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Randomized Controlled Trial of Total Hip Arthroplasty

Primary Purpose

Hip Arthritis, Total Hip Arthroplasty (THA)

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Total Hip Arthroplasty
Physical Therapy
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Arthritis focused on measuring Hip Arthritis, Total Hip Arthroplasty, THA, Conservative Treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kuopio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Operative Treatment

Conservative Treatment

Arm Description

Total Hip Arthroplasty

Physical therapy

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
40m Fast-paced Walk Test
How fast can a patient walk 40 meters measured in seconds. Lower scores mean a better outcome.
Stair Climb Test
The time (in seconds) it takes to ascend and descend a flight of stairs. Lower scores mean a better outcome.
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.
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.
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.
BMI
Body Mass Index (BMI). Weight and height will be combined to report BMI in kg/m^2.
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
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.
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.
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.
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.
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.
Leg length discrepancy
Leg length is measured from the highest point of ileum. Measurement is done by physical therapist and reported in centimeters.

Full Information

First Posted
December 10, 2018
Last Updated
March 22, 2023
Sponsor
Kuopio University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05093361
Brief Title
Randomized Controlled Trial of Total Hip Arthroplasty
Official Title
Randomized Controlled Trial of Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
January 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuopio University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthritis, Total Hip Arthroplasty (THA)
Keywords
Hip Arthritis, Total Hip Arthroplasty, THA, Conservative Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Operative Treatment
Arm Type
Active Comparator
Arm Description
Total Hip Arthroplasty
Arm Title
Conservative Treatment
Arm Type
Active Comparator
Arm Description
Physical therapy
Intervention Type
Procedure
Intervention Name(s)
Total Hip Arthroplasty
Intervention Description
Total Hip Arthroplasty for the treatment of hip arthritis.
Intervention Type
Procedure
Intervention Name(s)
Physical Therapy
Intervention Description
Self-driven training according to the training plan instructed by physical therapist.
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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
Title
Harris Hip Score (HHS)
Description
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
Secondary Outcome Measure Information:
Title
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Pain
Description
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
Title
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Stiffness
Description
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
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Physical Function
Description
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
Title
30s Chair Stand Test
Description
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
Title
40m Fast-paced Walk Test
Description
How fast can a patient walk 40 meters measured in seconds. Lower scores mean a better outcome.
Time Frame
From baseline to one year
Title
Stair Climb Test
Description
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
Title
Grip Strength
Description
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
Title
Short Form 36 Health Survey Questionnaire (SF-36)
Description
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.
Time Frame
Baseline to one year
Title
painDetect
Description
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
Title
BMI
Description
Body Mass Index (BMI). Weight and height will be combined to report BMI in kg/m^2.
Time Frame
Baseline to one year
Title
Use of pain medication
Description
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
Time Frame
Baseline to one year
Title
Training diary
Description
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
Title
Range of motion in hip extension
Description
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
Title
Range of motion in hip flexion
Description
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
Title
Range of motion in hip inner rotation
Description
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
Title
Range of motion in hip outer rotation
Description
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
Title
Leg length discrepancy
Description
Leg length is measured from the highest point of ileum. Measurement is done by physical therapist and reported in centimeters.
Time Frame
Baseline to one year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aapo Talonpoika
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jari Arokoski
Organizational Affiliation
Kuopio University Hospital and Helsinki University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lauri Karttunen
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hannu Luomajoki
Organizational Affiliation
Zürcher Hochschule für Angewandte Wissenschaften ZHAW Departement Gesundheit, Institut für Physiotherapie
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jukka Huopio
Organizational Affiliation
Kuopio University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Antti Jaroma
Organizational Affiliation
Kuopio University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joonas Sirola
Organizational Affiliation
Kuopio University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Heikki Kröger
Organizational Affiliation
Kuopio University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
State/Province
Pohjois-Savo
ZIP/Postal Code
70029
Country
Finland

12. IPD Sharing Statement

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Randomized Controlled Trial of Total Hip Arthroplasty

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