Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT01330732
Status:
UNKNOWN
Last Update Posted:
2011-04-07
First Post:
2009-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Kyphosis Evaluation Using SPINESCAN®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007738', 'term': 'Kyphosis'}], 'ancestors': [{'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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2009-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-06', 'studyFirstSubmitDate': '2009-03-15', 'studyFirstSubmitQcDate': '2011-04-06', 'lastUpdatePostDateStruct': {'date': '2011-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kyphosis degree (by SPINESCAN®)', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SPINESCAN®', 'kyphosis'], 'conditions': ['Kyphosis']}, 'referencesModule': {'references': [{'pmid': '16705434', 'type': 'BACKGROUND', 'citation': 'Ovadia D, Bar-On E, Fragniere B, Rigo M, Dickman D, Leitner J, Wientroub S, Dubousset J. Radiation-free quantitative assessment of scoliosis: a multi center prospective study. Eur Spine J. 2007 Jan;16(1):97-105. doi: 10.1007/s00586-006-0118-8. Epub 2006 May 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the accuracy of SPINESCAN® with standard lateral x-rays of the spine in patients monitored for kyphosis.', 'detailedDescription': "Kyphosis is usually a developmental deformity of the spine in the sagittal plane. Once diagnosed, serial X-rays are used for followup. These are usually required at yearly intervals.\n\nSPINESCAN® is a computerized digital inclinometer, design for evaluating angular spine deformities.\n\nPatients examined in the spine clinic with recent X-rays will be examined with SPINESCAN® and it's results compared with the classical radiological assessment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Main group: patients examined in scoliosis clinic for kyphosis with recent lateral spine X-rays.\n\nAge: 7 and above.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients examined in scoliosis clinic for kyphosis with recent lateral spine X-rays.\n* Age: 7 years old and above.\n\nExclusion Criteria:\n\n* Less than 7 years old.\n* No informed consent.'}, 'identificationModule': {'nctId': 'NCT01330732', 'briefTitle': 'Kyphosis Evaluation Using SPINESCAN®', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'The Correlation Between Radiological Evaluation of Kyphosis and Evaluation Using SPINESCAN®', 'orgStudyIdInfo': {'id': '109/08'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Main group: patients examined in scoliosis clinic for kyphosis with recent lateral spine X-rays.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Ẕerifin', 'country': 'Israel', 'facility': 'Assaf HaRofeh Medical Center', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}], 'centralContacts': [{'name': 'Yoram Anekstein, MD', 'role': 'CONTACT', 'email': 'nuritan@zahav.net.il', 'phone': '+972-57-7345403'}], 'overallOfficials': [{'name': 'Yigal Mirovsky, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assaf-Harofeh Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Yoram Anekstein, MD', 'oldOrganization': 'Assaf-Harofeh Medical Center'}}}}