SURGICAL STABILIZATION OF RIB FRACTURES

SURGICAL STABILIZATIONOF RIB FRACTURES

DSUS/CMF/0415/0359 1

April 2015

• Background• Clinical Challenges• Evolution of Treatment• Evidence for Surgical Rib Fixation• Guidelines• MatrixRIB™ Fixation System

Index

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• Rib fractures occur in approximately 10% of patients admitted to a trauma center and are a marker for severe injury1

• Rib fractures can lead to defects in the chest wall and significant pain which may hinder breathing. These patients have an increased risk of developing:2,3

− chest infection− impaired pulmonary function− sepsis− atelectasis− respiratory failure and other

pulmonary pathologies− prolonged hospitalizations

Rib Fractures are Associated with Signficant Mortality & Morbidity

1 Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma 1994;37(6):975-979.2 Pressley CM, et al. Am J Surg. 2012;204(6):910-3; discussion 913-4.3 Shackford SR. Journal of Intensive Care Medicine [Internet]. 1986; (3):125–36.

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Courtesy of Mario Gasparri, MD

• As the number of fractured ribs increases, a patient’s risk for undesired outcomes is increased1,2,3

• Elderly patients who sustain blunt chest trauma with rib fractures have twice the mortality and thoracic morbidity of younger patients with similar injuries 4

• Contribution of rib fractures to prolonged disability is greater than traditionally expected:5− Prevalence of chronic pain of 22 % and disability of 53% among patients

with rib fractures at 6 months6


1 Brasel KJ, et al. Crit Care Med 2006;34:1642–6.2 Flagel BT,et al. Surgery 2005;138:717–23.3 Tanaka H et al. The Journal of trauma. 2002;52(4):727–732.4 Bulger E,, et al. The Journal of Trauma, Injury, Infection, and Critical Care 2000;48(6):1040-10475 Fabricant L,, et al. Am J Surg. 2013;205(5):511-5.6 Gordy S, et al. Am J Surg. 2014;207(5):659-62; discussion 662-3.

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• Patients with multiple rib fractures or a flail chest (unilateral fractures of at least 3 consecutive ribs, each with 2 or more fractures):1− flail chest occurs in 5-13% of patients with chest wall trauma2

− frequently require mechanical ventilation3

− mortality rate of up to 33%4,5

• In the US, patients with flail chest are in the hospital an average of 11 days, predominantly in the intensive care setting6

• More than 30% of patients require additional care in post acute settings6

• Indirect societal costs result from inability to work or reduced workplace productivity.


1 Schmit-Neuerburg KP, et al. Injury 1982;14:26–34.2 LoCicero J, et al. Surgical Clinics of North America. 1989;69(1): 15-19. 3 Simon B, et al. J Trauma Acute Care Surg. 2012 Nov;73(5 Suppl 4):S351-614 Ciraulo DL, et al. J Am Coll Surg. 1994;178(5): 466-470.5 Dehghan N, et al. J Trauma Acute Care Surg. 2014;76: 462-468.6 Healthcare Cost and Utilization Project. 2012. Hospital discharges with International Classification of Diseases, Clinical Modification, 9th Revision (ICD-9-CM) for flail chest (807.4) as a primary diagnosis.

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Evolution of Treatment

• The treatment of multiple rib fractures, particularly with a flail component, has changed considerably over the past half-century

• This evolution has paralleled our understanding and appreciation of the injury

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Early treatment consisted of external tractionusing weights and towel clips/wires to reduce flail

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Am J Surg. 1946 Nov;72(5):753-5 Ann Surg. 1951 Jan;133(1):135-8

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Dismal results due to prolonged bedrest andimmobility and local wound problems

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• Internal Pneumatic Stabilization• Internally stabilize chest wall• Ensure adequate ventilation• Allow improved pulmonary hygiene

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MortalityPulmonary

Complications Author

16% Diethelm 1971

22% 76% Relihan 1973

16% 84% Richardson 1975

Results with Internal Pneumatic Stabilization

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• Treatment strategy• judicious resuscitation• selective intubation• adequate analgesia• pulmonary hygiene

Focus shifted to the underlying pulmonary contusion

EAST 2006Management Guideline“Pulmonary Contusion - Flail Chest”

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Courtesy of Mario Gasparri, MD


Long-term morbidity in survivors

62 patients with flail chest

In-hosp mortality = 12.5%

Survivors (F/U = 5 yrs)49% - chest wall pain35% - dyspnea39% - no return to work

Landerscaper et al - 1984

22 patients with flail chest

64% long-term morbiditychronic painchest wall deformitydyspnea

22% - permanent disability

Beal et al - 1985

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• Despite the clinical and economic impact of rib fractures, current treatment primarily consists of little more than supportive treatment including pain control, rest and mechanical ventilation1,2,3

