Randomized Controlled Trial of Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effect of total hip arthroplasty and conservative treatment to hip pain, to activities of daily life and to the quality of life in patients with hip osteoarthritis.

Detailed Description
-----------------
The purpose of this randomized controlled study is to compare the effect of total hip arthroplasty and conservative treatment (that consists of self-driven exercises that physical therapists teach to the patients) to hip pain, to activities of daily life and to the quality of life in patients with hip osteoarthritis. Also the ill effects and cost effectiveness of total hip arthroplasty and conservative treatment are evaluated. Further more the aim is to investigate if total hip arthroplasty alleviates osteoarthritic pain in 12-month follow-up and if it enhances performance and quality of life.

Official Title
-----------------
Randomized Controlled Trial of Total Hip Arthroplasty

Conditions
-----------------
Hip Arthritis, Total Hip Arthroplasty (THA)

Intervention / Treatment
-----------------
* Procedure: Total Hip Arthroplasty
* Procedure: Physical Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hip osteoarthritis that is in X-ray pictures ≥2 in Kellgren - Lawrence classification Primary osteoarthritis Patients symptoms of hip osteoarthritis are so severe, that an experienced orthopedist would suggest total hip arthroplasty as a treatment Exclusion Criteria: Patients symptoms are so severe that total hip arthroplasty should be done within the next three months ASA > 3 (ASA physical status classification system) Normal contraindications to surgery Previous surgery to the same hip that has the osteoarthritis (including total hip arthroplasty, surgery for fracture, osteotomy, arthroscopy) The referring orthopedist has placed the patient in line for hip arthroplasty Secondary osteoarhritis
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Operative Treatment<br>Total Hip Arthroplasty | Procedure: Total Hip Arthroplasty<br>* Total Hip Arthroplasty for the treatment of hip arthritis.<br>|
| Active Comparator: Conservative Treatment<br>Physical therapy | Procedure: Physical Therapy<br>* Self-driven training according to the training plan instructed by physical therapist.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. Higher scores indicate worse pain, stiffness, and functional limitations. | From baseline to one year | 
| Harris Hip Score (HHS) | The Harris Hip Score (HHS) is a clinician-based outcome measure frequently used for the evaluation of patients following a total hip arthroplasty. Four subscales make up HHS. The first is pain, which measures pain severity (44 points); function, which is made up of daily activities and gait (47 points); the absence of deformity, which is a subscale that measures hip flexion, adduction, internal rotation, leg length discrepancy and range of motion measures.(4 points), and range of motion (5 points). The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes. | From baseline to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Pain | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The WOMAC measures five items for pain (score range 0-20). Higher scores indicate worse pain. | From baseline to one year | 
| The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Stiffness | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The WOMAC measures two items for stiffness (score range 0-8). Higher scores indicate worse stiffness. | From baseline to one year | 
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Physical Function | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The WOMAC measures 17 items for functional limitation (score range 0-68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. Higher scores indicate worse functional limitations. | From baseline to one year | 
| 30s Chair Stand Test | How many times a patient can stand up and sit down on a chair in 30 seconds. Higher scores mean a better outcome. | From baseline to one year | 
| 40m Fast-paced Walk Test | How fast can a patient walk 40 meters measured in seconds. Lower scores mean a better outcome. | From baseline to one year | 
| Stair Climb Test | The time (in seconds) it takes to ascend and descend a flight of stairs. Lower scores mean a better outcome. | Baseline to one year | 
| Grip Strength | Maximum grip strength with dominant hand. Three squeezes are measured with Jamar Hand Dynamometer. Higher scores mean a better outcome. Force is measured in kilograms. | Baseline to one year | 
| Short Form 36 Health Survey Questionnaire (SF-36) | The 36-Item Short Form Survey (SF-36) is an self-reported measure of health. It stems from a study called the Medical Outcomes Study. It comprises 36 questions which cover eight domains of health: Limitations in physical activities because of health problems. Limitations in social activities because of physical or emotional problems Limitations in usual role activities because of physical health problems Bodily pain General mental health (psychological distress and well-being) Limitations in usual role activities because of emotional problems Vitality (energy and fatigue) General health perceptions Patients or individuals are asked to fill out the questionnaire (tick boxes) by themselves and then it is scored by a clinician or researcher. Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high QOL. | Baseline to one year | 
| painDetect | painDETECT is a nine-item questionnaire that consists of seven sensory symptom items for pain that are graded from 0= never to 5= strongly, one temporal item on pain-course pattern graded -1 to +1, and one spatial item on pain radiation graded 0 for no radiation or +2 for radiating pain. A total score that ranges from -1 to 38 can be calculated from the nine items, with higher scores indicating higher levels of neuropathic pain. | Baseline to one year | 
| BMI | Body Mass Index (BMI). Weight and height will be combined to report BMI in kg/m^2. | Baseline to one year | 
| Use of pain medication | Rate of pain medication use (paracetamol, NSAID and opioid pain medication) in four stage rating. Not at all Few days a month Few days a week Daily | Baseline to one year | 
| Training diary | Patients keep a record of the training they do at home. The exercises are taught by the physical therapists and patients mark the number of days per week, that they have done the exercises. | Baseline to one year | 
| Range of motion in hip extension | Measurement of hip extension in side lying position. Measurement is done by physical therapist with a goniometer and it is reported in degrees. | Baseline to one year | 
| Range of motion in hip flexion | Measurement of hip flexion in side lying position. Measurement is done by physical therapist with a goniometer and it is reported in degrees. | Baseline to one year | 
| Range of motion in hip inner rotation | Measurement of hip inner rotation in supine position. Measurement is done by physical therapist with a goniometer and it is reported in degrees. | Baseline to one year | 
| Range of motion in hip outer rotation | Measurement of hip inner rotation in supine position. Measurement is done by physical therapist with a goniometer and it is reported in degrees. | Baseline to one year | 
| Leg length discrepancy | Leg length is measured from the highest point of ileum. Measurement is done by physical therapist and reported in centimeters. | Baseline to one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip Arthritis, Total Hip Arthroplasty, THA, Conservative Treatment