Treating bone fracture non-union

Bone fractures are a common result of trauma and most will heal within a few weeks of treatment. However, failure of the fracture to heal (non-union) can result in the need for complex and prolonged management which can affect the patient’s quality of life and can be costly for the NHS. Evidence shows that around 7.5% of fractures do not heal properly,1 which, according to the National Institute for Health and Care Excellence (NICE), translates to around 10,000 completed consultant episodes annually.2 In 2013, NICE published medical technology guidance which supports the use of Exogen – an ultrasound bone healing system for the treatment of stable, aligned long-bone fractures with non-union, which it has defined as showing no healing after nine months.3 For its guidance advice, NICE considered the findings of 17 separate clinical studies that involved 1,710 patients and commissioned the Health Economics Research Group, of Brunel University to examine the estimated cost consequences where Exogen avoids surgery. The guidance document, which is specific to the Exogen low intensity pulsed ultrasound signal device, concluded that the clinical data showed high rates of fracture healing and supported the efficacy and utility of the treatment, adding that it offered a costeffective solution, when compared with current management for the treatment of non-union. Separate research stated that the success rate for healing of non-union fractures using Exogen is 86%, equivalent to surgery.4

About the device

Exogen is a hand-held, battery operated device that is used by the patient at home. It requires a small transducer to be placed onto the fracture site for 20 minutes a day. The patient feels no sensation during treatment and there are no known side effects. When switched on the transducer delivers low-intensity pulsed ultrasound waves which stimulates the production of growth factors and proteins5 that increase the removal of old bone, increases the production of new bone and accelerates the rate at which fibrous matrix is converted to mineralised bone at the fracture site. More recently, and in recognition of the potential benefits of this technology identified by NICE, the NHS Technology Adoption Centre (NTAC) created an adoption pack to help NHS Trusts successfully implement the ultrasound bone healing device in a planned and sustainable manner, for patients who have suffered a long-bone fracture with nonunion after nine months.6