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Chronic Refractory Osteomyelitis

INTRODUCTION

Treatment Protocol Guidelines

The following hyperbaric medicine treatment protocol is based upon the recommendations of the Hyperbaric Oxygen Committee of the Undersea and Hyperbaric Medical Society.

The protocol is designed to standardize therapeutic regimens, whenever possible, in order to optimize clinical outcomes and cost-effectiveness, and provide the basis for prospective analysis of data.  Care plans may need to be individualized according to a particular patient’s general medical condition and relevant medical history. Where the clinical decision is to deviate from the protocols, including the upper treatment threshold, a case audit is initiated.

Medical Necessity

The listing of treatment indications for hyperbaric oxygen therapy represent the commonly accepted uses. It is important to note, however, that there are minor “medically necessary” differences between the various providers of health insurance.  The approved uses and indications are standardized across the country and can be found National Coverage Determination (NCD) 20.29. [1]

It is recommended, therefore, that contact is made (pre-authorization) with each patient’s insurance company in order to clarify benefits. Each health insurance company’s decision-making process for inclusion or exclusion of a particular indication for hyperbaric oxygen therapy is based upon several factors. Literature-specific reviews by panels of experts, technology assessments, resourcing of evidence-based repositories and historical precedent are tools used for “medically necessary‟ determination. 

TREATMENT PROTOCOL


 HBO request requirements checklist   | Sample Physician Order   | $ ICD-10 Crosswalk   |  Treatment Table


Objectives

  1. Oxygenate ischemic tissues.
  2. Enhance host-defense mechanisms via improved leukocyte activity.
  3. Enhance antibiotic activity.
  4. Stimulate angiogenesis
  5. Stimulate osteoclastic activity.

Diagnosis

  1. X-rays, Gallium scan, bone scan, CT, sinogram or tomograms that demonstrate osteomyelitis.
  2. Demonstrated failure to respond to adequate surgical debridement (where indicated), specific bone culture sensitive antibiotic administration at bactericidal serum level for a minimum of four to six weeks.

Criteria for hbo therapy

(two or more of the following should exist)

  1. Documented evidence of chronicity.
  2. Documented evidence of wound culture sensitivities.
  3. Failure to resolve following surgical debridement and appropriate antibiotics.


Work-Up
Considerations 

  1. Comprehensive history. Past medical records must be available to document chronicity, and the refractory nature of the disease.
  2. Physical examination
  3. Labs to order or review
    • CBC
    • SMA-12
    • Electrolytes
    • Urinalysis                         
    • Sedimentation rate
    • CRP
  4. C&S of affected area
  5. X-rays to order or review
    • Chest
    • Affected area
  6. ECG: order or review, where indicated
  7. Wound photographs, where indicated (after signed consent)
  8. Consider removal of all orthopedic hardware within infected bone*
  9. Nutritional assessment, as indicated
  10. No (limit) use of nicotine products during the hyperbaric treatment course
  11. Debridement and appropriate dressing changes as necessary

* Commonly ordered and followed by ID and/or orthopaedics

Treatment

After signed informed consent:

  1. Hyperbaric oxygen therapy, at 2.0 ATA oxygen for 90 minutes. (Table 1) This may be provided on a QD basis, or BID with inpatients, in limb-threatening cases. Where pseudomonas or E. coli is isolated, consider increasing pressure to 2.5 ATA oxygen, with two 10 minute air breaks.
  2. One should anticipate that any existing soft tissue fistulae will heal-in before the underlying infection has been eradicated/controlled. Therefore, the fistula should be packed to maintain patency during the treatment course.
  3. Continue HBO therapy for a minimum of 14 treatments after cessation of wound drainage or up to 40 treatments,
  4. X-rays and/or MRI of affected area at 20 and 40 treatments
  5. Consider tetracycline 250 mg PO QID for 7-10 days as bone labeling prior to debridements
  6. Consider weekly CBC and sedimentation rate
  7. Consider weekly C & S of affected area
  8. Dressing changes as needed
  9. Re-evaluate and document weekly for wound status (appearance and dimensions).
  10. No (limit) use of nicotine products during the hyperbaric treatment course

Follow-Up

  1. Referring physician likely to repeat x-rays at 6 months, 12 months, then annually
  2. Visual acuity assessment
  3. Wound photography

Treatment Threshold

20 – 40 treatments

ICD-9 to ICD-10 Crosswalk

Refer to the ICD-10 Guideline for the appropriate ICD-10 code


Notes

  1. In diabetic patients, obtain finger stick for blood glucose prior to each treatment.
  2. Avoid petroleum based dressings and ointments.
  3. It is important to confirm that this indication meets the “medically necessary” reimbursement standard of the patient’s health insurance plan.

