Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-30 @ 3:42 PM
Study NCT ID:
NCT01042132
Status:
COMPLETED
Last Update Posted:
2016-12-01
First Post:
2010-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intramedullary Femoral Reaming, Human Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}], 'ancestors': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-04', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-30', 'studyFirstSubmitDate': '2010-01-04', 'studyFirstSubmitQcDate': '2010-01-04', 'lastUpdatePostDateStruct': {'date': '2016-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiopulmonary alterations', 'timeFrame': 'the first three postoperative days'}, {'measure': 'coagulation, fibrinolytic and cytokine response', 'timeFrame': 'pre-, per- and first 3 days postoperatively'}], 'secondaryOutcomes': [{'measure': 'fracture healing', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intramedullary reaming', 'inflammatory response', 'human', 'femoral shaft fracture', 'Reamer-irrigator-aspirator'], 'conditions': ['Pulmonary Complications', 'Organ Failure', 'Systemic Inflammatory Response Syndrome']}, 'descriptionModule': {'briefSummary': 'To what extent the cardiopulmonary and inflammatory response is affected by initial femoral intramedullary nailing in the already traumatized and inflammatory activated patient was analyzed in the present study with the attention to survey the additional burden of this operative treatment. The patients are monitored with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively. The study is partly randomized 1)where delayed intramedullary nailing is compared with primary nailing of the femur, and 2) a new reaming technique (RIA) is compared with a standard reaming technique (TR).', 'detailedDescription': 'To what extent the cardiopulmonary and inflammatory response is affected by initial femoral intramedullary nailing in the already traumatized and inflammatory activated patient was analyzed in the present study with the attention to survey the additional burden of this operative treatment. The patients are monitored with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively. The study is partly randomized 1)where delayed intramedullary nailing is compared with primary nailing of the femur, and 2) a new reaming technique (RIA) is compared with a standard reaming technique (TR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* femoral shaft fracture suitable for intramedullary nailing\n* \\< 24 hours postinjury\n\nExclusion Criteria:\n\n* previous fracture of the femur\n* pathological fracture\n* femur deformities\n* pregnancy\n* previous intramedullary nailing or external fixation'}, 'identificationModule': {'nctId': 'NCT01042132', 'briefTitle': 'Intramedullary Femoral Reaming, Human Study', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Pathophysiological Effects of- and Inflammatory Response to Intramedullary Femoral Nailing in Patients With Femoral Shaft Fracture', 'orgStudyIdInfo': {'id': '02066'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1) IMN and EF/IMN', 'description': 'Two parts of the study are randomized;\n\n1)initial intramedullary reaming and primary external fixation with secondary intramedullary nailing', 'interventionNames': ['Procedure: the effect of delayed intramedullary reaming']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2) TR and RIA', 'description': 'Two parts of the study are randomized; 2)traditional reaming (TR)is compared to a new reaming device, RIA, which is a reamer connected to suction and flushing for prevention of increased intramedullary pressure', 'interventionNames': ['Procedure: the reaming of the femoral canal is performed with two different reaming devices']}], 'interventions': [{'name': 'the effect of delayed intramedullary reaming', 'type': 'PROCEDURE', 'description': 'in one group intramedullary reaming and nailing is performed immediately, femoral fractures in the second group are external fixated and than secondary nailed.', 'armGroupLabels': ['1) IMN and EF/IMN']}, {'name': 'the reaming of the femoral canal is performed with two different reaming devices', 'type': 'PROCEDURE', 'description': 'the reaming of the femoral canal is performed with two different reaming devices; a traditional reamer (TR)and the reamer-irrigator-aspirator (RIA)', 'armGroupLabels': ['2) TR and RIA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0407', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Orthopedic Center, Ullevål University Hopspital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Olav Røise, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Orthopedic Centre, Ullevaal University Hospital, Oslo, Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ullevaal University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Elisabeth Ellingsen Husebye', 'investigatorAffiliation': 'Oslo University Hospital'}}}}