A Multicenter Randomized Trial on the Early Stabilization of Fracture Ribs (SOFRIB) Darwin Ang, MD PhD MPH FACS Ocala Regional Medical Center
Disclosure • This project is funded by a private industry competitive grant. • Request for Proposal: “A Multicenter Prospective Randomized Trial on the Intervention of Rib Fixation (within 2-5 Days) for Clinically Severe Fractures from Trauma” 2
Objective To create a multicenter randomized study investigating the differences in clinical outcomes between patients who receive rib fixation and those who receive modern critical care and pain control after sustaining clinically significant rib fractures from trauma.
Stabilization of Fractured Ribs (SOFRIB) Consortium • PI and site PIs • Site coordinators – Blake, Bayonet Point, Ocala, Lawnwood, Kendall, Grand Strand (South Carolina), Research (Kansas), Osceola Medical Center, – Research Coordinator, Donna Nayduch • Study Administrators, Sarah Cannon Research Institute (SCRI), Erika Frazier (Director, Health Economics & Outcomes Research Group) • Biostatistician and Epidemiologist, Dr. Jonathan Sugimoto, (University of Washington) • Database Coordinator, Annette O’Dell (USF) • Data Analyst and Statistical Support, Huazhi Liu (HCA) 4
Study Aims • Primary • Aim 1: To determine if patients who have clinically significant rib fractures will have shorter lengths of ICU stays between those who receive non-operative management and those who undergo rib fixation. • Hypothesis: Patients who receive rib fixation will have significantly lower ICU lengths of stay.
Secondary Study Aims • Aim 2: To evaluate the quality of life and individual health assessments of patients who underwent rib fixation versus those who received non-operative treatment • Hypothesis: Patients who receive the SF-36 and PIQ-6 surveys will report significantly better outcomes among those who received rib fixation compared to those who were managed non- operatively.
Secondary Study Aims • Aim 3: To compare rates of hospital acquired complication rates (see definition) between those where received rib fixation to those who received non-operative management • Hypothesis: Patients who had rib fixation will have significantly lower complication rates (see definition) compared to those who were managed non-operatively
Secondary Study Aims – Ventilator days, ventilator free days, time to wean from ventilator – Pain control documented by the Functional Pain Scale: admission, postop, and at time of discharge – Narcotic usage converted to units of morphine – Mortality rates – Hospital length of stay – Complications and their rates • Pneumonia: 480-486 , Urinary Tract Infection: 599.0, 771.82, Arrhythmias: 427.9, 427.41, Sepsis: 995.91, 771.81, 995.92, Reintubation: 9604 (procedure code), Wound Infection: 998.51, 998.59, Cardiac arrest: 427.5, 779.85, 668.1, 668.10, 668.11, 668.12, 668.13, 668.14, Deep venous thrombus: 453.4x, 453.8, Coagulopathy: 286.6, 286.9, Pulmonary embolus: 415.1x – Tracheostomy rates – Charges and costs – Pulmonary Function: Forced Vital Capacity (FVC), FEV1 • Measured at discharge, 3 months, and 6 months – Return to work • 6 month follow up
Inclusion Criteria (3 or more ribs) • ≥3 ribs (any type) with worsening oxygenation (↑O2 support) or worsening ventilation (↑RR >25 bpm or failure to wean from vent) • Flail chest defined as 3 or more consecutive ribs fractured in more than one place • Pain and disability of a FPS (Functional Pain Scale) rating of 3 or higher • Any rib with Deformity and Defect (intrapleural deformity) • 3 or more rib fractures with rib displacement of more than 1 rib cortical diameter
Functional Pain Scale Rating Description 0 No pain 1 Tolerable (and does not prevent any activities) 2 Tolerable (but does prevent some activities) 3 Intolerable (but can use telephone, watch TV, or read) 4 Intolerable (but cannot use telephone, watch TV, or read) 5 Intolerable (and unable to verbally communicate because of pain) Source: Gloth FM III, Scheve AA, Stober CV, Chow S, Prosser J. The Functional Pain Scale: reliability, validity, and responsiveness in an elderly population. J Am Med Dir Assoc . 2001;2(3):110- 114. 10
Exclusion Criteria • Active bacteremia • Active shock (distributive, cardiogenic, obstructive, or hypovolemic) • Severe Traumatic Brain Injury with GCS < 8 • Age 17 years or less or age greater than 90 years old • Chronic pulmonary disease requiring home oxygenation • Acute Respiratory Distress Syndrome (ARDS) • Penetrating chest trauma (because cannot randomize to non-operative arm) • Chronic Opioid dependence or use • Fractures less than 3 cm from the vertebral spine 11
