Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
Study NCT ID:
NCT01327508
Status:
TERMINATED
Last Update Posted:
2018-03-14
First Post:
2011-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
TRIGEN SURESHOT™ Distal Targeting System Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cathy.newbill@smith-nephew.com', 'phone': '800-821-5700', 'title': 'Cathy Newbill', 'organization': 'Smith & Nephew, Inc.'}, 'certainAgreement': {'otherDetails': "* Sponsor shall have the sole right for 12 mo after completion of Study at all sites to arrange for the submission of the multi-center article or presentation\n* After the 12 mo, upon Sponsor approval or after the multicenter publication occurs, Investigator may publish, present and use for instruction and research, Investigator's results arising out of its conduct of the Study at the Site. Investigator may not disclose Sponsor Confidential Information, and Sponsor protects its proprietary rights", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Operative and immediate postoperative', 'eventGroups': [{'id': 'EG000', 'title': 'TRIGEN SURESHOT Distal Targeting', 'description': 'TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.\n\nTRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system', 'otherNumAtRisk': 30, 'otherNumAffected': 4, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Nailing Instrumentation.', 'description': 'Free-hand technique utilizes x-rays to find screw holes\n\nFree-hand technique: Free-hand technique utilizes x-rays to find screw holes.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Change out screw', 'notes': 'Change out distal locking screw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Probe misplacement', 'notes': 'Probe not correctly placed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Radiation Exposure Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TRIGEN SURESHOT Distal Targeting', 'description': 'TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.\n\nTRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system'}, {'id': 'OG001', 'title': 'Standard Nailing Instrumentation.', 'description': 'Free-hand technique utilizes x-rays to find screw holes\n\nFree-hand technique: Free-hand technique utilizes x-rays to find screw holes.'}], 'timeFrame': 'Intraoperative', 'description': 'Radiation exposure measured in two ways:\n\nWhole body badge TLD ring badge', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary endpoint voided. Dosimeters did not capture radiation dose as expected.'}, {'type': 'SECONDARY', 'title': 'Distal Locking Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TRIGEN SURESHOT Distal Targeting', 'description': 'TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.\n\nTRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system'}, {'id': 'OG001', 'title': 'Standard Nailing Instrumentation.', 'description': 'Free-hand technique utilizes x-rays to find screw holes\n\nFree-hand technique: Free-hand technique utilizes x-rays to find screw holes.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '8.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative', 'description': 'Distal locking time is defined as the period between successful nail insertion without locking and the confirmation of accurate insertion of both distal screws.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TRIGEN SURESHOT Distal Targeting', 'description': 'TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.\n\nTRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system'}, {'id': 'FG001', 'title': 'Standard Nailing Instrumentation.', 'description': 'Free-hand technique utilizes x-rays to find screw holes\n\nFree-hand technique: Free-hand technique utilizes x-rays to find screw holes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TRIGEN SURESHOT Distal Targeting', 'description': 'TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.\n\nTRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system'}, {'id': 'BG001', 'title': 'Standard Nailing Instrumentation.', 'description': 'Free-hand technique utilizes x-rays to find screw holes\n\nFree-hand technique: Free-hand technique utilizes x-rays to find screw holes.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'spread': '19.0', 'groupId': 'BG000'}, {'value': '35.3', 'spread': '19.5', 'groupId': 'BG001'}, {'value': '36.5', 'spread': '19.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Unilateral femoral shaft fracture requiring treatment with intramedullary nails, in which the use of sterotactic surgery may be appropriate.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'whyStopped': 'Primary endpoint voided. Dosimeters did not capture radiation dose as expected.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-14', 'studyFirstSubmitDate': '2011-03-30', 'resultsFirstSubmitDate': '2014-06-06', 'studyFirstSubmitQcDate': '2011-03-31', 'lastUpdatePostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-01-05', 'studyFirstPostDateStruct': {'date': '2011-04-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiation Exposure Measurement', 'timeFrame': 'Intraoperative', 'description': 'Radiation exposure measured in two ways:\n\nWhole body badge TLD ring badge'}], 'secondaryOutcomes': [{'measure': 'Distal Locking Time', 'timeFrame': 'Intraoperative', 'description': 'Distal locking time is defined as the period between successful nail insertion without locking and the confirmation of accurate insertion of both distal screws.