Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-26 @ 3:03 PM
Study NCT ID:
NCT04528459
Status:
TERMINATED
Last Update Posted:
2025-03-04
First Post:
2020-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Computer-Assisted Fixation of Trochanteric Femur Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wkt2106@cumc.columbia.edu', 'phone': '2123059192', 'title': 'Wakenda K. Tyler, MD, MPH', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'At time of enrollment; 1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Traditional Fluoroscopy', 'description': 'Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Stryker© ADAPT™ Platform', 'description': 'Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tip-apex Distance (TAD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Traditional Fluoroscopy', 'description': 'Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care).'}, {'id': 'OG001', 'title': 'Stryker© ADAPT™ Platform', 'description': 'Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw.'}], 'timeFrame': 'Immediate post-operative period', 'description': 'Tip-apex distance of the lag screw in the femoral head as measured on postoperative anteroposterior and lateral x-rays', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.'}, {'type': 'SECONDARY', 'title': 'Lag Screw Position', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Traditional Fluoroscopy', 'description': 'Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care).'}, {'id': 'OG001', 'title': 'Stryker© ADAPT™ Platform', 'description': 'Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw.'}], 'timeFrame': 'Immediate postoperative period', 'description': 'Lag screw position in the femoral head/neck as described by Cleveland et al. (1959)', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.'}, {'type': 'SECONDARY', 'title': 'Operative Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Traditional Fluoroscopy', 'description': 'Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care).'}, {'id': 'OG001', 'title': 'Stryker© ADAPT™ Platform', 'description': 'Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw.'}], 'timeFrame': 'Intraoperative period', 'description': 'The amount of time required to complete the surgical procedure', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.'}, {'type': 'SECONDARY', 'title': 'Fluoroscopy Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Traditional Fluoroscopy', 'description': 'Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care).'}, {'id': 'OG001', 'title': 'Stryker© ADAPT™ Platform', 'description': 'Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw.'}], 'timeFrame': 'Intraoperative period', 'description': 'The amount of fluoroscopy utilized during the surgical procedure as measured in seconds', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.'}, {'type': 'SECONDARY', 'title': 'K-wire Passes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Traditional Fluoroscopy', 'description': 'Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care).'}, {'id': 'OG001', 'title': 'Stryker© ADAPT™ Platform', 'description': 'Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw.'}], 'timeFrame': 'Intraoperative period', 'description': 'The total number of K-wire passes prior to final lag screw placement', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.'}, {'type': 'SECONDARY', 'title': 'Evidence of Lag Screw Cut-out', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Traditional Fluoroscopy', 'description': 'Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care).'}, {'id': 'OG001', 'title': 'Stryker© ADAPT™ Platform', 'description': 'Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw.'}], 'timeFrame': '3 months, 6 months, 1 year, and 2 years after surgery', 'description': 'Evidence of lag screw cut-out as seen on postoperative hip radiographs', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.'}, {'type': 'SECONDARY', 'title': 'Hip Range of Motion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Traditional Fluoroscopy', 'description': 'Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care).'}, {'id': 'OG001', 'title': 'Stryker© ADAPT™ Platform', 'description': 'Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw.'}], 'timeFrame': '3 months, 6 months, 1 year, and 2 years after surgery', 'description': 'Postoperative range of motion of the affected hip as measured on physical examination', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.'}, {'type': 'SECONDARY', 'title': 'Patient Mobility and Social Dependency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Traditional Fluoroscopy', 'description': 'Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care).'}, {'id': 'OG001', 'title': 'Stryker© ADAPT™ Platform', 'description': 'Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw.'}], 'timeFrame': '3 months, 6 months, 1 year, and 2 years after surgery', 'description': 'Postoperative patient mobility and social dependency as defined by the Harris Hip Score', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.'}, {'type': 'SECONDARY', 'title': 'Pain Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Traditional Fluoroscopy', 'description': 'Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care).'}, {'id': 'OG001', 'title': 'Stryker© ADAPT™ Platform', 'description': 'Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw.'}], 'timeFrame': '3 months, 6 months, 1 year, and 2 years after surgery', 'description': 'Postoperative pain level as defined by the visual analog scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Traditional Fluoroscopy', 'description': 'Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care).'}, {'id': 'FG001', 'title': 'Stryker© ADAPT™ Platform', 'description': 'Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Traditional Fluoroscopy', 'description': 'Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care).'}, {'id': 'BG001', 'title': 'Stryker© ADAPT™ Platform', 'description': 'Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '82.7', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '82.0', 'spread': '14.6', 'groupId': 'BG001'}, {'value': '82.3', 'spread': '13.