A Multicenter, Randomized Controlled Trial of Surgical Stabilization of Rib Fractures in Patients With Severe, Non-flail Fracture Patterns
Phase: NA
Conditions: Rib Fracture Multiple
Sponsor: Denver Health and Hospital Authority

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A Multicenter, Prospective, Controlled Clinical Trial of Surgical Stabilization 
of Rib Fractures in Patients with Severe, Non-flail Fracture Patterns (CWIS 
NON-FLAIL) 
 
 
 
 
 
NCT: 03221595 
 
 
 
 
Study Protocol and Statistical Analysis Plan 
 
 
 
 
Date: 12/14/2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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COMIRB Protocol 
COLORADO MULTIPLE INSTITUTIONAL REVIEW BOARD CAMPUS 
BOX F-490 TELEPHONE: 303-724-1055 Fax: 303-724-0990 
 
Protocol #: 17-1432 (NCT: 03221595) 
Project Title: 
A Multicenter, randomized controlled trial of surgical stabilization of rib fractures in 
patients with severe, non-flail fracture patterns (CWIS NON-FLAIL) 
Principal Investigator: Fredric M. Pieracci MD, MPH, FACS Version 
Date:  12/14/18  
 
I. Hypotheses and Specific Aims:  
  
The objective of this trial is to investigate the efficacy of surgical stabilization of rib fractures (SSRF), as 
compared to non-operative management, for hospitalized patients with non-flail, severe rib fractures. The study 
will be conducted within expert, high volume centers that participate in the Chest Wall Injury Society (CWIS). 
The hypothesis of this trial is that SSRF, as compared to standardized non-operative management, improves 
pulmonary function, risk of complications, quality of life, pain control, and reduces the need for opioid pain 
medication among patients with severe, non-flail chest fracture patterns. 
 
II. Background and Significance:  
 
 
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. 

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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. 
 
III. Preliminary Studies/Progress Report:  
 
 
Our group has previously conducted a similar, single institution, observational study, which included 
mostly patients with flail chest, but also approximately 20% of patients without flail chest [13]. In this study, 
SSRF was beneficial. Other groups have reported favorable outcomes with SSRF in non-flail chest patients, 
although these patients have comprised a small minority of the total patients in the study group [14]. 

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IV. Research Methods 
 
A. Outcome Measure(s): 
 
• 
Primary Outcome:  
1. Chest Wall Specific Quality of Life Questionnaire: Obtained at two week, one month, and two month 
follow up visits (Attachment 1). 
 
• 
Secondary Outcomes: 
 
2. Numeric pain score: Obtained daily while hospitalized, and at two week, one month, and two month 
follow-up 
3. Narcotic use: Obtained daily while hospitalized, and at two week, one month, and two month follow-
up visits and using a standardized equi-analgesic scale (Attachment 2) [18]. 
4. Incentive spirometry: Obtained daily while hospitalized, and at two week, one month, and two month 
follow-up visits (Attachment 3). The best value of three attempts will be used. 
 
5. Pulmonary function testing: Obtained once at 2 week follow-up visit 
 
 
 
B. Description of Population to be Enrolled: 
 
 
Inclusion Criteria: 
 
 
In an effort to identify non-flail rib fracture patients for whom there is relative equipoise for SSRF vs. non-
operative management, the CWIS conducted a survey of surgeons who perform SSRF regularly [19]. The 
survey presented a series of hypothetical trauma patients with non-flail chest, severe rib fractures. Patient age, 
degree of traumatic brain injury, and number of deranged pulmonary physiologic variables at the time of 
consideration for surgery were varied, and respondents were asked if they would recommend SSRF. The 
degree of consensus which most closely approximately true equipoise was 44.8%; this hypothetical scenario 
involved a patient with  

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≥ 3  fractures with at least 50% displacement, aged 18 – 80 years, and with either no or mild traumatic  brain 
injury (TBI). This hypothetical patient served as the basis for our 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 (Attachment 3) 
 
c. Numeric pain score > 5 
 
d. 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 (Intra-cranial hemorrhage visualized on CT head with GCS at 
the time of consideration for enrollment < 12) 
4. Intubation 
 
5. Severe pulmonary contusion, defined as Blunt Pulmonary Contusion 18 (BPC18) score > 12 [20]. 
6. Prior or expected emergency exploratory laparotomy during this admission. 
 
