NCT02247791进行中（未招募）不适用
Study of Prosthesis Choice in Older Patients With a Dislocated Femoral Neck Fracture of the Hip
Danderyd Hospital2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2009年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Hip related complication rate
研究概览
简要总结
The purpose of this study is to evaluate whether an uncemented hip prosthesis is as safe as an cemented hip prosthesis for patients undergoing total hip arthroplasty surgery following a displaced femoral neck fracture.
详细描述
The study will randomize patients between an uncemented and cemented stem
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 (Participant)
入排标准
- 年龄范围
- 65 Years 至 79 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute Displaced femoral neck fracture
- •Subject is aged between 65-79 years
- •Independent walker with or without walking aides
- •Subject is able and capable of providing consent to participate in the study
排除标准
- •Patients with Rheumatoid Arthritis
- •Patients with an impaired cognitive dysfunction
- •Patients with Pathological fractures
- •Patients with substance abuse
- •Patients with fracture older than 36-hours on arrival at the A&E
- •Patients suffering from cancer
- •Patients determined by principal investigator to be unsuitable for inclusion
结局指标
主要结局
Hip related complication rate
时间窗: 2 years
All hip-related complications
Health-related Quality of Life
时间窗: 2 years
Health related quality of life
次要结局
- Intraoperative bleeding(2 years)
- Duration of surgery(2 years)
- Hip function(2 years)
研究者
Olof Skoldenberg
Director of research, Orthopaedic dept
Danderyd Hospital
研究点 (2)
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