Trial Outcomes & Findings for Multicenter RCT of SSRF in Non Flail Patients (NCT NCT03221595)
NCT ID: NCT03221595
Last Updated: 2021-05-06
Results Overview
Patient self-reported pain score on an 11 point scale scale ranging from 0-10; 0 being "no pain" to 10 "the worst pain imaginable".
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
Hospital days 1-7, day of discharge (an average of 1 week) and at 2, 4 and 8 weeks following discharge from hospital.
Results posted on
2021-05-06
Participant Flow
Participant milestones
| Measure |
Operative
Patients in the operative arm will undergo best medical management, in addition to surgical stabilization of their displaced rib fractures within 72 hours of admission to the hospital.
Operative: This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints
|
Non-Operative
Patients in the non operative arm will undergo best medical management of their displaced rib fractures.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
59
|
|
Overall Study
COMPLETED
|
51
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Operative
n=51 Participants
Patients in the operative arm will undergo best medical management, in addition to surgical stabilization of their displaced rib fractures within 72 hours of admission to the hospital.
Operative: This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints
|
Non-Operative
n=59 Participants
Patients in the non operative arm will undergo best medical management of their displaced rib fractures.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 15.4 • n=51 Participants
|
53.2 years
STANDARD_DEVIATION 16.1 • n=59 Participants
|
53.6 years
STANDARD_DEVIATION 15.2 • n=110 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=51 Participants
|
16 Participants
n=59 Participants
|
28 Participants
n=110 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=51 Participants
|
43 Participants
n=59 Participants
|
82 Participants
n=110 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
51 participants
n=51 Participants
|
59 participants
n=59 Participants
|
110 participants
n=110 Participants
|
PRIMARY outcome
Timeframe: Hospital days 1-7, day of discharge (an average of 1 week) and at 2, 4 and 8 weeks following discharge from hospital.Patient self-reported pain score on an 11 point scale scale ranging from 0-10; 0 being "no pain" to 10 "the worst pain imaginable".
Outcome measures
| Measure |
Operative
n=51 Participants
Patients in the operative arm will undergo best medical management, in addition to surgical stabilization of their displaced rib fractures within 72 hours of admission to the hospital.
Operative: This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints
|
Non-operative
n=59 Participants
Patients in the non operative arm will undergo best medical management of their displaced rib fractures.
|
|---|---|---|
|
Numeric Pain Score
Day of discharge
|
4.1 score on a scale
Standard Deviation 2.3
|
5.2 score on a scale
Standard Deviation 2.4
|
|
Numeric Pain Score
Hospital day 1
|
7.5 score on a scale
Standard Deviation 2.4
|
7 score on a scale
Standard Deviation 2.3
|
|
Numeric Pain Score
Hospital day 2
|
6.3 score on a scale
Standard Deviation 2.6
|
6.0 score on a scale
Standard Deviation 2.4
|
|
Numeric Pain Score
Hospital day 3
|
5.3 score on a scale
Standard Deviation 2.8
|
5.9 score on a scale
Standard Deviation 2.1
|
|
Numeric Pain Score
Hospital day 4
|
5.3 score on a scale
Standard Deviation 2.8
|
6.1 score on a scale
Standard Deviation 2.4
|
|
Numeric Pain Score
Hospital day 5
|
5.0 score on a scale
Standard Deviation 2.3
|
5.9 score on a scale
Standard Deviation 2
|
|
Numeric Pain Score
Hospital day 6
|
4.7 score on a scale
Standard Deviation 2.1
|
5.8 score on a scale
Standard Deviation 2.1
|
|
Numeric Pain Score
Hospital day 7
|
4.7 score on a scale
Standard Deviation 2.6
|
6.3 score on a scale
Standard Deviation 2.3
|
|
Numeric Pain Score
2 week follow-up
|
2.9 score on a scale
Standard Deviation 2.1
|
4.5 score on a scale
Standard Deviation 2.2
|
|
Numeric Pain Score
4 week follow-up
|
2.4 score on a scale
Standard Deviation 2.4
|
3.3 score on a scale
Standard Deviation 2.6
|
|
Numeric Pain Score
8 week follow-up
|
1.5 score on a scale
Standard Deviation 1.3
|
3.3 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 2 months after injuryPatient length of stay in hospital and/or ICU.
