Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-01-13 @ 11:14 PM
Study NCT ID:
NCT06521593
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-26
First Post:
2024-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tourniquet in Total Knee Replacement Short and Long Duration: A Comparative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'patients were in the operation room and werent aware of'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2024-07-22', 'studyFirstSubmitQcDate': '2024-07-22', 'lastUpdatePostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood loss', 'timeFrame': 'immediately post operative', 'description': 'We measured the intraoperative blood loss by subtracting saline volume used in washing from the whole suction volume which was added to the value resulting from subtracting dry foments weight from the wet foments weight used in managing bleeding.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tourniquet Palsy']}, 'descriptionModule': {'briefSummary': 'Total knee arthroplasty (TKA) is an effective treatment in severe osteoarthritis. We aim to compare the advantages and disadvantages related to the duration of tourniquet application in TKA surgeries.', 'detailedDescription': 'Total knee arthroplasty (TKA) is considered an effective method in relieving pain and regaining function in severe osteoarthritis patients; however, it is associated with increased blood loss risk which can increase the need for blood transfusion. Tourniquet use during surgery is controversial as it provides a clear visualization which decreases the blood loss and ensures proper cementation which makes it used frequently during TKA. However, its use is associated with complications like nerve palsy, thigh pain, swelling, joint stiffness, wound complications, subcutaneous fat necrosis, vascular injury, deep venous thrombosis (DVT), and prolonged duration of quadriceps recovery.\n\nThe proper duration of tourniquet application is also controversial as it affects TKA postoperative outcomes as increasing tourniquet application duration can aggravate the complications risk because of the increased tissue exposure to ischemia. Therefore, minimization of the tourniquet application duration is important which makes researchers investigate if tourniquet application during the cementation process only in TKA could decrease the complications and fasten the recovery.\n\nLimited tourniquet application during TKA decreased swelling and joint pain while it was not associated with blood loss, recovery, or operation time. While applying a tourniquet only in cementation could reduce blood loss, fasten the recovery period, and reduce pain after TKA surgery.\n\nHowever, decreasing tourniquet application to be only during cementation was associated with increased blood transfusion risk which indicated that this approach was impractical if there was not any improvement in recovery. Therefore, a balance should exist between the increased blood loss and blood transfusion risk during cementation tourniquet application. Therefore, the application time of a tourniquet during cementation in TKA is controversial and no meta-analysis compared using a tourniquet only to the long tourniquet use in TKA surgeries.\n\nTherefore, randomized controlled trials (RCTs) are needed to compare which strategy is better which made us perform this study to compare both strategies regarding pain, Oxford Knee Score (OKS), hospital stay, pain, Knee Society Score (KSS), blood loss, and range of motion (ROM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* We included symptomatic grade IV knee primary osteoarthritis cases who were candidates for TKA surgery\n\nExclusion Criteria:\n\n* we excluded patients with a history of post-infection or traumatic osteoarthritis, knee deformity, hematological diseases, currant infection focus, immune-suppression, or inflammatory arthritis.'}, 'identificationModule': {'nctId': 'NCT06521593', 'briefTitle': 'Tourniquet in Total Knee Replacement Short and Long Duration: A Comparative Study', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Tourniquet in Total Knee Replacement Short and Long Duration: A Comparative Study', 'orgStudyIdInfo': {'id': 'N-414-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'patients who underwent short duration applying of tourniquet.', 'description': 'All patients underwent spinal anesthesia and the tourniquet was applied to the middle of the thigh; in group one who underwent long-duration application of a tourniquet, it was applied only before the skin incision by inflating it to 150 mmHg above the systolic blood pressure of the patients and deflation just before cementing', 'interventionNames': ['Procedure: Applying a tourniquet for either a short or long time during total knee replacement']}, {'type': 'EXPERIMENTAL', 'label': 'patients who underwent long duration applying of tourniquet.', 'description': 'All patients underwent spinal anesthesia and the tourniquet was applied to the middle of the thigh; in group one who underwent long-duration application of a tourniquet, it was applied only before the skin incision by inflating it to 150 mmHg above the systolic blood pressure of the patients and deflation finishing of bone cementation', 'interventionNames': ['Procedure: Applying a tourniquet for either a short or long time during total knee replacement']}], 'interventions': [{'name': 'Applying a tourniquet for either a short or long time during total knee replacement', 'type': 'PROCEDURE', 'description': 'All patients underwent spinal anesthesia and the tourniquet was applied to the middle of the thigh; in group one who underwent long-duration application of a tourniquet, it was applied only before the skin incision by inflating it to 150 mmHg above the systolic blood pressure of the patients and deflation finishing of bone cementation while in group two who underwent short duration application of a tourniquet, the tourniquet was only applied just before cementation, was inflated also to 150 mmHg above the systolic blood pressure of the patients, and was deflated after bone cementation.', 'armGroupLabels': ['patients who underwent long duration applying of tourniquet.', 'patients who underwent short duration applying of tourniquet.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11765', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alainy hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'May be shared upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Ahmed Omar Sabry', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}