Comparative Study of Minimally Invasive Surgical Approaches for Total Hip Arthroplasty

Study Overview
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Brief Summary
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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.

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

Conditions
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Hip Osteoarthritis, Hip Arthropathy, Minimal Invasive, Anterior Approach, Tissue Injury

Intervention / Treatment
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* Procedure: Mini posterior approach Total Hip Replacement
* Procedure: Anterior approach total hip replacement without a traction table
* Procedure: Anterior approach total hip replacement with a traction table


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients that sign the Informed consent Patients aged 18 years and over who are going to undergo primary total hip arthroplasty Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: total hip arthroplasty via the mini posterior approach<br>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. | Procedure: Mini posterior approach Total Hip Replacement<br>* Total hip replacement in patients suffering from hip osteoarthritis using the mini posterior approach<br>|
| Active Comparator: THR via the anterior approach without traction table<br>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. | Procedure: Anterior approach total hip replacement without a traction table<br>* Mini Anterior approach total hip replacement in patients suffering from hip osteoarthritis without the aid of a traction table<br>|
| Active Comparator: THR via the anterior approach with a traction table<br>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. | Procedure: Anterior approach total hip replacement with a traction table<br>* Mini Anterior approach total hip replacement in patients suffering from hip osteoarthritis with the aid of a traction table<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue damage change | 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. | Change from 6 to 24 and then 48 hours post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging | All patients will be subjected to imaging with a hip MRI | Day 30 after surgery | 
| Clinical Tests change | All patients will be monitored postoperatively for the prescribed period and data will be recorded. | Change to clinical test from Day 2 to day 15 and then day 30 post-surgery |