Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-02-25 @ 2:43 AM
Study NCT ID:
NCT01751633
Status:
TERMINATED
Last Update Posted:
2020-08-13
First Post:
2012-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spine FA3 - a Prospective, International, Multicenter Cohort Study on Treatment of of AO A3 Thoracolumbar Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000072700', 'term': 'Conservative Treatment'}, {'id': 'D002133', 'term': 'Calcium Sulfate'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008903', 'term': 'Minerals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'whyStopped': 'Administrative reason. Lack of funding.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2012-12-14', 'studyFirstSubmitQcDate': '2012-12-14', 'lastUpdatePostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Roland-Morris Disability Questionnaire (RMDQ)', 'timeFrame': '6 week follow up', 'description': 'Improvement in functional outcome from baseline to 6 week follow up (FU) measured with the Roland-Morris Disability Questionnaire (RMDQ)'}], 'secondaryOutcomes': [{'measure': 'Back pain related disability (Roland-Morris Disability Questionnaire RMDQ)', 'timeFrame': 'Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up'}, {'measure': 'Pain (Numeric Rating Scale (NRS))', 'timeFrame': 'Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months FU'}, {'measure': 'Radiologic progress taking into account RX, CT and optionally MRI', 'timeFrame': 'baseline and at follow up after 6 weeks, 3, 6, 12 and 24 months'}, {'measure': 'Quality of return to work (Denis Work Scale)', 'timeFrame': 'Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up'}, {'measure': 'Time to return to work', 'timeFrame': 'Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up'}, {'measure': 'Conservative treatment failure rate (eg, change to surgical treatment)', 'timeFrame': 'Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up'}, {'measure': 'Rates of local adverse events (AE)', 'timeFrame': 'Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Burst fractures', 'Thoracic or Lumbar Vertebrae/injuries [MeSH]', 'Thoracic or Lumbar Vertebrae/surgery [MeSH]', 'Spinal Fusion/methods [MeSH]', 'Thoracolumbar fracture management', 'Quality of life', 'Functional outcome'], 'conditions': ['Single Level Stable Thoracolumbar Fracture Type AO A3', 'Multiple Level Stable Thoracolumbar Fracture Type AO A3']}, 'descriptionModule': {'briefSummary': 'Thoracolumbar fractures are the most common spinal fractures with an average annual incidence between 18 and 30 per 100\'000 inhabitants. The majority of these fractures are AO type A3 ("burst fractures"). Although patients with burst fractures report a reduced quality of life and chronic pain, there is no clear evidence whether surgical or conservative treatment offer better functional and back-pain related outcomes. The indications for the selection of an ideal treatment for these fractures without neurological deficits remain controversial. The purpose of this study is to evaluate whether patients with thoracolumbar fractures without neurological deficit being surgically treated show faster recovery and better improvement of function than patients being conservatively treated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "140 subjects patients with thoracolumbar fractures will be assigned to ei-ther conservative or surgical treatment depending on the surgeon's decision. Patients will be treated at each institution per standard of care. Surgeons will use their expertise and preferences to determine the method of surgical or conservative intervention.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 years\n* Diagnosis of single or multiple stable thoracolumbar fracture(s)\n\n * Level T10- L3\n * Type AO A3 or A4\n * Radiologically confirmed by Rx or CT\n* Fracture induced kyphotic deformity lower or equal to 20-35 degrees\n* Definitive treatment (surgical or conservative) within 10 days after injury\n* American Spinal Injury Association (ASIA) Impairment Scale = E (normal )\n* Ability to understand patient information / informed consent form\n* Willingness and ability to participate in the clinical investigation including imaging and follow-up procedures (FUs)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Open fracture\n* Polytrauma\n* Pathologic fracture\n* Disruption of the posterior ligamentous complex between T10 and L3\n* Clinically evident osteoporosis as assessed by the investigator\n* Spinal luxation\n* Associated severe lesions as assessed by the investigator\n* Spinal lesion due to gun or projectile\n* Pre-existing spinal column deformity\n* Prior spinal surgeries\n* BMI \\> 40 kg/m2\n* Any severe medically not managed systemic disease\n* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reli-able assessment\n* Pregnancy or women planning to conceive within the study period\n* Prisoner\n* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study'}, 'identificationModule': {'nctId': 'NCT01751633', 'acronym': 'FA3', 'briefTitle': 'Spine FA3 - a Prospective, International, Multicenter Cohort Study on Treatment of of AO A3 Thoracolumbar Fractures', 'organization': {'class': 'OTHER', 'fullName': 'AO Innovation Translation Center'}, 'officialTitle': 'Comparison of Surgical Versus Conservative Treatment of AO Type A3 Thoracolumbar Fractures Without Neurological Deficits Prospective, International, Multicenter Cohort Study', 'orgStudyIdInfo': {'id': 'Spine FA3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical treatment', 'description': "Surgical treatment according to one of the following:\n\n* Posterior open approach\n* Posterior minimally-invasive surgery (MIS) approach The choice of the approach will be left upon the surgeon's discretion", 'interventionNames': ['Procedure: Surgical']}, {'label': 'Conservative treatment', 'description': "Conservative treatment according to hospital's standard of care", 'interventionNames': ['Procedure: Conservative treatment']}], 'interventions': [{'name': 'Surgical', 'type': 'PROCEDURE', 'otherNames': ['• Posterior open approach', '• Posterior minimally-invasive surgery (MIS) approach'], 'armGroupLabels': ['Surgical treatment']}, {'name': 'Conservative treatment', 'type': 'PROCEDURE', 'otherNames': ["Conservative treatment according to hospital's standard of care :", '- Bed rest followed by immobilization with:', '- Custom-moulded or prefabricated total body contact thoracolumbosacral orthosis (TLSO)', '- Thermoplastic removable brace, Jewett hyperextension braces, Anterior hyperextension brace (ASH), Taylor-Knight brace', '- Plaster of Paris (POP)'], 'armGroupLabels': ['Conservative treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Curitiba', 'country': 'Brazil', 'facility': 'Hospital Universitaria Cajuru', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Hospital Cristo Redentor', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Santa Marcelina', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Hospital Cristo Redentor', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Liberec', 'country': 'Czechia', 'facility': 'Krajská nemocnice Liberec', 'geoPoint': {'lat': 50.76711, 'lon': 15.05619}}, {'city': 'Munich', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar der Technischen Universität München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'Azienda Ospedaliero - Universitaria Policlinico', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Almada', 'country': 'Portugal', 'facility': 'Hospital Garcia e Orta, EPE', 'geoPoint': {'lat': 38.67902, 'lon': -9.1569}}], 'overallOfficials': [{'name': 'Giuseppe Barbagallo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliero - Universitaria Policlinico, Catania, Italy'}, {'name': 'Emiliano Vialle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catholic University of Parana - Curitiba, Brazil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AO Clinical Investigation and Publishing Documentation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}