Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:32 AM
Study NCT ID:
NCT04684160
Status:
UNKNOWN
Last Update Posted:
2020-12-24
First Post:
2020-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-21', 'studyFirstSubmitDate': '2020-12-16', 'studyFirstSubmitQcDate': '2020-12-21', 'lastUpdatePostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline Knee Society Score (KSS) at 3 and 5 years', 'timeFrame': 'Preoperative and Postoperative 3, 5 years', 'description': 'Patient-reported Outcome measure; The lower, the worse. Range: 0-200'}, {'measure': 'Change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 3 and 5 years', 'timeFrame': 'Preoperative and Postoperative 3, 5 years', 'description': 'Patient-reported Outcome measure; The higher, the worse. Range: 0-96'}, {'measure': 'Central Sensitization Index (CSI)', 'timeFrame': 'Postoperative 3 years', 'description': 'Questionnaire of evaluating how much the patients are sensitized on the pain. The higher, the worse. Range: 0-100'}, {'measure': 'Central Sensitization Index (CSI)', 'timeFrame': 'Postoperative 5 years', 'description': 'Questionnaire of evaluating how much the patients are sensitized on the pain. The higher, the worse. Range: 0-100'}, {'measure': 'Radiological outcomes', 'timeFrame': 'Postoperative 3 years', 'description': 'Measurements of radiological angles'}, {'measure': 'Radiological outcomes', 'timeFrame': 'Postoperative 5 years', 'description': 'Measurements of radiological angles'}], 'primaryOutcomes': [{'measure': 'Forgotten joint score', 'timeFrame': 'Postoperative 3 years', 'description': 'Questionnaire of evaluating how much the patients are aware of their operate joint during daily activities. The higher, the worse. Range: 0-100'}, {'measure': 'Crepitus', 'timeFrame': 'Postoperative 3 years', 'description': 'Any grating, crackling or popping sensation around knee when moving a joint'}], 'secondaryOutcomes': [{'measure': 'Forgotten joint score', 'timeFrame': 'Postoperative 5 years', 'description': 'Questionnaire of evaluating how much the patients are aware of their operate joint during daily activities. The higher, the worse. Range: 0-100'}, {'measure': 'Crepitus', 'timeFrame': 'Postoperative 5 years', 'description': 'Any grating, crackling or popping sensation around knee when moving a joint'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee', 'Arthropathy of Knee', 'Joint Awareness']}, 'descriptionModule': {'briefSummary': "Comparison of postoperative patient's joint awareness as well as clinical and radiological outcomes between fixed- and mobile-bearing total knee arthroplasty of which the prosthesis is coated with Titanium-nitride.", 'detailedDescription': 'Despite numerous comparison studies between mobile- and fixed-bearing TKA as well as several comparison studies regarding clinical and radiological outcomes using titanium-nitride(TiN) prosthesis, there has been no study on postoperative joint awareness despite mobile- and fixed-bearing TKA using TiN prosthesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with knee joint advanced osteoarthritis\n* Age over 55 years old\n* Scheduled to undergo primary total knee arthroplasty\n\nExclusion Criteria:\n\n* Post-traumatic or inflammatory osteoarthritis\n* Those who undertook previous ligamentous surgery\n* Those who do not understand and give answers to a survey'}, 'identificationModule': {'nctId': 'NCT04684160', 'briefTitle': 'Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses', 'orgStudyIdInfo': {'id': 'CUKorea MB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fixed-bearing group', 'interventionNames': ['Device: Fixed-bearing TKA']}, {'type': 'EXPERIMENTAL', 'label': 'Mobile-bearing group', 'interventionNames': ['Device: Mobile-bearing TKA']}], 'interventions': [{'name': 'Fixed-bearing TKA', 'type': 'DEVICE', 'armGroupLabels': ['Fixed-bearing group']}, {'name': 'Mobile-bearing TKA', 'type': 'DEVICE', 'armGroupLabels': ['Mobile-bearing group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea Seoul St Mary's hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yong In, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': "Seoul St. Mary's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yong In', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}