Kuopio University Hospital
Kuopio, Northern Savonia, 70029, Finland
NCT Number: NCT05093361
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.
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Interventional
Not applicable
Kuopio, Northern Savonia, 70029, Finland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Total Hip Arthroplasty for the treatment of hip arthritis.
Self-driven training according to the training plan instructed by physical therapist.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to one year
How fast can a patient walk 40 meters measured in seconds. Lower scores mean a better outcome.
Time frame: Baseline to one year
The time (in seconds) it takes to ascend and descend a flight of stairs. Lower scores mean a better outcome.
Time frame: 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.
Time frame: 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:
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.
Time frame: 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.
Time frame: Baseline to one year
Body Mass Index (BMI). Weight and height will be combined to report BMI in kg/m^2.
Time frame: Baseline to one year
Rate of pain medication use (paracetamol, NSAID and opioid pain medication) in four stage rating.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to one year
Leg length is measured from the highest point of ileum. Measurement is done by physical therapist and reported in centimeters.
Kuopio University Hospital
Other
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