7. Prior or expected emergency thoracotomy during this admission. 

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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, preparing meals). 
12. Pregnancy. 
 
13. Incarceration. 
 
 
C. Study Design and Research Methods 
 
Study type:  
Multicenter, randomized, non-blinded, clinical trial, with reserved option to collect data prospectively on 
subjects who decline randomization. 
 
 
Study Arms: 
 
1. Standardized best medical management of rib fractures 
 
2. Standardized best medical management of rib fractures plus surgery (SSRF) 
 
Recruitment  
 
 
Historically, about 50% of patients choose not to be randomized in trials that assign patients to either 
surgery or not [21]. This is due to many reasons; but one important one is the hesitancy to be randomized to 
an operation or not. This concern is of course understandable, and our plan for this trial is to prepare for this 
degree of declination and have a plan in place to still use these patients’ de-identified information for research 
(if they consent to it) to better understand of the optimal treatment of patients with severe rib fractures. We also 
want to maximize the likelihood that the study will be completed in a timely fashion in the ethical interest of the 
subjects.  
We believe that it is methodologically appropriate to collect patients’ information who do not wish to be 

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randomized given the following conditions, all of which we have been carefully incorporated into the study 
design: 
1. Subjects will first be asked if they are interested in hearing about a research study related to the treatment 
of their rib fractures prior to discussing randomization. If they decline, the discussion of enrollment will 
end there,Those receptive to participation will be informed up-front of randomization and the possibility of 
observation status should they decline randomization. In addition to discussion by study personal, a 
video will be displayed to clarify the study intervention and mission [attachment 6]. This video will be 
shown to all patients who are approached for consent. It begins by outlining the option for randomization in the 
trial. It next describes the option for observation should randomization not be desired. This video will be 
supplemented by our research personnel, who will reinforce the study design, and then ask the patient to 
verbalize the information back. This is intended to minimize the risk of coercion.  
2. Patients are approached for consent only after meeting 16 inclusion/exclusion criteria, which have been 
carefully specified in the protocol. This process will, by design, create a very similar group of patients with 
similar injury patterns and physiology, regardless of their decision to be randomized or not. In a recent 
trial, we found no significant clinical differences between patients who agreed to and declined 
randomization to a pain medication for rib fractures in our SICU (the same patient population as for the 
current trial) [22] Finally, any clinically relevant differences that may occur between patients who elect 
randomization vs. those who do not will be identified and controlled for in regression analyses.  
3. In order to minimize confounding (specifically, selection bias), patients in the observation arm will first be 
analyzed separately from those who are randomized, looking for significant differences in clinically 
relevant variables. Furthermore, when and if patients are ultimately grouped together for analysis (for 
example, randomized operative and observational operative), the randomized variable will be reported 
and controlled for using regression analysis. In the data analysis phase, four groups of patients will be 
reported: 1) those randomized to surgery, 2) those randomized to no surgery, 3) those observed who 
elect surgery and 4) those observed who elect no surgery 
 
 
 

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Participating Centers: 
 Recently, the CWIS was formed as an international group of expert chest wall surgeons 
(www.cwisociety.org). The CWIS membership is comprised of experienced, high volume SSRF surgeons with 
established successful protocols, pathways, and outcomes of patients with severe rib fractures. This group is 
also academic, published, and driven to conduct high quality research to refine the indications for SSRF. 
Participating centers were identified through the CWIS research committee based upon these criteria. 
 
