Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-05 @ 4:54 PM
Study NCT ID:
NCT02067533
Status:
COMPLETED
Last Update Posted:
2015-05-12
First Post:
2014-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Flexion Versus Extension Soft Tissue Repair in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
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[{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexion Position', 'description': 'soft tissue repair in flexion position'}, {'id': 'OG001', 'title': 'Extension Position', 'description': 'soft tissue repair in extension position'}], 'classes': [{'categories': [{'measurements': [{'value': '119', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '120', 'spread': '5.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year after total knee arthroplasty', 'description': 'in all patients ROM is measure 1 year after knee surgery by one of the study investigator using goniometer.', 'unitOfMeasure': 'degree', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Flexion Position', 'description': 'soft tissue repair in flexion position'}, {'id': 'FG001', 'title': 'Extension Position', 'description': 'soft tissue repair in extension position'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Flexion Position', 'description': 'soft tissue repair in flexion position'}, {'id': 'BG001', 'title': 'Extension Position', 'description': 'soft tissue repair in extension position'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '67.5', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '67.14', 'spread': '4.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'lastUpdateSubmitDate': '2015-05-08', 'studyFirstSubmitDate': '2014-02-18', 'resultsFirstSubmitDate': '2014-12-25', 'studyFirstSubmitQcDate': '2014-02-18', 'lastUpdatePostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-08', 'studyFirstPostDateStruct': {'date': '2014-02-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Range of Motion (ROM)', 'timeFrame': '1 year after total knee arthroplasty', 'description': 'in all patients ROM is measure 1 year after knee surgery by one of the study investigator using goniometer.'}]}, 'conditionsModule': {'conditions': ['Total Knee Arthroplasty(TKA)', 'Total Knee Replacement']}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to determine the influence of position of soft tissue repair (flexion versus extension) in post operative range of motion(ROM) and functional outcome in patients who underwent primary total knee arthroplasty (TKA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* were individuals with osteoarthritis indicated for primary Total Knee Arthroplasty\n\nExclusion Criteria:\n\n* previous fracture in thigh\n* previous fracture in leg\n* previous high tibial osteotomy'}, 'identificationModule': {'nctId': 'NCT02067533', 'briefTitle': 'Flexion Versus Extension Soft Tissue Repair in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'orgStudyIdInfo': {'id': '390187'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'flexion position', 'interventionNames': ['Procedure: soft tissue repair in flexion position']}, {'type': 'EXPERIMENTAL', 'label': 'extension position', 'interventionNames': ['Procedure: soft tissue repair in extension position']}], 'interventions': [{'name': 'soft tissue repair in flexion position', 'type': 'PROCEDURE', 'armGroupLabels': ['flexion position']}, {'name': 'soft tissue repair in extension position', 'type': 'PROCEDURE', 'armGroupLabels': ['extension position']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8174673461', 'city': 'Isfahan', 'state': 'Isfahan', 'country': 'Iran', 'facility': 'Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, Iran', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopedic surgery resident,Orthopedic department,Alzahra hospital,Isfahan University of Medical Sciences,Isfahan,Iran', 'investigatorFullName': 'Amin Nemati', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}