Osteoarthritis
Conditions
Keywords
aseptic loosening, femoral stem design
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURETotal Hip Replacement
Implantation of one of 3 stem designs
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients must be aged 60 yrs or more uncomplicated primary or secondary osteoarthritis of the hip undergoing unilateral cemented total hip arthroplasty using a metal on polyethylene bearing couple.
Exclusion criteria
* metabolic bone disorders, systemic disorders such as rheumatoid arthritis and patients who have taken pharmacological doses of oral steroids, hormone replacement therapy, tamoxifen, calcium or vitamin D supplements within the last year. Patients with a prior history of bisphosphonates and women of child bearing age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proximal femoral BMD change over 2 years measured by DXA | 2 years |
Secondary
| Measure | 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 | 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 |
Countries
United Kingdom
Outcome results
None listed