Trial Outcomes & Findings for Surgical Stabilization for Rib Fractures (NCT NCT04081233)

NCT ID: NCT04081233

Last Updated: 2024-04-02

Results Overview

Number of days patient is in the hospital

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 84 participants
• Primary outcome timeframe: 180 days after admission
• Results posted on: 2024-04-02

Participant Flow

Participant milestones

Measure	Early Surgical Stabilization 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Overall Study STARTED	42	42
Overall Study COMPLETED	36	32
Overall Study NOT COMPLETED	6	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Surgical Stabilization for Rib Fractures

Baseline characteristics by cohort

Measure	Early Surgical Stabilization n=42 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=42 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids	Total n=84 Participants Total of all reporting groups
Age, Continuous	50 years STANDARD_DEVIATION 15 • n=5 Participants	49 years STANDARD_DEVIATION 15 • n=7 Participants	49.5 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	31 Participants n=7 Participants	59 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian, non-Hispanic	29 Participants n=5 Participants	25 Participants n=7 Participants	54 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian, Hispanic	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants	42 participants n=7 Participants	84 participants n=5 Participants
Number of Participants Who Sustained Injury From a Motor Vehicle Collision	24 Participants n=5 Participants	19 Participants n=7 Participants	43 Participants n=5 Participants
Number of Participants Who Sustained Injury From a Motorcycle Collision	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Number of Participants Who Sustained Injury From a Fall	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Height	174 centimeters STANDARD_DEVIATION 10 • n=5 Participants	175 centimeters STANDARD_DEVIATION 10 • n=7 Participants	174.5 centimeters STANDARD_DEVIATION 10 • n=5 Participants
Weight	95 kilograms STANDARD_DEVIATION 25 • n=5 Participants	93 kilograms STANDARD_DEVIATION 22 • n=7 Participants	94 kilograms STANDARD_DEVIATION 23.5 • n=5 Participants
Body Mass Index	31 kg/m^2 STANDARD_DEVIATION 6 • n=5 Participants	30 kg/m^2 STANDARD_DEVIATION 6 • n=7 Participants	30.5 kg/m^2 STANDARD_DEVIATION 6 • n=5 Participants
Emergency Department Heart Rate	93 beats per minute STANDARD_DEVIATION 22 • n=5 Participants	93 beats per minute STANDARD_DEVIATION 18 • n=7 Participants	93 beats per minute STANDARD_DEVIATION 20 • n=5 Participants
Emergency Department Respiratory Rate	21 breaths per minute STANDARD_DEVIATION 5 • n=5 Participants	20 breaths per minute STANDARD_DEVIATION 5 • n=7 Participants	20.5 breaths per minute STANDARD_DEVIATION 5 • n=5 Participants
Emergency Department Systolic Blood Pressure	125 mmHg STANDARD_DEVIATION 30 • n=5 Participants	127 mmHg STANDARD_DEVIATION 35 • n=7 Participants	126 mmHg STANDARD_DEVIATION 32.5 • n=5 Participants
Emergency Department Diastolic Blood Pressure	79 mmHg STANDARD_DEVIATION 19 • n=5 Participants	79 mmHg STANDARD_DEVIATION 16 • n=7 Participants	79 mmHg STANDARD_DEVIATION 17.5 • n=5 Participants
Emergency Department Glasgow Coma Scale Score	15 score on a scale n=5 Participants	15 score on a scale n=7 Participants	15 score on a scale n=5 Participants
Injury Severity Score	22 score on a scale n=5 Participants	22 score on a scale n=7 Participants	22 score on a scale n=5 Participants
Abbreviated Injury Score Head	1.5 score on a scale n=5 Participants	1 score on a scale n=7 Participants	1 score on a scale n=5 Participants
Abbreviated Injury Score Face	0 score on a scale n=5 Participants	0 score on a scale n=7 Participants	0 score on a scale n=5 Participants
Abbreviated Injury Score Chest	3 score on a scale n=5 Participants	3 score on a scale n=7 Participants	3 score on a scale n=5 Participants
Abbreviated Injury Score Abdomen	1 score on a scale n=5 Participants	0 score on a scale n=7 Participants	0 score on a scale n=5 Participants
Abbreviated Injury Score Extremity	2 score on a scale n=5 Participants	2 score on a scale n=7 Participants	2 score on a scale n=5 Participants
Abbreviated Injury Score External	0 score on a scale n=5 Participants	0 score on a scale n=7 Participants	0 score on a scale n=5 Participants
Number of Participants Transferred From Another Institution	15 Participants n=5 Participants	19 Participants n=7 Participants	34 Participants n=5 Participants
Allocation Unit Intensive Care	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Allocation Unit Intermediate Care	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Allocation Unit Ward	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Time from arrival to randomizarion	50 hours STANDARD_DEVIATION 22 • n=5 Participants	54 hours STANDARD_DEVIATION 28 • n=7 Participants	52 hours STANDARD_DEVIATION 25.1 • n=5 Participants

