Comparative Study of Minimally Invasive Surgical Approaches for Total Hip Arthroplasty: a Biochemical, Imaging and Clinical Evaluation in the Early Postoperative Period
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
total hip arthroplasty via the mini posterior approach
total hip arthroplasty via the mini posterior approach. This approach was first described by Kocher and Langenbeck and later modified by Gibson in 1950. There is a convex incision centered on the posterior rim of the major trochanter. The incision follows the curve of the buttock and at the height of the posterior lip of the major trochanter, it is peripherally oriented along the posterior outer surface of the femur. The major gluteus is divided along the muscle fibers. Guiding sutures are inserted into the tendon mass of the hip rotor muscles just prior to their origin on the major trochanter and dissected to expose and subsequently retract the posterior hip capsule.
干预措施: Mini posterior approach Total Hip Replacement (Procedure)
THR via the anterior approach without traction table
The anterior approach is a modification of the classic Smith- Peterson anterior hip approach as described by Berend et al in 2009 [7]. This approach utilizes the intermuscular plane between the tendon fascia lata and the sartorius muscle, and laterally repairs the fibers of the rectus femur to expose and enclose the anterior pubic joint. A surgical traction table may be used during surgery.
干预措施: Anterior approach total hip replacement without a traction table (Procedure)
THR via the anterior approach with a traction table
The anterior approach is a modification of the classic Smith- Peterson anterior hip approach as described by Berend et al in 2009 [7]. This approach utilizes the intermuscular plane between the tendon fascia lata and the sartorius muscle, and laterally repairs the fibers of the rectus femur to expose and enclose the anterior pubic joint. A surgical traction table may be used during surgery.
干预措施: Anterior approach total hip replacement with a traction table (Procedure)
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
Vasileios S. Nikolaou
Associate Professor of Orthopaedics
National and Kapodistrian University of Athens