Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-17 @ 11:03 PM
Study NCT ID:
NCT03032133
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2017-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Control After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-11', 'studyFirstSubmitDate': '2017-01-24', 'studyFirstSubmitQcDate': '2017-01-24', 'lastUpdatePostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain', 'timeFrame': 'daily until day 7 after surgery', 'description': 'Pain on Visual Analog Scale'}], 'secondaryOutcomes': [{'measure': 'analgetics', 'timeFrame': 'daily until day 7 after surgery', 'description': 'Use of additional analgetics'}, {'measure': 'Mobility', 'timeFrame': 'daily until day 7 after surgery', 'description': 'grade of mobility'}, {'measure': 'Function', 'timeFrame': 'preoperative, 3 month, 1 year', 'description': 'Knee Society Score'}, {'measure': 'Patient reported outcome', 'timeFrame': 'preoperative, 3 month, 1 year', 'description': 'Oxford Knee Score'}, {'measure': 'Quality of Life', 'timeFrame': 'preoperative, 3 month, 1 year', 'description': 'EQ 5D'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total Knee Arthroplasty', 'Total Knee Replacement', 'Outcome', 'Results', 'Pain'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Patients are randomized to receive pain control after Total Knee Arthroplasty with either a regional pain catheter or a local intraarticular pain catheter. Pain, analgetic use and mobility is asessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication to Total Knee Arthroplasty\n* Signed informed consent\n\nExclusion Criteria:\n\n* Chronic pain\n* Allergy against local anaesthetics\n* Not understanding study or questionnaires'}, 'identificationModule': {'nctId': 'NCT03032133', 'briefTitle': 'Pain Control After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Pain After Total Knee Arthroplasty With Either Regional or Local Pain Katheter', 'orgStudyIdInfo': {'id': 'TKA pain'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Regional pain control', 'description': 'Regional pain catheter', 'interventionNames': ['Procedure: Regional pain control']}, {'type': 'EXPERIMENTAL', 'label': 'Local pain control', 'description': 'Local intraarticular pain catheter', 'interventionNames': ['Procedure: Local pain control']}], 'interventions': [{'name': 'Regional pain control', 'type': 'PROCEDURE', 'description': 'Regional pain catheter', 'armGroupLabels': ['Regional pain control']}, {'name': 'Local pain control', 'type': 'PROCEDURE', 'description': 'Local intraarticular pain catheter', 'armGroupLabels': ['Local pain control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Carl Gustav Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'overallOfficials': [{'name': 'Jörg Lützner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TU Dresden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mathys Ltd Bettlach', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}