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Completed

NCT Number: NCT05093361

Randomized Controlled Trial of Total Hip Arthroplasty

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kuopio University Hospital

Kuopio, Northern Savonia, 70029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Hip Arthroplasty

Procedure

Total Hip Arthroplasty for the treatment of hip arthritis.

physical therapy

Procedure

Self-driven training according to the training plan instructed by physical therapist.

Primary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    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.

  2. Harris Hip Score (HHS)

    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.

Secondary outcomes

  1. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score 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 five items for pain (score range 0-20). Higher scores indicate worse pain.

  2. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score 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 two items for stiffness (score range 0-8). Higher scores indicate worse stiffness.

  3. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Physical Function

    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.

  4. 30s Chair Stand Test

    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.

  5. 40m Fast-paced Walk Test

    Time frame: From baseline to one year

    How fast can a patient walk 40 meters measured in seconds. Lower scores mean a better outcome.

  6. Stair Climb Test

    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.

  7. Grip Strength

    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.

  8. Short Form 36 Health Survey Questionnaire (SF-36)

    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:

    • 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.

  9. painDetect

    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.

  10. BMI

    Time frame: Baseline to one year

    Body Mass Index (BMI). Weight and height will be combined to report BMI in kg/m^2.

  11. Use of pain medication

    Time frame: Baseline to one year

    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
  12. Training diary

    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.

  13. Range of motion in hip extension

    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.

  14. Range of motion in hip flexion

    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.

  15. Range of motion in hip inner rotation

    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.

  16. Range of motion in hip outer rotation

    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.

  17. Leg length discrepancy

    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.

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2021
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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