DOCUMENTATION

Adjunctive hyperbaric oxygen therapy has been shown to be beneficial in the treatment of osteomyelitis that has been refractory to appropriate antimicrobial and surgical intervention for a minimum of four to six weeks. Adequate surgical debridement must be performed to remove sequestrations of dead bone, which may otherwise remain a source for persistent infection.  In combination with aggressive surgical debridement and appropriate antibiotic therapy, HBO can decrease morbidity as well as hasten wound healing. In cases of cranial osteomyelitis, adjunctive HBO may help to eradicate infection while significantly lessening the requirement to remove bone grafts or other hardware. Adequate documentation is paramount to support medical necessity of adjunctive HBO for chronic refractory osteomyelitis. Below we explain in detail what needs to be documented. See also:

History and Physical

  • An initial assessment including a history and physical that clearly substantiates the condition for which HBO is recommended.
  • Prior medical, surgical and/or hyperbaric treatments.
  • Past medical records must be available to document chronicity, and the refractory nature of the disease.

Physical Exam

  • Documentation of the failure to resolve the following: surgical bony debridement and appropriate course of antibiotics.
  • Documentation of specific antibiotic administration for a minimum of four to six weeks.
  • Documented evidence of bone culture sensitivities, X-rays, Bone Scan, CT or MRI demonstrating osteomyelitis.
  • Documented consideration of removal of all orthopedic hardware within infected bone.
  • Documented evidence of wound chronicity despite standard wound care.
    • Initial Ulcer size - beginning of 30 days of standard wound care.
    • Ulcer size – (current) Following standard wound care
  • Documentation of optimization of nutritional status
    • Albumin
    • Pre-Albumin

Risk Assessment

  • Risk benefit ratio in favor of offering hyperbaric oxygen therapy, example statement:

The patient was informed of the possible risks and complications of hyperbaric oxygen therapy. These include, but are not limited to, fire, barotrauma of the ears, sinuses, and lungs to include air embolism, central nervous system oxygen toxicity resulting in seizure, cataracts, myopia, and exacerbation of congestive heart failure.

Having no absolute contraindication to hyperbaric oxygen therapy, the patient will be offered treatment 2.0 ATA for 90 minutes OR at 2.5 ATA for 90 minutes with two inter-current ten minute air breaks (Where pseudomonas or E. coli is isolated). Forty treatments will initially be provided on a once daily basis Monday through Friday. Thereafter, a re-evaluation of the patient’s clinical progress will be in order to determine if additional treatments may be required.

Impression

Refer to ICD – 10 crosswalk – Single diagnosis code meets medical necessity for Chronic Refractory Osteomyelitis

Plan

Example Statement supporting the role of hyperbaric oxygen therapy:

Mechanisms by which HBO has been shown to be beneficial include the following:

    1. Enhanced host immune competency - leukocyte oxidative killing requires oxygen as a substrate (~30mmHg) to allow for the leukocyte oxidative burst.  Increased oxygen partial pressures, achieved only under hyperbaric conditions, provide greater diffusion of oxygen and, thus greater tissue concentrations of oxygen in tissues at risk.
    2. Antibiotic synergism – oxygen is a crucial substrate in the mechanism by which many antibiotics penetrate bacterial and fungal cells. Increased tissue oxygen levels enhance antibiotic efficacy in the setting of necrotizing infections where microvascular injury typically compromises tissue oxygenation.
    3. Toxin inhibition and inactivation – toxins elaborated by Clostridial species, particularly the alpha and cardiac toxins, significantly contribute to the high mortality and morbidity of this disease. Rapid tissue destruction resulting from the highly diffusible alpha toxin is the primary pathophysiological process of this devastation disease. Hyperbaric oxygen has been shown to inhibit alpha toxin production thus limiting the extent of tissue destruction. This inhibition also provides a clear demarcation of viable tissue thereby limiting the extent of surgical debridement. Cardiotoxin is also inactivated preserving cardiac function in an otherwise critically ill patient.
    4.  Direct cidal activity – oxygen, at hyperbaric pressures, can be bacteriocidal to true anaerobic and microaerophilic strains of bacteria i.e. those bacterial lacking antioxidative defenses such as superoxide dismutase and catalase.
  1.  Hyperbaric Oxygen Therapy 2.0 ATA for 90 minutes breathing 100% oxygen.
  2.  Where pseudomonas or E. coli is isolated, consider 2.5 ATA for 90 minutes breathing 100% oxygen.
  3.  Treatment to be provided Q day
  4.  Total treatments ordered: 20 - 40
  5.  Institute air breaks as indicated.
  6.  Treatments are given on a QD basis
  7.  X-rays and/or MRI of affected area at 20 and 40 treatments
  8.  Consider weekly CBC and sedimentation rate
  9.  Consider weekly C & S of affected area
  10.  Dressing changes as needed
  11.  Re-evaluate and document weekly for wound status (appearance and dimensions).

