Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-01-19 @ 10:22 AM
Study NCT ID:
NCT03256058
Status:
UNKNOWN
Last Update Posted:
2017-10-24
First Post:
2017-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tourniquet Application on 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-22', 'studyFirstSubmitDate': '2017-08-16', 'studyFirstSubmitQcDate': '2017-08-18', 'lastUpdatePostDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '48 hours post surgery', 'description': 'tested by Visual Analogue Scale'}], 'secondaryOutcomes': [{'measure': 'The rate of postoperative limb swelling', 'timeFrame': '24 hours post surgery, 48 hours post surgery', 'description': 'test the perimeter of the surgary limb at four fingers under the inguen,then Calculate the rate by formula (postoperative perimeter-preoperative perimeter)/preoperative perimeter'}, {'measure': 'Endothelin-1', 'timeFrame': 'one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation', 'description': 'tested by ELISA'}, {'measure': 'Nitric Oxide', 'timeFrame': 'one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation', 'description': 'tested by ELISA'}, {'measure': 'Lac', 'timeFrame': 'one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation', 'description': 'blood gas analysis mmol/L'}, {'measure': 'Hemoglobin', 'timeFrame': 'one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation', 'description': 'blood gas analysis g/L'}, {'measure': 'partial pressure of oxygen in artery', 'timeFrame': 'one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation', 'description': 'blood gas analysis mmHg'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tourniquets', 'Total Knee Arthroplasty']}, 'referencesModule': {'references': [{'pmid': '17403789', 'type': 'RESULT', 'citation': 'Rama KR, Apsingi S, Poovali S, Jetti A. Timing of tourniquet release in knee arthroplasty. Meta-analysis of randomized, controlled trials. J Bone Joint Surg Am. 2007 Apr;89(4):699-705. doi: 10.2106/JBJS.F.00497.'}, {'pmid': '23018303', 'type': 'RESULT', 'citation': 'Hernandez AJ, Almeida AM, Favaro E, Sguizzato GT. The influence of tourniquet use and operative time on the incidence of deep vein thrombosis in total knee arthroplasty. Clinics (Sao Paulo). 2012 Sep;67(9):1053-7. doi: 10.6061/clinics/2012(09)12.'}, {'pmid': '3708997', 'type': 'RESULT', 'citation': 'Silver R, de la Garza J, Rang M, Koreska J. Limb swelling after release of a tourniquet. Clin Orthop Relat Res. 1986 May;(206):86-9.'}, {'pmid': '20836920', 'type': 'RESULT', 'citation': 'Butt U, Ahmad R, Aspros D, Bannister GC. Factors affecting wound ooze in total knee replacement. Ann R Coll Surg Engl. 2011 Jan;93(1):54-6. doi: 10.1308/003588410X12771863937124. Epub 2010 Sep 10.'}, {'pmid': '7702328', 'type': 'RESULT', 'citation': 'Palmer SH, Graham G. Tourniquet-induced rhabdomyolysis after total knee replacement. Ann R Coll Surg Engl. 1994 Nov;76(6):416-7.'}, {'pmid': '1911493', 'type': 'RESULT', 'citation': 'Gielen MJ, Stienstra R. Tourniquet hypertension and its prevention: a review. Reg Anesth. 1991 Jul-Aug;16(4):191-4. No abstract available.'}, {'pmid': '6461346', 'type': 'RESULT', 'citation': 'Kaufman RD, Walts LF. Tourniquet-induced hypertension. Br J Anaesth. 1982 Mar;54(3):333-6. doi: 10.1093/bja/54.3.333.'}, {'pmid': '3976320', 'type': 'RESULT', 'citation': 'Valli H, Rosenberg PH. Effects of three anaesthesia methods on haemodynamic responses connected with the use of thigh tourniquet in orthopaedic patients. Acta Anaesthesiol Scand. 1985 Jan;29(1):142-7. doi: 10.1111/j.1399-6576.1985.tb02175.x.'}, {'pmid': '11412159', 'type': 'RESULT', 'citation': 'Kam PC, Kavanagh R, Yoong FF. The arterial tourniquet: pathophysiological consequences and anaesthetic implications. Anaesthesia. 2001 Jun;56(6):534-45. doi: 10.1046/j.1365-2044.2001.01982.x.'}, {'pmid': '3591250', 'type': 'RESULT', 'citation': 'Valli H, Rosenberg PH, Kytta J, Nurminen M. Arterial hypertension associated with the use of a tourniquet with either general or regional anaesthesia. Acta Anaesthesiol Scand. 1987 May;31(4):279-83. doi: 10.1111/j.1399-6576.1987.tb02566.x.'