Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-01 @ 3:15 PM
Study NCT ID:
NCT04015167
Status:
COMPLETED
Last Update Posted:
2025-01-06
First Post:
2019-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013978', 'term': 'Tibial Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'monica.fleeman@stryker.com', 'phone': '251-465-5969', 'title': 'Monica Fleeman', 'organization': 'Stryker'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Assessment of long-term impacts were challenging due to a higher number of loss-to-follow-up, which resulted in missing data and reduced statistical power.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.', 'eventGroups': [{'id': 'EG000', 'title': 'T2 Alpha Tibia', 'description': 'Subjects in the clinical investigation will undergo placement of the Tibial Nail of the T2 Alpha Tibia Nailing System, according to the approved Instructions for Use and Operative Technique Manual.\n\nT2 Alpha Tibia Nailing System: The T2 Alpha Tibia Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.', 'otherNumAtRisk': 103, 'deathsNumAtRisk': 103, 'otherNumAffected': 11, 'seriousNumAtRisk': 103, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Delayed union (no bone consolidation within 4 months)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Implant loosening (screw)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection (deep)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-union (no bone consolidation within 6 months)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 4}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'SF-36 PCS (36-Item Short Form Health Survey Physical Component Summary)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'T2 Alpha Tibia', 'description': 'Subjects in the clinical investigation will undergo placement of the Tibial Nail of the T2 Alpha Tibia Nailing System, according to the approved Instructions for Use and Operative Technique Manual.\n\nT2 Alpha Tibia Nailing System: The T2 Alpha Tibia Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.21', 'spread': '9.65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the SF-36 PCS (36-Item Short Form Health Survey Physical Component Summary). The SF-36 PCS is a self-report measure of health status. SF-36 Physical Component Summary scores range from 0 to 100; higher SF-36 score results are linked to better subject results.\n\nConfirmation of efficacy/performance at 12 months will be based on an equal or higher (non-inferior) SF-36 Physical Component Summary (PCS) result of the T2 Alpha Tibia Nailing System compared to the T2 Tibia benchmark literature.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 55 subjects that completed the study, 53 subjects were available for the SF-36 assessment'}, {'type': 'SECONDARY', 'title': 'Safety Will be Measured by Capturing the Incidence Rate of Device-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'T2 Alpha Tibia', 'description': 'Subjects in the clinical investigation will undergo placement of the Tibial Nail of the T2 Alpha Tibia Nailing System, according to the approved Instructions for Use and Operative Technique Manual.\n\nT2 Alpha Tibia Nailing System: The T2 Alpha Tibia Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.'}], 'classes': [{'categories': [{'title': '*Delayed union (no bone consolidation within 4 months)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Implant loosening (screw)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Infection (deep)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Non-union (no bone consolidation within 6 months)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Pain', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Incidence of device-related adverse events will be monitored by 12 months through data collection and analyses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '11 out of 103 subjects had reportable Adverse Events.'}, {'type': 'SECONDARY', 'title': 'Efficacy/Performance Will be Measured by Demonstration of Bone Consolidation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'T2 Alpha Tibia', 'description': 'Subjects in the clinical investigation will undergo placement of the Tibial Nail of the T2 Alpha Tibia Nailing System, according to the approved Instructions for Use and Operative Technique Manual.\n\nT2 Alpha Tibia Nailing System: The T2 Alpha Tibia Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.'}], 'classes': [{'categories': [{'title': 'Bone Consolidation - Yes', 'measurements': [{'value': '48', 'groupId': 'OG000'}]}, {'title': 'Bone Consolidation - No', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Bone consolidation will be assessed by 12 months as measured by Investigator assessment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'of the 55 subjects that completed the study, 54 subjects were available for bone consolidation assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T2 Alpha Tibia', 'description': 'Subjects in the clinical investigation will undergo placement of the Tibial Nail of the T2 Alpha Tibia Nailing System, according to the approved Instructions for Use and Operative Technique Manual.\n\nT2 Alpha Tibia Nailing System: The T2 Alpha Tibia Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Subject went to jail', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'T2 Alpha Tibia', 'description': 'Subjects in the clinical investigation will undergo placement of the Tibial Nail of the T2 Alpha Tibia Nailing System, according to the approved Instructions for Use and Operative Technique Manual.