Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-01-29 @ 1:35 PM
Study NCT ID:
NCT04081233
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2019-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Surgical Stabilization for Rib Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013898', 'term': 'Thoracic Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'David.E.Meyer@uth.tmc.edu', 'phone': '713-500-7244', 'title': 'David E. Meyer, MD, MS, FACS', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 6, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 2, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Seroma', 'notes': 'Participants in the usual care arm are not at risk for the surgical complication of seroma.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retained Hemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Surgical site infection', 'notes': 'Participants in the usual care arm are not at risk for the surgical complication of surgical site infection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hospital Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '20'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '11'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '180 days after admission', 'description': 'Number of days patient is in the hospital', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 days after admission', 'description': 'Death following trauma injury involving rib fractures', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Respiratory Failure Requiring Mechanical Ventilation Greater Than 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'timeFrame': '24 hours after hospital admission', 'description': 'number of patients who require mechanical ventilation greater than 24 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Number of Patients Requiring Tracheostomy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Hospital discharge (about 20 to 30 days)', 'description': 'Number of patients requiring a tracheostomy due to prolonged mechanical ventilation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Developed Pneumonia During the Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months after admission', 'description': 'Number of patients diagnosed with pneumonia with greater than 10,000 cfu/ml on bronchioalveolar lavage or clinical diagnosis of pneumonia with subsequent antibiotic coverage', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Received Regional Analgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months after admission', 'description': 'Number of patients utilizing regional analgesia, such as epidural, paravertebral, intercostal or serratus plane anesthesia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '167'}, {'value': '79', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '169'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline', 'description': 'Opioid usage is reported in milligrams per patient pre-randomization', 'unitOfMeasure': 'milligrams', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'title': 'Opioid usage (all)', 'categories': [{'measurements': [{'value': '349', 'groupId': 'OG000', 'lowerLimit': '218', 'upperLimit': '686'}, {'value': '177', 'groupId': 'OG001', 'lowerLimit': '76', 'upperLimit': '387'}]}]}, {'title': 'Opioid usage (anesthesia)', 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000', 'lowerLimit': '92', 'upperLimit': '266'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '90'}]}]}, {'title': 'Opioid usage (non-anesthesia)', 'categories': [{'measurements': [{'value': '203', 'groupId': 'OG000', 'lowerLimit': '89', 'upperLimit': '477'}, {'value': '125', 'groupId': 'OG001', 'lowerLimit': '62', 'upperLimit': '279'}]}]}, {'title': 'Daily non-anesthesia opioid exposure', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '43'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '34'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Hospital discharge (about 20 to 30 days)', 'description': 'Opioid usage is reported in milligrams per patient from admission to discharge', 'unitOfMeasure': 'milligrams', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ventilator Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'timeFrame': 'Hospital discharge (about 20 to 30 days)', 'description': 'Number of inpatient hospital days patients did not require mechanical ventilation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Intensive Care Unit (ICU) Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '30'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Hospital discharge (about 20 to 30 days)', 'description': 'Number of inpatient hospital days patient was not in ICU in the first 30 days', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital (ICU) Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '24'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '27'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days post admission', 'description': 'Number of days patient was not in the hospital during the first 30 days after admission.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Re-intervention Rates for Surgical Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'title': 'Seroma', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Surgical Site Infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 days post admission', 'description': 'The number of times a procedure was required to treat surgical complications', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '22', 'groupId': 'OG000'}, {'value': '67', 'spread': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days post admission', 'description': 'Health status will be assessed by the Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L VAS score is directly reported by participants and ranges from 0 (the worst imaginable health) to 100 (the best imaginable health). A higher score indicates a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 5 in the early surgical stabilization arm, and data were not collected for 7 in the usual care arm.'}, {'type': 'SECONDARY', 'title': 'Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'spread': '24', 'groupId': 'OG000'}, {'value': '73', 'spread': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days post admission', 'description': 'Health status will be assessed by the Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L VAS score is directly reported by participants and ranges from 0 (the worst imaginable health) to 100 (the best imaginable health). A higher score indicates a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 8 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.'