An ultrasound system is being recommended by the National Institute for Health and Clinical Excellence (NICE) as promoting the healing of bone fractures.
In a NICE review, the EXOGEN ultrasound bone healing system was found to benefit patients and the NHS when used for treating long bone fractures that had failed to heal after nine months. However, the case for adopting EXOGEN routinely for long bone fractures that did not show radiological evidence of healing after three months was not supported due to uncertainties in the evidence.
We hope that this guidance will be useful for NHS staff providing treatment for people with long bone fractures that have failed to heal after nine months
NICE has now published guidance recommending its use for NHS patients with problematic fractures after nine months, with a view to reducing the need for surgery and the associated high costs.
Manufactured by Smith & Nephew, EXOGEN works by delivering low-intensity pulsed ultrasound waves to stimulate the production of growth factors and proteins that increase the removal of old bone and increase the production of new bone. Long bone fractures are suitable for treatment if the fracture is stable and well aligned.
The ultrasound waves are delivered straight to the fracture site via a small transducer which is secured by a strap. For patients wearing a cast, a hole is cut to allow the transducer to make contact with the skin at the fracture site. The device is programmed to deliver ultrasound in 20-minute sessions which the patient administers themselves each day at home.
In trials, treating non-union fractures using EXOGEN showed high rates of fracture healing, with an estimated cost saving of £1,164 per patient compared with current care pathways. The saving is achieved through avoiding the need for surgical intervention. For delayed healing fractures, there is some radiological evidence of improved healing, but there is too much uncertainty about the rate at which healing progresses between three and nine months after fracture and about whether or not surgery would otherwise be necessary. These uncertainties make modelling the cost consequences of using EXOGEN in this scenario complex, the NICE guidance states.
It is recommended for use on long bone fractures where the fracture is stable and well aligned. The NICE guidance does not indicate the technology for use in fractures of the skull or vertebrae or in children or adolescents due to skeletal immaturity.
Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation, said: “We are pleased to publish final Medical Technology Guidance which supports the use of EXOGEN for treating long bone fractures that have not healed after nine months.
NICE’s independent Medical Technologies Advisory Committee (MTAC) considered there was evidence to show that using the device in this situation resulted in high rates of fracture healing
“NICE’s independent Medical Technologies Advisory Committee (MTAC) considered there was evidence to show that using the device in this situation resulted in high rates of fracture healing.”
On the issue of healing after three months, she added: “While there is some evidence that EXOGEN can improve healing in fractures after three months, there are uncertainties. Because of these uncertainties, the modelling of the cost consequences was complex, and the case for the NHS routinely adopting EXOGEN for fractures which had not healed after just three months could not be supported.
“We hope that this guidance will be useful for NHS staff providing treatment for people with long bone fractures that have failed to heal after nine months.”
Clinical experts are suggesting that approximately a third of non-union tibial fractures might be suitable for treatment with the system in the future.
The guidance for EXOGEN is available by clicking here.