Medical Policy

 

Subject: Internal Rib Fixation Systems
Document #: SURG.00120 Publish Date:    11/15/2018
Status: Revised Last Review Date:    11/08/2018

Description/Scope

This document addresses the treatment of rib fracture(s) using an open approach and an internal fixation system. Operative reduction and internal fixation without use of an internal fixation device is not addressed in this document.

Position Statement

Medically Necessary:

The use of an internal rib fixation system is considered medically necessary for the treatment of flail chest resulting in the inability to discontinue mechanical ventilation in the absence of other causes of ventilator dependency such as severe brain injury.

Investigational and Not Medically Necessary:

The use of an internal rib fixation system is considered investigational and not medically necessary for all other indications.

Rationale

Rib fractures are one of the most common injuries of the chest. Ribs usually fracture at the point of impact or where they are the weakest (at the posterior angle). Typically the fifth through ninth ribs are affected. Simple rib fractures can be treated with analgesia and respiratory care (to prevent complications such as pneumonia or atelectasis). Complex rib fractures or multiple rib fractures may require a more aggressive treatment plan. Pain with inspiration and expiration, along with inability to properly inflate and deflate the lungs, may require mechanical ventilation to assist with respiratory effort. With multiple rib fractures, flail chest can occur. This paradoxical movement of the chest wall can alter respiratory effort and may hinder the ability to remove mechanical ventilation.

Surgical stabilization of rib fractures, particularly surgery using an internal fixation system, has been studied. Currently there are a limited number of randomized clinical trials available evaluating the use of surgical fixation vs. non-surgical management for flail chest. Tanaka and colleagues (2002) reported on a randomized controlled trial of the management of individuals with a diagnosis of severe flail chest. There were 37 individuals with flail chest and acute respiratory failure who were randomly assigned to either surgery or internal pneumatic stabilization at 5 days after injury. A total of 18 individuals underwent surgical fixation and 19 individuals had respiratory management positive end expiratory pressure (PEEP) ventilation with spontaneous intermittent mandatory ventilation mode with pressure support ventilation until they reached extubation criteria. In the surgical group, 5/18 individuals had pneumonia, length of mechanical ventilation was 10.8 days, length of intensive care unit (ICU) stay was 16.5 days, 3 individuals required tracheostomy. In the medical group, 17/19 individuals had pneumonia, length of mechanical ventilation was 18.3 days, length of ICU stay was 26.8 days, 15 individuals required tracheostomy. While the study has limitations including a small group size, the benefits are noted with decreased time in the ICU and decreased length of mechanical ventilation.

Another randomized controlled trial was conducted by Granetzny and colleagues (2005). This study involved 40 subjects prospectively assigned to either surgical treatment or standard non-surgical care. The results indicate significantly better results in the surgical intervention vs. the control group in terms of mean days of mechanical ventilation (2 vs. 12, p=0.001), shorter ICU stay (15.6 days vs. 9.6 days, p=0.001), and mean hospital stay (23.00 days vs. 11.7 days, p=0.001). Additionally, at 2 months follow-up, subjects in the surgical group demonstrated significantly better pulmonary function test results, including % forced vital capacity (FVC) (p=0.001), total lung capacity (TLC) (p=0.001), and forced midexpiratory flow rate (FEF) 75 (p=0.001).

In a 2011 retrospective review, Althausen and colleagues reported on 22 participants with flail chest who received open reduction internal fixation compared to 28 matched controls. The surgical group had shorter ICU days when compared to the matched controls (7.59 days vs. 9.68 days), decreased days on the ventilator (4.14 days versus 9.68 days), shorter overall hospital length of stay (11.9 days versus 19 days), fewer tracheostomies (4.55% versus 39.29%), less pneumonia (4.55% versus 25%), and a decreased requirement for oxygen at home (4.55% versus 17.86%). In the surgical group, there were no reported cases of hardware failure, hardware prominence, wound infection or nonunion. While this is a retrospective study with small group sizes, the study demonstrates potential benefits of surgical stabilization of flail chest.