}, {'type': 'SECONDARY', 'title': 'Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'spread': '23', 'groupId': 'OG000'}, {'value': '77', 'spread': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 days post admission', 'description': 'Health status will be assessed by the Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L VAS score is directly reported by participants and ranges from 0 (the worst imaginable health) to 100 (the best imaginable health). A higher score indicates a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.'}, {'type': 'SECONDARY', 'title': 'Health Status as Assessed by Index Score on the Euroqol-5D-5L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'categories': [{'measurements': [{'value': '0.44', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days post admission', 'description': 'Health Status will be assessed by the index score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L index score ranges from 0 (a state as bad as being dead) to 1 (full health), and it is a summary score based on societal preference weights for the cumulative health states measured by 5 different dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression). It is calculated using the 2017 United States time trade-off valuation data set. A higher score indicates a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 5 in the early surgical stabilization arm, and data were not collected for 7 in the usual care arm.'}, {'type': 'SECONDARY', 'title': 'Health Status as Assessed by Index Score on the Euroqol-5D-5L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'categories': [{'measurements': [{'value': '0.56', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days post admission', 'description': 'Health Status will be assessed by the index score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L index score ranges from 0 (a state as bad as being dead) to 1 (full health), and it is a summary score based on societal preference weights for the cumulative health states measured by 5 different dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression). It is calculated using the 2017 United States time trade-off valuation data set. A higher score indicates a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 8 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.'}, {'type': 'SECONDARY', 'title': 'Health Status as Assessed by Index Score on the Euroqol-5D-5L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'categories': [{'measurements': [{'value': '0.69', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.77', 'spread': '0.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 days post admission', 'description': 'Health Status will be assessed by the index score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L index score ranges from 0 (a state as bad as being dead) to 1 (full health), and it is a summary score based on societal preference weights for the cumulative health states measured by 5 different dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression). It is calculated using the 2017 United States time trade-off valuation data set. A higher score indicates a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.'}, {'type': 'SECONDARY', 'title': 'Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'title': 'Mobility', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '2'}]}]}, {'title': 'Self-care', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '2'}]}]}, {'title': 'Usual activities', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '5'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': 'Anxiety', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days post admission', 'description': 'Level of impairment will be assessed for five dimensions (Mobility, Self-care, Daily activities, Pain, Anxiety) by using the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). Each dimension is rated at five levels: no impairment (1); minor impairment (2); moderate impairment (3); severe impairment (4); and extreme impairment (5). A higher score indicates a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 5 in the early surgical stabilization arm, and data were not collected for 7 in the usual care arm.'}, {'type': 'SECONDARY', 'title': 'Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'title': 'Mobility', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': 'Self-care', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2.5'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': 'Usual activities', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3.25'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': 'Anxiety', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '90 days post admission', 'description': 'Level of impairment will be assessed for five dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression) by using the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). Each dimension is rated at five levels: no impairment (1); minor impairment (2); moderate impairment (3); severe impairment (4); and extreme impairment (5). A higher score indicates a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 8 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.'}, {'type': 'SECONDARY', 'title': 'Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'title': 'Mobility', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '2'}]}]}, {'title': 'Self-care', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '1'}]}]}, {'title': 'Usual activities', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': 'Anxiety', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '180 days post admission', 'description': 'Level of impairment will be assessed for five dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression) by using the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). Each dimension is rated at five levels: no impairment (1); minor impairment (2); moderate impairment (3); severe impairment (4); and extreme impairment (5). A higher score indicates a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.'}, {'type': 'SECONDARY', 'title': 'Time From Injury to Return to Work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '89'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '55'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '180 days post admission', 'description': "Number of days from time of injury until patient was able to return to work prior to injury per patient's assessment", 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.'