Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2026-01-03 @ 7:13 PM
Study NCT ID:
NCT05349461
Status:
UNKNOWN
Last Update Posted:
2022-04-27
First Post:
2022-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Post-operative Knee Range of Motion and Functions Between Intraoperative Complete and Incomplete Patellofemoral Articular Contacts in Patients Undergoing Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2022-04-21', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee range of motion (ROM)', 'timeFrame': 'Change from baseline Knee range of motion (ROM) at 3 months, 6 months, and 12 months after surgery', 'description': 'Goniometer measure range of motion (minimum 0, maximum 145)'}, {'measure': 'Knee flexion', 'timeFrame': 'Change from baseline knee flexion at 3 months, 6 months, and 12 months after surgery', 'description': 'Goniometer measure knee flexion (minimum 135, maximum 145)'}, {'measure': 'Knee extension', 'timeFrame': 'Change from baseline knee extension at 3 months, 6 months, and 12 months after surgery', 'description': 'Goniometer measure knee extension (minimum -10, maximum 0)'}], 'secondaryOutcomes': [{'measure': 'Knee Society and Knee Society function score', 'timeFrame': 'Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery', 'description': 'Knee Society and Knee Society function score (minimum 0, maximum 200)'}, {'measure': 'New patellar score', 'timeFrame': 'Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery', 'description': 'New patellar score (minimum 0, maximum 30)'}, {'measure': 'Oxford knee score', 'timeFrame': 'Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery', 'description': 'Oxford knee score (minimum 0, maximum 48)'}, {'measure': 'Prevalence of anterior knee pain ,AKP', 'timeFrame': 'Change from baseline Prevalence of anterior knee pain ,AKP 3 months, 6 months, and 12 months after surgery', 'description': 'Prevalence of anterior knee pain ,AKP (minimum 0, maximum 10)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complete Contact', 'Incomplete Contact']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare clinical outcome in knee range of motion and functions between intraoperative complete and incomplete patellofemoral articular contacts'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty\n* Age 50-80 year\n\nExclusion Criteria:\n\n* Revision surgery\n* Bilateral total knee arthroplasty\n* History of patellar fracture\n* History of patellar chondromalacia\n* History of Patellar instability'}, 'identificationModule': {'nctId': 'NCT05349461', 'briefTitle': 'Comparison of Post-operative Knee Range of Motion and Functions Between Intraoperative Complete and Incomplete Patellofemoral Articular Contacts in Patients Undergoing Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Navamindradhiraj University'}, 'officialTitle': 'Comparison of Post-operative Knee Range of Motion and Functions Between Intraoperative Complete and Incomplete Patellofemoral Articular Contacts in Patients Undergoing Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'COA 010/2563'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Complete contact', 'interventionNames': ['Procedure: Complete patellofemoral articular contact']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Incomplete contact', 'interventionNames': ['Procedure: Incomplete patellofemoral articular contact']}], 'interventions': [{'name': 'Complete patellofemoral articular contact', 'type': 'PROCEDURE', 'description': 'The patellofemoral condition is in constant contact with the femoral trochlea when the knee is bent from 30 to 90 degrees during the No thumb test.', 'armGroupLabels': ['Complete contact']}, {'name': 'Incomplete patellofemoral articular contact', 'type': 'PROCEDURE', 'description': 'The patellofemoral condition is in no constant contact with the femoral trochlea when the knee is bent from 30 to 90 degrees during the No thumb test.', 'armGroupLabels': ['Incomplete contact']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10300', 'city': 'Dusit', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Navamindradhiraj University', 'geoPoint': {'lat': 13.7775, 'lon': 100.51977}}], 'overallOfficials': [{'name': 'Satit Thiengwittayaporn, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'satitthh@hotmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Navamindradhiraj University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Satit Thiengwittayaporn', 'investigatorAffiliation': 'Navamindradhiraj University'}}}}