Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-27 @ 9:37 PM
Study NCT ID:
NCT06500195
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2024-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hybrid Construct Versus Pedicle Screw-only System for the Treatment Scoliosis
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': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-12', 'studyFirstSubmitDate': '2024-07-02', 'studyFirstSubmitQcDate': '2024-07-12', 'lastUpdatePostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correction efficacy', 'timeFrame': 'at the 3rd day after the surgery procedure', 'description': 'defined as the Cobb score baseline to endpoint change (Cobb angle change in the operated spine segment in % at endpoint: X-ray imaging was performed (AP and lateral)'}], 'secondaryOutcomes': [{'measure': 'length of surgery procedure', 'timeFrame': 'procedure (from skin incision to skin suture)', 'description': 'duration of the hospitalization measured in minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scoliosis Idiopathic', 'Dysplastic']}, 'descriptionModule': {'briefSummary': 'The placement of pedicular screws in spinal surgery has become the gold standard for scoliosis treatment. However, the use of sublaminar bands (SBs) on the apex of the curvature in idiopathic scoliosis (AIS) lowers the risk of neurological complications related to incorrect implementation of transpedicular screws into dysplastic pedicles without a cancellous channel. The latest research does not define a set of anatomical guidelines for applying SBs, nor does it use a dedicated classification system related to the structure of pedicles. The aim of this study was to assess the safety of the method and the correction attained through hypoplastic/aplastic pedicles when applying a hybrid instrumentation system to patients suffering from AIS Lenke type 1. Methods: Twenty patients were involved in a prospective, single-center, non-randomized case series study. The patients were assigned to the group "SCREWS" or "HYBRID" where SBs were used.', 'detailedDescription': 'Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformation of the spine. The goal of the treatment is to achieve a reduction in deformity, restoring proper alignment and the best possible function of the spine. Pedicular screw placement in spinal surgery has become the gold standard for scoliosis reduction techniques in the last 30 years \\[6\\]. The screw-only systems are relatively safe, as various authors have proven. However, if implemented incorrectly, the screws increase the risk of damage to nervous or vascular structures and internal organs. The latest research does not define a set of anatomical guidelines for applying SBs, nor does it use a dedicated classification system related to the structure of pedicles. The aim of this study was to assess the safety of the method and the correction attained through hypoplastic/aplastic pedicles when applying a hybrid instrumentation system to patients suffering from AIS Lenke type 1. Methods: Twenty patients were involved in a prospective, single-center, non-randomized case series study. The patients were assigned to the group "SCREWS" or "HYBRID" where SBs were used. The inclusion criteria were this being the patients\' first scoliosis operation due to AIS (Lenke type 1) and age under 18 years. The primary measured outcome involved correction efficacy, defined as the Cobb score baseline to endpoint change.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients who qualified for scoliosis surgery in this center underwent X-ray imaging (AP, lateral, lateral bending view), computed tomography, and magnetic resonance imaging. Patients with a Cobb angle greater than 45 degrees (or 40 degrees in highly progressive cases) were considered eligible for the study. Based on the computed tomography assessment that was performed prior to the surgery, patients were assigned to one of two groups depending on the pedicle type on the apex of the thoracic curvature according to Watanabe pedicle's classification.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* idiopathic scoliosis (AIS)\n* Lenke type 1\n\nExclusion Criteria:\n\n* AIS other than Lenke type 1 (neurogenic, congenial, or syndromic curvatures)\n* abnormalities in the structure of the central nervous system in the MRI image\n* advanced chronic respiratory or circulatory failure\n* emergency surgery\n* reoperation'}, 'identificationModule': {'nctId': 'NCT06500195', 'briefTitle': 'Hybrid Construct Versus Pedicle Screw-only System for the Treatment Scoliosis', 'organization': {'class': 'OTHER', 'fullName': 'Pomeranian Medical University Szczecin'}, 'officialTitle': 'Cobb Angle Comparison of Hybrid Construct Versus Pedicle Screw-only System for the Treatment of Lenke 1 Adolescent Idiopathic Scoliosis', 'orgStudyIdInfo': {'id': 'KB.006.112.2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SCREWS', 'description': 'The SCREWS group of patients operated on with the use of only transpedicular screws.'}, {'label': 'HYBRID', 'description': 'The HYBRID group of patients whose corrections were performed using the hybrid instrumentation system (screws and bands).', 'interventionNames': ['Procedure: implantation of the hybrid instrumentation system']}], 'interventions': [{'name': 'implantation of the hybrid instrumentation system', 'type': 'PROCEDURE', 'description': 'Surgery corrections were performed using the hybrid instrumentation system (screws and bands).', 'armGroupLabels': ['HYBRID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71-252', 'city': 'Szczecin', 'country': 'Poland', 'facility': 'Pomeranian Medical University', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'after personal request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pomeranian Medical University Szczecin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}