Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-23 @ 11:44 PM
Study NCT ID:
NCT03331094
Status:
UNKNOWN
Last Update Posted:
2023-03-07
First Post:
2017-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adult Scoliosis Correction by Bipolar Mini-invasive Assembly Without Graft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-06', 'studyFirstSubmitDate': '2017-10-24', 'studyFirstSubmitQcDate': '2017-10-31', 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of Cobb angle', 'timeFrame': 'change from baseline Cobb angle at 6 months', 'description': 'Cobb angle represent the degree of curvature of the scoliosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scoliosis']}, 'descriptionModule': {'briefSummary': 'The objective of the study will be to estimate the correction obtained with a metallic instrumentation, by mini-invasive technique with bipolar assembly and ilio-sacred EUROS ®) screw , without transplant at the adult as compared to that obtained with the surgery with complete exhibition of the rachis and bone graft.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'every patient with a scoliosis responding to the criteria above recovering for surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18\n* under guardianship\n* vertebral deformation \\>20°\n* accept to participate\n\nExclusion Criteria:\n\n* minor patient\n* surgery not including the pelvis'}, 'identificationModule': {'nctId': 'NCT03331094', 'briefTitle': 'Adult Scoliosis Correction by Bipolar Mini-invasive Assembly Without Graft', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Hôpital Saint-Joseph'}, 'officialTitle': 'Adult Scoliosis Correction by Bipolar Mini-invasive Assembly Without Graft', 'orgStudyIdInfo': {'id': 'SCOSANGREFF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'surgery with graft', 'description': 'The procedure is to place a metal instrumentation (rods and screws) in contact with the spine to correct the deformity. Added to this is a graft between the vertebrae that will allow a bone bridge of ankylosis making the spine completely rigid.', 'interventionNames': ['Procedure: Surgery with graft']}, {'label': 'surgery without graft', 'description': 'Adult scoliosis surgery is performed with instrumentation without grafting: the teams use variable stiffness rods made of metal or PEEK.', 'interventionNames': ['Procedure: surgery without graft']}], 'interventions': [{'name': 'Surgery with graft', 'type': 'PROCEDURE', 'description': 'arthrodesis with autologous bone graft and using pedicular ilio-sacred EUROS ® screw', 'armGroupLabels': ['surgery with graft']}, {'name': 'surgery without graft', 'type': 'PROCEDURE', 'description': 'arthrodesis without bone graft using pedicular ilio-sacred EUROS ® screw', 'armGroupLabels': ['surgery without graft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Helene BEAUSSIER, PharmD, PhD', 'role': 'CONTACT'}], 'facility': 'Groupe Hospitalier Paris Saint Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'WOLFF Stephane, MD', 'role': 'CONTACT', 'email': 'swolff@hpsj.fr', 'phone': '01 44 12 33 33'}, {'name': 'RIOUALLON Guillaume, MD', 'role': 'CONTACT', 'email': 'griouallon@hpsj.fr', 'phone': '01 44 12 33 33'}], 'overallOfficials': [{'name': 'WOLFF Stephane, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Hôpital Saint-Joseph'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}