Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT06464302
Status:
RECRUITING
Last Update Posted:
2025-06-15
First Post:
2024-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of the Effect of Age and Injury Severity on Short-term Intra-hospital Outcomes After Surgical Stabilized Rib Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012253', 'term': 'Rib Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013898', 'term': 'Thoracic Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2024-05-31', 'studyFirstSubmitQcDate': '2024-06-12', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In hospital-mortality', 'timeFrame': 'From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.', 'description': 'Mortality rate from injury to initial hospital discharge, binary'}, {'measure': 'Intensive care unit length of stay', 'timeFrame': 'From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.', 'description': 'The duration in days a patient spent in the intensive care unit from the time of hospital admission to the time of initial hospital discharge.'}], 'secondaryOutcomes': [{'measure': 'Intubation rate', 'timeFrame': 'From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.', 'description': 'Proportion of patients intubated at any time'}, {'measure': 'Multi-organ failure', 'timeFrame': 'From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.', 'description': 'Rate of Multi-organ failure'}, {'measure': 'Single organ failure', 'timeFrame': 'From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.', 'description': 'Rate of single organ failure'}, {'measure': 'Sepsis', 'timeFrame': 'From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.', 'description': 'Rate of Sepsis'}, {'measure': 'Lung-failure', 'timeFrame': 'From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.', 'description': 'Rate of Lung-failure'}, {'measure': 'Clinical outcome', 'timeFrame': 'At the time point of initial hospital discharge or at death, whichever came first, assessed up to 2 month.', 'description': 'Clinical outcome according to the Glasgow outcome scale (GOS)'}, {'measure': 'Duration of hospital stay', 'timeFrame': 'From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.', 'description': 'Duration of hospital stay in days from injury to initial discharge'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surgical stabilisation of rib fractures (SSRF)'], 'conditions': ['Rib Fractures', 'Rib Trauma', 'Rib Fracture Multiple', 'Thorax; Fracture']}, 'descriptionModule': {'briefSummary': 'The study aims to investigate the effect of surgical stabilisation of rib fractures (SSRF) on clinical outcomes measured during the hospital stay (mortality, days on a mechanical ventilator, intensive care unit and hospital length of stay, rate of complications). Furthermore, the effect of the patients age and overall injury severity on the outcomes after SSRF will be investigated. We hypothesise that the combination of high age and high injury severity will lead to worse outcomes after SSRF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '0 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The Patients will be sampled from all patients treated in the department for trauma, hand and reconstructive surgery of the university hospital Muenster', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of the University Hospital Muenster\n* Coded serial rib fractures (ICD S22.4 and S22.5)\n* Treatment for the rib fractures between 2019 and 2023\n\nExclusion Criteria:\n\n* pathological rib fractures (due to suspected malignancy)'}, 'identificationModule': {'nctId': 'NCT06464302', 'briefTitle': 'Investigation of the Effect of Age and Injury Severity on Short-term Intra-hospital Outcomes After Surgical Stabilized Rib Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Investigation of the Effect of Age and Injury Severity on Short-term Intra-hospital Outcomes After Surgical Stabilized Rib Fractures', 'orgStudyIdInfo': {'id': 'UKM_UCH_2024_002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Operative', 'description': 'Patients receiving surgical stabilisation of rib fractures (SSRF) by any operative technique', 'interventionNames': ['Procedure: Surgical stabilisation of rib fractures (SSRF)', 'Other: Non-operative management of rib fractures']}, {'label': 'Non-operative', 'description': 'Patients not receiving surgical stabilisation of rib fractures (SSRF)', 'interventionNames': ['Other: Non-operative management of rib fractures']}], 'interventions': [{'name': 'Surgical stabilisation of rib fractures (SSRF)', 'type': 'PROCEDURE', 'description': 'Surgical stabilisation of rib fractures using any fixation technique (including but not limited to plate fixation, intramedullary fixation, wire fixation) via any operative approach (including but not limited to open external approach, minimally invasive approach, thoracoscopic approach, thoracotomy approach).', 'armGroupLabels': ['Operative']}, {'name': 'Non-operative management of rib fractures', 'type': 'OTHER', 'description': 'Any supportive or specific treatment of rib fractures excluding surgical stabilisation of rib fractures. This includes, but is not limited to analgesia, physiotherapy, non-invasive ventilation, mechanical ventilation, oxygen-supplementation', 'armGroupLabels': ['Non-operative', 'Operative']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48149', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael D Huelskamp, Dr. med.', 'role': 'CONTACT', 'email': 'Michael.Huelskamp@ukmuenster.de', 'phone': '0049(0)251 9851786'}, {'name': 'Helena Duesing, Dr. med.', 'role': 'CONTACT', 'email': 'Helena.Duesing@ukmuenster.de'}], 'facility': 'Department for trauma, hand and reconstructive surgery, University hospital Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'centralContacts': [{'name': 'Michael D Huelskamp, Dr. med.', 'role': 'CONTACT', 'email': 'Michael.Huelskamp@ukmuenster.de', 'phone': '0049 (0)251 83 51786'}, {'name': 'Helena Duesing, Dr. med.', 'role': 'CONTACT', 'email': 'Helena.Duesing@ukmuenster.de'}], 'overallOfficials': [{'name': 'Steffen Rosslenbroich, PD Dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department for trauma, hand and reconstructive surgery, University hospital Muenster'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}