Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-27 @ 10:18 PM
Study NCT ID:
NCT05093361
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2018-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial of Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019644', 'term': 'Arthroplasty, Replacement, Hip'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-22', 'studyFirstSubmitDate': '2018-12-10', 'studyFirstSubmitQcDate': '2021-10-13', 'lastUpdatePostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': 'From baseline to one year', '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.\n\nThe 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.'}, {'measure': 'Harris Hip Score (HHS)', 'timeFrame': 'From baseline to one year', 'description': 'The Harris Hip Score (HHS) is a clinician-based outcome measure frequently used for the evaluation of patients following a total hip arthroplasty.\n\nFour 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).\n\nThe survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.'}], 'secondaryOutcomes': [{'measure': 'The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Pain', 'timeFrame': 'From baseline to one year', '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.\n\nThe WOMAC measures five items for pain (score range 0-20). Higher scores indicate worse pain.'}, {'measure': 'The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Stiffness', 'timeFrame': 'From baseline to one year', '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.\n\nThe WOMAC measures two items for stiffness (score range 0-8). Higher scores indicate worse stiffness.'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Physical Function', 'timeFrame': 'From baseline to one year', '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.\n\nThe 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.'}, {'measure': '30s Chair Stand Test', 'timeFrame': 'From baseline to one year', 'description': 'How many times a patient can stand up and sit down on a chair in 30 seconds. Higher scores mean a better outcome.'}, {'measure': '40m Fast-paced Walk Test', 'timeFrame': 'From baseline to one year', 'description': 'How fast can a patient walk 40 meters measured in seconds. Lower scores mean a better outcome.'}, {'measure': 'Stair Climb Test', 'timeFrame': 'Baseline to one year', 'description': 'The time (in seconds) it takes to ascend and descend a flight of stairs. Lower scores mean a better outcome.'}, {'measure': 'Grip Strength', 'timeFrame': 'Baseline to one year', '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.'}, {'measure': 'Short Form 36 Health Survey Questionnaire (SF-36)', 'timeFrame': 'Baseline to one year', '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.\n\nIt comprises 36 questions which cover eight domains of health:\n\n1. Limitations in physical activities because of health problems.\n2. Limitations in social activities because of physical or emotional problems\n3. Limitations in usual role activities because of physical health problems\n4. Bodily pain\n5. General mental health (psychological distress and well-being)\n6. Limitations in usual role activities because of emotional problems\n7. Vitality (energy and fatigue)\n8. General health perceptions\n\nPatients or individuals are asked to fill out the questionnaire (tick boxes) by themselves and then it is scored by a clinician or researcher.\n\nScores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high QOL.'}, {'measure': 'painDetect', 'timeFrame': 'Baseline to one year', '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.'}, {'measure': 'BMI', 'timeFrame': 'Baseline to one year', 'description': 'Body Mass Index (BMI). Weight and height will be combined to report BMI in kg/m\\^2.'}, {'measure': 'Use of pain medication', 'timeFrame': 'Baseline to one year', 'description': 'Rate of pain medication use (paracetamol, NSAID and opioid pain medication) in four stage rating.\n\n1. Not at all\n2. Few days a month\n3. Few days a week\n4. Daily'}, {'measure': 'Training diary', 'timeFrame': 'Baseline to one year', '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.'}, {'measure': 'Range of motion in hip extension', 'timeFrame': 'Baseline to one year', 'description': 'Measurement of hip extension in side lying position. Measurement is done by physical therapist with a goniometer and it is reported in degrees.'}, {'measure': 'Range of motion in hip flexion', 'timeFrame': 'Baseline to one year', 'description': 'Measurement of hip flexion in side lying position. Measurement is done by physical therapist with a goniometer and it is reported in degrees.'}, {'measure': 'Range of motion in hip inner rotation', 'timeFrame': 'Baseline to one year', 'description': 'Measurement of hip inner rotation in supine position. Measurement is done by physical therapist with a goniometer and it is reported in degrees.'}, {'measure': 'Range of motion in hip outer rotation', 'timeFrame': 'Baseline to one year', 'description': 'Measurement of hip inner rotation in supine position. Measurement is done by physical therapist with a goniometer and it is reported in degrees.'}, {'measure': 'Leg length discrepancy', 'timeFrame': 'Baseline to one year', 'description': 'Leg length is measured from the highest point of ileum. Measurement is done by physical therapist and reported in centimeters.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hip Arthritis', 'Total Hip Arthroplasty', 'THA', 'Conservative Treatment'], 'conditions': ['Hip Arthritis', 'Total Hip Arthroplasty (THA)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hip osteoarthritis that is in X-ray pictures ≥2 in Kellgren - Lawrence classification\n* Primary osteoarthritis\n* Patients symptoms of hip osteoarthritis are so severe, that an experienced orthopedist would suggest total hip arthroplasty as a treatment\n\nExclusion Criteria:\n\n* Patients symptoms are so severe that total hip arthroplasty should be done within the next three months\n* ASA \\> 3 (ASA physical status classification system)\n* Normal contraindications to surgery\n* Previous surgery to the same hip that has the osteoarthritis (including total hip arthroplasty, surgery for fracture, osteotomy, arthroscopy)\n* The referring orthopedist has placed the patient in line for hip arthroplasty\n* Secondary osteoarhritis'}, 'identificationModule': {'nctId': 'NCT05093361', 'briefTitle': 'Randomized Controlled Trial of Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': 'Randomized Controlled Trial of Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': '5203108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Operative Treatment', 'description': 'Total Hip Arthroplasty', 'interventionNames': ['Procedure: Total Hip Arthroplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conservative Treatment', 'description': 'Physical therapy', 'interventionNames': ['Procedure: Physical Therapy']}], 'interventions': [{'name': 'Total Hip Arthroplasty', 'type': 'PROCEDURE', 'description': 'Total Hip Arthroplasty for the treatment of hip arthritis.', 'armGroupLabels': ['Operative Treatment']}, {'name': 'Physical Therapy', 'type': 'PROCEDURE', 'description': 'Self-driven training according to the training plan instructed by physical therapist.', 'armGroupLabels': ['Conservative Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70029', 'city': 'Kuopio', 'state': 'Northern Savonia', 'country': 'Finland', 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}], 'overallOfficials': [{'name': 'Aapo Talonpoika', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kuopio University Hospital'}, {'name': 'Jari Arokoski', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kuopio University Hospital and Helsinki University Hospital'}, {'name': 'Lauri Karttunen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kuopio University Hospital'}, {'name': 'Hannu Luomajoki', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zürcher Hochschule für Angewandte Wissenschaften ZHAW Departement Gesundheit, Institut für Physiotherapie'}, {'name': 'Jukka Huopio', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kuopio University Hospital'}, {'name': 'Antti Jaroma', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kuopio University Hospital'}, {'name': 'Joonas Sirola', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kuopio University Hospital'}, {'name': 'Heikki Kröger', 'role': 'STUDY_CHAIR', 'affiliation': 'Kuopio University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}