Sample Order

Sample Physician Order

CLINICAL EVIDENCE AND RECOMMENDATIONS  

We suggest inclusion of HBO therapy in the patient’s treatment regimen, along with surgical debridement and culture-directed antibiotics for adult patients with osteomyelitis that is refractory to 4-6 weeks of appropriate surgical and antibiotic interventions (definition of chronic refractory osteomyelitis, or CRO) in cases:

  • 2C
    With uncomplicated extremity osteomyelitis (Grade 2C), OR
  • 2C
    In which significant patient morbidity or mortality is not likely to occur (Grade 2C)

We recommend inclusion of HBO therapy in the patient’s treatment regimen in the following cases:

  • 1C
    As an adjunctive therapy with antibiotics and surgical debridement, for adult patients with osteomyelitis of long bones or miscellaneous sites that is refractory to 4-6 weeks of appropriate surgical and antibiotic interventions only (CRO), with osteomyelitis classified as Cierny-Mader 3B or 4B (Grade 1C)
  • 1C
    As an adjunctive therapy with antibiotics, prior to surgical debridement (and after minimal debridement) for adult patients with CRO which results in high probability of mortality and morbidity (with osteomyelitis involving the spine, skull, sternum or other bony structures associated with a risk for high morbidity or mortality (Grade 1C)
  • 1C
    As an adjunctive therapy with antibiotics, prior to surgical debridement (and after minimal debridement) for children with CRO in any site (Grade 1C)
  • 1A
    As an adjunctive therapy for osteomyelitis in patient with diabetic foot ulcers (DFU) Wagner 3 or 4, refractory to 30 days of standard wound care (Grade 1A)  (See “HBO treatment - Diabetic Foot Ulcers”)

Rationale:  In general, low-certainty evidence (evidence level C) or expert opinion support the use of HBO to promote healing of CRO. As to date no RCT has been carried out and no systematic reviews/ meta-analyses have been published, evidence is drawn from several animal studies, case series and observational studies. [2] [3] According to the main guidelines in the field (by the UHMS and ECHMG), HBO therapy is a safe and an effective adjunct to management of CRO if guidelines are followed. [2] [3] For cases graded 1C, the benefits of adjunctive HBO outweighs the risks of side effects and complications. Data from animal and clinical studies suggest that management with culture-directed antibiotics, debridement and HBO is the strategy most likely to achieve CRO healing.  Medicare covers HBO for CRO as long as requirements are met ( osteomyelitis must be chronic and refractory to usual standard of care management - i.e., prolonged antibiotics therapy preferably directed by appropriate culture and sensitivity information, drainage of the abscesses, immobilization of the affected extremity, and surgical debridement with removal of infected bone. HBO for osteomyelitis that is not documented to be chronic and refractory to conventional treatment, and HBO not provided in an adjunctive fashion, is not covered) [1] [4] While HBO is costly, its addition to management of CRO when following guidelines appears to be associated with fewer surgical procedures, less antibiotics and shorter hospital length of stay  [2]

CODING

See ICD-10 Coding for CROM

APPENDIX

Summary of Evidence -  HBO for Chronic Refractory Osteomyelitis (back to text)

  1. Guidelines:
    1. The 2014 UHMS HBO Therapy Indications Book (Guidelines) and the 2017  European Committee for Hyperbaric Medicine Guidelines support the use of HBOT as an adjunctive therapy to treat chronic refractory osteomyelitis, and although the guidelines use different evidence grading methodologies, they are in agreement regarding strength of recommendation . [2] [3] See table below:

HBO therapy for chronic refractory osteomyelitis

UHMS, 2014

ECHMG, 2017

HBO + antibiotics + debridement in the treatment of chronic refractory osteomyelitis

AHA Class II (conflicting evidence and/or divergence of opinion)