Marasco and others (2013) described a small randomized controlled trial involving 46 subjects with traumatic flail chest. Participants were assigned to receive surgical treatment (n=22) or standard of care with pulmonary support (n=23). While the two groups were not significantly different for most factors, the control group did undergo a higher number of orthopedic and other general surgical procedures. This, difference, however, was not statistically significant (74% vs. 48%; p=0.07). In a multivariate analysis of immediate post-operative outcomes, the control group had a higher rate on non-invasive ventilation (p=0.01), longer ICU stay (p=0.03), and higher rate of tracheostomy (p=0.04). At 3 months follow-up, 2 subjects in the operative group had persistent flail chest symptoms. This study identifies several significant benefits of surgical fixation for flail chest, including shorter ICU and non-invasive ventilation times and a lower tracheostomy rate. However, the small subject pool in this study does not allow wider generalization of these findings.

Bottlang and others (2013) conducted a case series study involving 19 subjects with flail chest. They report that mean duration of mechanical ventilation was 6.4 days (range 0-37 days). Epidural analgesia was used for 15 subjects with a mean duration of 6.6 days (range 2-18 days). The mean duration of ICU stay was 7.9 days (range 1-34 days), and mean duration of hospitalization was 18.4 days (range 4-68 days). Postoperative complications included pneumonia (n=6), atelectasis (n=2), and wound infection (n=1). Three- and 6-month follow-up were obtained from 16 (84.2%) and 15 (78.9%) subjects, respectively. At 3 months, subjects were reported to have a % FVC of 84% and a % forced expiratory volume (FEV1) of 77%. These measures improved to 85% and 79% at 6 months. Return to pre-injury activities was reported for 5 subjects at 3 months and 7 subjects at 6 months. At 6 months, there were no reported hardware failures or migration. Complete healing of treated ribs was noted as well.

In a 2015 retrospective analysis by Zhang and colleagues, 24 individuals received open fixation surgery of the fractured ribs for their flail chest compared to 15 individuals who received conservative treatment only. In the non-surgical group, 2 individuals died, but there was no significant difference in mortality. Those in the surgical group had a hospital stay of 38 days compared to 60 days for the non-surgical group.

Slobogean and colleagues (2013) conducted a meta-analysis of studies comparing surgical fixation vs. non-operative management of flail chest. They identified 11 publications involving 753 subjects, but only 2 randomized controlled trials. They reported that surgical fixation resulted in better outcomes for all pooled analyses, including substantial decreases in ventilator days (mean 8 days, 95% confidence interval [CI], 5 to 10 days) and the odds of developing pneumonia (odds ratio [OR] 0.2, 95% CI, 0.11 to 0.32). Additional benefits included decreased ICU days (mean 5 days, 95% CI, 2 to 8 days), mortality (OR 0.31, 95% CI, 0.20 to 0.48), septicemia (OR 0.36, 95% CI, 0.19 to 0.71), tracheostomy (OR 0.06, 95% CI, 0.02 to 0.20), and chest deformity (OR 0.11, 95% CI, 0.02 to 0.60). All results were stable to basic sensitivity analysis. The authors noted that the results should be viewed in the context of the pooled studies, which were mostly small and retrospective in nature. With small group sizes, the authors note that  additional prospective randomized trials are still necessary.

Another meta-analysis by Leinicke and colleagues (2013) reported on nine studies which compared operative management to non-operative management in adults with flail chest. The outcomes included duration of mechanical ventilation, length of stay in the intensive care unit, length of stay in the hospital, mortality, pneumonia, and tracheostomy. While the studies overall showed reduction in the above mentioned outcomes, the surgical technique used varied among the studies and included the use of metal plates, absorbable plates, intramedullary fixation, Judet struts, and U-plates. Different surgical techniques may vary in terms of their safety and efficacy. Currently there is no standard approach to operative fixation for those individuals with flail chest. Further studies are necessary to help standardize other aspects of care that can also impact outcomes (for example, protocols which guide weaning from mechanical ventilation and sedation).

A 2017 meta-analysis by Swart and colleagues reported on 20 studies which compared nonoperative treatment to operative treatment for diagnosis of flail chest. The authors note that for the individuals who received operative management, there was a universal decrease in morbidity, pneumonia, and tracheostomy requirements when compared to non-operative management.

Previously, if rib fractures required surgical intervention, the most used method was a formal thoracotomy. The addition of intraoperative thoracoscopy and computed tomography have allowed for less invasive approaches with smaller incisions and muscle-sparing techniques.

While much of the current literature is limited to retrospective studies and small sample sizes, benefits are noted from surgical management of rib fractures which includes decreased hospital days, decreased ICU days, and decreased days of mechanical ventilation. Randomized controlled trials with larger populations are still necessary to allow generalization of findings and continued assessment of safety and efficacy of surgical management of rib fractures.