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Femoral Shaft Fracture']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to quantitate the amount of radiation both subjects and surgeons are exposed to during intramedullary nailing of the femur using the TRIGEN SURESHOT Distal Targeting System versus Standard nailing instrumentation.', 'detailedDescription': 'The TRIGEN SURESHOT™ Distal Targeting System was designed to be an intraoperative image-guided localization system to aid with drill positioning for screws during intramedullary nailing distal interlocking. It is hypothesized that this system will aid in identification of the distal holes leading to reduced exposure to radiation. The SURESHOT System provides information to the surgeon that is used to place surgical instruments utilizing electromagnetic tracking data obtained intraoperatively. It is indicated for long bone fractures treated with intramedullary nailing in which the use of stereotactic surgery may be appropriate. The hypothesis is that using the TRIGEN SURESHOT™ Distal Targeting System will allow accurate distal locking while effectively decreasing the amount of radiation exposure compared to the standard instrumentation process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Unilateral femoral shaft fracture requiring intramedullary nailing in which the use of stereotactic surgery may be appropriate.\n* Subject is between 18-80 years of age.\n* Subject is skeletally mature\n* Subject is of legal age and capable of providing legal consent.\n* Subject is suitable for current Intramedullary Nailing procedure\n* Subject willing to accept randomization either to the TRIGEN SURESHOT Distal Targeting System or TRIGEN standard instrumentation.\n\nExclusion Criteria\n\n* Femur shaft fracture not amenable to intramedullary nailing in which the use of sterotactic surgery may be inappropriate.\n* Fracture with vascular injury (Gustilo Type IIIC) requiring repair\n* Open fractures where open wound is in communication with distal targeting holes and therefore would influence duration of locking procedure (i.e. potentially no need for incisions for locking screw placement).\n* Fracture of the Metaphyseal distal femur with intraarticular comminution\n* Known Pathological Fracture\n* Subject is a prisoner\n* Operative procedure for closed fracture is scheduled for greater than 2 weeks for closed fractures\n* Subject has cognitive issue/mental status conditions that preclude intramedullary nailing in the judgment of the investigator.\n* Contralateral femoral shaft fracture'}, 'identificationModule': {'nctId': 'NCT01327508', 'acronym': 'Sureshot', 'briefTitle': 'TRIGEN SURESHOT™ Distal Targeting System Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'A Prospective, Multi-center, Randomized, Comparison Study of the TRIGEN SURESHOT™ Distal Targeting vs. Standard Targeting Instrumentation', 'orgStudyIdInfo': {'id': '09-TRI-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TRIGEN SURESHOT Distal Targeting', 'description': 'TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.', 'interventionNames': ['Device: TRIGEN SURESHOT Distal Targeting Instrumentation.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Nailing Instrumentation.', 'description': 'Free-hand technique utilizes x-rays to find screw holes', 'interventionNames': ['Other: Free-hand technique']}], 'interventions': [{'name': 'TRIGEN SURESHOT Distal Targeting Instrumentation.', 'type': 'DEVICE', 'otherNames': ['SURESHOT'], 'description': 'image-guided localization system', 'armGroupLabels': ['TRIGEN SURESHOT Distal Targeting']}, {'name': 'Free-hand technique', 'type': 'OTHER', 'description': 'Free-hand technique utilizes x-rays to find screw holes.', 'armGroupLabels': ['Standard Nailing Instrumentation.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Department of Orthopaedics and Rehabilitation', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '27707', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University Hospital Trauma Service', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Capital District Health Authority', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'overallOfficials': [{'name': 'Samir Mehta, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopaedic Surgery, Hospital of the University of Pennsylvania'}, {'name': 'Animesh Agarwal, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT Health Science Center, Dept of Orthopaedic'}, {'name': 'Marcus Sciadini, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland Baltimore, Department of Orthopaedics'}, {'name': 'Steven Olson, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University Medical Center of Orthopaedic'}, {'name': 'Chad Coles, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nova Scotia Health Authority'}, {'name': 'Richard Vlasak, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Orthopaedics & Rehab University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}