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-09', 'size': 105479, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-16T15:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients will be blinded to treatment group allocation, as will outcomes assessors. Clinicians performing the procedures will not be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be divided into two treatment arms: cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw. Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™platform to assist with insertion of the lag screw.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'ADAPT platform no longer supported', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2020-08-24', 'resultsFirstSubmitDate': '2025-01-16', 'studyFirstSubmitQcDate': '2020-08-24', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-11', 'studyFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tip-apex Distance (TAD)', 'timeFrame': 'Immediate post-operative period', 'description': 'Tip-apex distance of the lag screw in the femoral head as measured on postoperative anteroposterior and lateral x-rays'}], 'secondaryOutcomes': [{'measure': 'Lag Screw Position', 'timeFrame': 'Immediate postoperative period', 'description': 'Lag screw position in the femoral head/neck as described by Cleveland et al. (1959)'}, {'measure': 'Operative Time', 'timeFrame': 'Intraoperative period', 'description': 'The amount of time required to complete the surgical procedure'}, {'measure': 'Fluoroscopy Time', 'timeFrame': 'Intraoperative period', 'description': 'The amount of fluoroscopy utilized during the surgical procedure as measured in seconds'}, {'measure': 'K-wire Passes', 'timeFrame': 'Intraoperative period', 'description': 'The total number of K-wire passes prior to final lag screw placement'}, {'measure': 'Evidence of Lag Screw Cut-out', 'timeFrame': '3 months, 6 months, 1 year, and 2 years after surgery', 'description': 'Evidence of lag screw cut-out as seen on postoperative hip radiographs'}, {'measure': 'Hip Range of Motion', 'timeFrame': '3 months, 6 months, 1 year, and 2 years after surgery', 'description': 'Postoperative range of motion of the affected hip as measured on physical examination'}, {'measure': 'Patient Mobility and Social Dependency', 'timeFrame': '3 months, 6 months, 1 year, and 2 years after surgery', 'description': 'Postoperative patient mobility and social dependency as defined by the Harris Hip Score'}, {'measure': 'Pain Level', 'timeFrame': '3 months, 6 months, 1 year, and 2 years after surgery', 'description': 'Postoperative pain level as defined by the visual analog scale'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Peritrochanteric femur fractures'], 'conditions': ['Hip Fractures']}, 'referencesModule': {'references': [{'pmid': '13849408', 'type': 'RESULT', 'citation': 'CLEVELAND M, BOSWORTH DM, THOMPSON FR, WILSON HJ Jr, ISHIZUKA T. A ten-year analysis of intertrochanteric fractures of the femur. J Bone Joint Surg Am. 1959 Dec;41-A:1399-408. No abstract available.'}, {'pmid': '30782395', 'type': 'RESULT', 'citation': 'Herzog J, Wendlandt R, Hillbricht S, Burgkart R, Schulz AP. Optimising the tip-apex-distance in trochanteric femoral fracture fixation using the ADAPT-navigated technique, a longitudinal matched cohort study. Injury. 2019 Mar;50(3):744-751. doi: 10.1016/j.injury.2019.02.010. Epub 2019 Feb 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether the Stryker© ADAPT™ augmented-reality platform can assist surgeons in optimizing placement of the lag screw component of the Stryker© Gamma™ cephalomedullary nail.', 'detailedDescription': 'This will be a prospective, randomized, single-blinded, controlled trial with two treatment cohorts. Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw. Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw. Patients will be blinded to treatment group allocation as will clinicians/researchers during data processing and analysis.\n\nThe primary outcome will be tip-apex distance, as measured on anteroposterior and lateral hip radiographs. Secondary outcomes will be position of the lag screw as described by Cleveland et al, operative time, fluoroscopy time, and number of Kirschner wire passes prior to final placement of the lag screw. Additionally, evidence of lag screw cutout on hip radiographs, hip range of motion relative to the contralateral hip, overall mobility, social dependency, and pain level will be assessed at 3 month, 6 month, 1 year, and 2 year follow up visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1\\. Patients aged 18 years and older with isolated closed peritrochanteric femur fractures who are candidates for surgical fixation with a cephalomedullary nail device\n\nExclusion criteria:\n\n1. Patients with open peritrochanteric femur fractures or multiple injuries (i.e., polytrauma)\n2. Patients with peritrochanteric femur fractures better treated with a device other than a cephalomedullary nail, as determined by the attending orthopedic surgeon\n3. Patients less than 18 years of age'}, 'identificationModule': {'nctId': 'NCT04528459', 'briefTitle': 'Computer-Assisted Fixation of Trochanteric Femur Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Computer-Assisted Surgery for Internal Fixation of Peritrochanteric Femur Fractures: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'AAAS7055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional fluoroscopy', 'description': 'Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care).', 'interventionNames': ['Radiation: Traditional fluoroscopy']}, {'type': 'EXPERIMENTAL', 'label': 'Stryker© ADAPT™ platform', 'description': 'Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™platform to assist with insertion of the lag screw.', 'interventionNames': ['Device: Stryker© ADAPT™ platform']}], 'interventions': [{'name': 'Stryker© ADAPT™ platform', 'type': 'DEVICE', 'description': 'The ADAPT system is a software platform that utilizes augmented reality to assist surgeons with implant alignment, lag screw length and positioning, and distal interlocking screw placement for cephalomedullary fixation of peritrochanteric femur fractures.', 'armGroupLabels': ['Stryker© ADAPT™ platform']}, {'name': 'Traditional fluoroscopy', 'type': 'RADIATION', 'description': 'For patients in the control group, traditional fluoroscopy will be utilized for placement of the cephalomedullary nail.', 'armGroupLabels': ['Traditional fluoroscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Orthopedic Surgery', 'investigatorFullName': 'Wakenda K. Tyler, MD, MPH', 'investigatorAffiliation': 'Columbia University'}}}}