Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-03-05 @ 1:42 PM
Study NCT ID:
NCT03196193
Status:
COMPLETED
Last Update Posted:
2020-09-29
First Post:
2017-03-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CM Asia Nail With AS2 Without AS2 （AS2 Study）
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000070799', 'term': 'Open Fracture Reduction'}, {'id': 'D005593', 'term': 'Fracture Fixation, Internal'}], 'ancestors': [{'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'takahito.nakai@zimmerbiomet.com', 'phone': '+81-3-6402-6610', 'title': 'Senior Manager of Clinical Affairs', 'organization': 'Zimmer Biomet G.K.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 weeks after surgery', 'eventGroups': [{'id': 'EG000', 'title': 'ZNN CM Asia With AS2 Technique', 'description': 'Open Reduction and Internal Fixation with AS2 Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail.\n\nBone fragment will be stabilized by additional screw fixation (Anterior Support Screw).\n\nOpen Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.\n\nZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.\n\nAnterior Support Screw: Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw.', 'otherNumAtRisk': 121, 'deathsNumAtRisk': 121, 'otherNumAffected': 0, 'seriousNumAtRisk': 121, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'ZNN CM Asia Without AS2 Technique', 'description': 'Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.\n\nOpen Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.\n\nZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 0, 'seriousNumAtRisk': 119, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Cut-out', 'notes': 'Proximal fracture fragment was dislodged after surgery and required reoperation to hemi hip replacement surgery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patient With and Without Excessive Lag Screw Sliding Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZNN CM Asia With AS2 Technique', 'description': 'Open Reduction and Internal Fixation with AS2 Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail.\n\nBone fragment will be stabilized by additional screw fixation (Anterior Support Screw).\n\nOpen Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.\n\nZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.\n\nAnterior Support Screw: Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw.'}, {'id': 'OG001', 'title': 'ZNN CM Asia Without AS2 Technique', 'description': 'Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.\n\nOpen Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.\n\nZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.'}], 'classes': [{'categories': [{'title': 'Success (lag screw sliding distance <4mm)', 'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}, {'title': 'Failure (lag screw sliding distance >=4mm)', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Postoperative 2-3 week', 'description': 'Number of patient was counted based on CT measurement results. Relative position of lag screw between CT images taken at both immediate and 2-3 weeks postoperatively was measured and recorded in value (e.g., 1.5 mm). This was called as "lag screw sliding distance". Four millimeter was set as threshold to define success and failure. Less than 4mm of lag screw sliding distance was recognized as Success and equal to or more than 4mm of lag screw sliding distance was recognized as Failure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Surgery Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZNN CM Asia With AS2 Technique', 'description': 'Open Reduction and Internal Fixation with AS2 Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail.\n\nBone fragment will be stabilized by additional screw fixation (Anterior Support Screw).\n\nOpen Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.\n\nZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.\n\nAnterior Support Screw: Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw.'}, {'id': 'OG001', 'title': 'ZNN CM Asia Without AS2 Technique', 'description': 'Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.\n\nOpen Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.\n\nZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.2', 'spread': '21.8', 'groupId': 'OG000'}, {'value': '59.8', 'spread': '20.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative, an average of 1 hour', 'description': 'Surgery time from skin incision to closure', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Image Assessment Using Computed Tomography (CT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZNN CM Asia With AS2 Technique', 'description': 'Open Reduction and Internal Fixation with AS2 Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail.\n\nBone fragment will be stabilized by additional screw fixation (Anterior Support Screw).\n\nOpen Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.\n\nZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.\n\nAnterior Support Screw: Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw.'}, {'id': 'OG001', 'title': 'ZNN CM Asia Without AS2 Technique', 'description': 'Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.\n\nOpen Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.\n\nZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.'}], 'classes': [{'categories': [{'title': 'Reduction position maintained', 'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}, {'title': 'Reduction position changed', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2-3 weeks postoperatively', 'description': 'Number of patient was counted based on CT measurement results. When the fracture reduction position achieved at surgery was maintained at 2 to 3 weeks, then the patient was categorized as success (Reduction position maintained). On the other hand, patient was categorized as failure (Reduction position changed) in the case that the fracture reduction position was changed.\n\nFracture repair position was categorized into three; "Anterior", "Neutral" or "Posterior" based on relative position of proximal bone fragment and distal bone fragment.\n\nThis analysis only includes patients whose fracture reduction position at immediate postoperative CT was either "Anterior" or "Neutral".\n\nIf both immediate and 2-3 weeks postoperative CT images show same fracture reduction position (example: "Anterior" at immediate postoperatively \\& "Anterior" at 2-3 weeks postoperatively), then the patient was recognized as Success (Reduction position maintained).