Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT04496102
Status:
UNKNOWN
Last Update Posted:
2020-08-03
First Post:
2020-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cemented vs Cementless in Bilateral TKA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-30', 'studyFirstSubmitDate': '2020-07-17', 'studyFirstSubmitQcDate': '2020-07-30', 'lastUpdatePostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare mean Forgotten joint score between 2 groups', 'timeFrame': 'at 1 year', 'description': 'The total score ranges from 0-100, where a high score is the best outcome'}], 'secondaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'intra-operative assessment'}, {'measure': 'modified the Western Ontario and McMaster Universities Osteoarthritis Index score', 'timeFrame': 'post-op 2, 6 week, 3, 6, 12 month', 'description': 'The total score ranges from 0-96, where a high score is the worse outcome'}, {'measure': 'Pain level', 'timeFrame': 'Once daily 1-14 days after surgery then once a week until 3 months', 'description': 'VAS for pain (0-100)'}, {'measure': 'Range of knee motion', 'timeFrame': 'post-op 2, 6 week, 3, 6, 12 month', 'description': 'flexion and extension (degrees) which measured by long goniometer'}, {'measure': 'complication', 'timeFrame': 'until 1 year after surgery', 'description': 'such as fracture, infection, stiffness'}, {'measure': 'Radiological finding', 'timeFrame': 'post-op 2, 6 week, 3, 6, 12 month', 'description': 'Radiolucent line at femoral, tibial and patellar components which measured from radiolucent intervals (measured in millimetres) between the cement or prostheses and the bone according to the knee society total knee arthroplasty roentgenographic evaluation and scoring system'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['cemented', 'cementless', 'total knee arthroplasty', 'short term outcome', 'functional outcome'], 'conditions': ['Osteoarthritis', 'Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'To compare the functional outcomes between cemented and cementless TKA in bilateral knee replacement patient.', 'detailedDescription': 'To compare early functional outcomes, radiographic finding and operative time between cemented and cementless modern implant in sequential bilateral total kee arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA status 1 or 2\n* Diagnosed with bilateral osteoarthritis of the knees\n* Participant understand and consent to the protocol of the trial\n\nExclusion Criteria:\n\n* Morbid obesity (BMI \\>40)\n* Inflammatory arthritis\n* Osteoporosis\n* Metabolic bone disease\n* Bone defect that seen from radiographs'}, 'identificationModule': {'nctId': 'NCT04496102', 'briefTitle': 'Cemented vs Cementless in Bilateral TKA', 'organization': {'class': 'OTHER', 'fullName': 'Thammasat University'}, 'officialTitle': 'Comparison of Efficacy Between Cemented and Cementless Total Knee Arthroplasty in Bilateral Total Knee Arthroplasty. A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'OrthoTU12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cemented TKA', 'description': 'Cemented TKA (Triathlon, Stryker) include patellar resurfacing', 'interventionNames': ['Device: Triathlon']}, {'type': 'EXPERIMENTAL', 'label': 'Cementless TKA', 'description': 'Cementless TKA (Triathlon Tritanium, Stryker) include patellar resurfacing', 'interventionNames': ['Device: Triathlon']}], 'interventions': [{'name': 'Triathlon', 'type': 'DEVICE', 'description': 'Modern TKA design (Triathlon) with patellar resurfacing', 'armGroupLabels': ['Cemented TKA', 'Cementless TKA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12120', 'city': 'Khlong Luang', 'state': 'Changwat Pathum Thani', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'supakit kanitnate, M.D.', 'role': 'CONTACT', 'email': 'naypeng@hotmail.com', 'phone': '+66899853635'}, {'name': 'Nattapol Tammachote, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Thammasat University', 'geoPoint': {'lat': 14.06467, 'lon': 100.64578}}], 'centralContacts': [{'name': 'Supakit Kanitnate, M.D.', 'role': 'CONTACT', 'email': 'naypeng@hotmail.com', 'phone': '+66899853635'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thammasat University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Supakit Kanitnate', 'investigatorAffiliation': 'Thammasat University'}}}}