PRIMARY outcome

Timeframe: 180 days after admission

Number of days patient is in the hospital

Outcome measures

Measure	Early Surgical Stabilization n=42 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=42 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Hospital Length of Stay	9 days Interval 6.0 to 20.0	6 days Interval 3.0 to 11.0

SECONDARY outcome

Timeframe: 180 days after admission

Death following trauma injury involving rib fractures

Outcome measures

Measure	Early Surgical Stabilization n=42 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=42 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Mortality	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 hours after hospital admission

Population: Data were not collected for this outcome measure

number of patients who require mechanical ventilation greater than 24 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Hospital discharge (about 20 to 30 days)

Number of patients requiring a tracheostomy due to prolonged mechanical ventilation

Outcome measures

Measure	Early Surgical Stabilization n=42 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=42 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Number of Patients Requiring Tracheostomy	7 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 months after admission

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

Outcome measures

Measure	Early Surgical Stabilization n=42 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=42 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Number of Patients Who Developed Pneumonia During the Hospitalization	9 Participants	5 Participants

SECONDARY outcome

Timeframe: 6 months after admission

Number of patients utilizing regional analgesia, such as epidural, paravertebral, intercostal or serratus plane anesthesia

Outcome measures

Measure	Early Surgical Stabilization n=42 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=42 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Number of Patients Who Received Regional Analgesia	7 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline

Opioid usage is reported in milligrams per patient pre-randomization

Outcome measures

Measure	Early Surgical Stabilization n=42 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=42 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Opioid Usage	80 milligrams Interval 50.0 to 167.0	79 milligrams Interval 30.0 to 169.0

SECONDARY outcome

Timeframe: Hospital discharge (about 20 to 30 days)

Opioid usage is reported in milligrams per patient from admission to discharge

Outcome measures

Measure	Early Surgical Stabilization n=42 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=42 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Opioid Usage Opioid usage (all)	349 milligrams Interval 218.0 to 686.0	177 milligrams Interval 76.0 to 387.0
Opioid Usage Opioid usage (anesthesia)	149 milligrams Interval 92.0 to 266.0	0 milligrams Interval 0.0 to 90.0
Opioid Usage Opioid usage (non-anesthesia)	203 milligrams Interval 89.0 to 477.0	125 milligrams Interval 62.0 to 279.0
Opioid Usage Daily non-anesthesia opioid exposure	20 milligrams Interval 9.0 to 43.0	19 milligrams Interval 9.0 to 34.0

SECONDARY outcome

Timeframe: Hospital discharge (about 20 to 30 days)

Population: Data were not collected for this outcome measure.

Number of inpatient hospital days patients did not require mechanical ventilation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Hospital discharge (about 20 to 30 days)

Number of inpatient hospital days patient was not in ICU in the first 30 days

Outcome measures

Measure	Early Surgical Stabilization n=42 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=42 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Intensive Care Unit (ICU) Free Days	30 days Interval 20.0 to 30.0	30 days Interval 29.0 to 30.0

SECONDARY outcome

Timeframe: 30 days post admission

Number of days patient was not in the hospital during the first 30 days after admission.

