Medical Policy


Subject:Open Treatment of Rib Fracture(s) Requiring Internal Fixation
Policy #:  SURG.00120Current Effective Date:  01/14/2014
Status:ReviewedLast Review Date:  11/14/2013

Description/Scope

This document addresses the open treatment of rib fracture(s) using an internal fixation device.

Position Statement

Investigational and Not Medically Necessary:

The use of an internal rib fixation system is considered investigational and not medically necessary for all 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. One such treatment is surgical management with operative rib stabilization.

At this time there are only 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. Thirty-seven individuals with flail chest and acute respiratory failure were randomly assigned to either surgery or internal pneumatic stabilization at 5 days after injury. Eighteen 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.

A second 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 tests 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). 

Marasco and others (2013) described a small randomized controlled trial involving forty six 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 three months follow-up, two 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.

Nirula and colleagues (2006) studied the impact of operative stabilization of rib fractures on individuals with chest trauma and their subsequent dependence on a ventilator. Thirty individuals underwent a rib stabilization procedure and were matched with thirty control individuals who did not have surgical intervention. The primary indication for surgery was severe flail chest in the majority of the cases. The length of ICU days was similar for both groups, as was total hospital length of stay. For those individuals who had surgical rib fracture-stabilization procedures, there was a trend towards fewer total ventilation days compared to the control group (those without surgical intervention). However, the authors concluded this "did not reach statistical significance" and "long-term functional outcomes need to be assessed to ascertain the impact of this procedure."

In 2007, Richardson and colleagues reported on 7 individuals with multiple rib fractures requiring open reduction and internal fixation. Six individuals sustained an injury following a motor vehicle accident, one sustained injury after falling off a horse. Five of the individuals had surgery on an average of 6 days following their injury, due to pain, respiratory failure, or mechanical ventilation requirement. One individual underwent surgery 6 weeks following the injury and another individual underwent their surgery several years after the injury due to chronic nonunion and chest pain. All 7 individuals were noted to have a thin frame and crushing chest injury with an average of 8 rib fractures. Following surgery there were no complications, infections or evidence of nonunion. While good results were noted in this study, the authors concluded that almost all chest wall fractures will heal spontaneously given enough time and "it is difficult to objectively demonstrate a benefit because the primary indication for operation is pain."

Khandelwal et al. (2011) compared the intensity of pain and duration of return to normal activity in 61 individuals with rib fractures. A total of 32 individuals were treated with surgical stabilization of their rib fractures; 29 individuals were treated conventionally (without surgery). Pain was assessed using a numerical scale in numbers ranging from 0 (no pain) to 10 (worst pain). Those individuals who had a pain rating of 5 or more were treated conventionally for 10 days. Individuals were again assessed for pain on the eleventh day using the numerical scale. Only those individuals with a pain rating of 5 or more were followed. Individuals with a pain rating of 5, 6, or 7 were continued to be treated conventionally. Individuals with a pain rating of 8, 9, or 10 were chosen to have surgical stabilization of their fractured ribs. Pain was rated on days 5, 15, 30, post operative day and was assessed using the same numerical scale. Duration of return to normal activity was assessed by asking the participants when they were able to return to their usual daily activities. For those in the surgical group, pain was rated at 9.15 on day 5, 2.31 on day 15 and 1.12 on day 30. For those in the conventional group pain was rated at 6.25 on day 5, 5.96 on day 15 and 4.50 on day 30. For returning to normal activity, those in the surgical group had a mean of 26.62 days; the conventional group had a mean of 54.21 days. It appears that this study shows an overall reduction of pain and duration of disability compared to the conventional group, but there are several limitations to the study. The study was conducted on a small number of participants, the participants were not matched in terms of age, gender or nutritional status, and there was no standardized protocol for management of pain in the conventional group. Duration of hospital stay was not able to be assessed and more studies are required to address the limitations.

de Moya and colleagues (2011) reported on a retrospective case-control study which compared 16 individuals who underwent rib fixation to 32 individuals who didn't undergo rib fixation and were considered the control group. The primary outcome was the amount of narcotics administered during the hospital stay. The individuals who had rib fixation were noted to have a reduced need for analgesia. Morphine requirement was decreased from 110mg preoperatively to 63 mg postoperatively, but there were no differences noted in outcomes when compared with matched controls. The authors also hypothesized that the individuals who had surgical management of their rib fractures would have fewer pulmonary complications and shorter hospital stay due to improved pain control. The authors found that there were no significant differences noted in hospital stay, intensive care unit stay, ventilation days or pneumonia rates.

