Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT05100732
Status:
UNKNOWN
Last Update Posted:
2021-10-29
First Post:
2021-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Corrections of Anterior Imbalances by Posterior Instrumentation and Osteotomies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2023-03-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-21', 'studyFirstSubmitDate': '2021-10-21', 'studyFirstSubmitQcDate': '2021-10-21', 'lastUpdatePostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retrospective analysis of corrections of anterior imbalances by posterior instrumentation and osteotomies', 'timeFrame': 'Files analysed retrospectively from January 01, 2010 to December 31, 2010 will be examined]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arthrodesis', 'degenerative lumbar scoliosis', 'Scoliosis', 'spinal dysmorphism'], 'conditions': ['Arthrodesis']}, 'descriptionModule': {'briefSummary': "Several deformities of the spine exist such as the anterior imbalance. These deformities can generate functional discomfort and limit the patient's quality of life.\n\nIn the event of severe trunk imbalance and progression of the deformity, operative correction of the spinal deformity by instrumentation and posterior arthrodesis may be indicated.\n\nSurgical techniques and instrumentation have evolved over the past 5 years. These changes in surgical strategies have a potential impact on the patient's quality of life and the correction results in the medium and long term.\n\nthe aim of the study is to analyze the surgical corrections obtained by transpedicular osteotomy and radiological changes over time with classic 2-rod techniques versus modern 4-rod instrumentation techniques"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Major subjects with a surgical indication for arthrodesis and surgical correction of anterior imbalance by transpedicular osteotomy', 'eligibilityCriteria': 'Inclusion criteria:\n\n* Major subjects\\> 18 years old\n* Subject operated at HUS between 01/01/2010 to 31/12/2020\n* Subject with a surgical indication for arthrodesis and surgical correction of anterior imbalance by transpedicular osteotomy\n* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.\n\nExclusion criteria:\n\n* Subject having expressed opposition to participating in the study\n* Subject under guardianship or guardianship\n* Subject under safeguard of justice'}, 'identificationModule': {'nctId': 'NCT05100732', 'acronym': 'OTP', 'briefTitle': 'Corrections of Anterior Imbalances by Posterior Instrumentation and Osteotomies', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Analysis of Corrections of Anterior Imbalances by Posterior Instrumentation and Osteotomies', 'orgStudyIdInfo': {'id': '7963'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yann Philippe CHARLES, MD, PhD', 'role': 'CONTACT', 'email': 'YannPhilippe.CHARLES@chru-strasbourg.fr', 'phone': '33 3 68 76 52 68'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT'}, {'name': 'Yann Philippe CHARLES, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nicolas TUZIN, Statistician', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Yann Philippe CHARLES, MD, PhD', 'role': 'CONTACT', 'email': 'YannPhilippe.CHARLES@chru-strasbourg.fr', 'phone': '33 3 68 76 52 68'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}