Outcome measures

Measure	Early Surgical Stabilization n=42 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=42 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Hospital (ICU) Free Days	21 days Interval 10.0 to 24.0	24 days Interval 19.0 to 27.0

SECONDARY outcome

Timeframe: 180 days post admission

The number of times a procedure was required to treat surgical complications

Outcome measures

Measure	Early Surgical Stabilization n=42 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=42 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Re-intervention Rates for Surgical Complications Seroma	1 Participants	0 Participants
Re-intervention Rates for Surgical Complications Surgical Site Infection	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days post admission

Population: Data were not collected for 5 in the early surgical stabilization arm, and data were not collected for 7 in the usual care arm.

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.

Outcome measures

Measure	Early Surgical Stabilization n=37 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=35 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)	65 score on a scale Standard Deviation 22	67 score on a scale Standard Deviation 18

SECONDARY outcome

Timeframe: 90 days post admission

Population: Data were not collected for 8 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.

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.

Outcome measures

Measure	Early Surgical Stabilization n=34 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=32 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)	69 score on a scale Standard Deviation 24	73 score on a scale Standard Deviation 23

SECONDARY outcome

Timeframe: 180 days post admission

Population: Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.

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.

Outcome measures

Measure	Early Surgical Stabilization n=36 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=32 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)	74 score on a scale Standard Deviation 23	77 score on a scale Standard Deviation 20

SECONDARY outcome

Timeframe: 30 days post admission

Population: Data were not collected for 5 in the early surgical stabilization arm, and data were not collected for 7 in the usual care arm.

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.

Outcome measures

Measure	Early Surgical Stabilization n=37 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=35 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Health Status as Assessed by Index Score on the Euroqol-5D-5L	0.44 score on a scale Standard Deviation 0.34	0.53 score on a scale Standard Deviation 0.27

SECONDARY outcome

Timeframe: 90 days post admission

Population: Data were not collected for 8 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.

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.

Outcome measures

Measure	Early Surgical Stabilization n=34 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=32 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Health Status as Assessed by Index Score on the Euroqol-5D-5L	0.56 score on a scale Standard Deviation 0.32	0.61 score on a scale Standard Deviation 0.36

SECONDARY outcome

Timeframe: 180 days post admission

Population: Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.

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.

Outcome measures

Measure	Early Surgical Stabilization n=36 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=32 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Health Status as Assessed by Index Score on the Euroqol-5D-5L	0.69 score on a scale Standard Deviation 0.32	0.77 score on a scale Standard Deviation 0.26

SECONDARY outcome

Timeframe: 30 days post admission

Population: Data were not collected for 5 in the early surgical stabilization arm, and data were not collected for 7 in the usual care arm.

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.

Outcome measures

Measure	Early Surgical Stabilization n=37 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=35 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L Mobility	3 score on a scale Interval 2.0 to 3.0	2 score on a scale Interval 1.0 to 2.0
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L Self-care	2 score on a scale Interval 2.0 to 3.0	2 score on a scale Interval 1.0 to 2.0
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L Usual activities	3 score on a scale Interval 2.0 to 5.0	3 score on a scale Interval 2.5 to 5.0
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L Pain	3 score on a scale Interval 2.0 to 3.0	3 score on a scale Interval 2.0 to 3.0
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L Anxiety	2 score on a scale Interval 1.0 to 3.0	2 score on a scale Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: 90 days post admission

Population: Data were not collected for 8 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.

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.

Outcome measures

Measure	Early Surgical Stabilization n=34 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=32 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L Mobility	2 score on a scale Interval 1.0 to 3.0	1 score on a scale Interval 1.0 to 3.0
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L Self-care	1 score on a scale Interval 1.0 to 2.5	1 score on a scale Interval 1.0 to 3.0
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L Usual activities	3 score on a scale Interval 2.0 to 3.0	2 score on a scale Interval 1.0 to 3.25
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L Pain	3 score on a scale Interval 2.0 to 3.0	2 score on a scale Interval 2.0 to 3.0
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L Anxiety	2 score on a scale Interval 1.0 to 3.0	2 score on a scale Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: 180 days post admission

Population: Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.

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.