Background/Overview

The purpose of the ribs is to protect the internal organs such as the heart and lungs. The chest wall consists of 12 pairs of ribs. Ribs one to seven connect to both the sternum in the front (anteriorly) and the spine in the back (posteriorly). Ribs 8 to 10 attach to the costal cartilage anteriorly. The lowest two ribs are “floating” and do not connect anteriorly. The first three ribs are relatively protected by the scapula, clavicle, and soft tissue. The middle ribs (numbers 4 to 10) are the most vulnerable and susceptible to injury from blunt trauma. Direct trauma to the chest wall causes most rib fractures. This can be blunt trauma such as a motor vehicle crash or penetrating trauma such as a gunshot.

Rib fractures can be associated with internal injury such as to the abdominal organs, aorta, spleen, liver or lungs. Rib fractures can be painful which can hinder breathing. Once significant accompanying injuries have been ruled out, the cornerstone of rib fracture management is pain control. Pain relief is essential to avoid complications such as pneumonia. Severe injuries can lead to mechanical ventilatory support to assist the individual in breathing.

The United States Food and Drug Administration has granted 510(k) clearance to several devices for the fixation and stabilization of rib fractures.

Definitions

Atelectasis: A collapse of all or part of the lung.

Flail chest: Paradoxical movement of the chest wall, visible with respiration, caused by contiguous rib fractures (generally three or more ribs are fractured with two or more fractures in each rib).

Pneumonia: An infection of the lungs which can be caused by a virus or bacteria.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

CPT

 

21811

Open treatment of rib fracture(s) with internal fixation, includes thoracoscopic visualization when performed, unilateral; 1-3 ribs

21812

Open treatment of rib fracture(s) with internal fixation, includes thoracoscopic visualization when performed, unilateral; 4-6 ribs

21813

Open treatment of rib fracture(s) with internal fixation, includes thoracoscopic visualization when performed, unilateral; 7 or more ribs

 

 

ICD-10 Procedure

 

0PH104Z-0PH144Z

Insertion of internal fixation device into 1 to 2 ribs [by approach; includes codes 0PH104Z, 0PH134Z, 0PH144Z]

0PH204Z-0PH244Z

Insertion of internal fixation device into 3 or more ribs [by approach; includes codes 0PH204Z, 0PH234Z, 0PH244Z]

0PS104Z-0PS144Z

Reposition 1 to 2 ribs with internal fixation device [by approach; includes codes 0PS104Z, 0PS134Z, 0PS144Z]

0PS204Z-0PS244Z

Reposition 3 or more ribs with internal fixation device [by approach; includes codes 0PS204Z, 0PS234Z, 0PS244Z]

 

 

ICD-10 Diagnosis

 

S22.31XA-S22.39XS

Fracture of one rib

S22.41XA-S22.49XS

Multiple fractures of ribs

S22.5XXA-S22.5XXS

Flail chest

When services are Investigational and Not Medically Necessary:
For the procedure and diagnosis codes listed above when criteria are not met or for all other diagnoses not listed; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

References

Peer Reviewed Publications:

