Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-03-02 @ 5:52 PM
Study NCT ID:
NCT02663804
Status:
COMPLETED
Last Update Posted:
2018-03-08
First Post:
2016-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Knee Arthroplasty: Relation Between Patient Satisfaction and Implant Geometry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 380}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-07', 'studyFirstSubmitDate': '2016-01-07', 'studyFirstSubmitQcDate': '2016-01-21', 'lastUpdatePostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Satisfaction', 'timeFrame': 'Preop', 'description': 'Determining patient specific factors by use of validated questionnaires'}, {'measure': 'Patient Satisfaction', 'timeFrame': '3 months postoperative', 'description': 'Determining patient specific factors by use of validated questionnaires'}, {'measure': 'Patient Satisfaction', 'timeFrame': '6 months postoperative', 'description': 'Determining patient specific factors by use of validated questionnaires'}, {'measure': 'Patient Satisfaction', 'timeFrame': '1 year postoperative', 'description': 'Determining patient specific factors by use of validated questionnaires'}, {'measure': 'Patient Satisfaction', 'timeFrame': '2 years postoperative', 'description': 'Determining patient specific factors by use of validated questionnaires'}]}, 'conditionsModule': {'keywords': ['Total Knee Arthroplasty', 'Patient Satisfaction', 'PROMs', 'Implant Design'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'A RCT (randomized controlled trial) comparing 3 different TKA (total knee arthroplasty) implant designs and investigating the relation between patient satisfaction and the implant geometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients of all ages, scheduled for TKA\n* Primary osteoarthritis of the knee joint\n* post traumatic arthritis\n* rheumatoid arthritis\n\nExclusion Criteria:\n\n* previous TKA in same joint\n* evidence of neuromuscular or neurosensory deficiency\n* immunologic suppression'}, 'identificationModule': {'nctId': 'NCT02663804', 'briefTitle': 'Total Knee Arthroplasty: Relation Between Patient Satisfaction and Implant Geometry', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Total Knee Arthroplasty: Relation Between Patient Satisfaction and Implant Geometry', 'orgStudyIdInfo': {'id': 'EC/2014/0023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Implant design 1', 'description': 'Journey II, BCS, Smith\\&Nephew', 'interventionNames': ['Device: Total Knee Arthroplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Implant design 2', 'description': 'Persona, Zimmer', 'interventionNames': ['Device: Total Knee Arthroplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Implant design 3', 'description': 'Unity, Corin', 'interventionNames': ['Device: Total Knee Arthroplasty']}], 'interventions': [{'name': 'Total Knee Arthroplasty', 'type': 'DEVICE', 'otherNames': ['Journey II, Smith&Nephew', 'Persona, Zimmer', 'Unity, Corin'], 'armGroupLabels': ['Implant design 1', 'Implant design 2', 'Implant design 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Ghent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}