}, {'pmid': '23347808', 'type': 'RESULT', 'citation': 'Bostankolu E, Ayoglu H, Yurtlu S, Okyay RD, Erdogan G, Deniz Y, Hanci V, Can M, Turan IO. Dexmedetomidine did not reduce the effects of tourniquet-induced ischemia-reperfusion injury during general anesthesia. Kaohsiung J Med Sci. 2013 Feb;29(2):75-81. doi: 10.1016/j.kjms.2012.08.013. Epub 2012 Oct 13.'}, {'pmid': '20806768', 'type': 'RESULT', 'citation': 'Lin L, Wang L, Bai Y, Zheng L, Zhao X, Xiong X, Jin L, Ji W, Wang W. Pulmonary gas exchange impairment following tourniquet deflation: a prospective, single-blind clinical trial. Orthopedics. 2010 Jun 9;33(6):395. doi: 10.3928/01477447-20100429-15.'}, {'pmid': '15734253', 'type': 'RESULT', 'citation': 'Matziolis G, Drahn T, Schroder JH, Krocker D, Tuischer J, Perka C. Endothelin-1 is secreted after total knee arthroplasty regardless of the use of a tourniquet. J Orthop Res. 2005 Mar;23(2):392-6. doi: 10.1016/j.orthres.2004.08.021.'}, {'pmid': '21038696', 'type': 'RESULT', 'citation': 'Wang BQ, Kan YF, Yang QH. [The protective effect of the limb ischemia preconditioning on the hepatic injury related to NO/ET-1 system in rats]. Zhongguo Ying Yong Sheng Li Xue Za Zhi. 2010 Aug;26(3):376-9. Chinese.'}, {'pmid': '21419223', 'type': 'RESULT', 'citation': 'Shao D, Park JE, Wort SJ. The role of endothelin-1 in the pathogenesis of pulmonary arterial hypertension. Pharmacol Res. 2011 Jun;63(6):504-11. doi: 10.1016/j.phrs.2011.03.003. Epub 2011 Mar 16.'}, {'pmid': '11067800', 'type': 'RESULT', 'citation': 'Luscher TF, Barton M. Endothelins and endothelin receptor antagonists: therapeutic considerations for a novel class of cardiovascular drugs. Circulation. 2000 Nov 7;102(19):2434-40. doi: 10.1161/01.cir.102.19.2434.'}, {'pmid': '23836239', 'type': 'RESULT', 'citation': 'Tarwala R, Dorr LD, Gilbert PK, Wan Z, Long WT. Tourniquet use during cementation only during total knee arthroplasty: a randomized trial. Clin Orthop Relat Res. 2014 Jan;472(1):169-74. doi: 10.1007/s11999-013-3124-2.'}, {'pmid': '22571508', 'type': 'RESULT', 'citation': 'Mittal R, Ko V, Adie S, Naylor J, Dave J, Dave C, Harris IA, Hackett D, Ngo D, Dietsch S. Tourniquet application only during cement fixation in total knee arthroplasty: a double-blind, randomized controlled trial. ANZ J Surg. 2012 Jun;82(6):428-33. doi: 10.1111/j.1445-2197.2012.06083.x. Epub 2012 May 10.'}, {'pmid': '24258152', 'type': 'RESULT', 'citation': 'Chen S, Li J, Peng H, Zhou J, Fang H, Zheng H. The influence of a half-course tourniquet strategy on peri-operative blood loss and early functional recovery in primary total knee arthroplasty. Int Orthop. 2014 Feb;38(2):355-9. doi: 10.1007/s00264-013-2177-x. Epub 2013 Nov 21.'}, {'pmid': '17503044', 'type': 'RESULT', 'citation': 'Hernandez-Castanos DM, Ponce VV, Gil F. Release of ischaemia prior to wound closure in total knee arthroplasty: a better method? Int Orthop. 2008 Oct;32(5):635-8. doi: 10.1007/s00264-007-0376-z. Epub 2007 May 15.'}, {'pmid': '12442180', 'type': 'RESULT', 'citation': 'Wauke K, Nagashima M, Kato N, Ogawa R, Yoshino S. Comparative study between thromboembolism and total knee arthroplasty with or without tourniquet in rheumatoid arthritis patients. Arch Orthop Trauma Surg. 2002 Nov;122(8):442-6. doi: 10.1007/s00402-002-0404-9. Epub 2002 Apr 18.'}, {'pmid': '3968122', 'type': 'RESULT', 'citation': 'Sapega AA, Heppenstall RB, Chance B, Park YS, Sokolow D. Optimizing tourniquet application and release times in extremity surgery. A biochemical and ultrastructural study. J Bone Joint Surg Am. 1985 Feb;67(2):303-14.'}, {'pmid': '10210051', 'type': 'RESULT', 'citation': 'Kadoi Y, Ide M, Saito S, Shiga T, Ishizaki K, Goto F. Hyperventilation after tourniquet deflation prevents an increase in cerebral blood flow velocity. Can J Anaesth. 1999 Mar;46(3):259-64. doi: 10.1007/BF03012606.'}, {'pmid': '8772061', 'type': 'RESULT', 'citation': 'Huang CH, Wang MJ, Chen TL, Huang HH, Hsu HW, Susetio L, Liu CC. Blood and central venous pressure responses after serial tourniquet deflation during bilateral total knee replacement. J Formos Med Assoc. 1996 Jun;95(6):496-9.