Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT04924556
Status:
UNKNOWN
Last Update Posted:
2021-06-14
First Post:
2021-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Rıgıd Brace on Spinopelvic Parameters and GAP Score in Adolescents With Structural Hyperkyphosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012544', 'term': 'Scheuermann Disease'}, {'id': 'D013121', 'term': 'Spinal Curvatures'}], 'ancestors': [{'id': 'D055035', 'term': 'Spinal Osteochondrosis'}, {'id': 'D055034', 'term': 'Osteochondrosis'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007738', 'term': 'Kyphosis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-08-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-09', 'studyFirstSubmitDate': '2021-05-26', 'studyFirstSubmitQcDate': '2021-06-09', 'lastUpdatePostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from kyphosis angle at 6 months', 'timeFrame': '6 months after from beginning of study', 'description': 'Change from Baseline kyphosis angle(degree) in standing full-length lateral digital radiographs at 6 months. It will measure between T4-T12 vertebra.'}, {'measure': 'Change from lordosis angle at 6 months', 'timeFrame': '6 months after from beginning of study', 'description': 'Change from Baseline lordosis angle(degree) in standing full-length lateral digital radiographs at 6 months. It will measure from the L1-S1 and L4-S1 levels of the vertebra.'}, {'measure': 'Change from the global tilt at 6 months', 'timeFrame': '6 months after from beginning of study', 'description': 'Change from Baseline global tilt(degree) in standing full-length lateral digital radiographs at 6 months. The global tilt is the sum of the C7 vertical tilt and the pelvic tilt.'}, {'measure': 'Change from Global Alignment and Proportion (GAP) score at 6 months', 'timeFrame': '6 months after from beginning', 'description': 'GAP score is a new pelvic incidence-based proportional method to analyze sagittal alignment and balance, developed by the European Spine Study Group (ESSG). The GAP score evaluates the disproportion, magnitude and distribution of lumbar lordosis, and the global spinopelvic alignment proportionally rather than an absolute numerical value when compared to the ideal calculated for any individual. GAP score has five domains including relative pelvic version, relative lumbar lordosis, lordosis distribution index, relative spinopelvic alignment, and age factor. Scores of each of the four domains vary between 0 to 3 and age factor domain varies between 0 to 1. The total GAP score is between 0 and 13 points and obtained by adding the scores of these five domains. If the total score was 0 to 2, alignment accepted as proportional; 3 to 6 as moderate malalignment; ≥7 was accepted as severe malalignment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Scheuermann Disease', 'Adolescent Hyperkyphosis', 'Sagittal Balance', 'Spinopelvic Parameters'], 'conditions': ['Hyperkyphosis, Adolescent', 'Scheuermann Disease', 'Spinal Curvatures']}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate the effect of rıgıd brace treatment on spinopelvic parameters and GAP score in patients with adolescent hyperkyphosis. This was a retrospective analysis of prospectively collected data. Thirty-two patients who were diagnosed with structural hyperkyphosis and treated with CAD-CAM design rigid brace were included in the study in Formed Healthcare Scoliosis Treatment and Brace Center between December 2015-2020.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "10-18 years patients with Scheuermann's kyphosis or adolescent hyperkyphosis and treated with CAD-CAM design a rigid brace", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who diagnosed with Scheuermann's kyphosis or adolescent hyperkyphosis.\n* Inıtial curve magnitude between 55-75°\n* Patients who followed up at least 6 months\n* Patients who wearing CAD-CAM (Computer-Aided Design\\&Computer-Aided Manufacturing) design TLSO(Thoraco-lumbo-sacral orthosis) kyphosis brace in 16 hours/day or more\n\nExclusion Criteria:\n\n* History of spinal surgery or trauma\n* Patients has kyphosis due to congenital, neuromuscular, traumatic, tumor, infection causes\n* Ankylosing spondylitis and other spondyloarthropathies.\n* The lack of appropriate full-length lateral radiography with acceptable quality at the baseline or final assessment."}, 'identificationModule': {'nctId': 'NCT04924556', 'briefTitle': 'The Effect of Rıgıd Brace on Spinopelvic Parameters and GAP Score in Adolescents With Structural Hyperkyphosis', 'organization': {'class': 'OTHER', 'fullName': 'Halic University'}, 'officialTitle': 'The Effect of Rıgıd Brace on Spinopelvic Parameters and GAP Score in Adolescents With Structural Hyperkyphosis', 'orgStudyIdInfo': {'id': 'HUEK-'}}, 'contactsLocationsModule': {'locations': [{'zip': '34384', 'city': 'Istanbul', 'state': 'İ̇stanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ahsen Büyükaslan, MSc.', 'role': 'CONTACT', 'email': 'ahsen.buyukaslan@gmail.com', 'phone': '05336992960'}], 'facility': 'Formed Healthcare Scoliosis Treatment and Brace Center', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Ahsen Büyükaslan, PhD(c)', 'role': 'CONTACT', 'email': 'ahsen.buyukaslan@gmail.com', 'phone': '905336992960'}], 'overallOfficials': [{'name': 'Ahsen Büyükaslan, PhD(c)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medipol University'}, {'name': 'Kadir Abul, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Başakşehir Çam & Sakura City Hospital'}, {'name': 'Hürriyet Yılmaz, Prof.Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Halic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Halic University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medipol University', 'class': 'OTHER'}, {'name': 'Başakşehir Çam & Sakura City Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}