• The mortality and short term morbidity have not improved appreciably during the last four decades3,4

• Availability of rib fixation technology presents a potential option toward an effective approach to managing rib fracture

Unmet Clinical Need

1 Bhatnagar A et al. J Am Coll Surg. 2012;215(2):201-5.2 Nirula R et al. Am Surg 2006; 72:307–9.3 Simon B, et al. J Trauma Acute Care Surg. 2012 Nov;73(5 Suppl 4):S351-614 Allen GS and Coates NE. The American Surgeon 1996;62: 895-900. .

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Evidence for Surgical Rib Fixation

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• Slobogean et al. conducted a systematic review of previously published comparative studies using operative and nonoperative management of flail chest1

− total of 11 manuscripts with 753 patients were included1

• Leinecke et al., through an NIH-supported study, conducted a systematic review of previously published comparative studies using operative and nonoperative management of flail chest2

− however, 3% of patients in the operative arm and 7% in the nonoperative arm were non-flail chest2,3

− total of 9 studies with 538 patients met the inclusion criteria2

• The meta-analyses showed significant benefit of surgical fixation in terms of mortality, pneumonia, ventilator days, ICU days, tracheostomy, and septicemia1,2

Results from Two Meta-Analyses Show Benefits with Surgical Fixation

1 Slobogean GP et al. J Am Coll Surg. 2013;216(2):302-11.2 Leinicke JA et al. Ann Surg. 2013;258(6):914-21.3 de Moya M et al. J Trauma. 2011;71:1750–4.

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Operative Management is Associated with Statistically Significant Reduction in Mortality, Pneumonia, Tracheostomy, and Septicemia Compared to Non-Operative Management in Flail Chest1,2

1 Leinicke JA et al. Ann Surg. 2013;258(6):914-21.2 Slobogean GP et al. J Am Coll Surg. 2013;216(2):302-11.

57% Lower Odds of Mortality

55% Lower Odds of Pneumonia

75% Lower Odds of Tracheostomy

64% Lower Odds of Septicemia

57% Lower Risk of Mortality

55% Lower Risk of Pneumonia

75% Lower Risk of Tracheostomy

Leinecke et al.

Surgical Fixation Had*:

Slobogean et al.

Surgical Fixation Had:

Mortality: Pooled RR: 0.43; 95% CI: 0.28-0.69Pneumonia: Pooled RR: 0.45; 95% CI: 0.29-0.67Tracheostomy: Pooled RR: 0.25; 95% CI: 0.13-0.47*Septicemia not assessed

Mortality: OR 0.31; 95% CI: 0.20-0.48Pneumonia: OR 0.18; 95% CI: 0.11-0.32 Tracheostomy: OR 0.12; 95% CI: 0.04-0.32Septicemia: OR 0.36; 95% CI: 0.19-0.71

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Leinecke et al Slobogean et al.

Significantly Fewer Number of Ventilator Days, ICU Days, and Hospital Days with Operative Management Compared to Non-Operative Rib Fixation in Flail Chest1,2

# of

day

s

# of

day

s

Decrease in Ventilator Days with Surgery

Decrease in ICU Days with Surgery

Decrease in Hospital Days with Surgery

Decrease in Ventilator Days with Surgery

Decrease in ICU Days with Surgery

Decrease in Hospital Days with Surgery

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1 Leinicke JA et al. Ann Surg. 2013;258(6):914-21.2 Slobogean GP et al. J Am Coll Surg. 2013;216(2):302-11.

Ventilator Days: 95% CI: -5.54 to -3.50ICU Days: 95% CI: -6.01 to -0.80Hospital Days: 95% CI: -7.12 to -0.54

Ventilator Days: 95% CI: -5.0 to -9.9ICU Days: 95% CI: -1.6 to -7.9Hospital Days: 95% CI: -0.7 to -7.4

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• National Institute for Health and Clinical Excellence (NICE) recommend surgical stabilization of a flail chest based on consistent evidence of its efficacy and lack of major safety concerns1.

• Management of pulmonary contusion and flail chest: An Eastern Association for the Surgery of Trauma (EAST) practice management guideline2

“Surgical fixation may be considered in cases of severe flail chest failing to wean from the ventilatoror when thoracotomy is required for other reasons.”

