Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT01524718
Status:
UNKNOWN
Last Update Posted:
2012-09-05
First Post:
2012-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Internal Fixation of Hip Fractures Using Intraoperative Simultaneous Two Axis View
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005265', 'term': 'Femoral Neck Fractures'}], 'ancestors': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-09-02', 'studyFirstSubmitDate': '2012-01-10', 'studyFirstSubmitQcDate': '2012-02-01', 'lastUpdatePostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of surgery', 'timeFrame': '5 hours - operation time', 'description': 'time of operation'}], 'secondaryOutcomes': [{'measure': 'X-ray time during surgery', 'timeFrame': '5 hours - operation time', 'description': 'radiation time'}, {'measure': 'Accuracy of nail position', 'timeFrame': '5 hours - operation time'}, {'measure': 'Accuracy of reduction', 'timeFrame': '5 hours - operation time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['radiation', 'time surgery'], 'conditions': ['Fracture Neck of Femur']}, 'descriptionModule': {'briefSummary': 'Hip fractures are one of the most frequent operated fractures procedures in orthopedics, with a world wide annual incidence of approximately 1.7 million. These fractures are associated with substantial morbidity and mortality. As populations age and life expectancy increases worldwide, the incidence of these fractures is likely to raise, expected to triple in the next 50 years. The use of fluoroscopy and resultant exposure to radiation, is an integral part of surgical procedures aiming to reduce and fixate the fractured femur. The risk of contracting cancer is significantly higher for an orthopedic surgeon as Hip surgery is a major slice of the total radiation dose. Optimal positioning and control of the imaging intensifier device may result in significant reduction of radiation dose and time and in substantial shortening of the procedure.\n\nThe investigators hypothesis is that this technique would substantially shorten procedure time and reduce unnecessary radiation exposure for both the patient and the medical staff. Furthermore, by using this technique the investigators can eliminate the need for fluoroscopy technician during the surgery, as there is no need to alternate fluoroscopy views.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with intertrochanteric femoral fracture who are going to be operated by closed reduction and internal fixation with an intramedullary nail.'}, 'identificationModule': {'nctId': 'NCT01524718', 'briefTitle': 'Internal Fixation of Hip Fractures Using Intraoperative Simultaneous Two Axis View', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'orgStudyIdInfo': {'id': 'MMC-twoaxis-001.il'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imaging with two X-ray image intensifiers', 'description': 'There is no change in the procedure except for the imaging technique, while in the first group the X- ray image intensifier serves in the two planes, and being moved from one plane to the other, and in the second group the two devices are static in the same position, one in the AP plane and the other as the axial plane.', 'interventionNames': ['Radiation: Imaging with two X-ray image intensifiers']}, {'type': 'NO_INTERVENTION', 'label': 'Imaging with one X-ray image intensifier.', 'description': 'The X- ray image intensifier serves in the two planes, and being moved from one plane to the other'}], 'interventions': [{'name': 'Imaging with two X-ray image intensifiers', 'type': 'RADIATION', 'description': 'Two fluoroscopy apparatus one in the AP plane and the other as the axial plane.', 'armGroupLabels': ['Imaging with two X-ray image intensifiers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44281', 'city': 'Kfar Saba', 'country': 'Israel', 'contacts': [{'name': 'Yaron Shagra Brin, MD', 'role': 'CONTACT', 'email': 'yaronbrin@gmail.com'}, {'name': 'Ezequiel Palmanovich, MD', 'role': 'CONTACT', 'email': 'ezepalm@gmail.com'}, {'name': 'Yaron Shagra Brin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ezequiel Palmanovich, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'centralContacts': [{'name': 'Yaron Shagra Brin, MD', 'role': 'CONTACT', 'email': 'yaronbrin@gmail.com', 'phone': '+97297472549'}, {'name': 'Ezequiel Palmanovich, MD', 'role': 'CONTACT', 'email': 'ezepalm@gmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clalit Health Services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}