Ignite Creation Date:
2025-12-17 @ 1:46 PM
Ignite Modification Date:
2025-12-23 @ 4:53 PM
Study NCT ID:
NCT03521661
Status:
COMPLETED
Last Update Posted:
2018-05-22
First Post:
2018-04-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Kyphoplasty With a New Intervertebral Expander
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016103', 'term': 'Spinal Fractures'}], 'ancestors': [{'id': 'D013124', 'term': 'Spinal Injuries'}, {'id': 'D019567', 'term': 'Back Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058498', 'term': 'Kyphoplasty'}], 'ancestors': [{'id': 'D054854', 'term': 'Vertebroplasty'}, {'id': 'D060826', 'term': 'Cementoplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-19', 'studyFirstSubmitDate': '2018-04-30', 'studyFirstSubmitQcDate': '2018-04-30', 'lastUpdatePostDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiological evaluation', 'timeFrame': '12 months', 'description': 'Kyphosis angle in degree and vertebral body height in cm are measured on lateral x-ray'}], 'secondaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': '12 months', 'description': 'Scores range from 0 (no pain) to 10 (worst possible pain)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vertebral fracture', 'Kyphotic deformity', 'Kyphoplasty', 'Vertebroplasty'], 'conditions': ['Vertebral Body Compression']}, 'descriptionModule': {'briefSummary': 'Balloon kyphoplasty is a well-established treatment option to achieve pain relief and to correct kyphotic deformity caused by osteoporotic vertebral compression fracture. However, it has been demonstrated that reduction is partly lost as balloon is deflated in the vertebral body. An intravertebral expander was developed for better reduction and maintenance of vertebral body height while cement is injected. This study evaluates the efficacy of kyphoplasty with a new intravertebral expander with regard to correction of kyphosis angel and to restoration of vertebral body height.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with new osteoporotic vertebral body fractures who were eligible for kyphoplasty and were treated with kyphoplasty, were observed prospectively 12 months after the surgery. In the follow-up period the clinical and radiological data were collected', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Osteoporotic vertebral body fractures that were classified as A1 fractures according to Arbeitsgemeinschaft Osteosynthesis (AO) Classification\n\nExclusion Criteria:\n\n* More than 2 vertebral body fractures\n* Fractures of vertebral body based on malignancy\n* Previous spinal operation\n* Spinal infection\n* Spinal deformity (scoliosis)'}, 'identificationModule': {'nctId': 'NCT03521661', 'briefTitle': 'Efficacy of Kyphoplasty With a New Intervertebral Expander', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Efficacy of Kyphoplasty With an Intravertebral Expander for Correction of Spine Deformity After Osteoporotic Vertebral Fracture', 'orgStudyIdInfo': {'id': 'Kyphoplasty'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Kyphoplasty', 'description': 'Patients underwent kyphoplasty with an intravertebral expander', 'interventionNames': ['Procedure: Kyphoplasty']}], 'interventions': [{'name': 'Kyphoplasty', 'type': 'PROCEDURE', 'description': 'Fractured vertebral body was reduced with an intravertebral expander and was cement augmented thereafter', 'armGroupLabels': ['Kyphoplasty']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mohammad Arab Motlagh, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Goethe University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohammad ARAB MOTLAGH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Mohammad ARAB MOTLAGH', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}