Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT03464318
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2018-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low-dose Digital Radiographs in the Idiopathic Scoliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-22', 'studyFirstSubmitDate': '2018-03-07', 'studyFirstSubmitQcDate': '2018-03-07', 'lastUpdatePostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Repeatability and reproducibility', 'timeFrame': 'baseline (day 0)', 'description': 'Repeatability and reproducibility of the Cobb angle measurement'}], 'secondaryOutcomes': [{'measure': 'Repeatability and reproducibility', 'timeFrame': 'baseline (day 0)', 'description': 'Repeatability and reproducibility of kyphosis angle, lordosis angle, lumbosacral angle, Nash-Moe rotation index and Risser index measurement'}, {'measure': 'Radiation exposure', 'timeFrame': 'baseline (day 0)', 'description': 'collection of dosimetric data'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['idiopathic scoliosis', 'radiographs', 'low dose'], 'conditions': ['Idiopathic Scoliosis']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the intraobserver repeatability and the interobserver reproducibility of low-dose radiographs with a HELIOS DRF (CAT) imaging system in patients with idiopathic scoliosis.', 'detailedDescription': 'The 80% of scoliosis is idiopathic and begins mostly in adolescence (10-20 years).\n\nThe young patients need to undergo several radiographic controls for a correct therapeutic balance. However, the repeated radiation exposures is associated with a greater risk of carcinogenesis even if reduced with a digital imaging technique.\n\nThe aim of this study is to evaluate the intraobserver repeatability and the interobserver reproducibility of low-dose radiographs with a HELIOS DRF (CAT) imaging system in patients with idiopathic scoliosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '9 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with suspected or known idiopathic scoliosis selected at the Rizzoli Orthopaedic Institute', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with suspected or known idiopathic scoliosis\n* patients able to maintain orthostasis without medical devices\n* patients from 9 to 20 years old\n\nExclusion Criteria:\n\n* patients with known congenital, syndromic, neurological scoliosis\n* patients not able to maintain orthostasis\n* obese patients\n* low back pain or known tumor pathology\n* patients with vertebral arthrodesis\n* patients younger than 9 years old, or older than 20 years old'}, 'identificationModule': {'nctId': 'NCT03464318', 'briefTitle': 'Low-dose Digital Radiographs in the Idiopathic Scoliosis', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Repeatability and Reproducibility of Low-dose Digital Radiographs in the Idiopathic Scoliosis', 'orgStudyIdInfo': {'id': 'RXbd17'}}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Rizzoli Orthopaedic Institute', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Milva Battaglia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rizzoli Orthopaedic Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}