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants, whose immediate postoperative reduction position is assessed as either "Anterior" or "Neutral", were eligible.\n\nEight patients in ZNN CM Asia with AS2 technique group and 6 patients in ZNN CM Asia without AS2 technique group were excluded from this analysis (their immediate postoperative reduction position was "Posterior".)'}, {'type': 'SECONDARY', 'title': 'Intraoperative Safety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZNN CM Asia With AS2 Technique', 'description': 'Open Reduction and Internal Fixation with AS2 Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail.\n\nBone fragment will be stabilized by additional screw fixation (Anterior Support Screw).\n\nOpen Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.\n\nZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.\n\nAnterior Support Screw: Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw.'}, {'id': 'OG001', 'title': 'ZNN CM Asia Without AS2 Technique', 'description': 'Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.\n\nOpen Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.\n\nZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.'}], 'classes': [{'categories': [{'title': 'No adverse event', 'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}, {'title': 'adverse event', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative', 'description': 'This is to evaluate whether any adverse events specific to insert additional screw for AS2 technique were occurred.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat group'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ZNN CM Asia With AS2 Technique', 'description': 'Open Reduction and Internal Fixation with AS2 Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail.\n\nBone fragment will be stabilized by additional screw fixation (Anterior Support Screw).\n\nOpen Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.\n\nZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.\n\nAnterior Support Screw: Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw.'}, {'id': 'FG001', 'title': 'ZNN CM Asia Without AS2 Technique', 'description': 'Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.\n\nOpen Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.\n\nZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '119'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '119'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Computed Tomography (CT) data missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ZNN CM Asia With AS2 Technique', 'description': 'Open Reduction and Internal Fixation with AS2 Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail.\n\nBone fragment will be stabilized by additional screw fixation (Anterior Support Screw).\n\nOpen Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.\n\nZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.\n\nAnterior Support Screw: Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw.'}, {'id': 'BG001', 'title': 'ZNN CM Asia Without AS2 Technique', 'description': 'Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.\n\nOpen Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.\n\nZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '85.9', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '86.7', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '86.3', 'spread': '8.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '148.9', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '150.0', 'spread': '9.0', 'groupId': 'BG001'}, {'value': '149.4', 'spread': '8.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '45.3', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '46.2', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '45.8', 'spread': '9.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-05', 'size': 952670, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-09-20T19:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '(Investigational group) or ZNN CM Asia without AS2 technique (Control group). The randomization scheme is based on equal numbers per group. The randomization will occur via a random number generator (computer) using a blocked randomization procedure. The block size will not be disclosed to the sites, and the doctor or other health care professional will not have influence on the randomization scheme. Sealed opaque envelopes, which will be prepared based on predetermined randomization assignment, will be provided to each study site before study initiation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'At surgery, intervention group using ZNN CM Asia with AS2 technique. At surgery, conventional group using ZNN CM Asia without AS2 technique.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-08', 'studyFirstSubmitDate': '2017-03-28', 'resultsFirstSubmitDate': '2020-08-06', 'studyFirstSubmitQcDate': '2017-06-20', 'lastUpdatePostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-08', 'studyFirstPostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patient With and Without Excessive Lag Screw Sliding Distance', 'timeFrame': 'Postoperative 2-3 week', 'description': 'Number of patient was counted based on CT measurement results. Relative position of lag screw between CT images taken at both immediate and 2-3 weeks postoperatively was measured and recorded in value (e.g., 1.5 mm). This was called as "lag screw sliding distance". Four millimeter was set as threshold to define success and failure. Less than 4mm of lag screw sliding distance was recognized as Success and equal to or more than 4mm of lag screw sliding distance was recognized as Failure.'}], 'secondaryOutcomes': [{'measure': 'Surgery Time', 'timeFrame': 'Intraoperative, an average of 1 hour', 'description': 'Surgery time from skin incision to closure'}, {'measure': 'Image Assessment Using Computed Tomography (CT)', 'timeFrame': '2-3 weeks postoperatively', 'description': 'Number of patient was counted based on CT measurement results. When the fracture reduction position achieved at surgery was maintained at 2 to 3 weeks, then the patient was categorized as success (Reduction position maintained). On the other hand, patient was categorized as failure (Reduction position changed) in the case that the fracture reduction position was changed.