Patient-relevant Outcomes 8 Years After Minimally Invasive Total Hip Replacement - a Randomized Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 2
- 主要终点
- Physical function hip - Harris-Hip-Score (HHS)
研究概览
简要总结
There exists only limited scientific evidence concerning medium- to long-term benefits concerning minimally invasive (MI) total hip arthroplasty (THA). The investigators examined in a randomized study design 157 patients 8 years after THA, which were performed via 3 different surgical approaches.
详细描述
In contrast to reported short-term advantages of minimally invasive (MI) total hip arthroplasty (THA) there exists only limited scientific evidence concerning medium- to long-term benefits.
The investigators therefore sought to answer the following questions: Is the functional medium-term outcome in THA patients with MI-anterior(MI-A) and MI-anterolateral (MI-AL) approach superior to those treated by direct lateral approach (DLA)? Is the level of life quality increased by MI-THA? Is patient satisfaction higher by MI-THA? Is the revision rate reduced by MI-THA?
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical and radiologic signs of advanced hip joint Degeneration
- •Patients from age 18 to 75
排除标准
- •osteoporosis and
- •osteomalacia,
- •preceding surgery or radiation therapy in the proximity of the affected hip joint,
- •progressive neoplasia,
- •preceding or manifest infection of the affected joint and its surrounding soft tissues,
- •rheumatoid arthritis,
- •hip dysplasia Hartofilakidis type 2 or 3,
- •non-compliance,
- •chronic neurological or psychiatric diseases,
- •ongoing pregnancy
研究组 & 干预措施
anterior (MI-A) surgical approach
The minimally invasive anterior surgical approach was carried out using a modified Smith-Petersen access as described by Bender et al. (Bender et al. 2009) with the patient in supine position.
干预措施: surgical approach (Other)
anterolateral (MI-AL) surgical approach
For the minimally invasive anterolateral surgical approach, a modified Watson-Jones approach according to Röttinger (Rottinger et al. 2006) was applied with the patient in supine position.
干预措施: surgical approach (Other)
direct lateral (DLA) surgical approach
The direct lateral surgical approach was performed according to the technique described by Hardinge et al. (Hardinge et al. 1982) with the patient positioned supine
干预措施: surgical approach (Other)
结局指标
主要结局
Physical function hip - Harris-Hip-Score (HHS)
时间窗: change from baseline (preoperative) at 8 years after THA
Harris-Hip-Score (worst=0, best=100)
次要结局
- Physical function hip - WOMAC(change from baseline (preoperative) at 8 years after THA)
- Satisfaction Level(at 8 years after THA)
- health related Quality of life - Index(change from baseline (preoperative) at 8 years after THA)
- health related Quality of life - VAS(change from baseline (preoperative) at 8 years after THA)
- Physical Activity(change from baseline (preoperative) at 8 years after THA)
- Revision rate(at 8 years after THA)
- Physical Activity Performance Test: walking(change from baseline (preoperative) at 8 years after THA)
- Physical Activity Performance Test: stair climbing(change from baseline (preoperative) at 8 years after THA)