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| Name | Class |
|---|---|
| Corin | INDUSTRY |
| Oxford University Hospitals NHS Trust | OTHER |
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The primary objective of this study is to determine whether the Mini Hip (Corin, U.K.) femoral component has a predictable and stable migration pattern (mean migration of the femoral component in three-dimensions,in mm) over a three year period, compared to a conventional cementless stem (Metafix, Corin, U.K.). The secondary objectives of this study are to determine whether the Trinity (Corin, U.K.) acetabular component has a predictable and stable migration pattern over a three year period and to measure the linear wear of femoral head into the ECIMA Highly Cross-linked polyethylene.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MiniHip (Corin U.K.) | Experimental | MiniHip (Corin U.K.) femoral component |
|
| Metafix (Corin, U.K) | Active Comparator | Metafix (Corin, U.K) conventional cementless stem |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiniHip (Corin U.K.) | Device | MiniHip (Corin U.K.) femoral component |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Radiostereometric Analysis (RSA) measured migration (mm) | The images taken at each time point will be compared with the baseline to assess implant migration. Therefore the outcome is change in implant position measured using RSA. | Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamically Inducible Micromotion DIMM (mm) | Using RSA this compares standard images with images taken in a single leg stance. | Measured at 6, 12, 24 and 36 months post-operatively |
| Implant failure for femoral and acetabular components |
| Measure | Description | Time Frame |
|---|---|---|
| DEXA Scan | To monitor for peri-prosthetic changes in bone density following surgery | Pre-operatively (baseline) and at 12 months post-operatively |
Inclusion Criteria:
Exclusion Criteria:
The participants may not enter the study if ANY of the following apply:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John Broomfield | Contact | john.broomfield@ndorms.ox.ac.uk | ||
| Alice Harin | Contact | alice.harin@ouh.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Sion Glyn-Jones, MA MBBS MRCS FRCS | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuffield Orthopaedic Centre | Recruiting | Oxford | OX3 7LD | 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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| Metafix (Corin, U.K) |
| Device |
Metafix (Corin, U.K) conventional cementless stem |
|
Follow up assessment will monitor for signs of implant failure.
| Observed at 3, 6, 12, 18, 24 and 36 months post-operatively |
| Change in Oxford Hip Score | A PROM to assess patient benefit. | Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively |
| Change in Harris Hip Score | A clinician recorded outcome score to assess functional improvement. | Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively |
| D012216 |
| Rheumatic Diseases |