Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT01402167
Status:
WITHDRAWN
Last Update Posted:
2015-03-25
First Post:
2011-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'interventionBrowseModule': {'meshes': [{'id': 'D058498', 'term': 'Kyphoplasty'}, {'id': 'D054854', 'term': 'Vertebroplasty'}], 'ancestors': [{'id': 'D060826', 'term': 'Cementoplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Patients refuse randomization.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2011-07-25', 'studyFirstSubmitQcDate': '2011-07-25', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The volume (cm^3) of injected ciment', 'timeFrame': 'Baseline (Day 0)', 'description': 'The volume of injected ciment is measured by catscan extrapolated data.'}], 'secondaryOutcomes': [{'measure': 'Recovery of vertebral volume (%)', 'timeFrame': 'Day 1 to Day 7', 'description': 'Recovery of vertebral volume relative to theoretical volume based on neighboring vertebra.'}, {'measure': 'Change from baseline of the cyphotic angle (°)', 'timeFrame': 'Days 1 to 7', 'description': 'The number of degrees of change in the cyphotic angle of the corrected vertebra relative to baseline measurement (°)'}, {'measure': 'Change from baseline of the cyphotic angle (°)', 'timeFrame': '1 month', 'description': 'The number of degrees of change in the cyphotic angle of the corrected vertebra relative to baseline measurement (°)'}, {'measure': 'Change from baseline of the cyphotic angle (°)', 'timeFrame': '3 months', 'description': 'The number of degrees of change in the cyphotic angle of the corrected vertebra relative to baseline measurement (°)'}, {'measure': 'Change from baseline in vertebral height (mm)', 'timeFrame': 'Days 1 to 7', 'description': 'Change in vertebra height (mm) before and after surgery'}, {'measure': 'Change from baseline in vertebral height (mm)', 'timeFrame': '1 month', 'description': 'Change in vertebra height (mm) before and after surgery'}, {'measure': 'Change from baseline in vertebral height (mm)', 'timeFrame': '3 months', 'description': 'Change in vertebra height (mm) before and after surgery'}, {'measure': 'Volume of ciment leakage (cm^3)', 'timeFrame': 'Day 1', 'description': 'The volume of ciment leakage will be determined according to catscan data.'}, {'measure': 'Change in Visual Analog Scale (0 to 10) for pain before and after surgery', 'timeFrame': 'Day 0 (post-op)', 'description': 'Brute change in Visual Analog Scale (0 to 10) for pain before and after surgery'}, {'measure': 'Change in Visual Analog Scale (0 to 10) for pain before and after surgery', 'timeFrame': '1 month', 'description': 'Brute change in Visual Analog Scale (0 to 10) for pain before and after surgery'}, {'measure': 'Change in Visual Analog Scale (0 to 10) for pain before and after surgery', 'timeFrame': '3 months', 'description': 'Brute change in Visual Analog Scale (0 to 10) for pain before and after surgery'}, {'measure': '% Change in Visual Analog Scale (0 to 10) for pain before and after surgery', 'timeFrame': 'Day 0 (post-op)', 'description': 'The percentage change (%) in Visual Analog Scale (0 to 10) for pain before and after surgery'}, {'measure': '% Change in Visual Analog Scale (0 to 10) for pain before and after surgery', 'timeFrame': '1 month', 'description': 'The percentage change (%) in Visual Analog Scale (0 to 10) for pain before and after surgery'}, {'measure': '% Change in Visual Analog Scale (0 to 10) for pain before and after surgery', 'timeFrame': '3 months', 'description': 'The percentage change (%) in Visual Analog Scale (0 to 10) for pain before and after surgery'}, {'measure': 'The change in the ODI score before and after surgery', 'timeFrame': '3 months', 'description': 'The change in the Oswestry Disability Index before and after surgery'}, {'measure': 'The % change in the ODI score before and after surgery', 'timeFrame': '3 months', 'description': 'The percentage change (%) in the Oswestry Disability Index before and after surgery'}, {'measure': 'Change in SF-36 quality of life score before and after surgery', 'timeFrame': '1 month', 'description': 'Change in SF-36 quality of life score before and after surgery'}, {'measure': 'Change in SF-36 quality of life score before and after surgery', 'timeFrame': '3 months', 'description': 'Change in SF-36 quality of life score before and after surgery'}, {'measure': 'The % change in SF-36 quality of life score before and after surgery', 'timeFrame': '1 month', 'description': 'Percentage change (%) in SF-36 quality of life score before and after surgery'}, {'measure': 'The % change in SF-36 quality of life score before and after surgery', 'timeFrame': '3 months', 'description': 'Percentage change (%) in SF-36 quality of life score before and after surgery'}, {'measure': 