Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-27 @ 10:34 PM
Study NCT ID:
NCT01643395
Status:
COMPLETED
Last Update Posted:
2014-02-17
First Post:
2012-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050815', 'term': 'Fractures, Compression'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054854', 'term': 'Vertebroplasty'}, {'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D060826', 'term': 'Cementoplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-14', 'studyFirstSubmitDate': '2012-07-13', 'studyFirstSubmitQcDate': '2012-07-17', 'lastUpdatePostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disability scale', 'timeFrame': 'at 1 month'}], 'secondaryOutcomes': [{'measure': 'Spine radiological measurements', 'timeFrame': 'at 1, 3 and 6 months'}, {'measure': 'Disability and qol', 'timeFrame': 'at 3 and 6 months'}]}, 'conditionsModule': {'keywords': ['Trauma', 'vertebral', 'compression fracture', 'spinal', 'acute', 'vertebroplasty', 'conservative treatment'], 'conditions': ['Vertebral Compression Fracture', 'Spinal Trauma']}, 'referencesModule': {'references': [{'pmid': '37030247', 'type': 'DERIVED', 'citation': 'Chabert E, Hugonnet E, Kastler A, Sakka L, Rabbo FA, Zerroug A, Coudeyre E, Pereira B, Coll G. Vertebroplasty versus bracing in acute vertebral compression fractures: A prospective randomized trial. Ann Phys Rehabil Med. 2023 Sep;66(6):101746. doi: 10.1016/j.rehab.2023.101746. Epub 2023 Apr 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this protocol is to prove the efficacy of vertebroplasty in patients suffering from acute non osteoporotic vertebral compression fracture.\n\nVertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse.\n\nOur study will compare vertebroplasty versus conservative therapy (brace).', 'detailedDescription': 'The study is a prospective, randomized trial comparing conservative treatment (brace) and vertebroplasty in acute (less than 15 days after trauma) traumatic vertebral compression fracture (VCF) type A according Magerl classification'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 - 70 year old\n* volunteers\n* Vertebral compression fractures Magerl type A\n* Acute Trauma (less than 15 days)\n* Between T5 and L5\n* Patient able to undergo both vertebroplasty and conservative treatment\n* Consent form obtained\n\nExclusion Criteria:\n\n* Neural arch fracture\n* C1 to T4 fracture\n* Neurologic symptoms caused by the fracture\n* Encephalic trauma with Glasgow Coma Scale less than 15\n* Ongoing cancer\n* Routine painkillers intake\n* Local or systemic infection\n* Coagulation's disorder\n* Pregnancy\n* Involvement in an another clinical trial"}, 'identificationModule': {'nctId': 'NCT01643395', 'acronym': 'VOLCANO', 'briefTitle': 'VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures', 'orgStudyIdInfo': {'id': 'CHU-0122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vertebroplasty', 'interventionNames': ['Other: vertebroplasty']}, {'type': 'OTHER', 'label': 'conservative therapy (brace)', 'interventionNames': ['Other: conservative therapy']}], 'interventions': [{'name': 'vertebroplasty', 'type': 'OTHER', 'description': 'Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse', 'armGroupLabels': ['vertebroplasty']}, {'name': 'conservative therapy', 'type': 'OTHER', 'description': 'The study is a prospective, randomized trial comparing conservative treatment (brace) and vertebroplasty in acute (less than 15 days after trauma) traumatic vertebral compression fracture (VCF) type A according Magerl classification.', 'armGroupLabels': ['conservative therapy (brace)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Emmanuel CHABERT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}