Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2026-02-22 @ 7:22 PM
Study NCT ID:
NCT01993758
Status:
UNKNOWN
Last Update Posted:
2014-05-22
First Post:
2013-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Lower Tourniquet Pressure During Total Knee Arthroplasty
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', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-20', 'studyFirstSubmitDate': '2013-11-19', 'studyFirstSubmitQcDate': '2013-11-19', 'lastUpdatePostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acquisition of bloodless surgical field just after skin incision', 'timeFrame': 'just after skin incision during operation', 'description': 'Dichotomous variable determined during operation by operator (Yes or No)'}], 'secondaryOutcomes': [{'measure': 'Failure of acquiring bloodless surgical field during operation', 'timeFrame': 'after skin incision through the point of tourniquet deflation'}, {'measure': 'Increasement of tourniquet pressure to acquire bloodless surgical field', 'timeFrame': 'after skin incision though the point of tourniquet deflation', 'description': 'We will increase the tourniquet pressure by 30mmHg from the initial tourniquet pressure, if we will fail to achieve bloodless surgical field during operation. The increasement of tourniquet pressure will be recorded if it will be needed during operation.'}, {'measure': 'Thigh pain on the site of tourniquet application', 'timeFrame': 'postoperative 2nd day', 'description': 'measured by 11-point numerical visual analog scale (VAS)and 5-Likert scale'}, {'measure': 'Knee pain', 'timeFrame': 'postoperative 2nd day', 'description': 'measured by 11-point numerical visual analog scale (VAS)and 5-Likert scale'}, {'measure': 'Skin problem on the site of tourniquet application', 'timeFrame': 'posteoperative 2nd day', 'description': 'It includes ecchymosis, bullae formation and skin necrosis.'}, {'measure': 'Nerve palsy', 'timeFrame': 'within 7 days after surgery'}, {'measure': 'symptomatic venous-thromboembolism', 'timeFrame': 'within 7 days after surgery', 'description': 'It includes deep vein thrombosis and pulmonary embolism which are symptomatic and diagnosed by confirmative test, such as CT angiogram.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tourniquet pressure', 'total knee arthroplasty'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '31159799', 'type': 'DERIVED', 'citation': 'Kim TK, Bamne AB, Sim JA, Park JH, Na YG. Is lower tourniquet pressure during total knee arthroplasty effective? A prospective randomized controlled trial. BMC Musculoskelet Disord. 2019 Jun 4;20(1):275. doi: 10.1186/s12891-019-2636-7.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to determine whether the lower tourniquet pressure, which is set by adding 120mmHg (millimeter of mercury) on the systolic blood pressure just before tourniquet inflation, are efficient and safe during total knee arthroplasty, compared with the conventional tourniquet pressure: 150mmHg above the systolic blood pressure before tourniquet inflation.', 'detailedDescription': 'We will compare the two groups of patients undergoing total knee arthroplasty, which the tourniquet pressure will be set differently: systolic blood pressure plus 120mmHg vs. systolic blood pressure plus 150mmHg, the conventional method, in terms of efficacy and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients undergoing total knee arthroplasty\n\nExclusion Criteria:\n\n* Systolic blood pressure measured at ward \\> 200mmHg\n* Thigh circumference \\> 78cm\n* Anesthesia other than spinal anesthesia\n* Simultaneous bilateral total knee arthroplasty\n* The patients who disagreed the enrollment of this study'}, 'identificationModule': {'nctId': 'NCT01993758', 'briefTitle': 'Efficacy of Lower Tourniquet Pressure During Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Efficacy of Using Lower Tourniquet Pressure During Total Knee Arthroplasty: Comparison With Conventional Tourniquet Pressure Group', 'orgStudyIdInfo': {'id': 'B-1310/221-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional tourniquet pressure', 'description': 'The patients in this group will undertake total knee arthroplasty under conventional tourniquet pressure, which will be set as the pressure added by 150mmHg on the last systolic blood pressure just before tourniquet inflation.', 'interventionNames': ['Procedure: Conventional tourniquet pressure']}, {'type': 'EXPERIMENTAL', 'label': 'Low tourniquet pressure', 'description': 'The patients in this group will undertake total knee arthroplasty under low tourniquet pressure, which will be set as the pressure added by 120mmHg on the last systolic blood pressure just before tourniquet inflation.', 'interventionNames': ['Procedure: Low tourniquet pressure']}], 'interventions': [{'name': 'Low tourniquet pressure', 'type': 'PROCEDURE', 'description': 'Tourniquet pressure set as 120mmHg above the systolic blood pressure just before tourniquet inflation', 'armGroupLabels': ['Low tourniquet pressure']}, {'name': 'Conventional tourniquet pressure', 'type': 'PROCEDURE', 'description': 'Tourniquet pressure set as 150mmHg above the systolic blood pressure just before tourniquet inflation', 'armGroupLabels': ['Conventional tourniquet pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'T K Kim, MD, PhD', 'role': 'CONTACT', 'email': 'osktk@snubh.org', 'phone': '82-31-787-7196'}, {'name': 'T K Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Joint Reconstruction Center, Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'T K Kim, MD, PhD', 'role': 'CONTACT', 'email': 'osktk@snubh.org', 'phone': '82-31-787-7196'}], 'overallOfficials': [{'name': 'T K Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Joint Reconstruction Center, Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}