Effect of Cemented Stem Design on Periprosthetic Bone Mass Following Primary Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Proximal femoral BMD change over 2 years measured by DXA
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Proximal femoral BMD change over 2 years measured by DXA
时间窗: 2 years
次要结局
- 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)
- Femoral prosthetic stem y-axis migration (subsidence), ans stem/shaft angulation change measured by EBRA.(2 years)
- Biochemical markers of bone formation and resorption measured from serum and urine samples using the Elecsys system.(2 years)