EXOGEN Ultrasound Bone Healing System for Long Bone Fractures with Non-Union or Delayed Healing: A NICE Medical Technology Guidance

Abstract

A routine part of the process for developing National Institute for Health and Care Excellence (NICE) medical technologies guidance is a submission of clinical and economic evidence by the technology manufacturer. The Birmingham and Brunel Consortium External Assessment Centre (EAC; a consortium of the University of Birmingham and Brunel University) independently appraised the submission on the EXOGEN bone healing system for long bone fractures with non-union or delayed healing. This article is an overview of the original evidence submitted, the EAC’s findings, and the final NICE guidance issued.

Treatment of chronic (>1 year) fracture nonunion: Heal rate in a cohort of 767 patients treated with low-intensity pulsed ultrasound (LIPUS)

“…This is a complex question, but the simplest answer is that there are no RCTs that directly compare LIPUS to modern surgical techniques for nonunion [35]. In the absence of such trials, clinicians should be reluctant to recommend LIPUS over the proven benefits of nonunion surgery.…”

“…In the absence of such trials, clinicians should be reluctant to recommend LIPUS over the proven benefits of nonunion surgery. However, the National Institute for Health and Care Excellence (NICE) in the United Kingdom evaluated the evidence supporting LIPUS to promote healing of fracture nonunion [35]. NICE concluded that ''clinical evidence supports the use of [LIPUS] in non-union long bone fractures.…”

“…which have not healed after 9 months.'' LIPUS use in such cases was calculated to result in a cost savings of $1726 per patient, due to avoidance of surgery [35]. A more recent study concluded that patients who received nonunion surgery had total medical costs that averaged $6289 higher than patients who received LIPUS only [36].…”

“…LIPUS-only treatment of nonunion was projected to result in a cost savings of $4 billion annually in the United States [36]. NICE concluded that ''successful use of [LIPUS] may eliminate the need for surgery and its associated complications'' [35]. This suggests an urgent need for a direct comparison of LIPUS to surgery for fracture nonunion.…”

Low-intensity pulsed ultrasound promotes cell motility through vinculin-controlled Rac1 GTPase activity

“…S1A), to an intensity of 30 mW/cm 2 spatial averagetemporal average (SATA), with a power of 117 mW (Harrison et al, 2016). LIPUS shows particular efficacy in treating bone nonunion fractures (Nolte et al, 2001;Rutten et al, 2007;Zura et al, 2015a), and has been approved by the US FDA for treating both fresh fractures and nonunion fractures, and by NICE in the UK for treating nonunion fractures (Higgins et al, 2014).…”