Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:41 PM
Study NCT ID:
NCT01333969
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2011-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Ischemic Preconditioning in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019194', 'term': 'Ischemic Preconditioning'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'MemtsoudisS@hss.edu', 'phone': '646-797-8522', 'title': 'Dr. Stavros Memtsoudis', 'phoneExt': '8522', 'organization': 'Hospital for Special Surgery'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ishcemic Preconditioning', 'description': "In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).\n\nIschemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.", 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Postoperative Pain at Rest and Exercise as Assessed by Visual Analogue Scale (VAS) Scores at 48h After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ishcemic Preconditioning', 'description': "In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).\n\nIschemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase."}, {'id': 'OG001', 'title': 'Control', 'description': 'In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.'}], 'classes': [{'title': 'VAS score at rest', 'categories': [{'measurements': [{'value': '1.75', 'groupId': 'OG000', 'lowerLimit': '.02', 'upperLimit': '2.25'}, {'value': '.71', 'groupId': 'OG001', 'lowerLimit': '.02', 'upperLimit': '1.40'}]}]}, {'title': 'VAS score with exercise', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1.80', 'upperLimit': '4.2'}, {'value': '1.38', 'groupId': 'OG001', 'lowerLimit': '.44', 'upperLimit': '2.32'}]}]}], 'analyses': [{'pValue': '.043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-1.40', 'ciUpperLimit': '-0.02', 'statisticalMethod': 'GEE', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Regression analysis using the generalized estimating equations (GEE) method to compare the changes over time in VAS scores at rest and with exercise'}], 'paramType': 'MEAN', 'timeFrame': '48hrs after surgery', 'description': 'Visual Analogue Scale (VAS) are used to measure the intensity of pain. The total scale ranged from 0 (no pain) to 10 (excruciating pain). The average value at POD 48hours was reported for each arm/group.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Epidural Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ishcemic Preconditioning', 'description': "In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).\n\nIschemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase."}, {'id': 'OG001', 'title': 'Control', 'description': 'In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '140.5', 'spread': '68.4', 'groupId': 'OG000'}, {'value': '160.8', 'spread': '70.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.043', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At 48hrs after surgery', 'description': 'Postoperative pain management included an epidural infusion of 10mcg/ml bupivacaine 0.06%/hydromorphone with a basal rate of 4 mL, a demand dose of 4 mL, and a lockout of 10 minutes. Basal rates were reduced to 2 mL and 0 mL in the morning of postoperative Days 1 and 2, respectively and epidural catheters removed on postoperative Day 2. Overall epidural volume was the total volume given over 48 hours.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Muscle Oxygenation Over Calf at 48h After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ishcemic Preconditioning', 'description': "In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).\n\nIschemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase."}, {'id': 'OG001', 'title': 'Control', 'description': 'In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'spread': '22.4', 'groupId': 'OG000'}, {'value': '69', 'spread': '18.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.584', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.584', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At 48 hrs after surgery', 'description': 'muscle tissue oxygenation was measured using a novel noninvasive near infrared spectroscopy device at baseline and at 48 hours postoperatively', 'unitOfMeasure': 'percentage of muscle tissue', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Levels of Interleukin 6 (IL6) in Drainage Fluid at 24hr Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ischemic Preconditioning - IL6 Levels', 'description': "In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components)."}, {'id': 'OG001', 'title': 'Control - IL6 Levels', 'description': 'In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.79', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '6.6'}, {'value': '3.57', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '7.4'}]}]}], 'analyses': [{'pValue': '0.763', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.763', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'At 24 hours postoperatively', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'IL-6 levels could not be measured for all patients.'}, {'type': 'SECONDARY', 'title': 'Periarticular Circumference of the Knee at 6h, 24h, and 48h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ishcemic Preconditioning', 'description': "In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).