Guidelines Recommend Surgical Stabilization of Flail Chest

1 National Institute for Health and Clinical Excellence (NICE). Insertion of metal rib reinforcements to stabilize a flail chest wall (IPG361). October 2010. Available at: www.nice.org.uk/guidance/IPG361. Last accessed: June 27, 2014.2 Simon B, et al. J Trauma Acute Care Surg. 2012 Nov;73(5 Suppl 4):S351-61

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General Surgery News – September 2013

• Key endpoint• Returning to quality of life

• Ideal timing of treatment• 48 – 72 hours after admission

• Clinical indications in the acute setting• 3 or more rib fractures with rib displacement of more than 1 rib cortical diameter• Flail Segment• Uncontrolled pain despite adequate analgesia

• Definition of flail chest • 3 or more consecutive ipsilateral, segmental fractured ribs identified radiographically, in which

the outward manifestation is the classic paradoxical motion• Impaired pulmonary mechanics leading to diminished cough, ineffective ventilation and

increased atelectasis• Multiple consecutive rib fractures may be associated with a similar pattern of unstable chest

wall mechanics and impaired function

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• The MatrixRIB™ Fixation System* is comprised of:

− Pre-contoured titanium alloy locking low profile 1.5 mm thick plates with 2.9 mm diameter locking screws

− The plates are pre-contoured to fit the average rib shape, minimizing Intraoperative bending

− Plate stiffness of the MatrixRIB Fixation System is similar to cadaveric osteoporotic rib, allowing for flexibility of the rib cage1

− The pre-contoured plates are long enough to fixate multiple and comminuted/oblique fractures

− Anterior plating technique designed to avoid surgical disruption of intercostal soft tissues, and intramedullary splints allow minimally invasive procedures

− Instruments that enable rib stabilization of sub-scapular fractures

MatrixRIB™ Fixation System

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*Please refer to the MatrixRiB Fixation System technique guide and package insert for complete indications, contraindications, instructions for use, warnings and/or precautions 1Mechanical Test Data on File, Report MT08-481

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Studies Evaluating the MatrixRIB Fixation System

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• Doben et al. conducted a retrospective review of MatrixRIB Fixation System patients (n=10) matched to historical non-operative controls (n=11):− MatrixRIB Fixation System patients had a reduction in total ICU stay (18

days vs. 9 days, p =0.37)

− MatrixRIB Fixation System patients had a significant reduction in total ventilator days compared to the nonsurgical group (4.5 vs. 16.0; p =0.04)

− Patients with surgery were permanently liberated from the ventilator within a median of 1.5 days (0-8 days)

Reduction in Total Ventilator Days with MatrixRIB Fixation System

1 Doben AR et al. J Crit Care. 2014;29(1):139-43.

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84% of Patients Treated with MatrixRIB Fixation System had No Pain at 16 ± 1 Month Post Discharge1

No Pain 84%

Chronic Pain 4%

1 Majercik S, et al. Am J Surg. 2014 Jan 4.

Patients who no longer had pain said their rib pain was completely gone at 5.4 ± 1.1 weeks post discharge

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n=50

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Pulmonary Function 3 and 6 Months After MatrixRIB Fixation System Surgery1

1 Bottlang M, et al. Injury. 2013;44(2):232-8.

Forced Vital Capacity Forced Expiratory Volume (FEV1)

3 month(n=16)

6 month(n=15)

6 month(n=15)

3 month(n=16)

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• Bottlang et al. showed that at six months, 7 of 15 patients that completed the follow-up had returned to work1

• In a 16-month survey, Majercik et al found that of the patients who were employed:2− 33 of 36 (92%) patients returned to work at the same job that they did

preinjury− mean time to get back to full-time work was 7.9 ± 1.0 weeks

Return to Work with MatrixRIB Fixation System

1 Bottlang M, et al. Injury. 2013;44(2):232-8.2 Majercik S, et al. Am J Surg. 2014 Jan 4.

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• Majercik et al. measured satisfaction with MatrixRib Fixation System on a scale of 1 to 10 (with 1 being not satisfied at all, and 10 being very satisfied)1

− patients (n=50) rated their experience with MatrixRIB Fixation System and the results of the procedure as 9.2 ± 0.2.24

− 94% stated that they would recommend the surgery to injured friends/family

• In patients who underwent surgery using the MatrixRIB Fixation System, Billè et al. found:2− median quality of life and general health score (n=6) according to the

QLQ-C30 were 7 (range 6-7)

Patient Satisfaction and Quality of Life with MatrixRIB Fixation System

1 Majercik S, et al. Am J Surg. 2014 Jan 4.2 Billè A, et al Interact Cardiovasc Thorac Surg. 2012;15(4):588-95.

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• Two meta-analyses demonstrated the efficacy of surgical fixation in the treatment of rib fractures and its superiority to medical management (non-operative)1,2