 
Standardization of management protocols 
Both groups (SSRF and medical management) will receive identical non-operative management, 
including standardized analgesic and pulmonary toilet protocol. 
Standardized analgesia will include 1) standing acetaminophen 650 mg PO Q6h; 2) standing ibuprofen 
600 mg PO q6H; 3) standing gabapentin 300 mg PO tid 4) one of the following locoregional modalities a) thoracic 
epidural catheter; 2) pain catheter (i.e., on-Q pump); c) liposomal bupivacaine rib blocks. Beyond these 
medications, narcotics will be administered as needed and abstracted as an outcome variable. Additional 
modalities (e.g., IV ketamine) will be discouraged but abstracted when used. All of these are medications that are 
dictated by our clinical protocol for all patients with rib fractures. None of these medications will be used for 
research purposes only i.e. all rib fracture patients will receive all of these medications whether they are in the trial 
or not because they are clinically indicated. Standardized pulmonary toilet will include hourly incentive spirometry 
and cough assist q4 hours. 
For the SSRF group, the surgery will be standardized as follows: 1) flexible bronchoscopy on all 
patients; 2) muscle sparing incision whenever possible; 3) repair of all displaced fractures of ribs 3-8; 4) 
pleural irrigation with 500 mL sterile saline; 5) pleural drainage with either straight chest tube or silastic drain 
(18F – 24F); 6) loco-regional anesthesia using one of the above modalities. 
 
Randomization:  
Randomization will be accomplished at the lead study center (Denver, CO) using a standard function in 
Microsoft Excel that randomly chooses either the number 0 or 1. Each center will receive their own 
randomization log, such that approximately 50% of subjects from each center are randomized to surgery. 

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Of note, we anticipate a relatively high rate of declining randomization (approximately 50%). As such, 
we have incorporated a secondary, observational option for patients who decline randomization. In this arm, the 
decision to perform SSRF will be clinical, and left to the patient and their treatment team. Whatever that 
decision is, patients will be asked if they agree to prospective data collection, including the same endpoints as 
those randomized. 
 
Sample size calculation, trial feasibility, and projection duration: 
 
 
Sample size calculations for the primary and secondary outcome variables are shown below. The 
largest N total of 74 was selected and rounded up to 100 to maximize the likelihood of obtaining a significant 
difference. The mean annual number of SSRF performed per study center on patients who meet study criteria 
is 18. Assuming a 40% study decline rate, this would involve each center enrolling 11 patients over a one year 
time (lead site can enroll up to study total of 100 in the event the other centers have low enrollment numbers.) 
The 
study 
is 
thus 
feasible 
and 
powered 
to 
achieve 
target 
sample 
size 
in 
one 
year
Outcome variable 
Mean (SD) non- 
op 
Mean (SD) 
op 
Alpha 
Beta N / group 
N total 
Numeric pain score 
3 (3) 
5 (3) 
0.05 
0.80 
37 
74 
Incentive spirometry 
(mL) 
650 (300) 
850 (300) 
0.05 
0.80 
24 
48 
FEV1 % pred (PFTs) 
67% (20%) 
85% (20%) 
0.05 
0.80 
16 
42 
Overall QOL 
6 (2) 
8 (2) 
0.05 
0.80 
17 
34 

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Study Conduct: 
 
The study will be conducted and reported in accordance with the recommendations of the Consolidated 
Standards of Reporting Trials Statement [23] and registered with the U.S. National Institutes of Health 
(clinicaltrials.gov). The study will be approved by the Colorado Multiple Institution Review Board (COMIRB) and 
each sub site’s IRB. An independent data safety monitoring committee, comprised of 3 members that are all not 
involved with the trial (and where the majority of the 3 will be unaffiliated with the Chest Wall Injury Society)will 
submit written reports to COMIRB and the study sponsor after the first 50 patients have been enrolled, followed 
by increments of 50 enrollments, thereafter. Adverse events will be recorded and reported to both the data 
safety monitor and COMIRB. No interim analysis is planned. 
Each satellite site will contact the lead site PI or RC to obtain approval to proceed with consenting each 
subject, based on a review of the patient’s injury mechanism, fracture pattern, and inclusion/exclusion criteria. 
 
