Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-03 @ 4:38 AM
Study NCT ID:
NCT03166267
Status:
COMPLETED
Last Update Posted:
2021-07-06
First Post:
2017-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real Life Weight Bearing After Tibial Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016267', 'term': 'External Fixators'}], 'ancestors': [{'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-02', 'studyFirstSubmitDate': '2017-05-22', 'studyFirstSubmitQcDate': '2017-05-23', 'lastUpdatePostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Loading patterns', 'timeFrame': 'Up to 4 months', 'description': 'Average peak force per step'}], 'secondaryOutcomes': [{'measure': 'Activity', 'timeFrame': 'Up to 4 months', 'description': 'Patient activity measured as number of loading events per day'}, {'measure': 'Healing', 'timeFrame': 'Up to 4 months', 'description': 'Expert opinion'}, {'measure': 'Pain level', 'timeFrame': 'Up to 4 months', 'description': 'Numeric rating scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tibial Fractures', 'External Fixation Pin Site Infection']}, 'descriptionModule': {'briefSummary': 'In this prospective case series patients with a tibial fracture are monitored with smart biofeedback systems to document the healing progression and real life weight.', 'detailedDescription': 'Ten patients treated with a large external fixator after tibial fracture will be enrolled for this prospective case series.\n\nPatients will be equipped with the AO Fracture Monitor (a data logger device) attached post-operatively to a connection rod of the external fixator. The device continuously measures deformation of the fixator frame due to normal weight bearing for up to 12 months by means of a strain gauge. The strain signal is processed on-board and several parameters related to the loading characteristics of the fracture are stored.\n\nSimultaneously, patients will be equipped with a fully integrated sensor insole (OpenGo Insole, Moticon GmbH, München). This product offers long-term weight bearing data (recording and storage) and allows non-invasive documentation of real life loading in patients without affecting the daily life activity of the patient. Recording of weight-bearing data will be obtained for a maximum of 4 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All eligible patients from the participating clinic are invited to participate in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and older\n* Diagnosis of tibial fracture (AO 41-43)\n* External fracture fixation with large external fixator\n* Capable of at least partial weight-bearing\n* Bone segment transport (if applicable) must be completed\n* Informed consent obtained, i.e.:\n\n * Ability to understand the content of the patient information/ Informed Consent Form (ICF)\n * Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)\n * Signed and dated Ethics Committee (EC)\n\nExclusion Criteria:\n\n* External fixation as temporary stabilization\n* Bone fragment compression\n* Joint-bridging external fixation\n* Any not medically managed severe systemic disease\n* Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment\n* Pregnancy or women planning to conceive within the study period\n* Prisoner\n* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study'}, 'identificationModule': {'nctId': 'NCT03166267', 'briefTitle': 'Real Life Weight Bearing After Tibial Fractures', 'organization': {'class': 'OTHER', 'fullName': 'AO Innovation Translation Center'}, 'officialTitle': 'A Prospective Case Series Study to Monitor Healing Progression and Real Life Weight Bearing After Tibial Fracture Using Smart Biofeedback Systems', 'orgStudyIdInfo': {'id': 'SmartFix II - Moticon'}}, 'armsInterventionsModule': {'interventions': [{'name': 'External fixator', 'type': 'DEVICE', 'description': 'Tibia fracture (AO 41-43) treated with external fracture fixation (large external fixator)'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'BGU Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Stefan Döbele, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BGU Tübingen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AO Innovation Translation Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}