跳至主要内容
临床试验/NCT04157842
NCT04157842Unknown不适用

The Influence of Hip Replacement (Subtrochanteric Osteotomy vs. Non-osteotomy) on Lower Extremity Hemodynamics in Crowe IV Hip Dysplasia Patient

Second Affiliated Hospital, School of Medicine, Zhejiang University0 个研究点目标入组 100 人开始时间: 2019年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Hip Harris Score

研究概览

简要总结

Explore the influence of hip replacement on lower extremity hemodynamics in Crowe Ⅳ hip dysplasia patient.

详细描述

Changes of limb length after total hip replacement is common, especially for Crowe Ⅳ hip dysplasia patient. Such change potentially increases tension of vessel and influence lower extremity hemodynamics. Till now, little is known in this area.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Unilateral Crow IV hip dysplasia;
  • •Bilateral Crow IV hip dysplasia without osteoarthritis on the other side

排除标准

  • •Patients with serious medical disease;
  • •Patients with lower extremity vascular disease;
  • •Patients with severe mental illness.

研究组 & 干预措施

total hip replacement with subtrochanteral osteotomy

Experimental

subtrochanteral osteotomy is applied during total hip replacement

干预措施: total hip replacement with subtrochanteral osteotomy (Procedure)

total hip replacement with no osteotomy

Sham Comparator

no osteotomy is applied during total hip replacement.

干预措施: total hip replacement with no osteotomy (Procedure)

结局指标

主要结局

Hip Harris Score

时间窗: preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.

change of hip harris score scale from baseline(preoperative) to 1 year after surgery.

Radiographic Results

时间窗: 1 week, 12 weeks, 24 weeks and 1 year after the surgery.

change of Radiographic Results from 1 week after surger to 1 year after surgery

Lower Limb Arterial CT Angiography

时间窗: preoperative, 1 week, 12 weeks after the surgery.

change of vascular diameter and vascular cross-sectional from baseline(preoperative) to 1 year after surgery baseline(preoperative) to 12 weeks after surgery.

Blood Viscosity

时间窗: preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.

change of blood viscosity from baseline(preoperative) to 1 year after surgery.

Vascular Ultrasound Examination

时间窗: preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.

change of systolic peak velocity, end-diastolic velocity, pulsation index, resistance index and blood flow from baseline(preoperative) to 1 year after surgery.

Leg Length Change

时间窗: preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.

change of Leg Length from baseline(preoperative) to 1 year after surgery.

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

相似试验