 
 
D. Description, Risks and Justification of Procedures and Data Collection Tools: 
 
 
Surgical stabilization of rib fractures:  
This is an approximately two hour operation that occurs under general anesthesia. Fractures of ribs 3-10 
are repaired using thin, titanium plates through small incisions that minimize muscle division. These plates are 
the width of a typical rib and vary in length (Attachment 4). These plates are applied directly to the bone, across 
the fractures, typically on the outside of the rib Once the fractures are reduced, the plates are permanently fixed 
in place with screws, allowing the fractured pieces of rib to realign. 
There are several different companies that make and supply these plates and there may be a few 
different options available in a single hospital, depending on what the business contracts are with the suppliers 
for their hospital and what is in stock on the day of the operation. The device and the procedure in which to use 
them are all essentially the same across all brands. All are made out of titanium, all are about the width of a pen 
and vary in length depending on the extent of the patient’s fracture pattern, and all are permanently fixed on 
place with screws. Below are two different companies that at used at Denver Health and Hospital.

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                                             DePuy Synthes                                                              KLS Martin  
 
This trial does not dictate the use of a specific hardware system for the operation. There are currently four 
companies that offer FDA-approved rib fixation systems: DePuy Synthes, KLS Martin, Zimmer Biomet, and 
Acute Innovations. This is not an investigation of the superiority/inferiority of any particular hardware system, but 
rather an investigation of what is the best management of severe non-flail rib fractures: operative or non-
operative. Choice of system is left to the discretion of the operating surgeon, as no data exist documenting the 
superiority of one system over the other. We specifically have not mandated the use of the study sponsor’s 
system in order to create as much distance as possible between the influence of the study sponsor and the 
research team. In a pre-initiation site survey, all four fixation systems were used among participating centers. 
Three of the four systems are used at Denver Health Medical Center, depending on availability and surgeon 
preference. Finally, use of any of the hardware systems will be for an FDA approved indication and patient 
population, so we do not believe that an IND is required. 
During the surgery, any blood that has accumulated in the pleural space will also be irrigated and 
suctioned out. Loco-regional pain control will also be administered as either rib blocks or an indwelling pain 
catheter. Finally, bronchoscopy will be performed to suction out any mucous which may have accumulated in the 
lungs as a result of not taking deep breaths. Risks of surgery include post-operative pain, bleeding, infection, 
and movement of the plates. Bleeding, infection, and movement of the plates are each very rare, and occur in 
less than 1% of patients who undergo the procedure. The surgeons at Denver Health have performed 
approximately 120 operations to treat rib fractures with plates. 

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Pulmonary function tests:  
The subject will be asked to breath into a straw-like tube and values are recorded. This is non-invasive 
and painless. Some shortness of breath after the test is completed may occur and resolves after a few 
seconds. The testing is administered by certified respiratory therapists at Denver Health. 
 
Justification of procedures: 
 SSRF is an established surgery for the treatment of severe rib fractures, and is recognized as such in 
expert consensus statements [3]. There exists equipoise regarding the benefit of SSRF in the specific study 
population targeted for this trial [19] 
 
 
E. Potential Scientific Problems: 
 
The main anticipated problem is a relatively high rate of declining randomization to operative vs. non-
operative arms. We anticipate that approximately 50% of eligible patients approached will de- cline 
randomization. In anticipation of this, we have added an observation arm to the study; patients who decline 
randomization will be asked permission to collect their data throughout the same two month follow up period. In 
this case, treatment assignment to operative vs. non-operative is at the discretion of the patient and their 
treatment team. 
Additional problems include coordination of a multiple site study- the investigators have budgeted into 
the grant a 1.0 FTE research coordinator whose sole responsibility will be this study. 
Finally, standardization of management protocols, specifically both operative and non-operative. 
Standardized protocols will be distributed and monitored for adherence. Furthermore, a site initiation 
questionnaire has been drafted and will be completed by all centers interested in participation. Centers will be 
selected based on homogeneity in responses. 
 