• Surgical stabilization in isolated multiple non-flail and painful rib fractures has shown:3

− improved pain function, respiratory function, quality of life and reduced socio-professional disability

• Studies evaluating the MatrixRIB Fixation System: − patients had a significant reduction in total ventilator days compared to a nonsurgical group4

− most patients regained long-term pulmonary function 3 and 6 months post-surgery5

− patient-centered outcomes, including pain, satisfaction, quality of life, and return to work, were favorable with the MatrixRIB Fixation System in these case series5,6,7,8

Summary

1 Leinicke JA et al. Ann Surg. 2013;258(6):914-21.2 Slobogean GP et al. J Am Coll Surg. 2013;216(2):302-11.3 Girsowicz E et al. Interactive CardioVascular and Thoracic Surgery 2012;14:312-315.4 Doben AR et al. J Crit Care. 2014;29(1):139-43.5 Bottlang M, et al. Injury. 2013;44(2):232-8.6 Majercik S, et al. Am J Surg. 2014 Jan 4.7 Billè A, et al Interact Cardiovasc Thorac Surg. 2012;15(4):588-95.8 DeMoya M, et al. J Trauma. 2011;71:1750–4

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References

•Ahmed Z, Mohyuddin Z. Management of flail chest injury: internal fixation versus endotracheal intubation and ventilation. J Thorac Cardiovasc Surg. 1995;110(6):1676-80.

•Allen GS and Coates NE. Pulmonary contusion: A collective review. The American Surgeon 1996;62: 895-900.

•Althausen PL, Shannon S, Watts C, Thomas K, Bain MA, Coll D, O’mara TJ, Bray TJ. Early surgical stabilization of flail chest with locked plate fixation. J Orthop Trauma. 2011;25(11):641-7.

•Balci AE, Eren S, Cakir O, Eren MN. Open fixation in flail chest: review of 64 patients. Asian Cardiovasc Thorac Ann 2004;12:11e15.

•Bhatnagar A, Mayberry J, Nirula R. Rib fracture fixation for flail chest: what is the benefit? J Am Coll Surg. 012;215(2):201-5.

•Billè A, Okiror L, Karenovics W, Routledge T. Experience with titanium devices for rib fixation and coverage of chest wall defects. Interact Cardiovasc Thorac Surg. 2012;15(4):588-95.

•Billè A, Okiror L, Campbell A, Simons J, Routledge T. Evaluation of long-term results and quality of life in patients who underwent rib fixation with titanium devices after trauma. Gen Thorac Cardiovasc Surg. 2013;61(6):345-9.

•Borrelly J, Aazami MH. New insights into the pathophysiology of flail segment: the implications of anterior serratus muscle in parietal failure. Eur J Cardiothorac Surg. 2005;28(5):742-9.

• Bottlang M, Long WB, Phelan D, Fielder D, Madey SM. Surgical stabilization of flail chest injuries with MatrixRIB implants: aprospective observational study. Injury. 2013;44(2):232-8.

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•Brasel KJ, Guse CE, Layde P, et al. Rib fractures: relationship with pneumonia and mortality. Crit Care Med 2006;34:1642–6.

•Bulger E, Arneson MA, Mock CN, Jurkovich GJ. Rib fractures in the elderly. The Journal of Trauma, Injury, Infection, and Critical Care 2000;48(6):1040-1047.

•Bureau of Labor Statistics (BLS). Consumer Price Index (CPI) - Medical Care, U.S. City Average, Non-Seasonally Adjusted. Accessed April 30, 2014.Available at: http://data.bls.gov/

•Ciraulo, DL, Elliott D, Mitchell KA, Rodriguez A. Flail chest as a market for significant injuries. J Am Coll Surg. 1994;178(5): 466-470.

•Dehghan N, de Mestral C, McKee MD, Schemitsch EH, Nathens A. Flail chest injuries: A review of outcomes and treatment practices from the National Trauma Data Bank. J Truma Acute Care Surg. 2014;76: 462-468.

•de Moya M, Bramos T, Agarwal S, et al. Pain as an indication for rib fixation: a bi-institutional pilot study. J Trauma. 2011;71:1750–4.

•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. J Crit Care. 2014;29(1):139-43.

•Fabricant L, Ham B, Mullins R, Mayberry J. Prolonged pain and disability are common after rib fractures. Am J Surg. 2013;205(5):511-5.

•Flagel BT, Luchette FA, Reed RL, et al. Half-a-dozen ribs: the breakpoint for mortality. Surgery 2005;138:717–23.

