Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-27 @ 10:27 AM
Study NCT ID:
NCT04469166
Status:
COMPLETED
Last Update Posted:
2020-07-13
First Post:
2020-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of the Use of Tourniquet in Total Knee Arthroplasty on the Clinical and Functional Outcomes With 5 Years of Follow up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014111', 'term': 'Tourniquets'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blinded study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-10', 'studyFirstSubmitDate': '2020-07-03', 'studyFirstSubmitQcDate': '2020-07-10', 'lastUpdatePostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee society score', 'timeFrame': 'This score was assessed at 5 years postoperatively', 'description': 'Knee society score for functional outcome which will be low in poor function and high in best function'}, {'measure': 'Knee injury and osteoarthritis outcome scores', 'timeFrame': 'This score was assessed at 5 years post-operatively', 'description': 'Knee injury and osteoarthritis outcome score which will be low in poor function and high in better function'}, {'measure': 'VAS for thigh pain', 'timeFrame': 'This score was assessed at 1st day post-operatively', 'description': 'Visual analogue scale for thigh pain which will be high in more pain and low in less pain'}], 'secondaryOutcomes': [{'measure': 'Post operative complications', 'timeFrame': 'These complications as bleeding, infection, Deep venous thrombosis and revision are assessed at postoperative period.', 'description': 'The complications can occurred after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tourniquet', 'Total knee arthroplasty', 'Clinical outcomes', 'Functional outcomes'], 'conditions': ['Use of Tourniquet in Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'This study is randomized controlled trial with 5 years follow up and involved 101 patients divided in two groups; group A in which tourniquet was used in total knee arthroplasty while group B in which tourniquet was not used. All these patients were analyzed for the clinical and functional outcome measures.', 'detailedDescription': 'In this study, investigators have primary outcome measures and secondary outcome measures which were assessed in multiple periods to see the effects of using tourniquet in total knee arthroplasty on the clinical and functional outcomes with follow up of 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Grade 3 and 4 osteoarthritis\n* age 55-80 years\n* patients agree to participate in the study\n\nExclusion Criteria:\n\n* Smoking\n* Diabetes mellitus .Symptomatic spinal pathology with moderate to severe cervical or lumbosacral spinal stenosis.\n* Hip pathology like osteoarthritis or fractures\n* Neuromuscular disorders\n* Blood dyscrasia or anticoagulant treatment .Body mass index equal to 30 or more.\n* Previous knee surgery or knee infection\n* Peripheral vascular disease\n* Rheumatoid arthritis\n* Hemoglobin less than 12 gram/deciliter'}, 'identificationModule': {'nctId': 'NCT04469166', 'briefTitle': 'Effects of the Use of Tourniquet in Total Knee Arthroplasty on the Clinical and Functional Outcomes With 5 Years of Follow up', 'organization': {'class': 'OTHER', 'fullName': 'Hawler Medical University'}, 'officialTitle': 'Effects of the Use of Tourniquet in Total Knee Arthroplasty on the Clinical and Functional Outcomes With 5 Years of Follow up: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HMU/Sherwan 10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tourniquet', 'description': 'Group of tourniquet', 'interventionNames': ['Procedure: tourniquet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No tourniquet', 'description': 'Group of no tourniquet', 'interventionNames': ['Procedure: No tourniquet']}], 'interventions': [{'name': 'tourniquet', 'type': 'PROCEDURE', 'description': 'Use of tourniquet', 'armGroupLabels': ['Tourniquet']}, {'name': 'No tourniquet', 'type': 'PROCEDURE', 'description': 'No use of tourniquet', 'armGroupLabels': ['No tourniquet']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Upon the publication of our study, I will decide to share my patients data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hawler Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of orthopedic surgery', 'investigatorFullName': 'Sherwan Ahmed Ali Hamawandi', 'investigatorAffiliation': 'Hawler Medical University'}}}}