Outcome measures
| Measure |
Operative
n=51 Participants
Patients in the operative arm will undergo best medical management, in addition to surgical stabilization of their displaced rib fractures within 72 hours of admission to the hospital.
Operative: This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints
|
Non-operative
n=59 Participants
Patients in the non operative arm will undergo best medical management of their displaced rib fractures.
|
|---|---|---|
|
Length of Stay
Hospital length of stay
|
7 Days
Interval 5.5 to 10.0
|
6 Days
Interval 4.0 to 11.0
|
|
Length of Stay
ICU length of stay
|
2 Days
Interval 0.0 to 3.0
|
2 Days
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: Inpatient: occurred daily at 10 AM while the patient was hospitalized. Post-discharge: occurred at outpatient clinic follow-up encounter that occurred at 2, 4, and 8 weeks post discharge.Total standardized narcotic equivalents per day, which is calculated using an equil-analgesic scale: Narcotic Dose Unit Route Hydromorphone 1.5 mg IV Hydromorphone 7.5 mg PO Fentanyl 100 mcg IV Morphine 10 mg IV Morphine 30 mg PO Oxycodone 20 mg PO Hydrocodone 30 mg PO \*IV, intravenous; mcg, micrograms; mg, milligrams; PO, per oral
Outcome measures
| Measure |
Operative
n=51 Participants
Patients in the operative arm will undergo best medical management, in addition to surgical stabilization of their displaced rib fractures within 72 hours of admission to the hospital.
Operative: This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints
|
Non-operative
n=59 Participants
Patients in the non operative arm will undergo best medical management of their displaced rib fractures.
|
|---|---|---|
|
Daily Narcotic Use
Hospital Day 1
|
2.6 mg morphine equivalents
Interval 1.3 to 4.5
|
1.6 mg morphine equivalents
Interval 0.5 to 2.6
|
|
Daily Narcotic Use
Hospital Day 2
|
2.0 mg morphine equivalents
Interval 0.8 to 3.3
|
2.0 mg morphine equivalents
Interval 1.3 to 2.8
|
|
Daily Narcotic Use
Hospital Day 3
|
1.5 mg morphine equivalents
Interval 0.8 to 3.0
|
1.6 mg morphine equivalents
Interval 1.0 to 2.3
|
|
Daily Narcotic Use
Hospital Day 4
|
1.5 mg morphine equivalents
Interval 0.5 to 3.0
|
1.5 mg morphine equivalents
Interval 0.8 to 2.7
|
|
Daily Narcotic Use
Hospital Day 5
|
1.3 mg morphine equivalents
Interval 0.6 to 2.3
|
2.3 mg morphine equivalents
Interval 1.0 to 3.0
|
|
Daily Narcotic Use
Hospital Day 6
|
1.3 mg morphine equivalents
Interval 0.3 to 2.3
|
2.0 mg morphine equivalents
Interval 1.0 to 3.5
|
|
Daily Narcotic Use
Hospital Day 7
|
1.0 mg morphine equivalents
Interval 0.5 to 2.0
|
2.3 mg morphine equivalents
Interval 0.8 to 3.8
|
|
Daily Narcotic Use
Day of Discharge
|
0.5 mg morphine equivalents
Interval 0.3 to 1.5
|
0.8 mg morphine equivalents
Interval 0.5 to 1.5
|
|
Daily Narcotic Use
2 Week Follow-up
|
0.5 mg morphine equivalents
Interval 0.0 to 1.3
|
1.2 mg morphine equivalents
Interval 0.8 to 3.0
|
|
Daily Narcotic Use
4 Week Follow-up
|
0.3 mg morphine equivalents
Interval 0.0 to 0.6
|
1.5 mg morphine equivalents
Interval 0.0 to 2.0
|
|
Daily Narcotic Use
8 Week Follow-up
|
0.2 mg morphine equivalents
Interval 0.0 to 0.5
|
0.5 mg morphine equivalents
Interval 0.3 to 1.3
|
SECONDARY outcome
Timeframe: Inpatient: occurred daily at 10 AM while the patient was hospitalized. Post-discharge: occurred at outpatient clinic follow-up encounter that occurred at 2, 4, and 8 weeks post discharge.The maximum volume (ml) of inspired air through a handheld device called an incentive spirometer. Best value of 3 attempts is recorded. The value of the inspired volume is normalized for patients age, sex, and height and in measured in the percent predicted for that particular individual.
