Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-02-26 @ 12:36 AM
Study NCT ID:
NCT02595593
Status:
UNKNOWN
Last Update Posted:
2022-05-10
First Post:
2015-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rib Fixation for Clinically Severe Rib Fractures From Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012253', 'term': 'Rib Fractures'}, {'id': 'D005409', 'term': 'Flail Chest'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D013898', 'term': 'Thoracic Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 236}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-07', 'studyFirstSubmitDate': '2015-04-30', 'studyFirstSubmitQcDate': '2015-11-02', 'lastUpdatePostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Complication Rates', 'timeFrame': 'measured at 1 week, 3 months, 6 months', 'description': 'including, but not limited to, pneumonia, urinary tract infection, arrhythmia, sepsis, reintubation, wound infection'}, {'measure': 'Pain Control documented by the Functional Pain Scale', 'timeFrame': 'measured before and after surgery and at time of discharge, through study completion, up to 2 years', 'description': 'measured using the Functional Pain Scale'}, {'measure': 'Ventilator/Ventilator Free Days', 'timeFrame': 'measured through study completion, up to 2 years', 'description': 'measured in days on or off ventilation, based on length of stay in hospital'}, {'measure': 'Narcotic usage', 'timeFrame': 'measured at 1 week, 3 months, 6 months', 'description': 'converted to units of morphine'}, {'measure': 'Hospital length of stay', 'timeFrame': 'measured through study completion, up to 2 years', 'description': 'measured in days'}, {'measure': 'Pulmonary Function', 'timeFrame': 'measured at discharge, 3 months, and 6 months, through study completion, up to 2 years', 'description': 'as measured by FVC (forced vital capacity), FEV1, and TLC by spirometry'}, {'measure': 'Time to wean from ventilator', 'timeFrame': 'measured through study completion, up to 2 years', 'description': 'measured in days'}, {'measure': 'Tracheostomy rates', 'timeFrame': 'measured at 1 week, 3 months, 6 months', 'description': 'overall rate of tracheostomy in population'}], 'primaryOutcomes': [{'measure': 'ICU Length of Stay', 'timeFrame': 'measured through study completion, up to 2 years', 'description': 'length of stay in days'}], 'secondaryOutcomes': [{'measure': 'Quality of Life, as determined by SF-36 survey', 'timeFrame': 'measured at 1 week, 3 months, 6 months post-intervention', 'description': 'measured at 3 different time points post-hospital stay'}, {'measure': 'Number of participants with pneumonia as defined by the Centers for Disease Control', 'timeFrame': 'measured monthly through course of study, up to 2 years', 'description': 'based on classification as complication of rib trauma treatment'}, {'measure': 'Total cost of treatments', 'timeFrame': 'measured through study completion, up to 2 years', 'description': 'measured based on total costs during length of hospital stay'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Trauma', 'Rib Plate', 'Rib Fixation'], 'conditions': ['Rib Fracture', 'Flail Chest']}, 'descriptionModule': {'briefSummary': 'This is a multicenter randomized study investigating the differences in clinical outcomes of patients between two standard of care pathways for rib trauma: patients who receive rib fixation versus patients who receive modern critical care and pain control after sustaining clinically significant rib fractures from trauma.', 'detailedDescription': 'This study will compare the outcomes of patients between two standard of care pathways for rib trauma: those who have their ribs plated versus those who are managed by modern critical care and pain control. A study nurse (project) coordinator will identify subjects based on inclusion and exclusion criteria, then obtain consent for each of these patients prior to randomization. Randomization will be decided by a web-based computer program, accessible to the project coordinator. Although this randomization occurs, the study itself is purely observational, as the intervention is currently standard of care. None of the subjects or study group members will be blinded since it is not possible to disguise the intervention. Patients will be evaluated and a survey will be administered at set post-intervention intervals to determine endpoints and quality of life when data analysis will also take place.