Clinical and RSA Comparison of Hemi Versus Total Hip Arthroplasty After Displaced Femoral Neck Fracture. A Randomized Double-Blind Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Radiographic and clinical
研究概览
简要总结
This is a Randomized Controlled Trial study comparing hemialloplastik versus total joint replacement.
详细描述
Seventy patients over seventy years who are admitted in our hip fracture department with the indication for hemi joint replacement therapy, due to a Garden 3-4 femoral neck fracture or a fracture Garden 1-2 with over 20-degree posterior tilt are randomized to either hemialloplastik or total joint replacement. The patients are followed for 24 mouths with X-ray Stereo Photogrammetric Analysis (RSA) radiographs and clinical examinations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 70 years, admitted two our hip-fracture department with a 3-4 Garden femoral neck fracture or a fracture Garden 1-2 with over 20-degree posterior tilt.
- •Preoperative New Mobility Score ≥ 6th
- •Patients must be able to speak and understand Danish.
- •Patients must be able to give informed consent and be cognitively intact (Hindsøe score ≥ 6).
- •Patients should be expected to be able to implement the postoperative controls. Patients should not be medically ill: ASA-score ≤ 3rd
排除标准
- 未提供
结局指标
主要结局
Radiographic and clinical
时间窗: Five years
Migration / rotation: Migration is measured by X-ray Stereo Photogrammetric Analysis (RSA). Clinical assessment: The patient is assessed clinically using the WOMAC and EQ-5D.
次要结局
- Clinical(Five years)
研究者
Jakob Klit
MD
Hvidovre University Hospital