  1. Althausen PL, Shannon S, Watts C, et al. Early surgical stabilization of flail chest with locked plate fixation. J Orthop Trauma. 2011; 25(11):641-648.
  2. Bottlang M, Long WB, Phelan D, et al. Surgical stabilization of flail chest injuries with MatrixRIB implants: a prospective observational study. Injury. 2013; 44(2):232-238.
  3. Coughlin TA, Ng JW, Rollins KE, et al, Management of rib fractures in traumatic flail chest: a meta‐analysis of randomised controlled trials. Bone Joint J. 2016; 98‐B(8):1119‐1125.
  4. 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(6):1750-1754.
  5. Doben AR, Eriksson EA, Denlinger CE, et al. Surgical rib fixation for flail chest deformity improves liberation from mechanical ventilation. J Crit Care. 2014; 29(1):139-143.
  6. Granetzny A, Abd El-Aal M, Emam E, et al. Surgical versus conservative treatment of flail chest. Evaluation of the pulmonary status. Interact Cardiovasc Thorac Surg. 2005; 4(6):583-587.
  7. Khandelwal G, Mathur RK, Shukla S, Maheshwari A. A prospective single center study to assess the impact of surgical stabilization in patients with rib fracture. Int J Surg. 2011; 9(6):478-481.
  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):914-921.
  9. Majercik S, Cannon Q, Granger SR, et al. Long-term patient outcomes after surgical stabilization of rib fractures. Am J Surg. 2014; 208(1):88-92.
  10. Marasco SF, Davies AR, Cooper J, et al. Prospective randomized controlled trial of operative rib fixation in traumatic flail chest. J Am Coll Surg. 2013; 216(5):924-932.
  11. Middleton C, Edwards M, Lang N, Elkins J. Management and treatment of patients with fracture. Nurs Times. 2003; 99(5):30-32.
  12. Nirula R, Allen B, Layman R, et al. Rib fracture stabilization in patients sustaining blunt chest injury. Am Surg. 2006; 72(4):307-309.
  13. Nirula R, Diaz JJ Jr, Trunkey DD, Mayberry JC. Rib fracture repair: indications, technical issues, and future directions. World J Surg. 2009; 33(1):14-22.
  14. Nirula R; Mayberry JC. Rib fracture fixation: controversies and technical challenges. Am Surg. 2010; 76(8):793-802.
  15. Pieracci FM, Lin Y, Rodil M, et al. A prospective, controlled clinical evaluation of surgical stabilization of severe rib fractures. J Trauma Acute Care Surg. 2016; 80(2):187-194.
  16. Pieracci FM, Majercik S, Ali-Osman F, et al. Consensus statement: Surgical stabilization of rib fractures rib fracture colloquium clinical practice guidelines. Injury. 2017; 48(2):307‐321.
  17. Richardson JD, Franklin GA, Heffley S, Seligson D. Operative fixation of chest wall fractures: an underused procedure? Am Surg. 2007; 73(6):591-596.
  18. Slobogean GP, MacPherson CA, Sun T, et al. Surgical fixation vs nonoperative management of flail chest: a meta-analysis. J Am Coll Surg. 2013; 216(2):302-311.
  19. Swart E, Laratta J, Slobogean G, Mehta S. Operative treatment of rib fractures in flail chest injuries: a meta‐analysis and cost‐effectiveness analysis. J Orthop Trauma. 2017; 31(2):64‐70.
  20. Tanaka H, Yukioka T, Yamaguti Y, et al. Surgical stabilization or internal pneumatic stabilization? A prospective randomized study of management of severe flail chest patients. J Trauma. 2002; 52(4):727-732.
  21. Xu JQ, Qiu PL, Yu RG, et al. Better short-term efficacy of treating severe flail chest with internal fixation surgery compared with conservative treatments. Eur J Med Res. 2015; 20:55.
  22. Zhang Y, Tang X, Xie H, Wang RL. Comparison of surgical fixation and nonsurgical management of flail chest and pulmonary contusion. Am J Emerg Med. 2015; 33(7):937-940.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Synthes MatrixRIB Fixation System. No. K081623. Rockville, MD: FDA. September 8, 2008. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/K081623.pdf. Accessed on September 28, 2018.
Index

Modular RibLoc System®
Rib fracture
Synthes MatrixRIB Fixation System

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Revised

11/08/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. Added MN indications to include flail chest. Updated Rationale, Definitions, Coding and References sections.

Reviewed

07/26/2018

MPTAC review. Updated Rationale section.

Revised

11/02/2017

MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date.” Title change. Updated Description/Scope section.

 

10/01/2017

Updated Coding section with 10/01/2017 ICD-10-PCS procedure code descriptor changes.

Reviewed

11/03/2016

MPTAC review. Updated Rationale and References sections.

Reviewed

11/05/2015

MPTAC review. Updated Rationale and References sections. Removed ICD-9 codes from Coding section.

Reviewed

11/13/2014

MPTAC review. Updated Rationale and References. Updated Coding section with 01/01/2015 CPT changes; removed 0245T, 0246T, 0247T, 0248T deleted 12/31/2014.

Reviewed

11/14/2013

MPTAC review. Updated Rationale and References.

Reviewed

11/08/2012

MPTAC review. Updated Description/Scope, Rationale, Background/Overview, References and Index.

Reviewed

11/17/2011

MPTAC review. Updated Rationale and References.

 

02/17/2011

Updated Rationale and References.

New

11/18/2010

MPTAC review. Initial document development.