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial designed to research the effects of different tourniquet applications on postoperative pain in patients undergoing total knee arthroplasty, and to guide early postoperative recovery.', 'detailedDescription': 'Sixty participants undergoing unilateral TKA would be recruited in this study. On one side, the tourniquet would be inflated immediately before incision and deflated after the use of the cement , and 10 minutes later(after the hardening of the cement) , reinflate the tourniquet and deflate at the end of the operation. On the other side the tourniquet would be inflated immediately before incision and deflated at the end of the operation.The total time of tourniquet inflation is controlled within 90 minutes. The postoperative pain, limb swelling , the score of surgical field, blood pressure during the operation, blood loss, operating time, transfusion rate, deep vein thrombosis (DVT) incidence and clinical outcomes would be monitored for comparison.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of anesthesiologists Grade 1-3 Patients\n* Undergoing unilateral total knee arthroplasty under general anesthesia\n* Should be treated with tourniquet\n\nExclusion Criteria:\n\n* Tourniquet inflation time is less than 1h, greater than 1.5h\n* Abnormal coagulation function\n* BMI \\< 20kg/m2 or \\> 35kg/m2\n* History of cerebral infarction\n* History of Peripheral vascular disease\n* Anemia (hemoglobin\\<90g/L)\n* Systolic blood pressure (SBP) ≥ 170mmHg\n* Pregnant blood glucose \\> 10mmol/L or HbA1c \\> 8.5% of diabetic patients\n* History of chronic narcotic use\n* Participate in other clinical trials at the same time\n* Asked to withdraw from the trial'}, 'identificationModule': {'nctId': 'NCT03256058', 'briefTitle': 'Tourniquet Application on Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Xuzhou Medical University'}, 'officialTitle': 'The Effect of Different Applications of Tourniquet on Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'XYFY-2017-052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Reinflation after early deflation', 'description': 'The tourniquet would be inflated immediately before incision and deflated after the use of the cement, and 10 minutes later (after the hardening of the cement) , reinflate the tourniquet and deflate at the end of the operation.The total time of tourniquet inflation is controlled within 90 minutes.', 'interventionNames': ['Procedure: Reinflation after early deflation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'The tourniquet would be inflated immediately before incision and deflated at the end of the operation. The inflation of tourniquet should not last more than 90 minutes.', 'interventionNames': ['Procedure: Control']}], 'interventions': [{'name': 'Reinflation after early deflation', 'type': 'PROCEDURE', 'description': 'the tourniquet would be inflated immediately before incision and deflated after the use of the cement , and 10 minutes later (after the hardening of the cement) , reinflate the tourniquet and deflate at the end of the operation. The total time of tourniquet inflation is controlled within 90 minutes.', 'armGroupLabels': ['Reinflation after early deflation']}, {'name': 'Control', 'type': 'PROCEDURE', 'description': 'The tourniquet would be inflated immediately before incision and deflated at the end of the operation. The inflation of tourniquet should not last more than 90 minutes.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '221000', 'city': 'Xuzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guanglei Wang, MD', 'role': 'CONTACT', 'email': '13852087156@163.com', 'phone': '+86-13852087156'}, {'name': 'Pei Liu, Bachelor', 'role': 'CONTACT', 'email': 'xzflylp@163.com', 'phone': '18361205361'}], 'facility': 'The Affiliated Hospital of Xuzhou Medical University', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}], 'centralContacts': [{'name': 'Guanglei Wang, MD', 'role': 'CONTACT', 'email': '13852087156@163.com', 'phone': '+86-13852087156'}, {'name': 'Pei Liu, Bachelor', 'role': 'CONTACT', 'email': 'xzflylp@163.com', 'phone': '18361205361'}], 'overallOfficials': [{'name': 'Guanglei Wang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Affiliated Hospital of Xuzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will be available when this trial is finished and the article have been published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Xuzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}