Outcome measures

Measure	Early Surgical Stabilization n=36 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=32 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L Mobility	1 score on a scale Interval 1.0 to 2.0	1 score on a scale Interval 1.0 to 2.0
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L Self-care	1 score on a scale Interval 1.0 to 1.0	1 score on a scale Interval 1.0 to 1.0
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L Usual activities	2 score on a scale Interval 1.0 to 3.0	1.5 score on a scale Interval 1.0 to 3.0
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L Pain	2 score on a scale Interval 2.0 to 3.0	2 score on a scale Interval 1.0 to 3.0
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L Anxiety	1 score on a scale Interval 1.0 to 2.0	1 score on a scale Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: 180 days post admission

Population: Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.

Number of days from time of injury until patient was able to return to work prior to injury per patient's assessment

Outcome measures

Measure	Early Surgical Stabilization n=36 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=32 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Time From Injury to Return to Work	48 days Interval 35.0 to 89.0	43 days Interval 35.0 to 55.0

SECONDARY outcome

Timeframe: 180 days post admission

Population: Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.

Number of days from time of injury to time patient verbalized pain was resolved

Outcome measures

Measure	Early Surgical Stabilization n=36 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=32 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Time From Injury to Resolution of Pain	76 days Interval 35.0 to 104.0	54 days Interval 25.0 to 73.0

SECONDARY outcome

Timeframe: 180 days post admission

Population: Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.

Number of days from time of injury until patient was able to return to usual activities prior to injury per patient's assessment

Outcome measures

Measure	Early Surgical Stabilization n=36 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=32 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Time From Injury to Return to Usual Activity	92 days Interval 77.0 to 119.0	67 days Interval 52.0 to 112.0

SECONDARY outcome

Timeframe: Hospital discharge (about 20 to 30 days)

Outcome measures

Measure	Early Surgical Stabilization n=42 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=42 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Number of Participants Prescribed Opioids at Discharge Tramadol	22 Participants	24 Participants
Number of Participants Prescribed Opioids at Discharge Other Opioid	3 Participants	4 Participants

SECONDARY outcome

Timeframe: 30 days post admission

Population: Data were not collected for 5 in the early surgical stabilization arm, and data were not collected for 7 in the usual care arm.

Outcome measures

Measure	Early Surgical Stabilization n=37 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=35 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Number of Participants Back to Work or Normal Physical Activity	5 Participants	5 Participants

SECONDARY outcome

Timeframe: 90 days post admission

Population: Data were not collected for 8 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.

Outcome measures

Measure	Early Surgical Stabilization n=34 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=32 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Number of Participants Back to Work or Normal Physical Activity	14 Participants	17 Participants

SECONDARY outcome

Timeframe: 180 days post admission

Population: Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.

Outcome measures

Measure	Early Surgical Stabilization n=36 Participants 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=32 Participants This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Number of Participants Back to Work or Normal Physical Activity	19 Participants	19 Participants

Adverse Events

Early Surgical Stabilization

Serious events: 12 serious events

Other events: 6 other events

Deaths: 0 deaths

Usual Care

Serious events: 8 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Early Surgical Stabilization n=42 participants at risk 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=42 participants at risk This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Injury, poisoning and procedural complications Surgical site infection	2.4% 1/42 • 6 months	0.00% 0/42 • 6 months
Vascular disorders Deep vein Thrombosis	2.4% 1/42 • 6 months	0.00% 0/42 • 6 months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.4% 1/42 • 6 months	7.1% 3/42 • 6 months
Respiratory, thoracic and mediastinal disorders Pneumonia	21.4% 9/42 • 6 months	11.9% 5/42 • 6 months

Other adverse events

Measure	Early Surgical Stabilization n=42 participants at risk 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. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system	Usual Care n=42 participants at risk This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids
Injury, poisoning and procedural complications Seroma	2.4% 1/42 • 6 months	0.00% 0/42 • 6 months
Injury, poisoning and procedural complications Retained Hemothorax	11.9% 5/42 • 6 months	4.8% 2/42 • 6 months

Additional Information

David E. Meyer, MD, MS, FACS

The University of Texas Health Science Center at Houston

Phone: 713-500-7244

Email: David.E.Meyer@uth.tmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place