Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-31 @ 2:18 PM
Study NCT ID:
NCT01810094
Status:
COMPLETED
Last Update Posted:
2017-01-26
First Post:
2013-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimally Invasive Reduction and Fixation of Thoracolumbar Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005592', 'term': 'Fracture Fixation'}], 'ancestors': [{'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-25', 'studyFirstSubmitDate': '2013-02-26', 'studyFirstSubmitQcDate': '2013-03-12', 'lastUpdatePostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anterior wedge angle (AWA)', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Blood loss of the patient during surgery to stabilize the spine fracture', 'timeFrame': 'intraoperative'}, {'measure': 'OP duration', 'timeFrame': 'intraoperative'}, {'measure': 'Adverse events', 'timeFrame': 'Intraop and Postop'}, {'measure': 'VAS Spine Score', 'timeFrame': '3 days and 6 weeks'}, {'measure': 'VAS pain score', 'timeFrame': '3 days and 6 weeks'}, {'measure': 'accompanying pain medication (or "self medication")', 'timeFrame': '6 weeks'}, {'measure': 'patient satisfaction with operational results', 'timeFrame': '6 weeks', 'description': 'The patient is asked the question whether he is satisfied with the results of the operation, he has the choice between six answers: very satisfied, satisfied, partly satisfied, unsatisfied, no comment'}, {'measure': 'Hospital length of stay', 'timeFrame': 'discharge'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['thoracolumbar fracture', 'fixation', 'fixateur interne', 'minimal invasive', 'percutaneous'], 'conditions': ['Thoracic Fracture', 'Lumbar Fracture']}, 'descriptionModule': {'briefSummary': 'Spinal injuries, such as vertebral fractures, often result in a significant instability of the spine and lead to acute or delayed neurological deficits. Depending on the type of injury there are various methods available to stabilize the spine. The proposed study should clarify whether the combined reduction and fixation with a minimally invasive approach can actually be done with the same precision as in a conventional approach. The primary endpoint of this investigation is the monosegmental anterior wedge angle (AWA), and its maintenance over the first 6 postoperative weeks. It is the aim of the study to gather key radiological, clinical and subjective patient outcome parameters for its patient population that will allow to compare the results to a historical group of patients. The study design is non-interventional, prospective, open,and multicentric.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum age of the patients of 18 years\n* Indication for operative treatment of fractures of the thoracic or lumbar spine\n* Singular A3.1-3 fractures according to the AO classification system\n* Declaration of consent in participation in this study and willingness to the treatment according to the study protocol\n* Physical and mental ability to meet the clinical and radiological follow-up plan\n\nExclusion Criteria:\n\n* Additional severe trauma, that makes survey of the patient difficult or impossible influence the results of the fracture treatment significantly\n* Additional trauma or fractures of the spine\n* Other serious conditions complicating participation in the study\n* Systemic or local infections\n* Pregnancy or planned pregnancy\n* Neurological deficits\n* Severe blood coagulation disorders diagnosed preoperatively\n* Intake of preoperatively anticoagulants\n* Osteoporosis\n* Bone metabolism disorders\n* Laminectomy necessary during surgery results in exclusion of the patient either'}, 'identificationModule': {'nctId': 'NCT01810094', 'acronym': 'FRIFIX', 'briefTitle': 'Minimally Invasive Reduction and Fixation of Thoracolumbar Fractures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'Prospective Observational Study of Minimally Invasive Fixation of Thoracolumbar Fractures With the Fracture Fixation System S4, Performed With the Fracture Reduction Instrumentation FRI (FRIFIX)', 'orgStudyIdInfo': {'id': 'AAG-O-H-0910'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Minimally invasive Approach', 'description': 'Patients with a thoracolumbar Fracture A3.1 to A 3.3 treated by fracture fixation by a minimally invasive approach', 'interventionNames': ['Device: Fracture Fixation']}], 'interventions': [{'name': 'Fracture Fixation', 'type': 'DEVICE', 'description': 'Thoracolumbar Fracture Fixation', 'armGroupLabels': ['Minimally invasive Approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51429', 'city': 'Bergisch Gladbach', 'country': 'Germany', 'facility': 'Vinzenz-Pallotti-Hospital', 'geoPoint': {'lat': 50.9856, 'lon': 7.13298}}, {'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitätsklinik Bonn, Abteilung für Unfallchirurgie', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '50924', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinik Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '42929', 'city': 'Wermelskirchen', 'country': 'Germany', 'facility': 'Abteilung für Orthopädie und Unfallchirurgie, Krankenhaus Wermelskirchen', 'geoPoint': {'lat': 51.1397, 'lon': 7.21583}}], 'overallOfficials': [{'name': 'Hans Goost, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bonn'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}