\n\nIschemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase."}, {'id': 'OG001', 'title': 'Control', 'description': 'In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.602', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.602', 'statisticalMethod': 'GEE', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Regression analyses based on the generalized estimating equations (GEE) method'}], 'paramType': 'MEAN', 'timeFrame': 'measured at 6 hours, 24 hours, and 48 hours', 'description': 'Periarticular circumference of the knee as compared to contralateral side as crude marker of swelling at 6h, 24, and 48h postoperatively. The data from the specified time points (6h, 24h, and 48h) were combined and the average value was reported for each arm/group.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ishcemic Preconditioning', 'description': "In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).\n\nIschemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase."}, {'id': 'OG001', 'title': 'Control', 'description': 'In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.6', 'groupId': 'OG000', 'lowerLimit': '56.2', 'upperLimit': '145'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '63.4', 'upperLimit': '135.4'}]}]}], 'analyses': [{'pValue': '.8656', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.8656', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to discharge date', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Physical Therapy Milestone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ishcemic Preconditioning', 'description': "In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).\n\nIschemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase."}, {'id': 'OG001', 'title': 'Control', 'description': 'In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '4.0'}]}]}], 'analyses': [{'pValue': '.8422', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.8422', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to discharge date', 'description': 'Amount of time until patients reached their physical therapy milestone (40 ft ambulation) during admission', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Levels of Leukocytes in Drainage Fluid at 24hr Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ischemic Preconditioning - Leukocytes', 'description': "In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components)."}, {'id': 'OG001', 'title': 'Control - Leukocytes', 'description': 'In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '2487', 'spread': '2415.74', 'groupId': 'OG000'}, {'value': '2038', 'spread': '1778.74', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.526', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.526', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 hours postoperatively', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'some patients were lost to follow up.'}, {'type': 'SECONDARY', 'title': 'Levels of TNF-alpha in Drainage Fluid at 24hr Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ischemic Preconditioning - TNF-alpha', 'description': "In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components)."}, {'id': 'OG001', 'title': 'Control - TNF-alpha', 'description': 'In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.72', 'groupId': 'OG000', 'lowerLimit': '3.09', 'upperLimit': '4.65'}, {'value': '3.76', 'groupId': 'OG001', 'lowerLimit': '3.05', 'upperLimit': '5.82'}]}]}], 'analyses': [{'pValue': '.526', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.526', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours postoperatively', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'some patients were lost to follow up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ishcemic Preconditioning', 'description': "In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).\n\nIschemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase."}, {'id': 'FG001', 'title': 'Control', 'description': 'In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ishcemic Preconditioning', 'description': "In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).\n\nIschemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase."}, {'id': 'BG001', 'title': 'Control', 'description': 'In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '66.5', 'groupId': 'BG000', 'lowerLimit': '55.7', 'upperLimit': '77.3'}, {'value': '72.5', 'groupId': 'BG001', 'lowerLimit': '59.2', 'upperLimit': '85.8'}, {'value': '70.8', 'groupId': 'BG002', 'lowerLimit': '55.7', 'upperLimit': '85.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-23', 'studyFirstSubmitDate': '2011-04-11', 'resultsFirstSubmitDate': '2018-09-17', 'studyFirstSubmitQcDate': '2011-04-11', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-23', 'studyFirstPostDateStruct': {'date': '2011-04-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain at Rest and Exercise as Assessed by Visual Analogue Scale (VAS) Scores at 48h After Surgery', 'timeFrame': '48hrs after surgery', 'description': 'Visual Analogue Scale (VAS) are used to measure the intensity of pain. The total scale ranged from 0 (no pain) to 10 (excruciating pain). The average value at POD 48hours was reported for each arm/group.'