A. 
Data Analysis Plan: A standardized data collection tool will be used (Firefly Labs LLC). A sample 
data collection tool is attached (Attachment 5). All statistical analysis will be conducted using SAS version 9.4 
(SAS Inc., Carey, NC). Statistical significance will be defined as p <0.05.  The distribution of continuous variables 

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will be accessed for normality using the Kolmogorov- Smirnov test. Normally distributed continuous variables will 
be compared using the student’s t-test. Non-normally distributed variables will be compared using the Wilcoxon 
Rank test. Categorical variables will be compared using the chi-squared test, unless expected cell counts were < 
10, in which case Fischer’s exact test was used. 
Patients from both the randomized and observational cohorts will be grouped together in one analysis, 
and separately in a sub group analysis. The randomized and observed groups will be compared with respect to 
demographics, injury patterns, and rib fracture severity to unmask any potential biases. 
 
B. 
Summarize Knowledge to be Gained: SSRF is being performed increasingly outside of the 
indication of flail chest. Although there may be benefit to SSRF in patients without flail chest, there exists 
equipoise in this specific patient population as recognized by surveyed members of CWIS. We believe that it is 
imperative to establish evidence to support this operation in this patient population

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F. References: 
 
 
 
1. 
Fabricant L, Ham B, Mullins R, Mayberry J: Prolonged pain and disability are common after rib 
fractures. American journal of surgery 2013, 205(5):511-515; discusssion 
515-516. 
2. 
Mayberry JC, Kroeker AD, Ham LB, Mullins RJ, Trunkey DD: Long-term morbidity, pain, and 
disability after repair of severe chest wall injuries. The American surgeon 2009, 75(5):389-394. 
3. 
Pieracci FM, Majercik S, Ali-Osman F, Ang D, Doben A, Edwards JG, French B, Gasparri M, 
Marasco S, Minshall C et al: Consensus statement: Surgical stabilization of rib fractures rib 
fracture colloquium clinical practice guidelines. Injury 2017, 48(2): 
307-321. 
4. 
Pieracci FM, Rodil M, Stovall RT, Johnson JL, Biffl WL, Mauffrey C, Moore EE, Jurkovich GJ: 
Surgical stabilization of severe rib fractures. The journal of trauma and acute care surgery 2015, 
78(4):883-887. 
5. 
Pieracci FM, Johnson JL, Stoval RT, Jurkovich GJ: Completely Thoracoscopic, Intrapleural 
Reduction and Fixation of Severe Rib Fractures. Trauma Case Reports 2015. 
6. 
Doben AR, Eriksson EA, Denlinger CE, Leon SM, Couillard DJ, Fakhry SM, Minshall CT: Surgical 
rib fixation for flail chest deformity improves liberation from mechanical ventilation. Journal of 
critical care 2014, 29(1):139-143. 
7. 
Tanaka H, Yukioka T, Yamaguti Y, Shimizu S, Goto H, Matsuda H, Shimazaki S: Surgical stabilization 
of internal pneumatic stabilization? A prospective randomized study of management of severe 
flail chest patients. The Journal of trauma 2002, 52(4):727-732; discussion 732. 
8. 
Marasco SF, Davies AR, Cooper J, Varma D, Bennett V, Nevill R, Lee G, Bailey M, Fitzger- ald M: 
Prospective randomized controlled trial of operative rib fixation in traumatic flail chest. Journal 
of the American College of Surgeons 2013, 216(5):924-932. 
9. 
Granetzny A, Abd El-Aal M, Emam E, Shalaby A, Boseila A: Surgical versus conservative 
treatment of flail chest. Evaluation of the pulmonary status. Interactive cardiovas- cular and 
thoracic surgery 2005, 4(6):583-587. 
10. 
Leinicke JA, Elmore L, Freeman BD, Colditz GA: Operative management of rib fractures in the 
setting of flail chest: a systematic review and meta-analysis. Annals of surgery 2013, 258(6):914-
921. 
11. 
Slobogean GP, MacPherson CA, Sun T, Pelletier ME, Hameed SM: Surgical fixation vs nonoperative 
management of flail chest: a meta-analysis. Journal of the American Col- lege of Surgeons 2013, 
216(2):302-311 e301. 
12. 
Coughlin TA, Ng JW, Rollins KE, Forward DP, Ollivere BJ: Management of rib fractures in 
traumatic flail chest: a meta-analysis of randomised controlled trials. The bone & joint journal 
2016, 98-B(8):1119-1125. 
13. 
Pieracci FM, Lin Y, Rodil M, Synder M, Herbert B, Tran DK, Stoval RT, Johnson JL, Biffl WL, Barnett 
CC et al: A prospective, controlled clinical evaluation of surgical stabilization of severe rib 
fractures. The journal of trauma and acute care surgery 2016, 80(2):187-194. 
14. 
Majercik S, Cannon Q, Granger SR, VanBoerum DH, White TW: Long-term patient outcomes after 
surgical stabilization of rib fractures. American journal of surgery 2014, 208(1):88-92. 
15. 
Kasotakis G, Hasenboehler EA, Streib EW, Patel N, Patel MB, Alarcon L, Bosarge PL, Love J, 
Haut ER, Como JJ: Operative fixation of rib fractures after blunt trauma: A practice 
management guideline from the Eastern Association for the Surgery of Trauma. The journal 
of trauma and acute care surgery 2017, 82(3):618-626. 
16. 
Marasco S, Liew S, Edwards E, Varma D, Summerhayes R: Analysis of bone healing in flail chest 
injury: Do we need to fix both fractures per rib? The journal of trauma and acute care surgery 
2014, 77(3):452-458. 

