1year post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening | 1 year | |
| Difference demonstrated between pre-op and 5 year Harris Hip Score | 5 years post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tammy ODell, BS | DePuy International | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydney Adventist Hospital | Sydney | Australia | ||||
| General Hospital Eilbek |
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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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| Difference demonstrated between pre-op and 5 year Oxford Hip Score | 5years post surgery |
| Incidence of radiological signs on the post-operative x-rays | 3 months post surgery |
| Difference demonstrated between pre-op and 10 year Harris Hip Score | 10 years post surgery |
| Difference demonstrated between pre-op and 10 year Oxford Hip Score | 10 years post surgery |
| Incidence of radiological signs on the post-operative x-rays | 6 months post surgery |
| Incidence of radiological signs on the post-operative x-rays | 1 year post surgery |
| Incidence of radiological signs on the post-operative x-rays | 18 months post surgery |
| Incidence of radiological signs on the post-operative x-rays | 2 years post surgery |
| Incidence of radiological signs on the post-operative x-rays | 5 years post surgery |
| Incidence of radiological signs on the post-operative x-rays | 10 years post surgery |
| Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening | 2 years |
| Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening | 5 years |
| Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening | 10 years |
| Hamburg |
| Germany |