Randomized Controlled Trial of Total Hip Arthroplasty

Hip Arthritis Clinical Trial

Official title:

Randomized Controlled Trial of Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05093361
• Other study ID #: 5203108
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: January 20, 2023

Study information

• Verified date: April 2022
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 20, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Hip Arthritis
• Total Hip Arthroplasty (THA)

Intervention

Procedure:
• Total Hip Arthroplasty
Total Hip Arthroplasty for the treatment of hip arthritis.
• Physical Therapy
Self-driven training according to the training plan instructed by physical therapist.

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio	Pohjois-Savo

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	BMI	Body Mass Index (BMI). Weight and height will be combined to report BMI in kg/m^2.	Baseline to one year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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