Investigation of Efficacy of Use of a Bandage to Prevent Hip Dislocation After Total Hip Arthroplasty in Patients With Previous Dislocation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- number of dislocations
研究概览
简要总结
This trial investigates the effectiveness of using a bandage after dislocation of the hip after total hip arthroplasty.
Patients with a dislocated hip after total hip arthroplasty coming to the emergency department to have the hip relocated will be asked to participate in the trial. The patients will be randomised to either a bandage that reduces flexion, adduction and internal rotation of the hip or no bandage.
详细描述
This trial investigates the effectiveness of using a bandage after dislocation of the hip after total hip arthroplasty.
Patients with a dislocated hip after total hip arthroplasty coming to the emergency department to have the hip relocated will be asked to participate in the trial. The patients will be randomised to either a bandage that reduces flexion, adduction and internal rotation of the hip or no bandage. Patients in the intervention group will use the bandage for 12 weeks and patients in the control group will receive the normal treatment which is information by a physiotherapist on movement restrictions.
50 patients will be allocated in the intervention group and 50 patients will be allocated to the control group.
We will investigate:
- Whether there is a difference in number of dislocations between the two groups in the project period (12 weeks).
- Patients' hip function, quality of life and satisfaction with the treatment in the two groups
- The safety, wear and durability of the bandage after 12 weeks of use
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has had at least one previous hip dislocation after total hip arthroplasty
排除标准
- •Dislocation in other directions than posterior/superior
- •Loose prosthesis
- •wounds in the area of skin that is in contact with the bandage
研究组 & 干预措施
intervention
HipStop bandage for 12 weeks to prevent dislocation of the hip
干预措施: Hipstop bandage (Device)
control
normal procedure after dislocation of hip which is information on movement restrictions
结局指标
主要结局
number of dislocations
时间窗: 12 weeks
次要结局
- Hip function(12 weeks)
- Safety, wear and durability of bandage(12 weeks)
- Helat-related quality of life(12 weeks)
- Patient satisfaction(12 weeks)