Multicenter RCT of SSRF in Non Flail Patients (CWISNONFLAIL)

A Multicenter, Randomized Controlled Trial of Surgical Stabilization of Rib Fractures in Patients With Severe, Non-flail Fracture Patterns

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.

Study Overview

• Status: Completed
• Conditions: Rib Fracture Multiple
• Intervention / Treatment: Device: Operative

Detailed Description

Rib fracture are the most common serious injury following blunt trauma, and occur in approximately 10% of trauma patients [1]. Despite improvements in the care of rib fracture patients, outcomes remain poor and have not changed substantially over the last 15 years [2]. Poor outcomes resulting from serious rib fractures include both acute complications (e.g., pneumonia, prolonged mechanical ventilation, and death) and chronic disability (e.g., pain, dyspnea, and loss of productivity).

Over the last 10 years, surgical stabilization of rib fractures (SSRF) has emerged as a promising technology for the management of patients with severe chest wall injuries [3]. Conceptually, SSRF applies the fundamental orthopedic principles of reduction and fixation to rib fractures, restoring chest wall stability and minimizing pain with respiration, splinting, and secretion accumulation. The advent of muscle-sparring [4] and even minimally-invasive surgical techniques [5], as well as a relatively low complication rate [6], has improved the appeal of this operation.

To date, three randomized clinical trials (RCTs) [7-9] and three meta-analyses of these and other trials [10-12] have limited their scope to patients with flail chest, a specific clinical diagnosis characterized by paradoxical motion of a portion of the chest wall due to fractures of two or more ribs in at least two places. Flail chest represents the most severe form of chest wall injury, with an associated, very high morbidity and mortality. Each of the aforementioned RCTs, as well as multiple prospective, non-randomized investigations [13, 14], have found a benefit to SSRF as compared to best medical management in this patient population. Accordingly, expert consensus statements have recommended this operation in this subset of patients [3, 15].

Based upon the favorable reported efficacy of SSRF in patients with flail chest, many surgeons have broadened indications to patients with severe, non-flail rib fracture patterns, most commonly ≥ 3 severely displaced fractures. Although these injuries differ anatomically from flail chest, many of the same pathophysiologic principles are at work: namely, painful motion at the fracture sites cause respiratory compromise, bony bridging [16], and risk of subsequent non-union, chronic pain, and restrictive lung disease. However, it is not clear if stabilization of these fractures confers the same benefits as in the case of flail chest. This lack of efficacy data has been recognized in recent guidelines, which were unable to recommend SSRF for non-flail fracture patterns pending further data. Furthermore, long term quality of life data for both flail and non-flail fracture patterns managed with SSRF are not available.

The use of SSRF is increasing exponentially. Somewhat alarmingly, nearly one half of the procedures were performed in patients without flail chest [17]. A combination of the favorable results observed for SSRD in flail chest, the increasing prevalence of SSRF for non flail-chest, and the lack of quality evidence to support this operation in this patient population, lead to the design of the current RCT. The objective of this trial is to investigate the efficacy of SSRF, as compared to non-operative management, for hospitalized patients with specific, non-flail, severe rib fractures, and within expert, high volume centers that participate in the Chest Wall Injury Society. The investigators hypothesize that SSRF, as compared to standardized medical management, improves pain control, pulmonary function, risk of complications, and quality of life among patients with severe, non-flail chest fracture patterns.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Hospitalization with ≥ 3 severely displaced (≥ 50% of rib width) acute rib fractures.

2. Two or more of the following pulmonary physiologic derangements (at the time of consideration for enrollment and after best medical therapy).

   1. Respiratory rate > 20 breaths per minute
   2. Incentive spirometry < 50% predicted (appendix D)
   3. Numeric pain score > 5
   4. Poor cough (as documented by respiratory therapist)
3. Surgery anticipated < 72 hours from injury

Exclusion Criteria:

1. Age < 18 years or ≥ 80 years
2. Flail chest: either radiographic or clinical. Radiographic flail chest is defined on CT chest as ≥ 2 ribs each fractured in ≥ 2 places. Clinical flail is defined as visualization of a segment of chest wall with paradoxical motion on physical exam.
3. Moderate or severe traumatic brain injury (GCS at the time of consideration for enrollment < 12)
4. Intubation
5. Severe pulmonary contusion, defined as Blunt Pulmonary Contusion 18 (BPC18) score > 12 [19].
6. Prior or expected emergency exploratory laparotomy during this admission.
7. Prior or expected emergency thoracotomy during this admission.
8. Prior or expected emergency craniotomy during this admission.
9. Spinal cord injury
10. Pelvic fracture that has required, or is expected to require, operative intervention during this admission.
11. The patient was unable to accomplish activities of daily living independently prior to injury (e.g., dressing, bathing, prepearing meals).
12. Pregnancy.
13. Incarceration.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Operative; This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints; Other Names: Surgical stabilization of rib fractures, rib plating
No Intervention: Non-operative; Patients in the non operative arm will undergo best medical management of their displaced rib fractures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Score	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 days 1-7, day of discharge (an average of 1 week) and at 2, 4 and 8 weeks following discharge from hospital.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	Patient length of stay in hospital and/or ICU.	2 months after injury
Daily Narcotic Use	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	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.
Incentive Spirometry	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.	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.
Pulmonary Function Testing	Forced expired volume in 1 second, measured in pulmonary function lab	once, at first follow-up, outpatient, clinic visit, which occurred at 2 weeks post discharge.
Number of Patients With Pneumonia	CDC definition of nosocomial pneumonia	Study participants were followed up to 2 months after index admission date.
Days of Ventilator-dependent Respiratory Failure	Mechanical ventilation for > 24 hours at any time during index hospitalization	Study participants were followed up to 2 months after index admission date.
Chest Wall Specific Quality of Life Questionnaire	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, 4 and 8 weeks after discharge from the index admission

Collaborators and Investigators

• Sponsor: Denver Health and Hospital Authority
• Collaborators: DePuy Synthes
• Investigators: Principal Investigator: Fredric M Pieracci, MD MPH, Denver Health Medical Center

Publications and helpful links

General Publications

• Pieracci FM, Majercik S, Ali-Osman F, Ang D, Doben A, Edwards JG, French B, Gasparri M, Marasco S, Minshall C, Sarani B, Tisol W, VanBoerum DH, White TW. Consensus statement: Surgical stabilization of rib fractures rib fracture colloquium clinical practice guidelines. Injury. 2017 Feb;48(2):307-321. doi: 10.1016/j.injury.2016.11.026. Epub 2016 Nov 27. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): October 22, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: April 9, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries; Multiple Trauma; Fractures, Bone; Rib Fractures; Fractures, Multiple
• Other Study ID Numbers: COMIRB 17-1432

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No