Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-03-02 @ 4:05 AM
Study NCT ID:
NCT00549627
Status:
SUSPENDED
Last Update Posted:
2009-02-04
First Post:
2007-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the PediGuard™ for Pedicle Screw Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'whyStopped': 'New funding sources being sought', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-03', 'studyFirstSubmitDate': '2007-10-24', 'studyFirstSubmitQcDate': '2007-10-24', 'lastUpdatePostDateStruct': {'date': '2009-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'At least 90% of screws placed with the PediGuard™ will be positioned correctly in the pedicle (defined as less than 2 mm breach by CT scan).', 'timeFrame': 'Post-op CT prior to discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Posterior Spinal Fusion']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine the relative effectiveness of the PediGuardTM , a device manufactured by SpineVision, Inc, for placement of a pedicle screw pilot (drill) hole and for reducing pedicle screw breaches during thoracic and lumbar pedicle screw fixation of the spine.\n\nHypothesis #1 The PediGuardTM will be more accurate for pedicle screw placement as compared to other standard manual techniques of similar size of pedicle screw insertion. At least 90% of screws placed with the PediGuardTM will be positioned correctly in the pedicle (defined as less than 2 mm breach by CT scan). In contrast, only 80% of screws using manual placement will be positioned correctly in the pedicle.\n\nHypothesis #2 The PediGuardTM will not be inferior to fluoroscopic techniques for pedicle screw insertion. Both techniques will achieve at least 90% accuracy in the placement of pedicle screws.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing primary spinal fusion with pedicle screw fixation of the spine anywhere from T1to S1\n* Subjects must be skeletally mature as defined by closed growth plates on wrist via radiographs\n* Written informed consent and assent (assent for adolescents)\n\nExclusion Criteria:\n\n* Pedicle screw insertion by image guided techniques, including Fluoronav\n* Tumor\n* Diagnoses associated with diminished bone mineral density such as osteogenesis imperfecta, severe osteopenia, neurofibromatosis\n* Severe senile osteoporosis (\\> 2 standard deviations below the norm)\n* Women who are pregnant\n* Children with open growth plates\n* Previously fused spinal levels\n* Unwillingness to sign written informed consent and assent.'}, 'identificationModule': {'nctId': 'NCT00549627', 'briefTitle': 'Evaluation of the PediGuard™ for Pedicle Screw Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Shriners Hospitals for Children'}, 'officialTitle': 'Evaluation of the PediGuard™ for Pedicle Screw Insertion', 'orgStudyIdInfo': {'id': '4727'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pediguard', 'type': 'DEVICE', 'description': 'PediGuard™ is a hand-held drilling tool that allows real-time detection of vertebral pedicle and body breaches in all directions.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80401', 'city': 'Golden', 'state': 'Colorado', 'country': 'United States', 'facility': 'Panorama Orthopedics and Spine Center', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Miami Children's Hospital", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Spine Institute', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Hospital for Joint Diseases', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Shriners Hospitals for Children', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': 'N6A4G5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Victoria Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Randal Betz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shriners Hospitals for Children'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shriners Hospitals for Children', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Randal Betz, MD', 'oldOrganization': 'Shriners Hospitals for Children'}}}}