}, {'type': 'SECONDARY', 'title': 'Time From Injury to Resolution of Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '104'}, {'value': '54', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '73'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '180 days post admission', 'description': 'Number of days from time of injury to time patient verbalized pain was resolved', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.'}, {'type': 'SECONDARY', 'title': 'Time From Injury to Return to Usual Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000', 'lowerLimit': '77', 'upperLimit': '119'}, {'value': '67', 'groupId': 'OG001', 'lowerLimit': '52', 'upperLimit': '112'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '180 days post admission', 'description': "Number of days from time of injury until patient was able to return to usual activities prior to injury per patient's assessment", 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Prescribed Opioids at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'title': 'Tramadol', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Other Opioid', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Hospital discharge (about 20 to 30 days)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Back to Work or Normal Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post admission', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 5 in the early surgical stabilization arm, and data were not collected for 7 in the usual care arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Back to Work or Normal Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days post admission', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 8 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Back to Work or Normal Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 days post admission', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Early Surgical Stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.\n\nsurgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'This arm will be usual care only. Usual care will include pain managment.\n\nUsual care: Usual care typically consists of breathing exercises and pain control,often including opioids'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '15', 'groupId': 'BG000'}, {'value': '49', 'spread': '15', 'groupId': 'BG001'}, {'value': '49.5', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'Caucasian, non-Hispanic', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Caucasian, Hispanic', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of Participants Who Sustained Injury From a Motor Vehicle Collision', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants Who Sustained Injury From a Motorcycle Collision', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants Who Sustained Injury From a Fall', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '174', 'spread': '10', 'groupId': 'BG000'}, {'value': '175', 'spread': '10', 'groupId': 'BG001'}, {'value': '174.5', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '95', 'spread': '25', 'groupId': 'BG000'}, {'value': '93', 'spread': '22', 'groupId': 'BG001'}, {'value': '94', 'spread': '23.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '6', 'groupId': 'BG000'}, {'value': '30', 'spread': '6', 'groupId': 'BG001'}, {'value': '30.5', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Emergency Department Heart Rate', 'classes': [{'categories': [{'measurements': [{'value': '93', 'spread': '22', 'groupId': 'BG000'}, {'value': '93', 'spread': '18', 'groupId': 'BG001'}, {'value': '93', 'spread': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Emergency Department Respiratory Rate', 'classes': [{'categories': [{'measurements': [{'value': '21', 'spread': '5', 'groupId': 'BG000'}, {'value': '20', 'spread': '5', 'groupId': 'BG001'}, {'value': '20.5', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'breaths per minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Emergency Department Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '125', 'spread': '30', 'groupId': 'BG000'}, {'value': '127', 'spread': '35', 'groupId': 'BG001'}, {'value': '126', 'spread': '32.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Emergency Department Diastolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '79', 'spread': '19', 'groupId': 'BG000'}, {'value': '79', 'spread': '16', 'groupId': 'BG001'}, {'value': '79', 'spread': '17.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Emergency Department Glasgow Coma Scale Score', 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000', 'lowerLimit': '14', 'upperLimit': '15'}, {'value': '15', 'groupId': 'BG001', 'lowerLimit': '15', 'upperLimit': '15'}, {'value': '15', 'groupId': 'BG002', 'lowerLimit': '14', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Glagcow Coma Scale (GCS) asses the level of consciousness in a person. The GSC is scored between 3 and 15, the higher the score the better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Injury Severity Score', 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000', 'lowerLimit': '17', 'upperLimit': '32'}, {'value': '22', 'groupId': 'BG001', 'lowerLimit': '15', 'upperLimit': '27'}, {'value': '22', 'groupId': 'BG002', 'lowerLimit': '17', 'upperLimit': '29'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Injury Severity Score (ISS) asses the traumatic injury of 6 body regions. The total ISS score ranges between 1 to 75, a higher score indicating a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Abbreviated Injury Score Head', 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Abbreviated Injury Scale (AIS) is an anatomically-based injury severity scoring system. The score ranges from 0 (no injury) to 6 (maximal), a higher score indicating a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Abbreviated Injury Score Face', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Abbreviated Injury Scale (AIS) is an anatomically-based injury severity scoring system. The score ranges from 0 (no injury) to 6 (maximal), a higher score indicating a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Abbreviated Injury Score Chest', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '4'}, {'value': '3', 'groupId': 'BG001', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Abbreviated Injury Scale (AIS) is an anatomically-based injury