Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-26 @ 1:33 AM
Study NCT ID:
NCT04992533
Status:
UNKNOWN
Last Update Posted:
2021-08-05
First Post:
2021-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tourniquet vs. no Tourniquet During High Tibial Osteotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'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': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-28', 'studyFirstSubmitDate': '2021-07-28', 'studyFirstSubmitQcDate': '2021-07-28', 'lastUpdatePostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative blood loss', 'timeFrame': 'within operation', 'description': 'The calculation of intraoperative blood loss includes the fluid in the aspirator bottle minus the flushing fluid used in the operation, plus the net weight added by the gauze pad weighing'}, {'measure': 'Postoperative blood loss', 'timeFrame': 'The third day after operation', 'description': 'Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume.'}, {'measure': 'Volume of drainage', 'timeFrame': 'Postoperative Day One', 'description': 'Reactive blood loss'}, {'measure': 'Thigh pain measured by Visual Analogue Scale Postoperative Day 1', 'timeFrame': '1 day after surgery', 'description': 'Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.'}, {'measure': 'Thigh pain measured by Visual Analogue Scale Postoperative Day 2', 'timeFrame': '2 day after surgery', 'description': 'Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.'}, {'measure': 'Thigh pain measured by Visual Analogue Scale Postoperative Day 3', 'timeFrame': '3 day after surgery', 'description': 'Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.'}, {'measure': 'Thigh pain measured by Visual Analogue Scale Postoperative Day 5', 'timeFrame': '5 day after surgery', 'description': 'Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.'}, {'measure': 'Thigh pain measured by Visual Analogue Scale Postoperative Week 1', 'timeFrame': '1 week after surgery', 'description': 'Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.'}, {'measure': 'Thigh pain measured by Visual Analogue Scale Postoperative Week 4', 'timeFrame': '4 week after surgery', 'description': 'Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.'}, {'measure': 'Thigh pain measured by Visual Analogue Scale Postoperative Week 12', 'timeFrame': '12 week after surgery', 'description': 'Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.'}, {'measure': 'Crus pain measured by Visual Analogue Scale Postoperative Day 1', 'timeFrame': '1 day after surgery', 'description': 'Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.'}, {'measure': 'Crus pain measured by Visual Analogue Scale Postoperative Day 2', 'timeFrame': '2 day after surgery', 'description': 'Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.'}, {'measure': 'Crus pain measured by Visual Analogue Scale Postoperative Day 3', 'timeFrame': '3 day after surgery', 'description': 'Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.'}, {'measure': 'Crus pain measured by Visual Analogue Scale Postoperative Day 5', 'timeFrame': '5 day after surgery', 'description': 'Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.'}, {'measure': 'Crus pain measured by Visual Analogue Scale Postoperative Week 1', 'timeFrame': '1 week after surgery', 'description': 'Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.'}, {'measure': 'Crus pain measured by Visual Analogue Scale Postoperative Week 4', 'timeFrame': '4 week after surgery', 'description': 'Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.'}, {'measure': 'Crus pain measured by Visual Analogue Scale Postoperative Week 12', 'timeFrame': '12 week after surgery', 'description': 'Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '31626006', 'type': 'BACKGROUND', 'citation': "Goel R, Rondon AJ, Sydnor K, Blevins K, O'Malley M, Purtill JJ, Austin MS. Tourniquet Use Does Not Affect Functional Outcomes or Pain After Total Knee Arthroplasty: A Prospective, Double-Blinded, Randomized Controlled Trial. J Bone Joint Surg Am. 2019 Oct 16;101(20):1821-1828. doi: 10.2106/JBJS.19.00146."}, {'pmid': '30539303', 'type': 'BACKGROUND', 'citation': 'Jawhar A, Stetzelberger V, Kollowa K, Obertacke U. Tourniquet application does not affect the periprosthetic bone cement penetration in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2019 Jul;27(7):2071-2081. doi: 10.1007/s00167-018-5330-7. Epub 2018 Dec 11.'}, {'pmid': '26745962', 'type': 'BACKGROUND', 'citation': 'Wang K, Ni S, Li Z, Zhong Q, Li R, Li H, Ke Y, Lin J. The effects of tourniquet use in total knee arthroplasty: a randomized, controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Sep;25(9):2849-2857. doi: 10.1007/s00167-015-3964-2. Epub 2016 Jan 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to correlate functional outcomes and perioperative complications with tourniquet use during high tibial osteotomy.', 'detailedDescription': 'Tourniquet is widely used in orthopedic surgery, but its effect and safety in high tibial osteotomy have not been studied. This study evaluated the efficacy and safety of tourniquets by comparing different timing of use.Investigators aimed to quantify the effect of tourniquet use on reducing blood loss and to evaluate the impact of tourniquet use on functional and clinical outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Simple knee medial compartment osteoarthritis High tibial osteotomy.\n* 2\\. With varus deformity, medial proximal tibia angle \\<85°\n* 3\\. Unilateral High tibial osteotomy\n* 4\\. Informed consent: Participants must be able to understand and voluntarily sign a written informed consent and follow the research protocol and interview process\n\nExclusion Criteria:\n\n* 1.Patients who underwent other knee surgery within 6 months\n* 2.Preoperative combined anemia (Hb\\<100g/l)\n* 3.Patients with severe cardiovascular, hepatic, renal and hematopoietic diseases'}, 'identificationModule': {'nctId': 'NCT04992533', 'briefTitle': 'Tourniquet vs. no Tourniquet During High Tibial Osteotomy', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'Tourniquet vs. no Tourniquet During High Tibial Osteotomy：A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Qilu200326'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Long-duration tourniquet', 'description': 'Tourniquets inflated before arthroscopic exploration and deflated after high tibial osteotomy', 'interventionNames': ['Procedure: Long-duration tourniquet']}, {'type': 'EXPERIMENTAL', 'label': 'Short-duration tourniquet', 'description': 'Tourniquet should be inflated before arthroscopic exploration and deflated immediately after the exploration', 'interventionNames': ['Procedure: Short-duration tourniquet']}], 'interventions': [{'name': 'Long-duration tourniquet', 'type': 'PROCEDURE', 'description': 'Tourniquet is used in arthroscopic exploration and high tibial osteotomy', 'armGroupLabels': ['Long-duration tourniquet']}, {'name': 'Short-duration tourniquet', 'type': 'PROCEDURE', 'description': 'Tourniquet is only used for arthroscopic exploration', 'armGroupLabels': ['Short-duration tourniquet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250014', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'songlin Li, MD', 'role': 'CONTACT', 'email': 'bysonglin@126.com', 'phone': '15634057227'}], 'facility': 'Qilu hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Songlin Li, MD', 'role': 'CONTACT', 'email': 'bysonglin@126.com', 'phone': '053182166541'}, {'name': 'Peilai Liu, MD', 'role': 'CONTACT', 'email': 'gklpl@163.com', 'phone': '053182166541'}], 'overallOfficials': [{'name': 'Peilai Liu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The datasets used and/or analysed during the current study are available from the overall study officials on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}