Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-02-28 @ 9:05 PM
Study NCT ID:
NCT02190435
Status:
COMPLETED
Last Update Posted:
2017-05-24
First Post:
2014-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Computer-Assisted Navigation for Intramedullary Nail Fixation of Intertrochanteric Femur Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'denise.koueiter@beaumont.org', 'phone': '248-551-5166', 'title': 'Denise Koueiter, MS', 'organization': 'William Beaumont Hospital'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Start of surgery until end of surgery', 'eventGroups': [{'id': 'EG000', 'title': 'ADAPT', 'description': 'Patients that receive intramedullary nail fixation with use of the ADAPT system\n\nStryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Patients that receive intramedullary nail fixation without use of the ADAPT system', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tip-to-apex Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ADAPT', 'description': 'Patients that receive intramedullary nail fixation with use of the ADAPT system\n\nStryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients that receive intramedullary nail fixation without use of the ADAPT system'}], 'classes': [{'categories': [{'measurements': [{'value': '14.1', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '14.9', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative', 'description': 'Distance between lag screw tip and head surface as measured on the ADAPT system', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Radiation Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ADAPT', 'description': 'Patients that receive intramedullary nail fixation with use of the ADAPT system\n\nStryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients that receive intramedullary nail fixation without use of the ADAPT system'}], 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '18.8', 'spread': '8.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative', 'description': 'Intraoperative fluoroscopy exposure time for lag screw placement (seconds)', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ADAPT', 'description': 'Patients that receive intramedullary nail fixation with use of the ADAPT system\n\nStryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3'}, {'id': 'FG001', 'title': 'Control', 'description': 'Patients that receive intramedullary nail fixation without use of the ADAPT system'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'First 12 patients were lead-ins', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': '3 consented screen fails', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ADAPT', 'description': 'Patients that receive intramedullary nail fixation with use of the ADAPT system\n\nStryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3'}, {'id': 'BG001', 'title': 'Control', 'description': 'Patients that receive intramedullary nail fixation without use of the ADAPT system'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-17', 'studyFirstSubmitDate': '2014-07-11', 'resultsFirstSubmitDate': '2017-04-17', 'studyFirstSubmitQcDate': '2014-07-14', 'lastUpdatePostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-17', 'studyFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tip-to-apex Distance', 'timeFrame': 'Intraoperative', 'description': 'Distance between lag screw tip and head surface as measured on the ADAPT system'}], 'secondaryOutcomes': [{'measure': 'Radiation Exposure', 'timeFrame': 'Intraoperative', 'description': 'Intraoperative fluoroscopy exposure time for lag screw placement (seconds)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Computer-assisted navigation', 'ADAPT', 'Intramedullary nail', 'Intertrochanteric femur fracture'], 'conditions': ['Intertrochanteric Femur Fractures']}, 'referencesModule': {'references': [{'pmid': '7608228', 'type': 'BACKGROUND', 'citation': 'Baumgaertner MR, Curtin SL, Lindskog DM, Keggi JM. The value of the tip-apex distance in predicting failure of fixation of peritrochanteric fractures of the hip. J Bone Joint Surg Am. 1995 Jul;77(7):1058-64. doi: 10.2106/00004623-199507000-00012.'}, {'pmid': '20832795', 'type': 'BACKGROUND', 'citation': 'Lobo-Escolar A, Joven E, Iglesias D, Herrera A. Predictive factors for cutting-out in femoral intramedullary nailing. Injury. 2010 Dec;41(12):1312-6. doi: 10.1016/j.injury.2010.08.009. Epub 2010 Sep 15.'}, {'pmid': '19618186', 'type': 'BACKGROUND', 'citation': 'Geller JA, Saifi C, Morrison TA, Macaulay W. Tip-apex distance of intramedullary devices as a predictor of cut-out failure in the treatment of peritrochanteric elderly hip fractures. Int Orthop. 