Anterolateral Watson Jones Approach Versus Transgluteal Approach for Uncemented Hemi- Arthroplasty in Displaced Femoral Neck Fracture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale Pain and Patient Satisfaction
研究概览
简要总结
Hemiarthroplasty is a well established treatment of Femoral Neck Fractures in the Elderly. During the last decade the use of Minimal Invasive Surgical( MIS) approaches have been increasing. Our hypothesis is that Patients with a Femoral Neck Fracture may benefit from a MIS approach.
详细描述
The study's main objective: The purpose of the study is to test the following hypothesis. Patients 70 to 90 years with a displaced femoral neck fracture, operated with a hemiarthroplasty through an anterolateral approach, have less pain and better patient satisfaction as measured by PROMs than patients operated through the lateral approach.
The study's subsidiary objectives. We aim to shed light on the following subsidiary hypotheses.
- A hemiarthroplasty inserted through an anterolateral approach gives less bone resorption, as measured by DEXA around the stem, than a hemiarthroplasty inserted via a direct lateral approach.
- A hemiarthroplasty inserted through an anterolateral approach causes lesser degree of muscle damage, as measured by CK, than a direct lateral approach
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
- 70 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 70- 85 Years of Age -
排除标准
- •Dementia, Infection Not Suitable for Hemiarthroplasty
结局指标
主要结局
Visual Analogue Scale Pain and Patient Satisfaction
时间窗: Pre and postoperative, 3 and 12 Months
次要结局
- Timed up and go(postoperative, 3 and 12 Monthes)
- EuroQol(Postoperative, 3 and 12 Months)
- Harris Hip Score(Pre / Postoperative, 3 and 12 Months)
- Hip Osteoarthritis Disability Score(Postoperative, 3 and 12 Months)