Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-08 @ 8:56 AM
Study NCT ID:
NCT02332018
Status:
COMPLETED
Last Update Posted:
2017-02-20
First Post:
2015-01-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurements Of Lower Limbs And Spine Based On Biplanar Radiographs: Microdose Compared To Standard Dose Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-17', 'studyFirstSubmitDate': '2015-01-05', 'studyFirstSubmitQcDate': '2015-01-05', 'lastUpdatePostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2D- and 3D- measurements (torsion angles, scoliotic and kyphotic angles, length etc.) on biplanar radiographs with and without "MicroDose"-protocol and comparison of image quality parameters', 'timeFrame': '12 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Underdevelopment; Congenital Malformation, Lower Limb', 'Scoliosis']}, 'descriptionModule': {'briefSummary': 'Evaluation of accuracy and reliability of 2D and 3D measurements of the spine and lower limbs in adults based on biplanar radiographs with MicroDose protocol compared to a standard dose protocol', 'detailedDescription': 'Evaluation of accuracy and reliability of 2D and 3D measurements of the spine and lower limbs in adults based on biplanar radiographs with MicroDose protocol compared to a standard dose protocol\n\nPart 1: retrospective evaluation of 50 patients: lower limb images with MicroDose protocol and lower limb images with standard dose protocol Part 2: prospective evaluation of 100 patients: lower limb images with MicroDose protocol and lower limb images with standard dose protocol Part 3: prospective evaluation of 150 patients: spine images with MicroDose protocol and spine limb images with standard dose protocol'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients referred for assessment of spine or lower limb with biplanar x-ray-scanner', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion: All patients referred for biplanar radiographs of spine and lower limb (from 18 to 99 years of age)\n\nExclusion Criteria:\n\n* Exclusion criteria: no informed consent'}, 'identificationModule': {'nctId': 'NCT02332018', 'briefTitle': 'Measurements Of Lower Limbs And Spine Based On Biplanar Radiographs: Microdose Compared To Standard Dose Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Balgrist University Hospital'}, 'officialTitle': 'Two-dimensional And Three-dimensional Measurements Of Torsion And Length Of Lower Limbs And Spine Based On Biplanar Radiographs: Microdose Imaging Protocol Compared To Standard Dose Imaging Protocol', 'orgStudyIdInfo': {'id': 'KEK-ZH-Nr.: 2014-0405'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Limb Torsion', 'description': 'adult patients, lower limb assessment retrospectively limb length and limb axis, torsion biplanar x-ray images', 'interventionNames': ['Radiation: Biplanar x-ray images']}, {'label': 'Limb Length and Axis', 'description': 'adult patients, lower limb assessment prospectively limb length and limb axis biplanar x-ray images', 'interventionNames': ['Radiation: Biplanar x-ray images']}, {'label': 'Spine', 'description': 'adult patients, spine assessment prospectively Cobb angles, plumbline biplanar x-ray images', 'interventionNames': ['Radiation: Biplanar x-ray images']}], 'interventions': [{'name': 'Biplanar x-ray images', 'type': 'RADIATION', 'description': 'biplanar x-ray images with microdose and low-dose protocol', 'armGroupLabels': ['Limb Length and Axis', 'Limb Torsion', 'Spine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Radiology Department, Balgrist University Clinic', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Andrea Rosskopf', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Balgrist University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balgrist University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}