In October of 2018, the Norwegian Institute of Public Health (NIPH) has published a single technology assessment regarding the external ultrasound stimulation - Exogen™ in the treatment of femoral or tibial non-union. This assessment was commissioned by the Commissioning Forum in the National System for Managed Introduction of New Health Technologies within the Specialist Health Service in Norway. The Forum requested the Norwegian Institute of Public Health to evaluate the efficacy, safety and health economic documentation for EXOGEN™ compared to surgical treatment for the management of patients with non-union of a fracture.
The identified results are very low as the studies of high quality were not found. No conclusion is provided regarding the effects of EXOGEN™ compared to surgery for patients with non-union fractures. The assessment of the cost-effectiveness of EXOGEN™ in comparison to alternatives was not possible.
The key conclusions from the report are provided below:
Efficacy and safety :
- Studies using patient history as controls suggest that EXOGEN™ induces healing in non-union fractures. Data from studies examining surgery as the treatment option also indicate that surgery induce healing of non-union fractures. However, as the interventions has not been compared directly in the same study, using the same kind of patients, it is not possible to estimate or conclude on which treatment option has the highest healing rate or fastest healing. Thus, there is no reason to assume equal efficacy. Heterogeneity within the studies for each of the interventions does not favor pooling data to get more precise estimates of effect and safety. In conclusion, the present documentation does not give evidence to assess the clinical effectiveness of EXOGEN™ for the treatment of non-union fractures compared to surgery, nor sham;
Cost-effectiveness:
- The submitted model shows that EXOGEN™ is the dominant treatment. The EXOGEN™ device would in this case be considered cheaper and give higher effectiveness in patients having non-union fractures. However, because of the very low quality of the data on clinical effectiveness, we are unable to assess if EXOGEN™ is cost saving or not, compared to surgical treatment.
See the main results of the assessments in Norwegian and English here.
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