Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-27 @ 5:13 AM
Study NCT ID:
NCT04691466
Status:
RECRUITING
Last Update Posted:
2020-12-31
First Post:
2020-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Efficacy of Joint Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}], 'ancestors': [{'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-30', 'studyFirstSubmitDate': '2020-12-27', 'studyFirstSubmitQcDate': '2020-12-30', 'lastUpdatePostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Body mass index (BMI)', 'timeFrame': '12 months', 'description': 'Measurement of weight in kilograms and height in meters to combined to report BMI in kg/m\\^2; to be measured twice, before intervention and after 12 months.'}, {'measure': 'Activity', 'timeFrame': '12 months', 'description': 'Measured with the Tegner Activity Score (TAS); 1-10 points, worst to best; to be measured twice, before intervention and after 12 months.'}], 'primaryOutcomes': [{'measure': "Assessment of the patients' opinion about their hip. Change over time", 'timeFrame': '12 months', 'description': 'Change between the following assessments as measured with the Hip disability and Osteoarthritis Outcome Score (HOOS) in patients undergoing total hip replacement; 0-100 points, worst to best; minimal clinical difference (MCD) = 10 points.'}, {'measure': "Assessment of the patients' opinion about their knee. Score change over time", 'timeFrame': '12 months', 'description': 'Change between the following assessments as measured with the Knee injury and Osteoarthritis Outcome Score (KOOS) in patients undergoing total knee replacement; 0-100 points, worst to best; minimal clinical difference (MCD) = 10 points.'}], 'secondaryOutcomes': [{'measure': 'Assessment of the quality of life. Score change over time', 'timeFrame': '12 months', 'description': 'Results of the generic PROM, the Short Form Health Survey-36 (SF-36) in both, patients undergoing hip and knee replacement; 0-100 points, worst to best.'}, {'measure': 'Pain intensity. Change over time', 'timeFrame': '12 months', 'description': 'Measured with the Visual Analog Scale (VAS); 0-10 points, worst to best.'}, {'measure': 'Hip abductors muscle strength. Change over time', 'timeFrame': '12 months', 'description': "Determination of the Trendelenburg's sign in patients undergoing total hip replacement in following assessments; positive or negative."}, {'measure': 'Range of motion.', 'timeFrame': '12 months', 'description': 'Assessment of range of motion in hips and knees, respectively, in following assessments; degrees.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Replacement', 'Arthroplasty', 'Patient-relevant outcome measure (PROM)', 'KOOS', 'HOOS'], 'conditions': ['Osteoarthritis, Knee', 'Osteoarthritis, Hip']}, 'descriptionModule': {'briefSummary': 'Patient-related outcomes were originally designed to measure outcomes in clinical studies. They were not developed to predict outcomes, however, different studies showed close association between values achieved preoperatively and postoperative outcomes. The aim of the present trial is to identify patients with satisfactory and unsatisfactory outcomes after joint replacement and to investigate whether there are any potential predicting potential in preoperative results of the patient-related outcomes and if there exist other predicting factors for functional recovery or treatment failure after joint replacement surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult population with osteoarthritis of the hip or knee.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with primary or secondary hip- and knee osteoarthritis undergoing joint replacement surgery.\n\nExclusion Criteria:\n\n1. An inability to understand the Polish language,\n2. Presence of neuromuscular disease and cognitive impairment,\n3. Having a prosthesis in another joint of the ipsilateral or contralateral lower limb placed within 6 months before the current surgery,\n4. Having rheumatoid arthritis,\n5. Symptoms in several joints (hip, knee or ankle) with expected total joint arthroplasty within 1 year.'}, 'identificationModule': {'nctId': 'NCT04691466', 'acronym': 'SEVERE', 'briefTitle': 'Study Evaluating the Efficacy of Joint Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Nicolaus Copernicus University'}, 'officialTitle': 'Assessment of Clinical Outcome Following Total Hip and Knee Replacement', 'orgStudyIdInfo': {'id': 'WN758'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIP_R', 'description': 'Patients undergoing hip replacement surgery', 'interventionNames': ['Procedure: Joint replacement']}, {'label': 'KNEE_R', 'description': 'Patients undergoing knee replacement surgery', 'interventionNames': ['Procedure: Joint replacement']}], 'interventions': [{'name': 'Joint replacement', 'type': 'PROCEDURE', 'otherNames': ['Joint arthroplasty'], 'description': 'Routinely performed hip- or knee replacement', 'armGroupLabels': ['HIP_R', 'KNEE_R']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PL-85-067', 'city': 'Bydgoszcz', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Przemysław T Tomasz, MD, PhD', 'role': 'CONTACT', 'email': 'P.Paradowski@cm.umk.pl', 'phone': '+48575908432'}, {'name': 'Marek K Gojło, MD, PhD', 'role': 'CONTACT', 'email': 'marekgojlo@gmail.com', 'phone': '+48503084950'}], 'facility': 'Ludwik Rydygier Collegium Medicum, Faculty of Health Sciences, Jagiellońska 13/15', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}], 'centralContacts': [{'name': 'Przemysław T Paradowski, MD, PhD', 'role': 'CONTACT', 'email': 'P.Paradowski@cm.umk.pl', 'phone': '+48575908432'}, {'name': 'Marek K Gojło, MD, PhD', 'role': 'CONTACT', 'email': 'marekgojlo@gmail.com', 'phone': '+48503084950'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nicolaus Copernicus University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Warmia and Mazury Oncology Centre', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D.', 'investigatorFullName': 'Przemyslaw Paradowski', 'investigatorAffiliation': 'Nicolaus Copernicus University'}}}}