severity scoring system. The score ranges from 0 (no injury) to 6 (maximal), a higher score indicating a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Abbreviated Injury Score Abdomen', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '2.75'}, {'value': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Abbreviated Injury Scale (AIS) is an anatomically-based injury severity scoring system. The score ranges from 0 (no injury) to 6 (maximal), a higher score indicating a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Abbreviated Injury Score Extremity', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Abbreviated Injury Scale (AIS) is an anatomically-based injury severity scoring system. The score ranges from 0 (no injury) to 6 (maximal), a higher score indicating a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Abbreviated Injury Score External', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Abbreviated Injury Scale (AIS) is an anatomically-based injury severity scoring system. The score ranges from 0 (no injury) to 6 (maximal), a higher score indicating a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Number of Participants Transferred From Another Institution', 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Allocation Unit', 'classes': [{'categories': [{'title': 'Intensive Care', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Intermediate Care', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Ward', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time from arrival to randomizarion', 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '22', 'groupId': 'BG000'}, {'value': '54', 'spread': '28', 'groupId': 'BG001'}, {'value': '52', 'spread': '25.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-28', 'size': 698614, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-12-21T15:12', 'hasProtocol': True}, {'date': '2021-10-12', 'size': 286511, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-03-02T15:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-31', 'studyFirstSubmitDate': '2019-09-04', 'resultsFirstSubmitDate': '2023-12-26', 'studyFirstSubmitQcDate': '2019-09-04', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-24', 'studyFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital Length of Stay', 'timeFrame': '180 days after admission', 'description': 'Number of days patient is in the hospital'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '180 days after admission', 'description': 'Death following trauma injury involving rib fractures'}, {'measure': 'Incidence of Respiratory Failure Requiring Mechanical Ventilation Greater Than 24 Hours', 'timeFrame': '24 hours after hospital admission', 'description': 'number of patients who require mechanical ventilation greater than 24 hours'}, {'measure': 'Number of Patients Requiring Tracheostomy', 'timeFrame': 'Hospital discharge (about 20 to 30 days)', 'description': 'Number of patients requiring a tracheostomy due to prolonged mechanical ventilation'}, {'measure': 'Number of Patients Who Developed Pneumonia During the Hospitalization', 'timeFrame': '6 months after admission', 'description': 'Number of patients diagnosed with pneumonia with greater than 10,000 cfu/ml on bronchioalveolar lavage or clinical diagnosis of pneumonia with subsequent antibiotic coverage'}, {'measure': 'Number of Patients Who Received Regional Analgesia', 'timeFrame': '6 months after admission', 'description': 'Number of patients utilizing regional analgesia, such as epidural, paravertebral, intercostal or serratus plane anesthesia'}, {'measure': 'Opioid Usage', 'timeFrame': 'Baseline', 'description': 'Opioid usage is reported in milligrams per patient pre-randomization'}, {'measure': 'Opioid Usage', 'timeFrame': 'Hospital discharge (about 20 to 30 days)', 'description': 'Opioid usage is reported in milligrams per patient from admission to discharge'}, {'measure': 'Ventilator Free Days', 'timeFrame': 'Hospital discharge (about 20 to 30 days)', 'description': 'Number of inpatient hospital days patients did not require mechanical ventilation'}, {'measure': 'Intensive Care Unit (ICU) Free Days', 'timeFrame': 'Hospital discharge (about 20 to 30 days)', 'description': 'Number of inpatient hospital days patient was not in ICU in the first 30 days'}, {'measure': 'Hospital (ICU) Free Days', 'timeFrame': '30 days post admission', 'description': 'Number of days patient was not in the hospital during the first 30 days after admission.'}, {'measure': 'Re-intervention Rates for Surgical Complications', 'timeFrame': '180 days post admission', 'description': 'The number of times a procedure was required to treat surgical complications'}, {'measure': 'Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)', 'timeFrame': '30 days post admission', 'description': 'Health status will be assessed by the Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L VAS score is directly reported by participants and ranges from 0 (the worst imaginable health) to 100 (the best imaginable health). A higher score indicates a better outcome.'}, {'measure': 'Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)', 'timeFrame': '90 days post admission', 'description': 'Health status will be assessed by the Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L VAS score is directly reported by participants and ranges from 0 (the worst imaginable health) to 100 (the best imaginable health). A higher score indicates a better outcome.'}, {'measure': 'Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)', 'timeFrame': '180 days post admission', 'description': 'Health status will be assessed by the Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L VAS score is directly reported by participants and ranges from 0 (the worst imaginable health) to 100 (the best imaginable health). A higher score indicates a better outcome.'}, {'measure': 'Health Status as Assessed by Index Score on the Euroqol-5D-5L', 'timeFrame': '30 days post admission', 'description': 'Health Status will be assessed by the index score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L index score ranges from 0 (a state as bad as being dead) to 1 (full health), and it is a summary score based on societal preference weights for the cumulative health states measured by 5 different dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression). It is calculated using the 2017 United States time trade-off valuation data set. A higher score indicates a better outcome.'