Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-02-28 @ 11:40 AM
Study NCT ID:
NCT03251534
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2017-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contribution of Stereography (EOS Imaging System) in the Quantification of Femoral Shaft Fractures.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-07', 'studyFirstSubmitDate': '2017-08-11', 'studyFirstSubmitQcDate': '2017-08-11', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative evaluation of rotational disturbances', 'timeFrame': '24 months', 'description': 'Rotation disorder (degree angle), measured in a standardized and comparative way compared to the healthy side, by the EOS © software.'}], 'secondaryOutcomes': [{'measure': 'Correlation of the rotation disorder with the clinical condition of the patient.', 'timeFrame': '24 months', 'description': 'Rotation disorder (angle in degree).'}, {'measure': 'Quantitative evaluation of the shortening or the lengthening of the operated limb (cranio-caudal plane).', 'timeFrame': '24 months', 'description': 'Shortening or lengthening of the entire operative limb and of the femur alone (measured in mm), recorded in a standardized and comparative way compared to the healthy side, by the EOS © software'}, {'measure': 'Correlation of shortening or limb lengthening with the clinical condition of the patient.', 'timeFrame': '24 months', 'description': 'Shortening or lengthening of limb (measured in mm).'}, {'measure': 'Quantitative evaluation of the varus-valgus (lateral-medial plane).', 'timeFrame': '24 months', 'description': 'Varus-valgus (angle in degree), taken standardized and comparative way compared to the healthy side, by the EOS © software.'}, {'measure': 'Correlation of the varus-valgus with the clinical condition of the patient', 'timeFrame': '24 months', 'description': 'Varus-valgus (angle in degree).'}, {'measure': 'Quantitative evaluation of the flessum-recurvatum', 'timeFrame': '24 months', 'description': 'Flessum-recurvatum (angle in degree), measured in standardized and comparative way compared to the healthy side, by the EOS © software.'}, {'measure': 'Correlation of the flessum-recurvatum with the clinical condition of the patient.', 'timeFrame': '24 months', 'description': 'Flessum-recurvatum (angle in degree)'}, {'measure': 'Idendification of the main risk factors of post-nailing rotational disturbances of femoral shaft fractures', 'timeFrame': '24 months', 'description': 'Rotational disturbance (angle in degree)'}, {'measure': 'Identification of the main risk factors of limb shortening or lengthening (cranio-caudal plane) after femoral nailing of femoral shaft fractures.', 'timeFrame': '24 months', 'description': 'Shortening or limb lengthening (measured in mm).'}, {'measure': 'Identification of the main risk factors for the varus-valgus (lateral-medial plane) after femoral nailing of fhe femoral shaft fractures', 'timeFrame': '24 months', 'description': 'Varus-valgus (angle in degree).'}, {'measure': 'Identification of the main risk factors of the flessum-recurvatum after femoral nailing of fhe femoral shaft fractures', 'timeFrame': '24 months', 'description': 'Flessum-recurvatum (angle in degree).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eos imaging stereography', 'Centromedullary nailing', 'Quantification of malunions'], 'conditions': ['Femoral Shaft Fracture']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cic-it.fr/cic-it-grenoble.php', 'label': 'Clinical Investigation Centre for Innovative Technology Network'}]}, 'descriptionModule': {'briefSummary': 'This observational study is a collection of clinical and imaging data of patients with a femoral shaft fracture treated by nails. The aim of this research is the contribution of the EOS imaging system in the quantification of malunions.', 'detailedDescription': 'The study is based on the collection of clinical and imaging data (using EOS imaging system) necessary for the follow-up of patients who have benefited, most often in the emergency, of a centromedullary nailing of the femoral shaft. The study does not lead to any further examination for the patient since they are followed until the removal of the material, which usually takes place 24 months after the fracture episode. This observational and pilot study is monocentric, prospective on a continuous series of 40 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with surgery of femoral shaft fracture treated by nails', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged at least 16 years (parental agreement signed for minors) or adults at the time of data collection\n* Patients with a femoral shaft fractures since january 2014\n* Patients with a post-nailing femoral shaft fracture\n* Patients with unilateral fracture\n* Patients with regional origin allowing a follow-up in Grenoble center\n\nExclusion Criteria:\n\n* Patients who refuse to sign a non-objective form\n* Patients with femoral shaft fracture untreted with nails'}, 'identificationModule': {'nctId': 'NCT03251534', 'acronym': 'FEOS', 'briefTitle': 'Contribution of Stereography (EOS Imaging System) in the Quantification of Femoral Shaft Fractures.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Contribution of Stereography in the Quantification of Malunions Femoral Shaft Fractures Operated by Centromedullary Nailing. A Case Serie of 40 Patients', 'orgStudyIdInfo': {'id': 'DCIC-1550'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Centromedullary nailing', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Orthopedic and Trauma Department, University Hospital, Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Tonetti Jerôme, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopedic and Trauma department, University Hospital, Grenoble'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinical Investigation Centre for Innovative Technology Network', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}