Hip ArthritisNCT05093361
Randomized Controlled Trial of Total Hip Arthroplasty
A study testing Total Hip Arthroplasty and Physical Therapy in people with Hip Arthritis and Total Hip Arthroplasty (THA), run by Kuopio University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hip Arthritis, Total Hip Arthroplasty (THA)
- What is being tested?
- Total Hip Arthroplasty and Physical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- 1 Sep 2017to 20 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hip Arthritis, Total Hip Arthroplasty (THA)
- Being tested
- Total Hip Arthroplasty, Physical Therapy
- Keywords
- Hip Arthritis, Total Hip Arthroplasty, THA, Conservative Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyProcedure or surgery
Total Hip Arthroplasty for the treatment of hip arthritis.
Physical TherapyProcedure or surgery
Self-driven training according to the training plan instructed by physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| Operative Treatment | Active comparator | Total Hip Arthroplasty Receives: Procedure: Total Hip Arthroplasty |
| Conservative Treatment | Active comparator | Physical therapy Receives: Procedure: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline to one year
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to one year
BMI
Body Mass Index (BMI). Weight and height will be combined to report BMI in kg/m^2.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Sep 2017
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aapo Talonpoika, Principal investigator, Kuopio University HospitalJari Arokoski, Study director, Kuopio University Hospital and Helsinki University HospitalLauri Karttunen, Principal investigator, Kuopio University HospitalHannu Luomajoki, Study director, Zürcher Hochschule für Angewandte Wissenschaften ZHAW Departement Gesundheit, Institut für PhysiotherapieJukka Huopio, Study director, Kuopio University HospitalAntti Jaroma, Study director, Kuopio University HospitalJoonas Sirola, Study director, Kuopio University HospitalHeikki Kröger, Study chair, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093361
- Sponsor's protocol ID
- 5203108
- Status last verified
- Apr 2022
- First submitted
- 10 Dec 2018
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05093361
- Acronym / sponsor ID
- 5203108
- Conditions
- Hip Arthritis, Total Hip Arthroplasty (THA)
- Keywords
- Hip Arthritis, Total Hip Arthroplasty, THA, Conservative Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative Treatment | Active comparator | Procedure: Total Hip ArthroplastyTotal Hip Arthroplasty |
| Conservative Treatment | Active comparator | Procedure: Physical TherapyPhysical therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Hip ArthroplastyTotal Hip Arthroplasty for the treatment of hip arthritis. | Procedure or surgery | Operative Treatment |
| Physical TherapySelf-driven training according to the training plan instructed by physical therapist. | Procedure or surgery | Conservative Treatment |
Primary outcome
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.
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.
17 secondary outcomes
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) Sub Score Stiffness
Time frame: From baseline to one year
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Physical Function
Time frame: From baseline to one year
30s Chair Stand Test
Time frame: From baseline to one year
40m Fast-paced Walk Test
Time frame: From baseline to one year
Stair Climb Test
Time frame: Baseline to one year
Grip Strength
Time frame: Baseline to one year
Short Form 36 Health Survey Questionnaire (SF-36)
Time frame: Baseline to one year
painDetect
Time frame: Baseline to one year
BMI
Time frame: Baseline to one year
Use of pain medication
Time frame: Baseline to one year
Training diary
Time frame: Baseline to one year
Range of motion in hip extension
Time frame: Baseline to one year
Range of motion in hip flexion
Time frame: Baseline to one year
Range of motion in hip inner rotation
Time frame: Baseline to one year
Range of motion in hip outer rotation
Time frame: Baseline to one year
Leg length discrepancy
Time frame: Baseline to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aapo Talonpoika principal investigator
Kuopio University Hospital
Jari Arokoski study director
Kuopio University Hospital and Helsinki University Hospital
Lauri Karttunen principal investigator
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Hip Arthroplasty and Physical Therapy in people with Hip Arthritis and Total Hip Arthroplasty (THA), run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: From baseline to one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.