Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-29 @ 4:49 PM
Study NCT ID:
NCT04681404
Status:
UNKNOWN
Last Update Posted:
2023-03-30
First Post:
2020-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balance After Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-29', 'studyFirstSubmitDate': '2020-02-12', 'studyFirstSubmitQcDate': '2020-12-22', 'lastUpdatePostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Center of pressure track (COPT)', 'timeFrame': 'Before surgery', 'description': 'Posturographic Parameter'}, {'measure': 'Center of pressure track (COPT)', 'timeFrame': 'Day 3-7 after surgery', 'description': 'Posturographic Parameter'}, {'measure': 'Center of pressure track (COPT)', 'timeFrame': '3 months after surgery', 'description': 'Posturographic Parameter'}, {'measure': 'Center of pressure track (COPT)', 'timeFrame': '1 year after surgery', 'description': 'Posturographic Parameter'}], 'secondaryOutcomes': [{'measure': 'Functional reach test', 'timeFrame': 'Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery'}, {'measure': 'Timed up and go - test', 'timeFrame': 'Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score', 'timeFrame': 'Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery', 'description': 'Scale: Points, Minimum: 0, Maximum: 100, higher score means better outcome'}, {'measure': 'EQ-5D - Score', 'timeFrame': 'Before surgery; 1 year after surgery', 'description': 'Scale: Points, Minimum: 1, Maximum: \\<0, higher score means better outcome'}, {'measure': '10 m Walking test', 'timeFrame': 'Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery'}, {'measure': 'WOMAC Score', 'timeFrame': 'Before surgery; 1 year after surgery, higher score means better outcome', 'description': 'Scale: Points, Minimum: 0, Maximum: 240, higher score means worse outcome'}, {'measure': 'Forgotten Joint Score', 'timeFrame': 'Before surgery; 1 year after surgery', 'description': 'Scale: Points, Minimum: 0, Maximum: 100, higher score means better outcome'}, {'measure': 'Oxford Knee Score', 'timeFrame': 'Before surgery; 1 year after surgery', 'description': 'Scale: Points, Minimum: 12, Maximum: 60, higher score means worse outcome'}, {'measure': 'Knee Society Score', 'timeFrame': 'Before surgery; 1 year after surgery', 'description': 'Scale: Points, Minimum: 0, Maximum: 100, higher score means better outcome'}, {'measure': 'The University of California at Los Angeles Activity Score', 'timeFrame': 'Before surgery; 1 year after surgery', 'description': 'Scale: Points, Minimum: 1, Maximum: 10, higher score means better outcome'}, {'measure': 'Area of Sway', 'timeFrame': 'Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery', 'description': 'Posturographic Parameter'}, {'measure': 'Frequency of Sway', 'timeFrame': 'Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery', 'description': 'Posturographic Parameter'}, {'measure': 'Harmony Index', 'timeFrame': 'Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery', 'description': 'Posturographic Parameter'}, {'measure': 'Stability energy', 'timeFrame': 'Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery', 'description': 'Posturographic Parameter'}, {'measure': 'Movement control', 'timeFrame': 'Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery', 'description': 'Posturographic Parameter'}, {'measure': 'Feedback (visual, somatosensoric, vestibular)', 'timeFrame': 'Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery', 'description': 'Posturographic Parameter'}, {'measure': 'Weight Distribution Index', 'timeFrame': 'Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery', 'description': 'Posturographic Parameter'}, {'measure': 'Fulfillment of Tests', 'timeFrame': 'Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery', 'description': 'Posturographic Parameter'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postural Balance', 'Knee Arthroplasty', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'Evaluation of patients before and after knee arthroplasty regarding balance, function and quality of life. Comparison of total and unicompartmental knee arthroplasty. Comparison of the primary outcome parameter and selected secondary outcome parameters to healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary gonarthrosis\n* planned TKA or UKA\n* adequate cognitive and lingual competence\n* informed consent\n\nExclusion Criteria:\n\n* TKA or UKA revision\n* Surgery after trauma\n* Rheumatic disease\n* Neurologic disease\n* previous arthroplasty of the lower extremity (\\<9 months)\n* cardiovascular disease\n* restricted weight bearing of the lower extremity after surgery'}, 'identificationModule': {'nctId': 'NCT04681404', 'briefTitle': 'Balance After Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Kepler University of Linz'}, 'officialTitle': 'Assessment of Balance, Function and Quality of Life in Patients Before and After Knee Replacement', 'orgStudyIdInfo': {'id': 'PMR_Knee TKA 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Total Knee Arthroplasty (TKA)', 'description': 'Patients intended to undergo surgery for total knee arthroplasty', 'interventionNames': ['Procedure: Knee Arthroplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Unicompartmental Knee Arthroplasty (UKA)', 'description': 'Patients intended to undergo surgery for unicompartmental knee arthroplasty', 'interventionNames': ['Procedure: Knee Arthroplasty']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy Control'}], 'interventions': [{'name': 'Knee Arthroplasty', 'type': 'PROCEDURE', 'description': 'Comparison of TKA, UKA and healthy controls in relation to balance, function and QOL', 'armGroupLabels': ['Total Knee Arthroplasty (TKA)', 'Unicompartmental Knee Arthroplasty (UKA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4020', 'city': 'Linz', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christian Mittermaier, M.D.', 'role': 'CONTACT', 'email': 'christian.mittermaier@kepleruniklinikum.at'}], 'facility': 'Kepler University Hospital', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}], 'centralContacts': [{'name': 'Christian Mittermaier, Dr', 'role': 'CONTACT', 'email': 'christian.mittermaier@kepleruniklinikum.at', 'phone': '+43 5 7680 83', 'phoneExt': '73779'}], 'overallOfficials': [{'name': 'Christian Mittermaier, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kepler University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Kepler University of Linz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kepler University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Christian Mittermaier, MD', 'investigatorFullName': 'Christian Mittermaier', 'investigatorAffiliation': 'Johannes Kepler University of Linz'}}}}