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临床试验/NCT06538519
NCT06538519已完成不适用

Gait Analysis and Clinical Outcomes of Anterior and Lateral Approach Total Hip Arthroplasty. A Prospective Randomized Study.

Ain Shams University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
hemoglobin drop

研究概览

简要总结

The goal of this Prospective Randomized Study is to confirm presence or absence of differences in gait mechanics in direct anterior and lateral approaches for total hip arthroplasty. and to compare the clinical outcomes of both approaches.

The main questions it aims to answer are:

if the anterior approach to the hip is faster recovery than lateral approach? if the anterior approach to the hip has better gait mechanics than lateral approach?

Participants will:

undergo one of the two approaches for total hip arthroplasty. All patients will be followed up at 2 weeks, 6 weeks, 3 months and 18 months. gait analysis will be done at 6wks, 3m, and 18months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with primary osteoarthritis or osteonecrosis of the hip who consented for treatment with a total hip arthroplasty (THA) through an anterior or lateral approach.
  • Age between 20 - 60 years of age.
  • The participant had to be independent and physically active, which characterized as having the capacity to carry out daily tasks, ascend two flights of stairs, and able to walk for 15 minutes.

排除标准

  • Patients with bilateral hip affection.
  • Body mass index (BMI) greater than
  • Diagnosis other than primary osteoarthritis or osteonecrosis.
  • Prior hip or spine surgery.
  • chronic uncontrolled comorbidities, psychological disorders.
  • American Society of Anaesthesiologists score (ASA) higher than 2
  • chronic neurological deficits that influence gait.
  • any limb length discrepancy more than 1 cm.
  • Any postoperative complication that will lead to delay in weight bearing.

结局指标

主要结局

hemoglobin drop

时间窗: postoperative day one

hemoglobin drop level between pre and postoperative.

hospital stays

时间窗: immediately after the procedure

by ''Day'' as the unit, no special description. postoperative stay days from operation day to discharge day.

surgery time

时间窗: intraoperative time starting from skin incision to skin closure

by ''Minute'' as the unit, no special description.

pain score

时间窗: 2 weeks 6 weeks 3 months 18 months

using visual analogue scale (VAS) from 0-10 the more scale the worst the pain

Harris hip score

时间窗: 2 weeks 6 weeks 3 months 18 months

for measuring hip function from 0-100 the more the score the better hip function

次要结局

  • gait analysis(at 6 weeks, 3 months, 18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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