CWIS NON-FLAIL Randomized Controlled Trial

Frequently Asked Questions

Rib fractures 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 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-sparing [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 that 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 [15]. 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 SSRF 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.

 

What is CWIS NON-FLAIL?

A multi-center randomized controlled trial of surgery versus no surgery for severely displaced, non-flail rib fractures.  It is being conducted by the Chest Wall Injury Society.

 

Who is the Principal Investigator?

Fredric M. Pieracci, MD, MPH, FACS

 

Who is the Study Coordinator?

Kiara Leasia, MD

 

Which hospitals are participating as satellite sites?

Click here to see a list and map of all included sites.

 

Who is funding the trial?

The trial is funded by the Chest Wall Injury Society, DePuy Synthes, and the respective satellite sites. 

 

What are the patient 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).
          a. Respiratory rate > 20 breaths per minute
          b. Incentive spirometry < 50% predicted
          c. Numeric pain score > 5
          d. Poor cough (as documented by respiratory therapist)
3. Surgery anticipated < 72 hours from injury

 

How much follow-up will be required of participating patients?

Once the patient is discharged from the hospital, they will return to clinic for follow-up visits as per standard-of-care: 2 weeks, 1 month, and 2 months. During these visits, continued collection of the study variables will occur in addition to a Severe Rib Fracture Quality of Life Survey.
(Please refer to the Variables Checklist and CWIS Non-Flail Data Dictionary for further explanation.)

In addition to their standard-of-care assessments, all study patients will undergo a pulmonary function testing (PFT) at their two week follow-up appointment by pulmonary medicine or respiratory therapy. This appointment for spirometry should be scheduled at the same time they are scheduled for their first follow-up appointment (2 weeks after discharge.)

 

(Participating Surgeons) Am I required to use a certain fixation system for my patients who are randomly selected for surgery ?

No, each satellite site/surgeon is encouraged to use the plating system of their choice.

  

(Participating Surgeons) Am Is there funding available for the satellite sites?

The per-site funding anticipated for the study  includes IRB review fees (should there be any - up to $2,600 per site) and one PFT per patient , which is all the study requires.  The PFT testing will be reimbursed up to $186 per patient (should the test not be standard of care).  Satellite sites will be remunerated on a reimbursement basis.  

All other follow-up should fall under standard of care with the exception of the administration of a one page rib fracture questionnaire at each OP visit that should not require any additional teaching nor personnel.

 

How can I find out more information?

Patients and/or healthcare professionals may contact SarahAnn Whitbeck (CWIS Executive Director) for additional information about qualifications to participate and next steps.  She can be reached via email at sarahann@cwisociety.org.