Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-27 @ 4:05 PM
Study NCT ID:
NCT02902250
Status:
COMPLETED
Last Update Posted:
2023-01-05
First Post:
2016-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Comparative Study About the Effect of Vertebral Body Decompression Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003664', 'term': 'Decompression'}, {'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011312', 'term': 'Pressure'}, {'id': 'D055595', 'term': 'Mechanical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-03', 'studyFirstSubmitDate': '2016-09-10', 'studyFirstSubmitQcDate': '2016-09-10', 'lastUpdatePostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Pain Scale', 'timeFrame': 'until 3 months after procedure', 'description': 'Pain status'}], 'secondaryOutcomes': [{'measure': 'Oswestry Disability Index', 'timeFrame': 'until 3 months after procedure', 'description': 'Health status'}, {'measure': 'EQ5D-5L', 'timeFrame': 'until 3 months after procedure', 'description': 'Quality of Life'}, {'measure': 'Leed Dyspepsia Questionnaire', 'timeFrame': 'until 3 months after procedure', 'description': 'Abdominal discomfort d/t medication and injection'}, {'measure': 'Radiographic outcome', 'timeFrame': 'until 3 months after procedure', 'description': 'Compression rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vertebroplasty', 'Core decompression', 'Osteoporosis'], 'conditions': ['Osteoporotic Vertebral Compression Fracture']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the treatment efficacy between vertebral body decompression procedure and conservative treatment with non-inferiority design'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* osteoporotic vertebral compression fracture\n\nExclusion Criteria:\n\n* malignancy or inflammatory disease\n* severe pain in other joints\n* coagulopathy\n* an inappropriate person considered by investigator'}, 'identificationModule': {'nctId': 'NCT02902250', 'briefTitle': 'The Comparative Study About the Effect of Vertebral Body Decompression Procedure', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Comparative Study About the Effect of Vertebral Body Decompression Procedure and Conservative Treatment for Benign Vertebral Compression Fracture - Prospective Randomized Control Study', 'orgStudyIdInfo': {'id': 'Decon_001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Decompression', 'description': 'bone marrow decompression at fractured vertebral body', 'interventionNames': ['Procedure: Decompression']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conservative Treatment', 'description': 'Conservative Treatment for compression fracture', 'interventionNames': ['Procedure: Conservative Treatment']}], 'interventions': [{'name': 'Decompression', 'type': 'PROCEDURE', 'description': 'vertebral body decompression in compression fracture', 'armGroupLabels': ['Decompression']}, {'name': 'Conservative Treatment', 'type': 'PROCEDURE', 'description': 'Conservative Treatment in vertebral compression fracture', 'armGroupLabels': ['Conservative Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam-si', 'state': 'Gyounggido', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Sang-Min Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Jin S. Yeom', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}