\n\nT2 Alpha Tibia Nailing System: The T2 Alpha Tibia Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.81', 'spread': '18.53', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Black or African', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Caucasian', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-23', 'size': 3840308, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-18T17:07', 'hasProtocol': True}, {'date': '2021-07-23', 'size': 2519265, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-18T17:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2019-07-08', 'resultsFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2019-07-08', 'lastUpdatePostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-14', 'studyFirstPostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SF-36 PCS (36-Item Short Form Health Survey Physical Component Summary)', 'timeFrame': '12 months', 'description': 'The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the SF-36 PCS (36-Item Short Form Health Survey Physical Component Summary). The SF-36 PCS is a self-report measure of health status. SF-36 Physical Component Summary scores range from 0 to 100; higher SF-36 score results are linked to better subject results.\n\nConfirmation of efficacy/performance at 12 months will be based on an equal or higher (non-inferior) SF-36 Physical Component Summary (PCS) result of the T2 Alpha Tibia Nailing System compared to the T2 Tibia benchmark literature.'}], 'secondaryOutcomes': [{'measure': 'Safety Will be Measured by Capturing the Incidence Rate of Device-related Adverse Events', 'timeFrame': '12 months', 'description': 'Incidence of device-related adverse events will be monitored by 12 months through data collection and analyses.'}, {'measure': 'Efficacy/Performance Will be Measured by Demonstration of Bone Consolidation', 'timeFrame': '12 months', 'description': 'Bone consolidation will be assessed by 12 months as measured by Investigator assessment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Tibial Fractures']}, 'descriptionModule': {'briefSummary': "This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 80 subjects will be enrolled. Neither subjects nor investigators are blinded to treatment and the clinical investigation includes a historical control which will be compared to the T2 Alpha Tibia Nailing System.\n\nTotal duration of enrollment, 12 month follow-up and analysis is expected to take 31 months. The clinical investigation has been designed to follow the surgeon's standard of care for tibia fractured subjects, in addition to a 12 month follow-up visit.\n\nThe primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the SF-36 Physical Component Summary (PCS). Confirmation of efficacy/performance at 12 months will be based on an equal or higher (non-inferior) SF-36 Physical Component Summary (PCS) result of the T2 Alpha Tibia Nailing System compared to the benchmark literature.", 'detailedDescription': 'The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the T2 Alpha Tibia Nailing System. Efficacy/performance of the procedure will be measured by an equal or higher (non-inferior) SF-36 Physical Component Summary (PCS) score result of the T2 Alpha Tibia Nailing System compared to the T2 Tibia benchmark literature at 12 months.\n\nIn addition, demonstration of bone consolidation in correct alignment will be measured by Investigator assessment by 12 months. Safety of the T2 Alpha Tibia Nailing System will be demonstrated through reporting of device related intra-operative and post-operative Adverse Events/incidents by 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Approximately 80 subjects are to be enrolled in this clinical investigation. Subjects participating in this clinical investigation will be recruited from the investigator's standard subject population, where all subjects presenting for treatment of tibial fractures will be evaluated for clinical investigation participation based on the eligibility criteria.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is a male or non-pregnant female age 18 years or older at the time of surgery;\n* Subject is willing and able to give written informed consent and comply with the requirements of this Clinical Investigation Plan;\n* Subject is intended to be, treated with the Tibial Nail of the T2 Alpha Tibia Nailing System in accordance with the following legally cleared/ approved Indications for Use:\n\nIndications for Use approved In United States and Canada include:\n\n* Open and closed tibial fractures\n* Pseudoarthrosis and correction osteotomy\n* Pathologic fractures, impending pathologic fractures and tumor resections\n* Fractures involving osteopenic and osteoporotic bone\n* Nonunions and malunions\n\nExclusion Criteria:\n\n* Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device clinical investigation that, in the opinion of the Investigator, may confound results;\n* Per the Investigator, the subject is in poor general health or undergoing any concurrent disease that would place the subject in excessive risk to surgery (i.e. significant circulatory problems, cardiac disease).'}, 'identificationModule': {'nctId': 'NCT04015167', 'briefTitle': 'A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Trauma and Extremities'}, 'officialTitle': 'A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System', 'orgStudyIdInfo': {'id': 'T2 Alpha Tibia'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'T2 Alpha Tibia', 'description': 'Subjects in the clinical investigation will undergo placement of the Tibial Nail of the T2 Alpha Tibia Nailing System, according to the approved Instructions for Use and Operative Technique Manual.', 'interventionNames': ['Device: T2 Alpha Tibia Nailing System']}], 'interventions': [{'name': 'T2 Alpha Tibia Nailing System', 'type': 'DEVICE', 'description': 'The T2 Alpha Tibia Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.', 'armGroupLabels': ['T2 Alpha Tibia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56377', 'city': 'Sartell', 'state': 'Minnesota', 'country': 'United States', 'facility': 'St. Cloud Orthopedic Associates, Ltd', 'geoPoint': {'lat': 45.62163, 'lon': -94.20694}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'UC Health', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax Medical Campus', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}], 'overallOfficials': [{'name': 'Rebecca Gibson', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Stryker Trauma and Extremities'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Trauma and Extremities', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}