Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Cemented and Uncemented Hemiarthroplasties for Femoral Neck Fractures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Acetabular wear in mm
研究概览
简要总结
Substudy and continuation of HEMI-SAB-UUS (NCT00491673)
Study on radiostereometric measurements of acetabular wear in bipolar hemiarthroplasties and measurements of periprosthetic bone mineral density in cemented and uncemented hemiarthroplasties in patients with femoral neck fractures.
Null hypothesis: No difference in acetabular wear or in bone mineral density changes between cemented and uncemented hemiarthroplasties
详细描述
Patients are randomised to treatment with cemented or uncemented bipolar hemiarthroplasty. 1mm tantalum markers are inserted in the pelvis during surgery. RSA X-rays and DEXA measurements conducted postoperatively, after 3 and 12 months. Follow-up visits and clinical examination at 3 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Femoral neck fracture
- •65 years or older
- •Able to walk independently
排除标准
- •Cognitive dysfunction
- •Infection
- •Fracture caused by malignant disease
结局指标
主要结局
Acetabular wear in mm
时间窗: 1 year
Loss of bone mineral density (BMD)
时间窗: 1 year
次要结局
- Functional outcome including pain (Harris Hip Score)(1 year)
- Activities Of Daily Living (Barthels ADL-Index)(1 year)
- Quality Of Life (EQ-5D)(1 year)