The Need for Supine Position Advise During Sleep in the First 8 Week After a Total Hip Replacement to Prevent Hip Dislocation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- Percentage early hip dislocations
研究概览
简要总结
Aim of the current study is to test the non-inferiority hypothesis of differences in early hip dislocation between a group of patients who will be restricted to sleep in supine position and a group without restricted sleeping position during the first eight weeks after a total hip replacement following a posterolateral surgical approach
详细描述
stratified block randomized controlled trial
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Placement of a primary total hip replacement via the posterolateral approach by a high volume orthopaedic surgeon
- •Patients with a ASA-classification of I or II
排除标准
- •Blindness
- •Replacement of 2nd total hip within six months after the1st total hip replacement surgery
- •Insufficient knowledge of the Dutch language
- •Collum fracture
- •Infection of total hip replacement
- •Cognitive dysfunction
- •Wheelchair dependability
- •Hypermobility
- •Alcohol abuse
- •Neurological disorders such as Parkinson and stroke
研究组 & 干预措施
Sleep position: supine
Subjects will be instructed to sleep in a supine position during the first eight weeks after a total hip replacement following a posterolateral surgical approach
干预措施: Sleep position: supine (Behavioral)
Sleep position: no restrictions
Patients do not have any restrictions in sleeping position during the first eight weeks after a total hip replacement following a posterolateral surgical approach
干预措施: Sleep position: no restrictions (Behavioral)
结局指标
主要结局
Percentage early hip dislocations
时间窗: in first eight weeks after THP
次要结局
- EQ-5D(eight weeks and six months post-operative)
- VAS/NRS hip(eight weeks and six months post-operative)
- Compliance anti-dislocation instructions(eight weeks post-operative)
- HOOS(eight weeks and six months post-operative)
- VHS(eight weeks and six months post-operative)