}, {'measure': 'Health Status as Assessed by Index Score on the Euroqol-5D-5L', 'timeFrame': '90 days post admission', 'description': 'Health Status will be assessed by the index score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L index score ranges from 0 (a state as bad as being dead) to 1 (full health), and it is a summary score based on societal preference weights for the cumulative health states measured by 5 different dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression). It is calculated using the 2017 United States time trade-off valuation data set. A higher score indicates a better outcome.'}, {'measure': 'Health Status as Assessed by Index Score on the Euroqol-5D-5L', 'timeFrame': '180 days post admission', 'description': 'Health Status will be assessed by the index score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L index score ranges from 0 (a state as bad as being dead) to 1 (full health), and it is a summary score based on societal preference weights for the cumulative health states measured by 5 different dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression). It is calculated using the 2017 United States time trade-off valuation data set. A higher score indicates a better outcome.'}, {'measure': 'Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L', 'timeFrame': '30 days post admission', 'description': 'Level of impairment will be assessed for five dimensions (Mobility, Self-care, Daily activities, Pain, Anxiety) by using the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). Each dimension is rated at five levels: no impairment (1); minor impairment (2); moderate impairment (3); severe impairment (4); and extreme impairment (5). A higher score indicates a worse outcome.'}, {'measure': 'Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L', 'timeFrame': '90 days post admission', 'description': 'Level of impairment will be assessed for five dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression) by using the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). Each dimension is rated at five levels: no impairment (1); minor impairment (2); moderate impairment (3); severe impairment (4); and extreme impairment (5). A higher score indicates a worse outcome.'}, {'measure': 'Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L', 'timeFrame': '180 days post admission', 'description': 'Level of impairment will be assessed for five dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression) by using the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). Each dimension is rated at five levels: no impairment (1); minor impairment (2); moderate impairment (3); severe impairment (4); and extreme impairment (5). A higher score indicates a worse outcome.'}, {'measure': 'Time From Injury to Return to Work', 'timeFrame': '180 days post admission', 'description': "Number of days from time of injury until patient was able to return to work prior to injury per patient's assessment"}, {'measure': 'Time From Injury to Resolution of Pain', 'timeFrame': '180 days post admission', 'description': 'Number of days from time of injury to time patient verbalized pain was resolved'}, {'measure': 'Time From Injury to Return to Usual Activity', 'timeFrame': '180 days post admission', 'description': "Number of days from time of injury until patient was able to return to usual activities prior to injury per patient's assessment"}, {'measure': 'Number of Participants Prescribed Opioids at Discharge', 'timeFrame': 'Hospital discharge (about 20 to 30 days)'}, {'measure': 'Number of Participants Back to Work or Normal Physical Activity', 'timeFrame': '30 days post admission'}, {'measure': 'Number of Participants Back to Work or Normal Physical Activity', 'timeFrame': '90 days post admission'}, {'measure': 'Number of Participants Back to Work or Normal Physical Activity', 'timeFrame': '180 days post admission'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trauma Chest', 'Rib Fracture Multiple']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the usual care alone to usual care plus early surgical stabilization in adult trauma patients who have been admitted with rib fractures, to evaluate for heterogeneity of treatment effect in high risk subgroups and to determine the the impact of multiple rib fractures on post-discharge health status and time to return to work or usual physical activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Blunt trauma mechanism\n* Severe chest wall injury (defined by one of the 3 below):\n\nRadiographic flail segment (defined as greater than 2 fractures in greater than 3 consecutive ribs) or greater than 5 consecutive rib fractures or greater than 1 rib fractures with bicortical displacement\n\n* At least one true rib (1-7) fractured and accessible for stabilization\n\nExclusion Criteria:\n\n* Severe traumatic brain injury (best resuscitated GCS less than 8 as measured at 24 hours)\n* Spinal cord injury\n* Pre-existing congestive heart failure or oxygen-dependent pulmonary disease\n* Any reason for which SSRF could not occur within 72 hours of admission'}, 'identificationModule': {'nctId': 'NCT04081233', 'acronym': 'SSRF', 'briefTitle': 'Surgical Stabilization for Rib Fractures', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'The Effect of Early Stabilization of Rib Fractures on Patient-Centered Outcomes: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'HSC-MS-19-0649'}, 'secondaryIdInfos': [{'id': 'KL2TR003168', 'link': 'https://reporter.nih.gov/quickSearch/KL2TR003168', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early surgical stabilization', 'description': 'This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.', 'interventionNames': ['Procedure: surgical stabilization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'This arm will be usual care only. Usual care will include pain managment.', 'interventionNames': ['Procedure: Usual care']}], 'interventions': [{'name': 'surgical stabilization', 'type': 'PROCEDURE', 'otherNames': ['Rib plating'], 'description': 'Surgical procedure utilizing any commercially available internal rib fixation system', 'armGroupLabels': ['Early surgical stabilization']}, {'name': 'Usual care', 'type': 'PROCEDURE', 'description': 'Usual care typically consists of breathing exercises and pain control,often including opioids', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'David E Meyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'David E. Meyer, MD, MS, FACS', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}