Refractory Osteomyelitis

Chronic refractory osteomyelitis, according to the Centers for Medicare & Medicaid Services' (CMS) National Coverage Determination (NCD) 20.29, is an identified condition covered for treatment with adjunctive hyperbaric oxygen (HBO₂) therapy. Within the NCD (20.29) chronic refractory osteomyelitis is outlined as being unresponsive to conventional medical and surgical management [1]. From a practical perspective, patients can be appropriately diagnosed with chronic refractory osteomyelitis when they demonstrate no significant improvement or demonstrate worsening of the underlying osteomyelitis despite 30 days of combined conventional surgical and medical treatment that included systemic antimicrobial therapy. To date, no conclusive randomized clinical trials examining the effects of HBO₂ therapy on refractory osteomyelitis exist. Additionally, many of the initial studies that resulted in positive outcomes were conducted in hospital settings safeguarding compliance, and thus, not unexpectedly, the outcomes have not translated exactly to the outpatient clinic setting. Nonetheless, based on a comprehensive review of the scientific literature, the addition of HBO₂ therapy to routine surgical and antibiotic treatment of previously refractory osteomyelitis appears to be both safe and ultimately improves infection resolution rates. In most cases, the best clinical results are obtained when HBO₂ treatment is administered concomitantly with culture-directed antibiotics and initiated soon after clinically indicated surgical debridement. In situations where extensive surgical debridement or removal of fixation hardware is relatively contraindicated (i.e., cranial, spinal, sternal, or pediatric osteomyelitis), a trial of systemic culture-directed antibiotics and HBO₂ therapy prior to undertaking more than limited surgical interventions provides a reasonable prospect for osteomyelitis cure.