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 606 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 six month follow-up were obtained from 16 (84.2%) and 15 (78.9%) subjects, respectively. At three 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 six months. Return to pre-injury activities was reported for 5 subjects at 3 months and 7 subjects at 6 months. At six months, there were no reported hardware failures or migration. Complete healing of treated ribs was noted as well.

Finally, Slobogean and colleagues (2013) conducted a meta-analysis of studies comparing surgical fixation vs. non-operative management of flail chest. They identified eleven 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% 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. While these findings are promising, the authors noted that they must be viewed in the context of the pooled studies, which were mostly small and retrospective in nature. Furthermore, the two randomized studies involved only 37 and 40 subjects each. The authors commented that the current evidence addressing the various surgical methods and hardware available is not sufficient to provide any conclusions regarding comparative efficacy. They conclude that additional prospective randomized trials are still necessary.

In the past if rib fractures required surgical intervention, the most used method was a formal thoracotomy. The addition of intraoperative thorascopy and computed tomography have allowed for less invasive approaches with smaller incisions and muscle-sparing techniques. Under study are minimally invasive techniques for rib fracture repair, but the benefit, durability and safety of these techniques have not been established.

Current literature is limited to small group sizes and additional confirmatory randomized controlled trials with adequate populations to allow generalization of findings have yet to be performed. There is a paucity of evidence concerning the net benefit of operative rib stabilization versus conservative management. Further study is needed regarding the safety and efficacy of these surgical procedures.

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 1 to 7 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 2 ribs are "floating" and do not connect anteriorly. The first 3 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: A condition in which at least three consecutive ribs are fractured in two or more places. Seen clinically when the paradoxical motion of an incompetent segment of chest wall is visible with respiration.

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 are Investigational and Not Medically Necessary: 

CPT  
0245TOpen treatment of rib fracture requiring internal fixation, unilateral; 1-2 ribs 
0246TOpen treatment of rib fracture requiring internal fixation, unilateral; 3-4 ribs 
0247TOpen treatment of rib fracture requiring internal fixation, unilateral; 5-6 ribs 
0248TOpen treatment of rib fracture requiring internal fixation, unilateral; 7 or more ribs 
   
ICD-9 Procedure[For dates of service prior to 10/01/2014] 
79.39Open reduction of fracture with internal fixation, other specified bone [when specified as rib fracture]
  
ICD-9 Diagnosis[For dates of service prior to 10/01/2014]
807.00-807.09Fracture of rib(s), closed 
807.10-807.19Fracture of rib(s), open 
807.4Flail chest 
   
ICD-10 Procedure[For dates of service on or after10/01/2014] 
0PH104Z-0PH144ZInsertion of internal fixation device into right rib [by approach; includes codes 0PH104Z, 0PH134Z, 0PH144Z] 
0PH204Z-0PH244ZInsertion of internal fixation device into left rib [by approach; includes codes 0PH204Z, 0PH234Z, 0PH244Z] 
0PS104Z-0PS144ZReposition right rib with internal fixation device [by approach; includes codes 0PS104Z, 0PS134Z, 0PS144Z] 
0PS204Z-0PS244ZReposition left rib with internal fixation device [by approach; includes codes 0PS204Z, 0PS234Z, 0PS244Z] 
   
ICD-10 Diagnosis[For dates of service on or after 10/01/2014] 
S22.31XA-S22.39XSFracture of one rib 
S22.41XA-S22.49XSMultiple fractures of ribs 
S22.5XXA-S22.5XXSFlail chest 
References

Peer Reviewed Publications:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. Middleton C, Edwards M, Lang N, Elkins J. Management and treatment of patients with fracture. Nurs Times. 2003; 99(5):30-32.
  7. Nirula R, Allen B, Layman R, et al. Rib fracture stabilization in patients sustaining blunt chest injury. Am Surg. 2006; 72(4):307-309.
  8. 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.
  9. Nirula R; Mayberry JC. Rib fracture fixation: controversies and technical challenges. Am Surg. 2010; 76(8):793-802.
  10. Richardson JD, Franklin GA, Heffley S, Seligson D. Operative fixation of chest wall fractures: an underused procedure? Am Surg. 2007; 73(6):591-596.
  11. 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.
  12. 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.

 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 October 1, 2013.
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

Reviewed11/14/2013Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Rationale and References
Reviewed11/08/2012MPTAC review. Updated Description/Scope, Rationale, Background/Overview, References and Index.
Reviewed11/17/2011MPTAC review. Updated Rationale and References.
 02/17/2011Updated Rationale and References.
New11/18/2010MPTAC review. Initial document development.