Grade 2C (weak recommendation, conditions do not allow for proper RCTs but there is ample and  international expert consensus)

HBO + antibiotics + debridement for patients with CRO of long bone or miscellaneous sites, classified as more severe Cierny-Mader Class 3B or 4B disease

AHA Class IIa (Weight of evidence/opinion is in favor of

usefulness/efficacy)

n/a

HBO + antibiotics for patients with osteomyelitis involving the spine, skull, sternum or other bony structures associated with a risk for high morbidity or mortality or for children, prior to debridement

AHA Class IIa (Weight of evidence/opinion is in favor of

usefulness/efficacy)

n/a

HBO + antibiotics + debridement for patients with associated Wagner Grade 3 or 4 diabetic ulcer

AHA Class I (Conditions for which there is evidence, general

agreement, or both that a given procedure or treatment is

useful and effective)

n/a

HBO + antibiotics + debridement for compromised patients

n/a

Grade 2C

HBO protocol be individualized based  on the condition and compliance of the patient

n/a

Grade 2C

Evaluate effects of HBO repeatedly during and after treatment using the same  diagnostic methods as used pre HBOT. Perform at least 11−12 weeks of HBOT, approx. 60 sessions, before any significant clinical effect should be expected.

n/a

Grade 1C

We reviewed the guidelines and studies published since guidelines were last updated.  Applying the GRADE framework to the combined body of evidence, we found that:

  • In general, low-certainty evidence (evidence level C) or expert opinion support the use of HBO to promote healing of CRO. As to date no RCT has been carried out and no systematic reviews/ meta-analyses have been published, evidence is drawn from several animal studies, case series and observational studies. The UHMS guideline [2] based its recommendations on 9 prospective animal studies, and 31 human studies, most case series (classed AHA level of evidence 5) or observational studies  (AHA level of evidence 3 or 4). In general, these studies support HBO therapy as safe and an effective adjunct to management of CRO. The ECHMG did not cite any published sources of reference and thus assigned a score Grade 2C using the Grade system through an expert consensus. [3]. Since the latest UHMS update, another clinical retrospective study was published in 2015. This study evaluated the effectiveness of HBO therapy as an adjunctive therapy for 23 patients with chronic refractory osteomyelitis found that 82.6% of patients presented with successful or improved outcomes. The study is observational, with small sample size (evidence level C) [5]
  • Evidence gathered from studies on HBO in management of CRO stratified by topographical site/indications was drawn from case series/observational studies, and thus classified as low-certainty (evidence level C). One exception is CRO in diabetic foot ulcers (DFU), which is covered in another topic (See “HBO treatment - Diabetic Foot Ulcers”). Use of adjunctive HBO to treat CRO in DFU is supported by meta-analyses of 5 RCT (118 participants) that concluded that adjunctive HBO is effective in reducing risk of amputation in patients with CRO and DFU [RR 0.31, 95% confidence interval (0.13-0.71)]  [1] [6]


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REFERENCES

  1. . Local Coverage Determination for Hyperbaric Oxygen (HBO) Therapy (L35021) . Date of publication 2017 Oct 7;volume ():.
  2. . National Coverage Determination (NCD) for Hyperbaric Oxygen Therapy (20.29) . Date of publication 2017 Oct 7;volume ():.
  3. Mathieu, Daniel; Marroni, Alessandro; Kot, Jacek et al. Tenth European Consensus Conference on Hyperbaric Medicine: recommendations for accepted and non-accepted clinical indications and practice of hyperbaric oxygen treatment. Diving and hyperbaric medicine. Date of publication 2017 Mar 1;volume 47(1):24-32.
  4. Roeckl-Wiedmann, I; Bennett, M; Kranke, P et al. Systematic review of hyperbaric oxygen in the management of chronic wounds. The British Journal of Surgery. Date of publication 2005 Jan 1;volume 92(1):24-32.
  5. Skeik, Nedaa; Porten, Brandon R; Isaacson, Erin; Seong, Jenny; Klosterman, Deana L; Garberich, Ross F; Alexander, Jason Q; Rizvi, Adnan; Manunga, Jesse M; Cragg, Andrew; Graber, John; Alden,... et al. Hyperbaric oxygen treatment outcome for different indications from a single center. Annals of Vascular Surgery. Date of publication 2015 Feb 1;volume 29(2):206-214.
  6. Undersea and Hyperbaric Medical Society Hyperbaric Oxygen Committee,, et al. Hyperbaric Oxygen Therapy Indications . Date of publication 2014 Oct 7;volume ():.