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17. 
Kane ED, Jeremitsky E, Pieracci FM, Majercik S, Smith SR, Doben AR: Surgical Stabilization of 
Rib Fractures: Increasing at an Alarming Rate? Oral Presentation at 47th Annual Meeting of the 
Western Trauma Association, March 5-10, Snowbird, UT 2017. 
18. 
Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe 
AM et al: Clinical practice guidelines for the management of pain, agitation, and delirium in 
adult patients in the intensive care unit. Critical care medicine 2013, 41(1):263-306. 
19. 
Pieracci FM, Agarwal S, Doben A, Shiroff A, Lottenberg L, Whitbeck SA, White TW: Indications for 
Surgical Stabilization of Rib Fractures in Patients Without Flail Chest: Surveyed Opinions of 
Members of the Chest Wall Injury Society. International Orthopedics 2017, In press. 
20. 
Tyburski JG, Collinge JD, Wilson RF, Eachempati SR: Pulmonary contusions: quantifying the 
lesions on chest X-ray films and the factors affecting prognosis. The Journal of trauma 1999, 
46(5):833-838. 
21.         Treweek S, Mitchell E, Pitkethly M, Cook J, Kjeldstrøm M, Johansen M et al. Strategies to improve 
recruitment to randomized controlled trials. Cochrane Database of Systematic Reviews 
2010,Issue 4. Art. No.: MR000013 
22.         Pieracci et al. A randomized controlled trial of the efficacy of Gabapentin versus placebo for 
adjuvant pain control following acute rib fractures. 2017. Prepublication. 
23. 
Moher D, Schulz KF, Altman D: The CONSORT statement: revised recommendations for 
improving the quality of reports of parallel-group randomized trials. Jama 2001, 285(15):1987-
1991. 

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Attachment 1 
 
 
 

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Attachment 2 
 
 
 
 

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Attachment 5

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Attachment 6 

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