Outcome measures
| Measure |
Operative
n=51 Participants
Patients in the operative arm will undergo best medical management, in addition to surgical stabilization of their displaced rib fractures within 72 hours of admission to the hospital.
Operative: This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints
|
Non-operative
n=59 Participants
Patients in the non operative arm will undergo best medical management of their displaced rib fractures.
|
|---|---|---|
|
Incentive Spirometry
Hosp Day 1
|
39 % of predicted ml for age/sex/height
Interval 21.0 to 61.0
|
39.5 % of predicted ml for age/sex/height
Interval 27.5 to 49.5
|
|
Incentive Spirometry
Hosp Day 2
|
40 % of predicted ml for age/sex/height
Interval 23.0 to 59.0
|
41.5 % of predicted ml for age/sex/height
Interval 32.0 to 60.0
|
|
Incentive Spirometry
Hosp Day 3
|
46 % of predicted ml for age/sex/height
Interval 31.0 to 65.0
|
49 % of predicted ml for age/sex/height
Interval 42.0 to 64.0
|
|
Incentive Spirometry
Hosp Day 4
|
48.5 % of predicted ml for age/sex/height
Interval 33.5 to 67.5
|
49.5 % of predicted ml for age/sex/height
Interval 42.0 to 66.0
|
|
Incentive Spirometry
Hosp Day 5
|
59 % of predicted ml for age/sex/height
Interval 37.0 to 66.0
|
51 % of predicted ml for age/sex/height
Interval 42.0 to 59.0
|
|
Incentive Spirometry
Hosp Day 6
|
52 % of predicted ml for age/sex/height
Interval 41.0 to 67.0
|
49 % of predicted ml for age/sex/height
Interval 41.5 to 60.0
|
|
Incentive Spirometry
Hosp Day 7
|
55 % of predicted ml for age/sex/height
Interval 45.0 to 72.0
|
54 % of predicted ml for age/sex/height
Interval 37.0 to 70.0
|
|
Incentive Spirometry
Day of Discharge
|
63 % of predicted ml for age/sex/height
Interval 55.0 to 78.0
|
61 % of predicted ml for age/sex/height
Interval 49.0 to 74.0
|
|
Incentive Spirometry
2 Week Follow-Up
|
87 % of predicted ml for age/sex/height
Interval 63.0 to 100.0
|
90 % of predicted ml for age/sex/height
Interval 73.0 to 100.0
|
|
Incentive Spirometry
4 Week Follow-Up
|
100 % of predicted ml for age/sex/height
Interval 68.0 to 112.0
|
100 % of predicted ml for age/sex/height
Interval 85.0 to 113.0
|
|
Incentive Spirometry
8 Week Follow-Up
|
100 % of predicted ml for age/sex/height
Interval 81.0 to 120.5
|
97.5 % of predicted ml for age/sex/height
Interval 77.0 to 141.0
|
SECONDARY outcome
Timeframe: once, at first follow-up, outpatient, clinic visit, which occurred at 2 weeks post discharge.Forced expired volume in 1 second, measured in pulmonary function lab
Outcome measures
| Measure |
Operative
n=51 Participants
Patients in the operative arm will undergo best medical management, in addition to surgical stabilization of their displaced rib fractures within 72 hours of admission to the hospital.
