NCT03695497已完成不适用
A Randomized Controlled Trial Comparing Direct Anterior Approach to Direct Lateral Approach in Patients Receiving a Total Hip Arthroplasty for Femoral Neck Fracture - a 1 Year Follow-up Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Difference in Timed Up and Go Test (TUG) between the groups
研究概览
简要总结
The primary objective is to examine if in patients with a dislocated femoral neck fracture who receive a total hip arthroplasty, direct anterior approach will give a better result in terms of mobilization, function and pain in the first weeks and months postoperatively, than direct lateral approach.
详细描述
first included patient 23th November 2018
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dislocated femoral neck fracture
排除标准
- •Infection around the hip (soft tissue or bone)
- •Pathologic fracture
- •Excessive alcohol or substance abuse that most likely will give reduced compliance
- •Patients with any fractures of the long bones in the lower extremity, fracture of the spine, and/or intra-thoracic or intra-abdominal injury (i.e., multiple trauma). Because the outcomes and clinical course of patients with multiple trauma may be quite different from a non-trauma patient.
- •Bedridden patients/non-walkers
- •Patients with an underlying illness that doesn't have life expectancy beyond six months
- •In case of severe cognitive impairment where the patients are not able to give their informed consent
研究组 & 干预措施
Direct anterior approach
Experimental
total hip arthroplasty with direct anterior approach
干预措施: Direct anterior approach (Procedure)
Direct Lateral Approach
Experimental
total hip arthroplasty with direct lateral approach
干预措施: Direct Lateral Approach (Procedure)
结局指标
主要结局
Difference in Timed Up and Go Test (TUG) between the groups
时间窗: 6 weeks postoperatively.
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
次要结局
- Difference in Forgotten Joint Score for hip (FJS-12) between the groups(2,6,12 weeks, and 1 year)
- Difference in EQ-5D-5L score between the groups(2,6,12 weeks, and 1 year)
- Difference in Oxford Hip Score (OHS) between the groups(2,6,12 weeks, and 1 year)
- Difference in Timed Up and Go Test (TUG) between the groups(2,12 weeks, 1 year.)
- Difference in EQ5D-VAS between the groups(2,6,12 weeks, and 1 year)
- radiological results 1.(postoperative, 3,12 months.)
- radiological results 2.(postoperative, 3,12 months.)
- radiological results 3.(postoperative, 3,12 months.)
- radiological results 4.(postoperative, 3,12 months.)
- radiological results 5.(postoperative, 3,12 months.)
- radiological results 6.(postoperative, 3,12 months.)
- complications(Within the first year postoperatively.)
研究者
研究点 (1)
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