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Flail chest, defined as 3 or more consecutive ribs fractured in more than one place\n* Pain and disability of an FPS (Functional Pain Scale) rating of 3 or higher\n* Deformity and Defect\n* Non-Union\n* Thoracotomy for other indications\n* 3 or more rib fractures with rib displacement of more than 1 rib cortical diameter\n* Failure to wean from ventilator\n\nExclusion Criteria:\n\n* Active bacteremia\n* Active shock\n* Severe Traumatic Brain Injury with GCS \\< 8\n* Age 17 years or less or age greater than 90 years old\n* Chronic pulmonary disease requiring home oxygenation\n* Acute Respiratory Distress Syndrome\n* Penetrating chest trauma\n* Chronic opioid dependence\n* Fractures less than 3cm from vertebral spine'}, 'identificationModule': {'nctId': 'NCT02595593', 'acronym': 'SOFRIB', 'briefTitle': 'Rib Fixation for Clinically Severe Rib Fractures From Trauma', 'organization': {'class': 'OTHER', 'fullName': 'SCRI Development Innovations, LLC'}, 'officialTitle': 'A Multicenter Prospective Randomized Trial on the Intervention of Rib Fixation for Clinically Severe Rib Fractures From Trauma', 'orgStudyIdInfo': {'id': 'SCRI HEOR_02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rib Fixation System', 'description': 'This group of subjects will receive a surgical rib plating procedure after trauma', 'interventionNames': ['Device: Rib Fixation System']}, {'type': 'NO_INTERVENTION', 'label': 'Critical Care and Pain Control', 'description': 'This group will receive critical care and pain control after trauma'}], 'interventions': [{'name': 'Rib Fixation System', 'type': 'DEVICE', 'otherNames': ['DePuySynthes MatrixRIB Contoured Rib Implants'], 'description': 'This intervention involves a surgical procedure to affix rib plates to broken ribs', 'armGroupLabels': ['Rib Fixation System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32547', 'city': 'Fort Walton Beach', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Fort Walton Beach Medical Center', 'geoPoint': {'lat': 30.42059, 'lon': -86.61707}}, {'zip': '34950', 'city': 'Ft. Pierce', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jamie Santos, RN', 'role': 'CONTACT'}], 'facility': 'Lawnwood Regional Medical Center', 'geoPoint': {'lat': 27.44671, 'lon': -80.32561}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Osceola Regional Medical Center', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark McKenney, MD', 'role': 'CONTACT'}], 'facility': 'Kendall Regional Medical Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Donna A Nayduch, RN, MSN', 'role': 'CONTACT', 'email': 'dnayduch@cfl.rr.com', 'phone': '352-401-1022'}, {'name': 'Darwin Ang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ocala Regional Medical Center - Health Trauma', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '32073', 'city': 'Orange Park', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Orange Park Medical Center', 'geoPoint': {'lat': 30.16607, 'lon': -81.70648}}, {'zip': '32771', 'city': 'Sanford', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'William Campbell, RN', 'role': 'CONTACT', 'email': 'william.campbell5@hcahealthcare.com'}], 'facility': 'Central Florida Regional Hospital', 'geoPoint': {'lat': 28.80055, 'lon': -81.27312}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Research Medical Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '29572', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Heather Rhodes, RN', 'role': 'CONTACT'}], 'facility': 'Grand Strand Regional Medical Center', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '23225', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stanley Kurek, DO', 'role': 'CONTACT'}], 'facility': 'Chippenham Johnston-Willis Hospital', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'centralContacts': [{'name': 'Donna Nayduch, RN, MSN', 'role': 'CONTACT', 'email': 'donna.nayduch@hcahealthcare.com', 'phone': '352-401-1022'}], 'overallOfficials': [{'name': 'Darwin Ang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HCA Trauma Network'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Darwin Ang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, Medical Trauma Services, Ocala Health Trauma', 'investigatorFullName': 'Darwin Ang', 'investigatorAffiliation': 'SCRI Development Innovations, LLC'}}}}