NCT03221595: CWISNONFLAIL

Multicenter RCT of SSRF in Non Flail Patients

Completed NA Results posted Last updated 6 May 2021

What this trial tests

NA trial testing Operative in Rib Fracture Multiple in 110 participants. Completed in 1 January 2020.

Timeline

2 January 2018

Primary endpoint
22 October 2019

1 January 2020

Quick facts

Lead sponsor	Denver Health and Hospital Authority
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	110
Start date	2 January 2018
Primary completion	22 October 2019
Estimated completion	1 January 2020
Sites	1 location across United States

Drugs / interventions tested

• Operative

Conditions studied

• Rib Fracture Multiple — all drugs for Rib Fracture Multiple →

Sponsor

Denver Health and Hospital Authority

Who can join

Adults 18 to 80, any sex, with Rib Fracture Multiple. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Numeric Pain Score Primary · 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".

Hospital day 1

Group	Value	95% CI
Operative	7.5	± 2.4
Non-operative	7	± 2.3

Hospital day 2

Group	Value	95% CI
Operative	6.3	± 2.6
Non-operative	6.0	± 2.4

Hospital day 3

Group	Value	95% CI
Operative	5.3	± 2.8
Non-operative	5.9	± 2.1

Hospital day 4

Group	Value	95% CI
Operative	5.3	± 2.8
Non-operative	6.1	± 2.4

Hospital day 5

Group	Value	95% CI
Operative	5.0	± 2.3
Non-operative	5.9	± 2

Hospital day 6

Group	Value	95% CI
Operative	4.7	± 2.1
Non-operative	5.8	± 2.1

Hospital day 7

Group	Value	95% CI
Operative	4.7	± 2.6
Non-operative	6.3	± 2.3

Day of discharge

Group	Value	95% CI
Operative	4.1	± 2.3
Non-operative	5.2	± 2.4

Length of Stay Secondary · 2 months after injury

Patient length of stay in hospital and/or ICU.

Hospital length of stay

Group	Value	95% CI
Operative	7	5.5 – 10
Non-operative	6	4 – 11

ICU length of stay

Group	Value	95% CI
Operative	2	0 – 3
Non-operative	2	0 – 3

Daily Narcotic Use Secondary · 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

Hospital Day 1

Group	Value	95% CI
Operative	2.6	1.3 – 4.5
Non-operative	1.6	0.5 – 2.6

Hospital Day 2

Group	Value	95% CI
Operative	2.0	0.8 – 3.3
Non-operative	2.0	1.3 – 2.8

Hospital Day 3

Group	Value	95% CI
Operative	1.5	0.8 – 3
Non-operative	1.6	1 – 2.3

Hospital Day 4

Group	Value	95% CI
Operative	1.5	0.5 – 3
Non-operative	1.5	0.8 – 2.7

Hospital Day 5

Group	Value	95% CI
Operative	1.3	0.6 – 2.3
Non-operative	2.3	1 – 3

Hospital Day 6

Group	Value	95% CI
Operative	1.3	0.3 – 2.3
Non-operative	2.0	1 – 3.5

Hospital Day 7

Group	Value	95% CI
Operative	1.0	0.5 – 2
Non-operative	2.3	0.8 – 3.8

Day of Discharge

Group	Value	95% CI
Operative	0.5	0.3 – 1.5
Non-operative	0.8	0.5 – 1.5

Incentive Spirometry Secondary · 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.

Hosp Day 1

Group	Value	95% CI
Operative	39	21 – 61
Non-operative	39.5	27.5 – 49.5

Hosp Day 2

Group	Value	95% CI
Operative	40	23 – 59
Non-operative	41.5	32 – 60

Hosp Day 3

Group	Value	95% CI
Operative	46	31 – 65
Non-operative	49	42 – 64

Hosp Day 4

Group	Value	95% CI
Operative	48.5	33.5 – 67.5
Non-operative	49.5	42 – 66

Hosp Day 5

Group	Value	95% CI
Operative	59	37 – 66
Non-operative	51	42 – 59

Hosp Day 6

Group	Value	95% CI
Operative	52	41 – 67
Non-operative	49	41.5 – 60

Hosp Day 7

Group	Value	95% CI
Operative	55	45 – 72
Non-operative	54	37 – 70

Day of Discharge

Group	Value	95% CI
Operative	63	55 – 78
Non-operative	61	49 – 74

Pulmonary Function Testing Secondary · 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

Group	Value	95% CI
Operative	75.5	± 17.6
Non-operative	75.8	± 15.8

Number of Patients With Pneumonia Secondary · Study participants were followed up to 2 months after index admission date.

CDC definition of nosocomial pneumonia

Group	Value	95% CI
Operative	1
Non-operative	4

Days of Ventilator-dependent Respiratory Failure Secondary · Study participants were followed up to 2 months after index admission date.

Mechanical ventilation for \> 24 hours at any time during index hospitalization

Group	Value	95% CI
Operative	0	0 – 0
Non-operative	0	0 – 0

Chest Wall Specific Quality of Life Questionnaire Secondary · 2, 4 and 8 weeks after discharge from the index admission

An 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.

2 Week Follow-Up

Group	Value	95% CI
Operative	20.6	± 11
Non-operative	25.3	± 10.1

4 Week Follow-Up

Group	Value	95% CI
Operative	16.9	± 10.6
Non-operative	22.4	± 8.8

8 Week Follow-Up

Group	Value	95% CI
Operative	10.4	± 10.9
Non-operative	15.7	± 8.2

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 months after study participant was discharged from index admission.. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Operative

Serious: 0/51 (0%)

Deaths: 0/51

Non-operative

Serious: 0/59 (0%)

Deaths: 0/59

Other adverse events (4 terms — click to expand)

Reaction	System	Operative	Non-operative
Local Infection	Respiratory, thoracic and mediastinal disorders	—	—
Systemic Infection	Immune system disorders	—	—
Acute Kidney Injury	Renal and urinary disorders	—	—
Take back to operating room for bleeding	Respiratory, thoracic and mediastinal disorders	—	—

Data from ClinicalTrials.gov NCT03221595 adverse events section.

Sponsor's own description

This study evaluates the efficacy of surgical stabilization of rib fractures, as compared to best medical management, for patients with multiple, displaced rib fractures.

Half of patients will be randomized to surgery (in addition to best medical management), whereas the other half will be randomized to medical therapy only.

The primary outcome will be the subjects overall quality of life measured at two months following injury.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Does Surgery Reduce the Risk of Complications Among Patients with Multiple Rib Fractures? A Meta-analysis.
   Liang YS, Yu KC, Wong CS, Kao Y, et al · · 2019 · cited 24× · PMID 30247228 · DOI 10.1097/corr.0000000000000495
2. Barriers to conducting a multi-center randomized controlled trial of surgical stabilization of rib fractures (and how to overcome them).
   Pieracci FM, Leasia K, Whitbeck S. · · 2019 · cited 12× · PMID 31205762 · DOI 10.21037/jtd.2018.12.126