2010 Jun;34(5):719-22. doi: 10.1007/s00264-009-0837-7. Epub 2009 Jul 18.'}, {'pmid': '22810396', 'type': 'BACKGROUND', 'citation': 'De Bruijn K, den Hartog D, Tuinebreijer W, Roukema G. Reliability of predictors for screw cutout in intertrochanteric hip fractures. J Bone Joint Surg Am. 2012 Jul 18;94(14):1266-72. doi: 10.2106/JBJS.K.00357.'}]}, 'descriptionModule': {'briefSummary': "There are approximately 250,000 hip fractures in the US every year, and intertrochanteric (IT) fractures (fractures that occur just below the femoral head) account for nearly half of these fractures. The use of intramedullary (IM) nails for fixation of IT femur fractures has become a well-accepted and increasingly more common procedure among orthopaedic traumatologists, and is standard of care at our institution.\n\nWhile advancements in intramedullary nail fixation have made it a relatively efficient procedure, the placement of the lag screw into the femoral head still remains a challenging step in the procedure. Inaccurate placement can lead to screw cut-out, one of the most commonly reported complications with IM nail fixation. Previous work has shown that the lag screw position is an important factor in reducing screw cut-out. This step of the procedure can be time demanding and often requires several intraoperative radiographs for accurate placement. Recently developed computer-assisted navigation systems provide surgeons with the ability to track screw placement in real-time. This could allow for improved screw placement and potentially reduce radiation exposure to the patient and surgeon. To date, the potential advantages of computer-assisted navigation have not been examined.\n\nThe primary objective of this study is to examine whether the use of Stryker's ADAPT computer-assisted navigation for Gamma nail fixation can result in improved lag screw placement. The secondary objective is to examine whether the use of the ADAPT for Gamma nail fixation can reduce intraoperative radiation exposure.Our hypothesis is that there is a difference in the lag screw placement (i.e. tip to apex distance measurement) between procedures using the ADAPT system versus the conventional technique for Gamma nail fixation. Additionally, we hypothesize that there is a difference in radiation exposure (i.e. fluoroscopy time) between procedures using the ADAPT system versus the conventional technique for Gamma nail fixation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing hip fracture fixation with a Gamma Nail by one of four orthopaedic trauma surgeons at William Beaumont Hospital Royal Oak\n* Diagnosis of an intertrochanteric femur fracture (AO Classification 31-A1,A2)\n* Low energy mechanism of injury (i.e. fall, twist)\n\nExclusion Criteria:\n\n* Minors (less than 18 years)\n* Pregnant\n* Have a high energy mechanism of injury (e.g. motor vehicle accident, fall from height)\n* Have an open fracture (i.e. the skin is broken at the fracture site), or\n* Present with multiple injuries to the ipsilateral lower extremity'}, 'identificationModule': {'nctId': 'NCT02190435', 'briefTitle': 'Computer-Assisted Navigation for Intramedullary Nail Fixation of Intertrochanteric Femur Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health East'}, 'officialTitle': 'Computer-Assisted Navigation for Intramedullary Nail Fixation of Intertrochanteric Femur Fractures', 'orgStudyIdInfo': {'id': '2014-111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADAPT', 'description': 'Patients that receive intramedullary nail fixation with use of the Stryker ADAPT computer-assisted navigation system', 'interventionNames': ['Device: Stryker ADAPT computer-assisted navigation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Patients that receive conventional technique intramedullary nail fixation without use of the Stryker ADAPT computer-assisted navigation system', 'interventionNames': ['Device: Conventional technique']}], 'interventions': [{'name': 'Stryker ADAPT computer-assisted navigation', 'type': 'DEVICE', 'description': 'Adaptive Positioning Technology for Gamma 3', 'armGroupLabels': ['ADAPT']}, {'name': 'Conventional technique', 'type': 'DEVICE', 'description': 'Conventional Technique', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}], 'overallOfficials': [{'name': 'Kevin Grant, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corewell Health East'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corewell Health East', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stryker Orthopaedics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kevin Grant, MD', 'investigatorAffiliation': 'Corewell Health East'}}}}