Operative: This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints
|
Non-operative
n=59 Participants
Patients in the non operative arm will undergo best medical management of their displaced rib fractures.
|
|---|---|---|
|
Pulmonary Function Testing
|
75.5 % of predicted ml for age/sex/height
Standard Deviation 17.6
|
75.8 % of predicted ml for age/sex/height
Standard Deviation 15.8
|
SECONDARY outcome
Timeframe: Study participants were followed up to 2 months after index admission date.CDC definition of nosocomial pneumonia
Outcome measures
| Measure |
Operative
n=51 Participants
Patients in the operative arm will undergo best medical management, in addition to surgical stabilization of their displaced rib fractures within 72 hours of admission to the hospital.
Operative: This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints
|
Non-operative
n=59 Participants
Patients in the non operative arm will undergo best medical management of their displaced rib fractures.
|
|---|---|---|
|
Number of Patients With Pneumonia
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Study participants were followed up to 2 months after index admission date.Mechanical ventilation for \> 24 hours at any time during index hospitalization
Outcome measures
| Measure |
Operative
n=51 Participants
Patients in the operative arm will undergo best medical management, in addition to surgical stabilization of their displaced rib fractures within 72 hours of admission to the hospital.
Operative: This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints
|
Non-operative
n=59 Participants
Patients in the non operative arm will undergo best medical management of their displaced rib fractures.
|
|---|---|---|
|
Days of Ventilator-dependent Respiratory Failure
|
0 Days
Interval 0.0 to 0.0
|
0 Days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 2, 4 and 8 weeks after discharge from the index admissionAn 8 question, validated quality of life (QoL) questionnaire administered at outpatient, clinic follow-up encounters after discharge from the index admission. Minimum score is 0 and indicates the worst outcome of QoL while maximum score is 55, which indicates the highest outcome of QoL.
Outcome measures
| Measure |
Operative
n=51 Participants
Patients in the operative arm will undergo best medical management, in addition to surgical stabilization of their displaced rib fractures within 72 hours of admission to the hospital.
Operative: This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints
|
Non-operative
n=59 Participants
Patients in the non operative arm will undergo best medical management of their displaced rib fractures.
|
|---|---|---|
|
Chest Wall Specific Quality of Life Questionnaire
2 Week Follow-Up
|
20.6 units on a scale
Standard Deviation 11
|
25.3 units on a scale
Standard Deviation 10.1
|
|
Chest Wall Specific Quality of Life Questionnaire
4 Week Follow-Up
|
16.9 units on a scale
Standard Deviation 10.6
|
22.4 units on a scale
Standard Deviation 8.8
|
|
Chest Wall Specific Quality of Life Questionnaire
8 Week Follow-Up
|
10.4 units on a scale
Standard Deviation 10.9
|
15.7 units on a scale
Standard Deviation 8.2
|
Adverse Events
Operative
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Non-operative
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Operative
n=51 participants at risk
Patients in the operative arm will undergo best medical management, in addition to surgical stabilization of their displaced rib fractures within 72 hours of admission to the hospital.
Operative: This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints
|
Non-operative
n=59 participants at risk
Patients in the non operative arm will undergo best medical management of their displaced rib fractures.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Local Infection
|
0.00%
0/51 • 2 months after study participant was discharged from index admission.
|
1.7%
1/59 • Number of events 1 • 2 months after study participant was discharged from index admission.
|
|
Immune system disorders
Systemic Infection
|
0.00%
0/51 • 2 months after study participant was discharged from index admission.
|
1.7%
1/59 • Number of events 1 • 2 months after study participant was discharged from index admission.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/51 • 2 months after study participant was discharged from index admission.
|
1.7%
1/59 • Number of events 1 • 2 months after study participant was discharged from index admission.
|
|
Respiratory, thoracic and mediastinal disorders
Take back to operating room for bleeding
|
2.0%
1/51 • Number of events 1 • 2 months after study participant was discharged from index admission.
|
0.00%
0/59 • 2 months after study participant was discharged from index admission.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place