Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach

Study Overview
=================
Brief Summary
-----------------
The aim of the study will be to compare functional outcomes of the two surgical hip approaches in total hip arthroplasty: anterior, posterolateral and anterolateral. Surgical approach may have influence on patients functional outcome.

Detailed Description
-----------------
Patients with primary hip osteoarthritis will be included in a randomized controlled trial and assigned to total hip arthroplasty using one the of hip approaches: anterior or anterolateral. Subjects will be assessed preoperative and 3 and 12 moths postoperative. Biomechanical gait parameters will be collected using tree-dimensional motion analysis system BTS SMART. Evaluation of the function of the middle gluteal muscle with superficial EMG (sEMG) percutaneous surface electromyography. Fatigue assessment (mean frequency and amplitude) of the gluteus medius muscle during isometric muscle contraction. Balance and coordination as well as fall risk will be assessed with use of dynamometric Biodex Balance platform. The study will determine the values of individual indicators: general stability index (OWS), anterior-posterior stability index (APW), the median lateral stability index (MLW) and the fall risk index (RU). Subjective assessment will be conducted with use of Visual Analogue Scale, WOMAC Index, Oxford Hip Score, The Short Form-36 (SF-36) and Harris Hip Score

Official Title
-----------------
Comparison of Early Objective and Subjective Outcome in Patients After Hip Arthroplasty, Operated From Direct Anterior, Posterolateraland Anterolateral Approach: Prospective Randomized Clinical Trial

Conditions
-----------------
Hip, Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Direct Anterior Approach (DAA)
* Procedure: Anterolateral approach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient's consent for anticipation in the study BMI less than 35 ability to walk the distance of 10m and stand up from the chair arthroplasty in one hip Exclusion Criteria: patient's lack of consent for anticipation in the study neurological diseases balance disorders reoperations in the area of endoprosthesis muscles diseases rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis) dizziness, vasovagal syncope

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct Anterior Approach (DAA)<br>Direct Anterior Approach surgery to replace the hip. | Procedure: Direct Anterior Approach (DAA)<br>* Direct Anterior Approach surgery to replace the hip.<br>Procedure: Anterolateral approach<br>* Anterolateral approach surgery to replace the hip.<br>|
| Active Comparator: Anterolateral approach<br>Anterolateral Approach surgery to replace the hip. | Procedure: Direct Anterior Approach (DAA)<br>* Direct Anterior Approach surgery to replace the hip.<br>Procedure: Anterolateral approach<br>* Anterolateral approach surgery to replace the hip.<br>|
| Active Comparator: Posterolateral approach<br>Posterolateral Approach surgery to replace the hip. | Procedure: Direct Anterior Approach (DAA)<br>* Direct Anterior Approach surgery to replace the hip.<br>Procedure: Anterolateral approach<br>* Anterolateral approach surgery to replace the hip.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in biomechanical gait parameters | Done by a biomechanics lab for patients to test their hip movements | from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively | 
| Gluteus medius muscle fatigue | Surface Electromyographic analysis performed for testing gluteus medius activity | from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively | 
| Change from baseline in Hip disability and Osteoarthritis Outcome Score (HOOS) activities of daily living (ADL) | This asks the patient how their hip functions during their daily life. It has 5 subscales measuring Pain, Symptoms, ADL, Sports/Recreation and Quality of Life (which is calculated using all the subscores). Each subscale is calculated using the mean score, with each score range being from 0 to 4. The subscore is normalized such that the lower the number the more extreme the problem is. To calculate Quality of Life, the mean of the other 4 subscores are taken to calculate the score. This asks the patient how their hip functions during their daily life. It has 5 subscales measuring Pain, Symptoms, ADL, Sports/Recreation and Quality of Life (which is calculated using all the subscores). Each subscale is calculated using the mean score, with each score range being from 0 to 4. The subscore is normalized such that the lower the number the more extreme the problem is. To calculate Quality of Life, the mean of the other 4 subscores are taken to calculate the score. | from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively | 
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | This measures health status as it relates to the hip. There are 3 subscales, pain which score ranges from 0-20, stiffness range from 0-8, physical function ranging from 0-68. The total score is just added up from the subscales. | from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively | 
| Change in Oxford scale | The Oxford scale is a physiotherapist objective-rated scale to asses muscle strength against the resistance. It is graded from 0 (flicker of movement) to 5 (Through full range actively against strong resistance) | from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively | 
| Change in SF-36 scale | The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best). | from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively | 
| Change in Visual Analog Scale (VAS) scale | To measure pain. This is a line with left most end representing no pain with the rightmost representing extreme pain. The participant puts a line where they feel that day and it is measured with a ruler to determine score out of 100. The line is 100mm long. | from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively | 
| Change in biomechanical gait balance | Done by a biomechanics lab for patients to test their gait balance | from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively | 
| Change in biomechanical coordination | Done by a biomechanics lab for patients to test their hip movements coordination | from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological analysis of implants positioning | To measure angles associated with proper implants positioning | from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
total, hip, arthroplasty, surgical, approach