References

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•Girsowicz E, Falcoz PE, Santelmo N, Massard G. Does surgical stabilization improve outcomes in patients with isolated multiple distracted and painful non-flail rib fractures? Interactive CardioVascular and Thoracic Surgery 2012;14:312-315.

•Gordy S, Fabricant L, Ham B, Mullins R, Mayberry J. The contribution of rib fractures to chronic pain and disability. Am J Surg.2014;207(5):659-62; discussion 662-3

•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 cardiovascular and thoracic surgery [Internet]. 2005;4(6):583–7.

•Healthcare Cost and Utilization Project (HCUP). 2011. ICD-9-CM principal diagnosis code 486: Pneumonia - Organism Nos.

•Healthcare Cost and Utilization Project. 2012. Hospital discharges with International Classification of Diseases, Clinical Modification, 9th Revision (ICD-9-CM) for flail chest (807.4) as a primary diagnosis.

•Karev DV. Operative management of the flail chest. Wiad Lek. 1997;50 Suppl 1 Pt 2:205-8.

•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.Ann Surg. 2013;258(6):914-21.

•LoCicero J and Mattox KL. Epidemiology of Chest Trauma. Surgical Clinics of North America. 1989;69(1): 15-19.

•Majercik S, Cannon Q, Granger SR, Vanboerum DH, White TW. Long-term patient outcomes after surgical stabilization of rib fractures. Am J Surg. 2014 Jan 4.

References

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•Marasco SF, Davies AR, Cooper J, Varma D, Bennett V, Nevill R, Lee G, Bailey M, Fitzgerald M. Prospective randomized controlled trial of operative rib fixation in traumatic flail chest. J Am Coll Surg. 2013;216(5):924-32.

•National Institute for Health and Clinical Excellence (NICE). Insertion of metal rib reinforcements to stabilise a flail chest wall (IPG361). October 2010. Available at: www.nice.org.uk/guidance/IPG361. Last accessed: June 27, 2014.

•Nirula R, Allen B, Layman R, Falimirski ME, Somberg. Rib fracture stabilization in patients sustaining blunt chest injury. AmSurg 2006; 72:307–9.

•Pressley CM, Fry WR, Philp AS, Berry SD, Smith RS. Predicting outcome of patients with chest wall injury. Am J Surg. 2012;204(6):910-3; discussion 913-4.

•Schmit-Neuerburg KP, Weiss H, Labitzke R. Indication for thoracotomy and chest wall stabilisation. Injury 1982;14:26–34.

•Shackford SR. Analytic Review: Blunt Chest Trauma: The Intensivist’s Perspective. Journal of Intensive Care Medicine [Internet]. 1986; (3):125–36.

•Sharma OP, Oswanski MF, Jolly S, et al. Perils of rib fractures. Am Surg 2008;74:310–314.

•Simon B, Ebert J, Bokhari F, Capella J, Emhoff T, Hayward T 3rd, Rodriguez A, Smith L; Eastern Association for the Surgery of Trauma. Management of pulmonary contusion and flail chest: an Eastern Association for the Surgery of Trauma practice management guideline. J Trauma Acute Care Surg. 2012 Nov;73(5 Suppl 4):S351-61.

•Slobogean GP, MacPherson CA, Sun T, Pelletier ME, Hameed SM. Surgical fixation vs non-operative management of flail chest: a meta-analysis. J Am Coll Surg. 2013;216(2):302-11.

•Mechanical Test Data on File, Report MT08-481

References

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•Solberg BD, Moon CN, Nissim A a, Wilson MT, Margulies DR. Treatment of chest wall implosion injuries without thoracotomy: technique and clinical outcomes. The Journal of trauma. 2009;67(1):8–13

•Tanaka H, Yukioka T, Yamaguti Y, Shimizu S, Goto H, Matsuda H, et al. 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.

•Testerman GM. Adverse outcomes in younger rib fracture patients. South Med J 2006;99:335–9.

• Voggenreiter G, Neudeck F, Aufmkolk M, Obertacke U, Schmit-Neuerburg KP. Operative chest wall stabilization in flail chest—outcomes of patients with or without pulmonary contusion. J Am Coll Surg 1998;187:130–48.

•Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994;37(6):975-979.

•Zilberberg MD, Shorr AF. Prolonged acute mechanical ventilation and hospital bed utilization in 2020 in the United States: implications for budgets, plant and personnel planning. BMC Health Serv Res. 2008;8:242.

References

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SURGICAL STABILIZATION OF RIB FRACTURES

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