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Prospective clinical investigation to determine the safety of Taperloc stems with BioGuard coating and Exceed ABT Taperfit acetabular cups with BioGuard coating when used in cementless total hip arthroplasty
Bioguard Safety Study: Prospective clinical investigation to determine the safety of Taperloc stems with BioGuard coating and Exceed ABT Taperfit acetabular cups with BioGuard coating when used in cementless total hip arthroplasty
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioguard Group | Experimental | Randomised study to either Bioguard or control stock |
|
| Control Group | Active Comparator | Randomised study to either Bioguard or control stock |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioguard Group | Device | Patients randomised to receive the study investigative device will receive a Bioguard implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in normalised peri-implant BMD as measured by DXA | 6 months post operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sudheer Karlakki, MD | RJAH, Oswestry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RJAH | Oswestry | United Kingdom |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control Group | Device | Patients randomised to receive the control device will receive a Exceed Taperlock implant |
|
|
| D012216 |
| Rheumatic Diseases |
| D008722 | Methods |