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Total hip replacement is a common procedure for the treatment of osteoarthrosis of the hips, the aims of this study are to determine the effect of implant stem design on bone quality surrounding the implant using three stem designs that are routinely implanted at this hospital.
120 patients will undergo routine hip replacements using either the C-Stem, Exeter Stem or Charnley stem implants. Patients will be clinically evaluated pre-operatively and randomised to one of the three implants. Post-operatively, patients will be clinically reviewed for 2 years using bone mineral density scans, radiological review, blood and urine analysis for bone markers and validated questionnaires to assess clinical data (Oxford Hip and Harries Hip). Patients will be assessed for prothesis migration using the EBRA methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | C-stem implant |
| |
| 2 | Charnley Implant |
| |
| 3 | Exeter Implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Hip Replacement | Procedure | Implantation of one of 3 stem designs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proximal femoral BMD change over 2 years measured by DXA | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Evaluation using patient centered questionnaire (Oxford Hip Score) | 2 years | |
| Surgeon centered clinical assessment (Harris Hip Score) | 2 years | |
| Plain radiographic assessment |
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Inclusion Criteria:
Exclusion Criteria:
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Pre-assessment clinics at Sheffield Hospitals, patients booked for hip replacements.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew J Hamer, FRCS | STH NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Department, Northern General Hospital | Sheffield | South Yorkshire | S5 7AU | United Kingdom |
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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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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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Blood and Urine only
| 2 years |
| Biochemical markers of bone formation and resorption measured from serum and urine samples using the Elecsys system. | 2 years |
| Femoral prosthetic stem y-axis migration (subsidence), ans stem/shaft angulation change measured by EBRA. | 2 years |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |