EXOGEN ultrasound bone healing system for long bone fractures with non-union or delayed healing

The Committee recognised that the available clinical data on the effectiveness of EXOGEN for treating long bone fractures with non-union show high rates of fracture healing and it judged them sufficient to support the efficacy and utility of EXOGEN treatment. Despite the absence of direct evidence on avoiding surgery, the Committee considered that the assumptions in the cost model were plausible and that EXOGEN is cost saving compared with current management for the treatment of non-union. Overall, therefore, the case for adoption of EXOGEN in the treatment of long bone fractures with non-union was found to be supported by the evidence.

For long bone fractures with delayed healing the Committee considered that the clinical evidence was more limited. In addition there were significant uncertainties about the rate at which healing progresses between 3 and 9 months after fracture, both with and without EXOGEN, and about whether or not surgery would be required if EXOGEN was not used. These and other considerations influenced the Committee's views about the most appropriate assumptions for cost modelling: the model considered to be most appropriate estimated that EXOGEN treatment would be more costly than current management. The Committee therefore judged that the case for adoption of EXOGEN to treat long bone fractures with delayed healing was not supported by the current evidence.