\n\nFracture repair position was categorized into three; "Anterior", "Neutral" or "Posterior" based on relative position of proximal bone fragment and distal bone fragment.\n\nThis analysis only includes patients whose fracture reduction position at immediate postoperative CT was either "Anterior" or "Neutral".\n\nIf both immediate and 2-3 weeks postoperative CT images show same fracture reduction position (example: "Anterior" at immediate postoperatively \\& "Anterior" at 2-3 weeks postoperatively), then the patient was recognized as Success (Reduction position maintained).'}, {'measure': 'Intraoperative Safety', 'timeFrame': 'Intraoperative', 'description': 'This is to evaluate whether any adverse events specific to insert additional screw for AS2 technique were occurred.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Trochanteric Fracture of Femur']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare reduction positon maintenance rate at 3 weeks post-operatively between patients operated with Anterior Support Screw (AS2) and without AS2 technique in RCT setting. Total 240 cases(each arm 120 cases) will be enrolled at maximum 15sites, total study duration is 22months.', 'detailedDescription': 'Objective： To compare fracture reduction maintenance rate at 2-3weeks post-operatively between patients operated with AS2 (investigational group) and patients operated without AS2 (Control group) using same implant system (ZNN CM Asia, Zimmer Biomet).\n\nEndpoint： Primary： The rate of reduction position maintenance at 2-3 weeks post-operatively. Secondary： Surgery time / fracture type / postoperative reduction position / CT assessment / Safety information'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria.\n\n* Eligible for intramedullary nailing.\n* Fracture type is classified as 3-partB or 4-part fracture in 3D-CT (Three Dimensional Computed Tomography) classification (Nakano), and combination with a subtype P in lateral classification (Ikuta) at preoperative CT (Computed Tomography) assessment.(In the case of classified in radiograph (X-ray) at preoperative: Classified as Type 4 or Type 5 in Jensen classification, and combination of subtype P in lateral classification (Ikuta))\n* Japanese Male or female\n* \\> 20 years of age\n* Primary closed intertrochanteric fracture of the femur\n* Subjects willing to return for follow-up evaluations.\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study.\n\n* Patient who cannot take CT image within 3 days and 2-3weeks after surgery.\n* Uncooperative patient or patient with neurologic disorders who are incapable of following directions.'}, 'identificationModule': {'nctId': 'NCT03196193', 'briefTitle': 'CM Asia Nail With AS2 Without AS2 （AS2 Study）', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'Randomized Controlled Study Comparing Zimmer Natural Nail System Cephalomedullary Asia Nail With Anterior Support Screw (AS2) Versus Conventional Technique', 'orgStudyIdInfo': {'id': 'T.CR.I.AP.16.4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ZNN CM Asia with AS2 technique', 'description': 'Open Reduction and Internal Fixation with AS2 Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail.\n\nBone fragment will be stabilized by additional screw fixation (Anterior Support Screw).', 'interventionNames': ['Procedure: Open Reduction and Internal Fixation', 'Device: ZNN CM Asia', 'Device: Anterior Support Screw']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ZNN CM Asia without AS2 technique', 'description': 'Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.', 'interventionNames': ['Procedure: Open Reduction and Internal Fixation', 'Device: ZNN CM Asia']}], 'interventions': [{'name': 'Open Reduction and Internal Fixation', 'type': 'PROCEDURE', 'description': 'Fractured bone fragments are reduced and stabilized by intramedullary nail.', 'armGroupLabels': ['ZNN CM Asia with AS2 technique', 'ZNN CM Asia without AS2 technique']}, {'name': 'ZNN CM Asia', 'type': 'DEVICE', 'description': 'Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.', 'armGroupLabels': ['ZNN CM Asia with AS2 technique', 'ZNN CM Asia without AS2 technique']}, {'name': 'Anterior Support Screw', 'type': 'DEVICE', 'otherNames': ['ACE 4.5/5.0mm cannulated lag-screw'], 'description': 'Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw.', 'armGroupLabels': ['ZNN CM Asia with AS2 technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '737-8505', 'city': 'Kure', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Kure Kyosai Hospital', 'geoPoint': {'lat': 34.23222, 'lon': 132.56658}}, {'zip': '668-8501', 'city': 'Toyooka', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Toyooka Hospital', 'geoPoint': {'lat': 35.54008, 'lon': 134.82038}}, {'zip': '486-8510', 'city': 'Aichi', 'state': 'Kasugai', 'country': 'Japan', 'facility': 'Kasugai Municipal Hospital', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'zip': '573-8511', 'city': 'Hirakata', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Hoshigaoka Medical Center', 'geoPoint': {'lat': 34.81352, 'lon': 135.64914}}, {'zip': '410-0302', 'city': 'Numazu', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Numazu City Hospital', 'geoPoint': {'lat': 35.1, 'lon': 138.86667}}, {'zip': '933-8525', 'city': 'Takaoka', 'state': 'Toyama', 'country': 'Japan', 'facility': 'Saiseikai Takaoka Hospital', 'geoPoint': {'lat': 36.75, 'lon': 137.01667}}, {'zip': '815-8588', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Kyushu Central Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '861-4193', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Saiseikai Kumamoto Hospital', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '950-8556', 'city': 'Niigata', 'country': 'Japan', 'facility': 'Niigata Central Hospital', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': '700-8607', 'city': 'Okayama', 'country': 'Japan', 'facility': 'Okayama Red Cross Hospital', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '702-8055', 'city': 'Okayama', 'country': 'Japan', 'facility': 'Okayama Rosai Hospital', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '840-8571', 'city': 'Saga', 'country': 'Japan', 'facility': 'Saga Pref. Medical Centre Koseikan', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}], 'overallOfficials': [{'name': 'Takashi Maehara, MD, Ph. D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kagawa Rosai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}