Low Intensity Ultrasound Accelerated Fracture Healing Device
Durable Medical Equipment
© Blue Cross and Blue Shield of Montana
Current Effective Date:
September 24, 2013
Original Effective Date:
December 18, 2009
September 24, 2013
September 1, 2011; November 08, 2012; August 29, 2013
Low-intensity pulsed ultrasound has been investigated as a technique to accelerate healing of fresh fractures, delayed unions, and nonunions. Ultrasound is delivered with the use of a transducer applied to the skin surface overlying the fracture site.
Ultrasound treatment can be self-administered with one daily 20-minute treatment, continuing until the fracture has healed. The mechanism of action at the cellular level is not precisely known but is thought to be related to a mechanical effect on cell micromotion/deformation, causing an increase in stimulation of transmembrane cell adhesion molecules and upregulation of cyclooxygenase-2.
The most appropriate candidates for ultrasound treatment may be those at high risk for delayed fracture healing or nonunion. These risk factors may include both of the following:
- Steroid therapy,
- History of alcoholism,
- History of smoking.
- Jones fracture,
- Fracture of navicular bone in the wrist (also called the scaphoid),
- Fracture of metatarsal,
- Fractures associated with extensive soft tissue or vascular damage.
The Sonic Accelerated Fracture Healing System, SAFHS® (also referred to as Exogen 2000®) was initially cleared for marketing by the U.S. Food and Drug Administration (FDA) in October 1994 as a treatment of fresh, closed, posteriorly displaced distal radius (Colles’) fractures and fresh, closed, or grade-I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization. In February 2000, the labeled indication was expanded to include the treatment of established nonunions, excluding skull and vertebra. According to the FDA labeling, a nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.
BCBSMT considers other applications of low-intensity ultrasound treatment experimental, investigational and unproven including, but not limited to, treatment of congenital pseudarthroses, open fractures, stress fractures, arthrodesis or failed arthrodesis.
S42.00xA – S42.92xA, S49.00xA – S49.199A, S52.00xA – S52.92xA, S59.00xA – S59.299A, S62.00xA – S62.92xA, S72.00xA – S72.92xA, S79.00xA – S79.199A, S82.00xA – S82.92xA, S89.00xA – S89.399A, S92.00xA – S92.919A, 3E00XGC
- Bhandari M, Fong K, Sprague S et al. Variability in the definition and perceived causes of delayed unions and nonunions: a cross-sectional, multinational survey of orthopaedic surgeons. J Bone Joint Surg Am 2012; 94(15):e1091-6.
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Ultrasound accelerated fracture healing. TEC Assessments 1995; Volume 10, Tab 14.
- Busse JW, Bhandari M, Kulkarni AV et al. The effect of low-intensity pulsed ultrasound therapy on time to fracture healing: a meta-analysis. CMAJ 2002; 166(4):437-41.
- Busse JW, Kaur J, Mollon B et al. Low intensity pulsed ultrasonography for fractures: systematic review of randomised controlled trials. BMJ 2009; 338:b351.
- Griffin XL, Smith N, Parsons N et al. Ultrasound and shockwave therapy for acute fractures in adults. Cochrane Database Syst Rev 2012; 2:CD008579.
- Kristiansen TK, Ryaby JP, McCabe J et al. Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am 1997; 79(7):961-73.
- Heckman JD, Ryaby JP, McCabe J et al. Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. J Bone Joint Surg Am 1994; 76(1):26-34.
- Lubbert PH, van der Rijt RH, Hoorntje LE et al. Low-intensity pulsed ultrasound (LIPUS) in fresh clavicle fractures: a multi-centre double blind randomised controlled trial. Injury 2008; 39(12):1444-52.
- Rue JP, Armstrong DW, 3rd, Frassica FJ et al. The effect of pulsed ultrasound in the treatment of tibial stress fractures. Orthopedics 2004; 27(11):1192-5.
- Emami A, Petren-Mallmin M, Larsson S. No effect of low-intensity ultrasound on healing time of intramedullary fixed tibial fractures. J Orthop Trauma 1999; 13(4):252-7.
- Leung KS, Lee WS, Tsui HF et al. Complex tibial fracture outcomes following treatment with low-intensity pulsed ultrasound. Ultrasound Med Biol 2004; 30(3):389-95.
- Summary of Safety and Effectiveness Data. Exogen 2000® or Sonic Accelerated Fracture Healing System (SAFHS®) Exogen®, a Smith and Nephew Company, Piscataway, NJ.
- Rutten S, Nolte PA, Guit GL et al. Use of low-intensity pulsed ultrasound for posttraumatic nonunions of the tibia: a review of patients treated in the Netherlands. J Trauma 2007; 62(4):902-8.
- Schofer MD, Block JE, Aigner J et al. Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial. BMC Musculoskelet Disord 2010; 11:229.
- Dudda M, Hauser J, Muhr G et al. Low-intensity pulsed ultrasound as a useful adjuvant during distraction osteogenesis: a prospective, randomized controlled trial. J Trauma 2011; 71(5):1376-80.
- National Institute for Health and Clinical Excellence. Low-intensity pulsed ultrasound to promote fracture healing. 2010. Available online at: http://www.nice.org . Last accessed September 2012.
- American Academy of Orthopaedic Surgeons. The treatment of distal radius fractures. 2009. Available online at: http://www.aaos.org . Last accessed November 2012.
- Ultrasound Accelerated Fracture Healing Device. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (December 2012) Medicine 1.01.05.
||Policy reviewed: updated references and rationale, policy statement change from NMN to investigational|
||Policy updated with literature search through July 2012; references 1, 5, 15 added; arthrodesis added to investigational statement; definition of delayed unions revised to 3 months for consistency with definition of nonunion.|
||Policy formatting and language revised. Policy statement unchanged. Title changed from "Bone Growth Stimulators: Ultrasound Accelerated Fracture Healing Device" to "Low Intensity Ultrasound Accelerated Fracture Healing Device".|