}], 'secondaryOutcomes': [{'measure': 'Overall Epidural Volume', 'timeFrame': 'At 48hrs after surgery', 'description': 'Postoperative pain management included an epidural infusion of 10mcg/ml bupivacaine 0.06%/hydromorphone with a basal rate of 4 mL, a demand dose of 4 mL, and a lockout of 10 minutes. Basal rates were reduced to 2 mL and 0 mL in the morning of postoperative Days 1 and 2, respectively and epidural catheters removed on postoperative Day 2. Overall epidural volume was the total volume given over 48 hours.'}, {'measure': 'Muscle Oxygenation Over Calf at 48h After Surgery', 'timeFrame': 'At 48 hrs after surgery', 'description': 'muscle tissue oxygenation was measured using a novel noninvasive near infrared spectroscopy device at baseline and at 48 hours postoperatively'}, {'measure': 'Levels of Interleukin 6 (IL6) in Drainage Fluid at 24hr Postoperatively', 'timeFrame': 'At 24 hours postoperatively'}, {'measure': 'Periarticular Circumference of the Knee at 6h, 24h, and 48h', 'timeFrame': 'measured at 6 hours, 24 hours, and 48 hours', 'description': 'Periarticular circumference of the knee as compared to contralateral side as crude marker of swelling at 6h, 24, and 48h postoperatively. The data from the specified time points (6h, 24h, and 48h) were combined and the average value was reported for each arm/group.'}, {'measure': 'Hospital Length of Stay', 'timeFrame': 'Up to discharge date'}, {'measure': 'Physical Therapy Milestone', 'timeFrame': 'Up to discharge date', 'description': 'Amount of time until patients reached their physical therapy milestone (40 ft ambulation) during admission'}, {'measure': 'Levels of Leukocytes in Drainage Fluid at 24hr Postoperatively', 'timeFrame': '24 hours postoperatively'}, {'measure': 'Levels of TNF-alpha in Drainage Fluid at 24hr Postoperatively', 'timeFrame': '24 hours postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Total Knee Arthroplasty', 'Ischemic Preconditioning', 'Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '23761178', 'type': 'RESULT', 'citation': 'Memtsoudis SG, Stundner O, Yoo D, Gonzalez Della Valle A, Boettner F, Bombardieri AM, Jules-Elysee K, Poultsides L, Ma Y, Sculco TP. Does limb preconditioning reduce pain after total knee arthroplasty? A randomized, double-blind study. Clin Orthop Relat Res. 2014 May;472(5):1467-74. doi: 10.1007/s11999-013-3106-4.'}]}, 'descriptionModule': {'briefSummary': 'The application of a tourniquet for 5 minutes and subsequent reperfusion before actual inflation of the tourniquet for total knee arthroplasty (ischemic preconditioning) decreases the level of local inflammation and therefore postoperative pain in response to reperfusion of the ischemic extremity.', 'detailedDescription': 'During knee surgery your surgeon routinely uses a device called a tourniquet that allows us to temporarily cut of blood supply to the site of surgery. This helps to reduce blood loss and improves operating conditions. When allowing blood back into your leg at the end of the procedure, debris (bone, fat, tissue breakdown products and cement from the surgery) gets washed out and gains access to the rest of your body. In the vast majority of cases this event bares no major clinical consequences, but can rarely result in signs of inflammation of various body systems. Patients with evidence of impaired organ system function such as pre-existing lung and heart disease may be more vulnerable. Previous studies suggest that cutting off the blood supply for a short period of time just before a prolonged episode, could lead to a decrease in the extent of tissue breakdown products in this extremity and may thus be associated with a decrease in the inflammation of other organ systems. We propose to study this theory in knee surgery patients by looking at levels of markers of inflammation present in the blood before and after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing primary total knee arthroplasty\n\nExclusion Criteria:\n\n* Patients who chronically use narcotics (\\<1 month).\n* Patients with contraindications (severe peripheral vascular disease, presence of femoral-popliteal bypass grafts, etc.) or no plan for tourniquet use as determined by the clinical care team.\n* Patients who are on corticosteroids prior to their surgery'}, 'identificationModule': {'nctId': 'NCT01333969', 'briefTitle': 'Ischemic Preconditioning in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'The Effect of Ischemic Preconditioning on Postoperative Pain After Total Knee Arthroplasty, a Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': '2012-038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ishcemic Preconditioning', 'description': "In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components).", 'interventionNames': ['Procedure: Ischemic Preconditioning']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.'}], 'interventions': [{'name': 'Ischemic Preconditioning', 'type': 'PROCEDURE', 'description': "In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.", 'armGroupLabels': ['Ishcemic Preconditioning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Stavros G. Memtsoudis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Special Surgery, New York'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}