跳至主要内容
临床试验/NCT04311125
NCT04311125Unknown不适用

Comparative Study of Minimally Invasive Surgical Approaches for Total Hip Arthroplasty: a Biochemical, Imaging and Clinical Evaluation in the Early Postoperative Period

National and Kapodistrian University of Athens2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
2
主要终点
Tissue damage change

研究概览

简要总结

Total hip arthroplasty is a method of choice for treating advanced osteoarthritis of the hip and one of the most frequent orthopedic procedures. Of all hip surgical approaches described, the tendency for minimally invasive techniques has been dominated over the last few years due to faster patient mobilization, reduced postoperative pain and need for blood transfusion. Two of the most common approaches used for minimally invasive total hip arthroplasty are: AMIS anterior approach and mini-posterior approach, which is a modification of the standard posterior approach. The purpose of this study is the biochemical, imaging and clinical evaluation of the tissue damage caused by the above-mentioned techniques of minimally invasive total hip arthroplasty.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • Patients that sign the Informed consent
  • Patients aged 18 years and over who are going to undergo primary total hip arthroplasty

排除标准

  • I. Active infection II. Previous hip operation in any leg III. Any kind of operation the past 3 months IV. Obesity (BMI, Body Mass Index >30) V. Autoimmune diseases or myositis of any etiology VI. Active cancer

结局指标

主要结局

Tissue damage change

时间窗: Change from 6 to 24 and then 48 hours post-surgery

Investigate and quantify at the biochemical level with all available biomarkers the extent of tissue damage caused during a hip arthroplasty between different hip surgical approaches.

次要结局

  • Clinical Tests change(Change to clinical test from Day 2 to day 15 and then day 30 post-surgery)
  • Imaging(Day 30 after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vasileios S. Nikolaou

Associate Professor of Orthopaedics

National and Kapodistrian University of Athens

研究点 (2)

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