Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT05045651
Status:
COMPLETED
Last Update Posted:
2021-09-16
First Post:
2021-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anterior Knee Pain Between Unisex Knee Prosthesis VS Gender Specific Knee Prosthesis Following MIS TKA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-12', 'studyFirstSubmitDate': '2021-08-29', 'studyFirstSubmitQcDate': '2021-09-12', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anterior knee pain', 'timeFrame': '4 years', 'description': 'Visual analog scale for pain ( 0= no pain to 10= maximum pain), incidence for anterior knee pain (percent)'}, {'measure': 'patellar tracking', 'timeFrame': '4 years', 'description': 'patellar tilt \\> 5 degrees and/or patellar shift\\> 5 mm= patellar maltracking'}], 'secondaryOutcomes': [{'measure': 'clinical outcome score', 'timeFrame': '4 years', 'description': 'knee society score (0-20= poor outcomes, 21-40=fair outcomes, 41-60= good outcomes, 61-80= very good outcomes, 81-100= excellent outcome)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anterior knee pain', 'gender knee prosthesis', 'patellar tracking', 'unisex knee prosthesis', 'total knee arthroplasty', 'patellar resurfacing'], 'conditions': ['Osteo Arthritis Knee', 'Knee Pain Chronic']}, 'descriptionModule': {'briefSummary': 'Unisex knee prosthesis and patient specific knee prosthesis has the same anterior knee pain and patellar tracking', 'detailedDescription': 'Background:The anterior knee pain (AKP) is one of major problem of TKA. The incidence of anterior knee after TKA was 4% to 49%. The cause of AKP after TKA from surgical technique errors including joint line elevation, instability, malalignment of prosthesis, and maltracking of patella. However, AKP still has presented even high volume surgeon that prosthesis had good alignment and good stability, one of the risk factor is female. Due to female has higher Q-angle, greater anteroposterior (AP)/mediolateral(ML) ratio, smaller anterior condyle, and trochlea has higher degree of valgus angle than male. Therefore, female should has AKP even surgery with good surgical technique. The gender specific knee prosthesis was design for female to restore Q-angle, reduce anteroposterior (AP)/mediolateral(ML) ratio for reducing overhang of femoral component, increase valgus angle of trochlea groove, and reduce thickness of anterior part of prosthesis for prevention overstuff with patella. For these reasons, the gender specific knee prosthesis should reduce AKP and improve patellar tracking in female. And there is no study to compare AKP and patellar tracking between Unisex knee prosthesis and gender specific knee prosthesis following minimally invasive surgery (MIS) TKA.\n\nInvestigators asked whether AKP and patellar tracking differ between unisex knee prosthesis and gender specific knee prosthesis following MIS TKA with patellar resurfacing.\n\nMethods:The participants were randomized into 2 groups (Gp) with computer program to make a list of random numbers of participant. Gp1 was gender specific knee prosthesis; consisted of 40 participants (40 knees) and Gp2 was unisex knee prosthesis; consisted of 40 participants (40 knees). The sample size was calculate base on anterior knee pain after TKA with a risk difference of 27% (3% versus 20%) (1,3). The 40 participants from each group would have 90% power at the 5% significant level.\n\nPatrticipants were follow up at 2 wks, 6 wks, 3 mo, 6mo, 1 year and 2 years. At each follow up, the % anterior knee pain, VAS for anterior knee pain were record. The knee society score also was recorded and compared between two group.\n\nAll participants were operated with same surgeon and same instrumentation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAymptomatic knee OA with\n\n* varus deformity \\< 30 degrees\n* range of motion \\> 90 degrees\n* flexion contracture \\< 20 degrees\n* recurvatum \\< 20 degrees\n\nExclusion Criteria:\n\n* gout\n* postraumatic arthritis\n* osteonecrosis of knee\n* inflammatory joint disease'}, 'identificationModule': {'nctId': 'NCT05045651', 'briefTitle': 'Anterior Knee Pain Between Unisex Knee Prosthesis VS Gender Specific Knee Prosthesis Following MIS TKA', 'organization': {'class': 'OTHER', 'fullName': 'Thammasat University'}, 'officialTitle': 'The Incidence of Anterior Knee Pain Between Unisex Knee Prosthesis and Gender Specific Knee Prosthesis Following Minimally Invasive Surgery Total Knee Arthroplasty: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MTU-EC-OT-1-005/55'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patient specific knee prosthesis', 'description': 'TKA with Gender Solution® posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA', 'interventionNames': ['Procedure: Gender Solution®posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA and standard posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA']}, {'type': 'EXPERIMENTAL', 'label': 'Unisex knee prosthesis', 'description': 'TKA with posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA', 'interventionNames': ['Procedure: Gender Solution®posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA and standard posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA']}], 'interventions': [{'name': 'Gender Solution®posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA and standard posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA', 'type': 'PROCEDURE', 'description': 'gender specific knee prosthesis:design for female to restore Q-angle, reduce anteroposterior (AP)/mediolateral(ML) ratio for reducing overhang of femoral component, increase valgus angle of trochlea groove, and reduce thickness of anterior part of prosthesis for prevention overstuff with patella. The standard TKA or unisex knee prosthesis was design for female and male.', 'armGroupLabels': ['Unisex knee prosthesis', 'patient specific knee prosthesis']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Boonchana Pongcharoen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of medicine, Thammasat university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thammasat University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated professor', 'investigatorFullName': 'Boonchana Pongcharoen', 'investigatorAffiliation': 'Thammasat University'}}}}