Percutaneous Assisted Approach for Total Hip Replacement and it's Effect on Functional Rehabilitation.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether revalidation following total hip replacement through the percutaneous approach is faster or better than following the anterolateral approach. We assume this would be the case since it is possible to spare a large part of the gluteus medius muscle with the percutaneous approach.

Official Title
-----------------
Percutaneous Assisted Approach for Total Hip Replacement and it's Effect on Functional Rehabilitation Compared to the Anterolateral Approach.

Conditions
-----------------
Total Hip Arthroplasty

Intervention / Treatment
-----------------
* Procedure: Ceramic on ceramic couple
* Procedure: Percutaneous assisted approach
* Procedure: Anterolateral approach
* Other: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral hip arthritis or avascular necrosis (AVN) in need for total hip replacement Exclusion Criteria: Comorbidities affecting functional outcome Symptomatic lumbar pathology Need of surgery or intervention on the ipsilateral knee and/or ankle/foot Neurological disorders such as Parkinsonism and previous cardiovascular accidents (CVA)

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous assisted approach<br>In this technique, a second small incision (1 cm) at the anterior border of the femur is made. A canulla is placed underneath the muscle and used to pass the reamers in the direction of the acetabulum. There's no need to enlarge the skin incision or to release more muscle insertion to achieve good working access to the acetabulum. Two advantages can be defined: sparing of the gluteus medius muscle and safe access to the acetabulum to obtain perfect positioning of the implants. | Procedure: Ceramic on ceramic couple<br>* All patients will get a standard total hip replacement (cementless hydroxyapatite coated cup and a titanium plasmasprayed stem) with a ceramic on ceramic (third generation biolox delta) couple. Preoperative leg length and offset are marked to reconstruct the preoperative leg length and to obtain the optimal offset.<br>Procedure: Percutaneous assisted approach<br> <br> Other: Usual care<br>* Both groups will receive usual care (UC) after surgery. This includes standard physiotherapy care consisting of mobilizing and strengthening techniques. All patients will receive a booklet containing information about the surgery, weight bearing after the surgery, and rehabilitation in general.<br>|
| Active Comparator: Anterolateral approach<br>A standard transgluteal approach is used. This means a large part of the gluteus medius muscle is released to obtain good access to the acetabulum. | Procedure: Ceramic on ceramic couple<br>* All patients will get a standard total hip replacement (cementless hydroxyapatite coated cup and a titanium plasmasprayed stem) with a ceramic on ceramic (third generation biolox delta) couple. Preoperative leg length and offset are marked to reconstruct the preoperative leg length and to obtain the optimal offset.<br>Procedure: Anterolateral approach<br> <br> Other: Usual care<br>* Both groups will receive usual care (UC) after surgery. This includes standard physiotherapy care consisting of mobilizing and strengthening techniques. All patients will receive a booklet containing information about the surgery, weight bearing after the surgery, and rehabilitation in general.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in time needed for the timed get up and go test | The subject is asked to stand up from a chair, walk 3m to a cone, return to the chair and sit down again. The time needed to perform this test is recorded in seconds. | baseline, 4 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surface electromyography (sEMG) of gluteus medius | sEMG of the gluteus medius is recorded during maximally voluntary isometric contraction and during single leg stance. | baseline | 
| Change in hip abductor muscle strength measured by MicroFET 2 | The patient lies supine. Resistance is administered on the lateral side of the leg, just proximal of the knee joint. Patients will be asked for a maximally voluntary isometric contraction. The test will be repeated 3 times. The mean value will be recorded. | baseline, 4 weeks, 12 weeks | 
| Change in knee extensor muscle strength measured by MicroFET 2 | The patient is seated with the hips and knees bent 90°. Resistance is administered on the ventral side of the leg, just proximal of the ankle joint. Patients will be asked for a maximally voluntary isometric contraction. The test will be repeated 3 times. The mean value will be recorded. | baseline, 4 weeks, 12 weeks | 
| Score on the Trendelenburg test | The patient is asked to raise one leg (sound side) and lift the non-stance side of the pelvis as high as possible for 30 seconds. The response is classified as followed: Normal: the pelvis on the non-stance side can be lifted maximally during 30 seconds The pelvis on the non-stance side can be lifted, but not maximally The pelvis on the non-stance side is elevated, but not maintained for 30 seconds. No elevating of the pelvis on the non-stance side Drooping of the pelvis Non-valid response: due to hip pain or uncooperative patient | baseline | 
| Change in score on the Oxford Hip Score | The Oxford Hip Score (OHS) is a disease-specific questionnaire that consists of 12 questions for the evaluation of pain and hip function in relation to various activities. Each question contains 5 quantifiable answers, leading to a total score that can range from 12 (least problems) to 60 (most problems). | baseline, 4 weeks, 12 weeks | 
| Change in score on the SF-36 and it's subscales | The SF-36 is a generic questionnaire that contains 36 items measuring health on 8 different dimensions. These dimensions cover functional status, wellbeing and overall evaluation of health. | baseline, 4 weeks, 6 weeks | 
| Change in time needed to complete the 5 times sit-to-stand test | This easily feasible test where the patient has to stand up and sit back down 5 times as fast as possible is a good predictor of falling. A worse score (i.e. a longer time needed to complete the test) on the 5 times sit to stand (5tSTS) implies a greater chance of falling. | baseline, 4 weeks, 12 weeks | 
| Change in distance walked during the 6 minute walking test | The test measures the distance a patient can quickly walk on a flat, hard surface in a time-period of 6 minutes. | baseline, 4 weeks, 12 weeks | 
| surface electromyography (sEMG) of gluteus medius | sEMG of the gluteus medius is recorded during maximally voluntary isometric contraction and during single leg stance. | 4 weeks | 
| surface electromyography (sEMG) of gluteus medius | sEMG of the gluteus medius is recorded during maximally voluntary isometric contraction and during single leg stance. | 12 weeks | 
| Score on the trendelenburg test | The patient is asked to raise one leg (sound side) and lift the non-stance side of the pelvis as high as possible for 30 seconds. The response is classified as followed: Normal: the pelvis on the non-stance side can be lifted maximally during 30 seconds The pelvis on the non-stance side can be lifted, but not maximally The pelvis on the non-stance side is elevated, but not maintained for 30 seconds. No elevating of the pelvis on the non-stance side Drooping of the pelvis Non-valid response: due to hip pain or uncooperative patient | 4 weeks | 
| Score on the Trendelenburg test | The patient is asked to raise one leg (sound side) and lift the non-stance side of the pelvis as high as possible for 30 seconds. The response is classified as followed: Normal: the pelvis on the non-stance side can be lifted maximally during 30 seconds The pelvis on the non-stance side can be lifted, but not maximally The pelvis on the non-stance side is elevated, but not maintained for 30 seconds. No elevating of the pelvis on the non-stance side Drooping of the pelvis Non-valid response: due to hip pain or uncooperative patient | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Hip Arthroplasty, Gluteus medius, Approach, Rehabilitation, Functional outcome