Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT00327158
Status:
COMPLETED
Last Update Posted:
2010-01-28
First Post:
2006-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Study to Determine the Effectiveness of Reaming in Reducing Fat Emboli to the Lungs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D004617', 'term': 'Embolism'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-27', 'studyFirstSubmitDate': '2006-05-16', 'studyFirstSubmitQcDate': '2006-05-16', 'lastUpdatePostDateStruct': {'date': '2010-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of Emboli', 'timeFrame': 'Immediately following surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Reaming', 'fracture', 'emboli'], 'conditions': ['Diaphyseal Femur Fracture']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to see if there is a difference in the amount of fat droplets reaching the heart during surgery between the standard reamer currently used and a new reamer system which is expected to reduce the fat going into the blood, via an intraoperative echocardiography done through the food pipe.', 'detailedDescription': 'Reamed intramedullary nailing of diaphyseal femur fractures remains the standard of care for treatment of these fractures. Pressurization of the femoral canal during reaming leads to extra vasations of fat emboli into the systemic circulation, resulting in deposition of fat droplets in the pulmonary vasculature. This phenomenon has been well documented by use of Transesophageal Echocardiography. A novel reaming system has recently become available that may limit this phenomenon. The new reamer system incorporates irrigation and aspiration during reaming, theoretically minimizing pressurization and fat emboli. Additionally, this reamer system allows for one pass reaming as compared to the current system which requires multiple reaming passes.\n\nThe objective of this study is to determine effectiveness of reaming in diminishing fat emboli to the lungs as evidenced by decreased numbers of large fat droplets entering the right heart as measured by transesophageal echocardiography during the reaming process. This will determine if there is a benefit to aspiration during reaming as would be expected.\n\nDuring the reaming process a transesophageal echo cardiogram will be performed to analyze the presence or absence of emboli and the mean regarding the total time that each of the embolic grades is present during each of the intervals across the patient groups'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diaphyseal femur fractures undergoing reamed intramedullary nailing\n* male or female\n* 18 years of age or older\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00327158', 'briefTitle': 'A Prospective Study to Determine the Effectiveness of Reaming in Reducing Fat Emboli to the Lungs', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Using Transesophageal Echocardiography To Assess Fat Emboli As A Result Of Reaming In A Prospective Randomized Control Trial To Determine The Effectiveness Of Reaming In Diminishing Fat Emboli To The Lungs', 'orgStudyIdInfo': {'id': '06-0296-F1V'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Transesophageal transducer', 'type': 'PROCEDURE', 'description': 'One time use of reamer during surgery'}, {'name': 'echocardiography', 'type': 'PROCEDURE', 'description': 'takes photos of right atrium during the reaming processes'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Chandler Medical Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'William Rosenblum, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky, Department of Orthopaedic Surgery'}, {'name': 'Jeffrey Selby, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky Department of Orthopaedic Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kentucky', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jeffrey Selby', 'oldOrganization': 'UK Orthopaedics'}}}}