Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-01-01 @ 5:28 PM
Study NCT ID:
NCT00765258
Status:
COMPLETED
Last Update Posted:
2013-08-21
First Post:
2008-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utility of CT Fluoroscopy Guidance During Percutaneous Sacroplasty With Quality of Life Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-19', 'studyFirstSubmitDate': '2008-09-30', 'studyFirstSubmitQcDate': '2008-10-01', 'lastUpdatePostDateStruct': {'date': '2013-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of pain and improved mobility in patients post percutaneous sacroplasty effectively assessed using the VAS pain scale and RMDQ both pre and post procedure.', 'timeFrame': '2008-2012', 'description': 'The average pre-treatment VAS score was significantly improved after sacroplasty in patients with sacral insufficiency fractures.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sacro-iliac Insufficiency Fractures']}, 'descriptionModule': {'briefSummary': "To examine, through retrospective and prospective chart review, the difference in pain and mobility, pre and post treatment, as assessed by the patient's completion of the VAS pain scale and Roland Morris Disability Questionnaire (RMDQ).\n\nCT fluoroscopy guidance during percutaneous sacroplasty is an effective treatment for sacro-iliac insufficiency fractures resulting in rapid reduction of pain and improved mobility in patients. This can be effectively assessed using the VAS pain scale and RMDQ both pre and post procedure.", 'detailedDescription': 'The purpose of the study is to report the use of CT fluoroscopy guidance during the performance of percutaneous sacroplasty. In addition, clinical results will be reported with the Roland Morris Disability Questionnaire(RMDQ)pre and post procedure, demonstrating the utility of the RMDQ in assessing improvement in patients pain, mobility and ability to perform activities of daily living.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patient's with pain and decreased mobility as a result of sacro-iliac insufficiency fracture(s).", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* greater than 18 years of age and treated with or about to be treated with percutaneous CT fluoro-guided sacroplasty, regardless of gender or ethnicity.\n\nExclusion Criteria:\n\n* less than 18 years old\n* pregnancy\n* inability to complete forms and surveys'}, 'identificationModule': {'nctId': 'NCT00765258', 'briefTitle': 'Utility of CT Fluoroscopy Guidance During Percutaneous Sacroplasty With Quality of Life Assessment', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Utility of CT Fluoroscopy Guidance During Percutaneous Sacroplasty With Quality of Life Assessment', 'orgStudyIdInfo': {'id': 'PRO00008209'}}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin / Froedtert Hospital', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Sean M Tutton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Winthrop University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sean Tutton, MD', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}