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| Name | Class |
|---|---|
| DePuy International | INDUSTRY |
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Hip replacements are being performed on an increasingly active population, who are likely to wear their implants out prematurely. New hip replacements have been devised to minimise the risk of failure. DePuy RSA RCT is a randomised controlled trial designed to compare the performance of two established types of hip replacements using Corail and Tri-Lock stems along with Deltamotion acetabular component. The primary objective of the trial is to compare the long term stability of these two devices.To do this, the study will use an advanced 3D Xray technique to detect migration of the components at 3 years. The study will also measure micromotion of Corail, Tri-Lock and Deltamotion components, patient reported outcome measures and change in bone density.This study is being conducted at a single site, at the Nuffield Orthopaedic Centre, Oxford.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DePuy Tri-LockĀ® | Active Comparator | Total hip replacement with DePuy Tri-LockĀ® femoral stem and DeltamotionĀ® acetabular component. The surgery will be conducted using a postero-lateral approach followed by post operative rehabilitation as per standard care. |
|
| DePuy CorailĀ® | Active Comparator | Total hip replacement with DePuy CorailĀ® femoral stem and DeltamotionĀ® acetabular component. The surgery will be conducted using a postero-lateral approach followed by post operative rehabilitation as per standard care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DePuy Tri-LockĀ® femoral stem + DeltamotionĀ® acetabular component | Device |
| ||
| DePuy CorailĀ® femoral stem + DeltamotionĀ® acetabular component |
| Measure | Description | Time Frame |
|---|---|---|
| Mean total Radio Stereometric Analysis (RSA) measured migration of DePuy Tri-LockĀ® femoral stem vs DePuy CorailĀ® femoral stem (mm/yr). | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamically Inducible Micromotion (DIMM) of DePuy CorailĀ®, Tri-LockĀ® and DeltamotionĀ® components (mm/yr). | 3 years | |
| Radio Stereometric Analysis (RSA) measured migration of DePuy DeltamotionĀ® acetabular component | 3 years |
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Inclusion Criteria:
Women aged between 18 and 65 years and men aged between 18 and 70 years.
Exclusion Criteria:
Any patients with an inflammatory arthropathy, osteoporosis or deformities of the proximal femur.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuffield Orthopaedic Centre | Recruiting | Oxford | OX3 7HE | United Kingdom |
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| Device |
|
| Change in Oxford Hip Score (OHS) at three years. | 3 years |
| Change in bone density using Dual Energy X-Ray Absorptiometry (DEXA) scan at 12 months. | 1 year |
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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