'Change in FABQ score before and after surgery', 'timeFrame': '1 month', 'description': 'Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery'}, {'measure': 'Change in FABQ score before and after surgery', 'timeFrame': '3 months', 'description': 'Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery'}, {'measure': '% Change in FABQ score before and after surgery', 'timeFrame': '1 month', 'description': 'Percentage change (%) in the Fear-Avoidance Beliefs Questionnaire score before and after surgery'}, {'measure': '% Change in FABQ score before and after surgery', 'timeFrame': '3 months', 'description': 'Percentage change (%) in the Fear-Avoidance Beliefs Questionnaire score before and after surgery'}, {'measure': 'Change in DPQ score before and after surgery', 'timeFrame': '1 month', 'description': 'Change in the Dallas Pain Questionnaire score before and after surgery'}, {'measure': 'Change in DPQ score before and after surgery', 'timeFrame': '3 months', 'description': 'Change in the Dallas Pain Questionnaire score before and after surgery'}, {'measure': '% Change in DPQ score before and after surgery', 'timeFrame': '3 months', 'description': 'Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery'}, {'measure': '% Change in DPQ score before and after surgery', 'timeFrame': '1 month', 'description': 'Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery'}, {'measure': 'Duration of surgery (minutes)', 'timeFrame': 'Day 0 (day of surgery)', 'description': 'Length of operative time (minutes)'}, {'measure': 'Presence / absence of per-operative complications', 'timeFrame': 'Day 0 (day of surgery)', 'description': 'Presence / absence of per-operative complications'}, {'measure': 'Presence / absence of post-operative complications', 'timeFrame': '1 month', 'description': 'Presence / absence of post-operative complications'}, {'measure': 'Presence / absence of post-operative complications', 'timeFrame': '3 months', 'description': 'Presence / absence of post-operative complications'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vertebral Body Compression Fractures']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare the volume of injected ciment (polymethyl methacrylate) between a group of patients treated with vertebroplasty and a group of patients treated via kyphoplasty. Secondary evaluation will compare the restoration of vertebral height, volume and cyphotic angle between the two techniques, as well as extravation of ciment and functional and quality of life aspects related to these techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have given his/her informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* The patient is available for 3 months of follow-up\n* Fracture type according to Magerl Classification (1994) must be one of the following: A1, A2.1, A3.1, A3.2\n* Cyphose of \\>10°\n* Spinal pain\n* Vertebral fracture \\< 3 weeks old located between D5 and L5\n* If fragments in the canal, they must protrude less than 40%\n* Absence of other lesions, including cancer\n\nExclusion Criteria:\n\n* The patient is participating in another study\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection, under tutorship or curatorship\n* The patient refuses to sign the consent\n* It is impossible to correctly inform the patient\n* Patient cannot read French\n* Patient is pregnant or breast feeding\n* Patient has a fracture on an adjacent vertebra\n* Patient has a contra-indication for a treatment used in this study\n* ASA class IV or V\n* Patient has a neurological deficit\n* Previous spinal surgery'}, 'identificationModule': {'nctId': 'NCT01402167', 'briefTitle': 'Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Evaluating Transcutaneous Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures: a Randomized Pilot Study Using Catscan Volumetry', 'orgStudyIdInfo': {'id': 'LOCAL/2011/PK-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kyphoplasty', 'description': 'Patients randomized to this arm will be treated via balloon kyphoplasty.', 'interventionNames': ['Procedure: Kyphoplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vertebroplasty', 'description': 'Patients randomized to this arm will be treated via vertebroplasty.', 'interventionNames': ['Procedure: Vertebroplasty']}], 'interventions': [{'name': 'Kyphoplasty', 'type': 'PROCEDURE', 'description': 'Patients will be treated via a balloon kyphoplasty surgical procedure', 'armGroupLabels': ['Kyphoplasty']}, {'name': 'Vertebroplasty', 'type': 'PROCEDURE', 'description': 'Patients will be treated via a transcutaneous vertebroplasty procedure.', 'armGroupLabels': ['Vertebroplasty']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pascal Kouyoumdjian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}