Randomized Controlled Trial of Total Hip Arthroplasty

Not Applicable

Completed

• Conditions: Total Hip Arthroplasty (THA); Hip Arthritis
• Interventions: Procedure: Physical Therapy; Procedure: Total Hip Arthroplasty

• Registration Number: NCT05093361
• Lead Sponsor: Kuopio University Hospital

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.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-26
• Status Verified: 2022-04
• Primary Completion: 2023-01-20
• Study Completion: 2023-01-20
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative Treatment	Physical Therapy	Physical therapy
Operative Treatment	Total Hip Arthroplasty	Total Hip Arthroplasty

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	From baseline to one year	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.
Harris Hip Score (HHS)	From baseline to one year	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.

Secondary Outcome Measures

Name	Time	Method
Training diary	Baseline to one year	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.
Range of motion in hip extension	Baseline to one year	Measurement of hip extension in side lying position. Measurement is done by physical therapist with a goniometer and it is reported in degrees.
Range of motion in hip flexion	Baseline to one year	Measurement of hip flexion in side lying position. Measurement is done by physical therapist with a goniometer and it is reported in degrees.
Range of motion in hip inner rotation	Baseline to one year	Measurement of hip inner rotation in supine position. Measurement is done by physical therapist with a goniometer and it is reported in degrees.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Pain	From baseline to one year	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.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Stiffness	From baseline to one year	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.
painDetect	Baseline to one year	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.
BMI	Baseline to one year	Body Mass Index (BMI). Weight and height will be combined to report BMI in kg/m\^2.
Range of motion in hip outer rotation	Baseline to one year	Measurement of hip inner rotation in supine position. Measurement is done by physical therapist with a goniometer and it is reported in degrees.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Physical Function	From baseline to one year	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.
Stair Climb Test	Baseline to one year	The time (in seconds) it takes to ascend and descend a flight of stairs. Lower scores mean a better outcome.
Grip Strength	Baseline to one year	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.
30s Chair Stand Test	From baseline to one year	How many times a patient can stand up and sit down on a chair in 30 seconds. Higher scores mean a better outcome.
40m Fast-paced Walk Test	From baseline to one year	How fast can a patient walk 40 meters measured in seconds. Lower scores mean a better outcome.
Short Form 36 Health Survey Questionnaire (SF-36)	Baseline to one year	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: 1. Limitations in physical activities because of health problems.; 2. Limitations in social activities because of physical or emotional problems; 3. Limitations in usual role activities because of physical health problems; 4. Bodily pain; 5. General mental health (psychological distress and well-being); 6. Limitations in usual role activities because of emotional problems; 7. Vitality (energy and fatigue); 8. 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.
Use of pain medication	Baseline to one year	Rate of pain medication use (paracetamol, NSAID and opioid pain medication) in four stage rating.; 1. Not at all; 2. Few days a month; 3. Few days a week; 4. Daily
Leg length discrepancy	Baseline to one year	Leg length is measured from the highest point of ileum. Measurement is done by physical therapist and reported in centimeters.

Trial Locations

Locations (1)

Kuopio University Hospital; 🇫🇮 Kuopio, Pohjois-Savo, Finland