Percutaneous Assisted Approach for Total Hip Replacement and it's Effect on Functional Rehabilitation Compared to the Anterolateral Approach.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- change in time needed for the timed get up and go test
研究概览
简要总结
The purpose of this study is to investigate whether revalidation following total hip replacement through the percutaneous approach is faster or better than following the anterolateral approach. We assume this would be the case since it is possible to spare a large part of the gluteus medius muscle with the percutaneous 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unilateral hip arthritis or avascular necrosis (AVN) in need for total hip replacement
排除标准
- •Comorbidities affecting functional outcome
- •Symptomatic lumbar pathology
- •Need of surgery or intervention on the ipsilateral knee and/or ankle/foot
- •Neurological disorders such as Parkinsonism and previous cardiovascular accidents (CVA)
研究组 & 干预措施
Percutaneous assisted approach
In this technique, a second small incision (1 cm) at the anterior border of the femur is made. A canulla is placed underneath the muscle and used to pass the reamers in the direction of the acetabulum. There's no need to enlarge the skin incision or to release more muscle insertion to achieve good working access to the acetabulum. Two advantages can be defined: sparing of the gluteus medius muscle and safe access to the acetabulum to obtain perfect positioning of the implants.
干预措施: Percutaneous assisted approach (Procedure)
Percutaneous assisted approach
In this technique, a second small incision (1 cm) at the anterior border of the femur is made. A canulla is placed underneath the muscle and used to pass the reamers in the direction of the acetabulum. There's no need to enlarge the skin incision or to release more muscle insertion to achieve good working access to the acetabulum. Two advantages can be defined: sparing of the gluteus medius muscle and safe access to the acetabulum to obtain perfect positioning of the implants.
干预措施: Ceramic on ceramic couple (Procedure)
Percutaneous assisted approach
In this technique, a second small incision (1 cm) at the anterior border of the femur is made. A canulla is placed underneath the muscle and used to pass the reamers in the direction of the acetabulum. There's no need to enlarge the skin incision or to release more muscle insertion to achieve good working access to the acetabulum. Two advantages can be defined: sparing of the gluteus medius muscle and safe access to the acetabulum to obtain perfect positioning of the implants.
干预措施: Usual care (Other)
Anterolateral approach
A standard transgluteal approach is used. This means a large part of the gluteus medius muscle is released to obtain good access to the acetabulum.
干预措施: Ceramic on ceramic couple (Procedure)
Anterolateral approach
A standard transgluteal approach is used. This means a large part of the gluteus medius muscle is released to obtain good access to the acetabulum.
干预措施: Anterolateral approach (Procedure)
Anterolateral approach
A standard transgluteal approach is used. This means a large part of the gluteus medius muscle is released to obtain good access to the acetabulum.
干预措施: Usual care (Other)
结局指标
主要结局
change in time needed for the timed get up and go test
时间窗: baseline, 4 weeks, 12 weeks
The subject is asked to stand up from a chair, walk 3m to a cone, return to the chair and sit down again. The time needed to perform this test is recorded in seconds.
次要结局
- surface electromyography (sEMG) of gluteus medius(12 weeks)
- Change in hip abductor muscle strength measured by MicroFET 2(baseline, 4 weeks, 12 weeks)
- Change in time needed to complete the 5 times sit-to-stand test(baseline, 4 weeks, 12 weeks)
- Change in distance walked during the 6 minute walking test(baseline, 4 weeks, 12 weeks)
- Score on the trendelenburg test(4 weeks)
- Change in knee extensor muscle strength measured by MicroFET 2(baseline, 4 weeks, 12 weeks)
- Score on the Trendelenburg test(12 weeks)
- Change in score on the Oxford Hip Score(baseline, 4 weeks, 12 weeks)
- Change in score on the SF-36 and it's subscales(baseline, 4 weeks, 6 weeks)
- surface electromyography (sEMG) of gluteus medius(baseline)
- Score on the Trendelenburg test(baseline)
- surface electromyography (sEMG) of gluteus medius(4 weeks)
研究者
Claudia Hendrickx
PhD student
Universiteit Antwerpen