Randomization Figure 1: CONSORT Randomized control trial flow diagram Assess for eligibility Excluded Stratified by injury Randomize severity and research site Non-operative Rib Plating Allocation Lost to follow up Lost to follow up Follow up Analyzed N Analyzed N Analysis 12
Two Study Arms • Operative • Indication: Patients who meet inclusion criteria and none of the exclusion criteria for this study. • Timing: should be performed after resuscitation and within 2-5 days of the injury • Diagnosis: All patient injuries will be diagnosed by CT scan. A 3- dimensional image of the bony elements of the thorax is preferred. • Technique – Surgical Approach: – contoured rib implants – Ribs 2-10 • Nonoperative: • A standard clinical pathway will be used to control pain based on evidence based measures, especially for rib fractures. 13
Non-Operative Management Randomized to nonoperative PCA IV Narcotics titrated by pain scale YES Contraindication to NSAID? No YES Adequate Pain PO Pain Meds Start NSAID Control? No Epidural or Paravertebral
ICU Admission and Discharge Criteria • ICU ADMIT CRITERIA (all pts) – Age > 64 WITH > 4 rib fractures (isolated rib injury) – 3 or more rib fractures requiring positive pressure ventilation to maintain Sats >90% or RR <30 – Solid organ injury – Trauma brain injury • ICU DISCHARGE CRITERIA (pulmonary criteria) – On or Transitioned to nasal cannula – SpO 2 > 92% – RR < 30 – Stable solid organ injury or TBI 15
Posterolateral Thoracotomy DJ12702A
Plating Technique – Open Approach* Confirm Rib Thickness (optional) Drill Position Plate *The above steps are only an overview of the complete surgical technique required for the MatrixRIB Fixation System. Prior to performing any surgical procedure with the MatrixRIB Fixation System, please ensure to fully review the MatrixRIB technique guide and package insert, which includes full Instructions for Use, Indications, Contraindications, Warnings, and Precautions. 17 DSUS/CMF/0315/0331
Power Analysis Categorical Outcomes Power Pneumonia Mortality* for Reintubation** Complication rates flail chest only 0.8 862 346 544 160 0.9 1128 446 724 206 Power Continuous Outcomes ICU days*** Ventilator days Hospital days SF-36 0.8 236 128 380 504 0.9 316 172 508 674 18
Data from USF/HCA Trauma Centers AHCA data used for this study Lawnwood (January 1, 2010) 2010 Q1 to 2013 Q1 Kendall (Nov. 19, 2011) 2012 Q1 to 2013 Q1 Blake (Nov. 19, 2011) 2012 Q1 to 2013 Q1 Bayonet (Nov. 19, 2011) 2012 Q1 to 2013 Q1 Orange Park (Nov. 19, 2011) 2012 Q1 to 2013 Q1 Ocala (Dec. 8, 2012) 2013 Q1
Non Rib Rib Fracture Rib Fracture Flail HCA Data Fractures (>=3) (<3) N=26 N=11,923 N=921 N=611 Age 18~54 46.1% 43.3% 47.5% 46.2% 55~64 12.7% 19.5% 16.2% 23.1% 65-74 12.6% 14.3% 14.4% 19.2% 75-84 15.8% 13.9% 11.8% 7.7% >84 12.8% 8.9% 10.2% 3.9% Gender Male 56.4% 65.6% 63.8% 69.2% Female 43.6% 34.4% 36.2% 30.8% Injury Mechanism Blunt 95.2% 99.2% 97.7% 100% Penetrating 2.8% 0.3% 1.8% 0% Burn 2.1% 0.4% 0.5% 0% Tracheostomy Yes 1.8% 7.4% 4.1% 34.6% No 98.2% 92.6% 95.9% 65.4% ICISS <0.5 2.3% 9.8% 5.2% 46.2% 0.5~0.6 0.8% 5.1% 3.0% 19.2% 0.6~0.7 1.5% 13.1% 7.4% 15.4% 0.7~0.8 4.4% 26.8% 15.6% 11.5% 0.8~0.9 19.4% 29.6% 34.9% 7.7% >0.9 71.6% 15.5% 34.0% 0%
Rib fracture outcomes in the USF/HCA Trauma Network Mortality OR OR* Rib Fracture (>=3) 3.8% 2.29 (1.74, 3.01) 2.31 (1.75, 3.06) Rib Fracture (<3) 3.9% 1.27 (0.84, 1.94) 1.27 (0.83, 1.94) Flail Chest 11.5% 4.06 (1.22, 13.59) 4.34 (1.28, 14.65) Non Rib Fracture 3.1% LOS Total Charges Rib Fracture (>=3) 9.5 (±12.8) 187,906 (±227,654) Rib Fracture (<3) 7.0 (±8.9) 145,423 (±174,896) Flail Chest 22.8 (±29.5) 476,543 (±561,522) Non Rib Fracture 5.5 (±8.8) 104,643 (±147,098) * Adjusted by age, gender, race, injury mechanism, ICISS
Prevalence of Complications HCA Trauma Centers Complication No Rib Rib Rib Flail Fractures Fracture Fracture (>=3) (<3) Pneumonia 3.9% 10.3% 7.0% 19.2% Urinary tract infection 8.1% 7.5% 7.2% 19.2% Arrhythmias 0.5% 0.8% 0.5% 0% Sepsis 2.4% 3.4% 2.0% 7.7% Reintubation 6.2% 16.1% 12.3% 38.5% Wound infection 0.5% 0.7% 0.8% 7.7% Cardiac arrest 0.9% 3.5% 2.3% 3.9% Deep venous thrombus 0.7% 0.8% 0.5% 3.9% Coagulopathy 0.5% 0.3% 1.2% 3.9% Pulmonary embolus 0.6% 0.8% 1.0% 3.9% >=3 of the 10 complications 0.4% 1.0% 0.8% 0% Overall Pts with at least 1 18.0% 27.1% 23.7% 61.5% Complication
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