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临床试验/NCT06659198
NCT06659198已完成不适用

Assessing the Perioperative Outcomes of Minimally Invasive Posterior Approach Versus Direct Anterior Approach Total Hip Arthroplasty: a Prospective Comparative Randomized Study on Blood and Pain Management.

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年4月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Number of participants requiring blood tranfusions

研究概览

简要总结

The aim of the present study is to compare the early post-operative outcomes of minimally invasive posterolateral approach (Mis-PLA) Vs. direct anterior approach (DAA) in the treatment of primary hip osteoarthritis, with regards to blood loss and postoperative pain.

Fifty patients treated with THA from 2022 to 2023 are randomly assigned to either receive Mis-PLA or DAA THA. Visual Analog Scale (VAS) is used to assess pain and recorder ad hospital admission and on postoperative days 1 and 3. Intraoperative and postoperative blood loss and blood transfusion rate are recorded, as well as operation time and length of stay (LOS).

详细描述

Total hip arthroplasty (THA) is considered a reliable surgical strategy for the treatment of end-stage hip osteoarthritis, although it is associated with postoperative complications, such as perioperative pain and blood loss sometimes leading to blood transfusions. Recently, the concept of enhanced recovery surgery in minimally invasive joint replacement surgery is gaining popularity, as opposed to traditional approaches, which possess disadvantages such as a higher risk of dislocation, longer hospital stays and rehabilitation periods, and increased soft tissue injuries.

The minimally invasive posterolateral approach (Mis-PLA) with preserved piriformis muscle was found to minimize the amount of time needed for functional recovery, preserve prosthesis stability, reduce postoperative pain, and cause less injury and perioperative blood loss when compared to the standard procedure. It has a number of benefits, such as a very simple procedure, a clearly visible surgical field, less damage to soft tissues, and better abductor muscle preservation.

Similarly, the direct anterior approach (DAA) offers several advantages like a lower risk of dislocation, quick recovery, and less intraoperative muscle injury, although according to some studies, it possesses a longer learning curve and it is associated with prolonged operation times and significant perioperative bleeding.

This study compares the early post-operative outcomes of Mis-PLA Vs. DAA in the treatment of primary hip osteoarthritis, with regards to blood loss and postoperative pain.

Fifty patients suffering from hip osteoarthritis treated with THA from 2022 to 2023 constitute the study sample size. Patients are subdivided into two groups and randomly assigned to either receive Mis-PLA or DAA 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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • clinical and instrumented diagnosis of unilateral primary or secondary end-stage hip osteoarthritis candidate to total hip arthroplasty
  • patients with body mass index<30 kg/m2,
  • absence of liver disease, coagulative pathology

排除标准

  • patients with history of bleeding or thrombotic disorder,
  • patients with history of liver or renal disease
  • patients with anticoagulant or antiplatelet therapy
  • refusal to participate in the study

结局指标

主要结局

Number of participants requiring blood tranfusions

时间窗: preop to 3 days postop

Number (percentage) of participants requiring blood tranfusions

次要结局

  • Visual analog scale (VAS) score for each patient(preop to 3 days postop)

研究者

发起方
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
申办方类型
Other
责任方
Sponsor

研究点 (1)

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