4.1 No studies were identified that included avoiding surgery as a result of treatment with EXOGEN as an outcome measure. In addition, no studies presented data on return to weight bearing and normal daily living after EXOGEN treatment, compared with surgery.
4.2 The Committee considered that any effective treatment that avoids or reduces the need for surgery is of significant benefit to patients and also has potential advantages to the NHS in terms of resource use. Such advantages might include reducing the duration of NHS care, the number of outpatient visits or the number of X-rays that patients need.
4.3 The Committee considered that the healing rates reported across the clinical studies indicate that surgery can be avoided and that healing time can be reduced by treatment with EXOGEN. The Committee heard persuasive comments from a patient expert about the benefits EXOGEN treatment can provide in terms of return to activity and quality of life.
4.4 The Committee discussed the proportion of patients who might avoid surgery as a result of treatment with EXOGEN. The Committee was advised by clinical experts that approximately one third of non-union tibial fractures might be suitable for treatment with EXOGEN, although estimates of the total number of non-union long bone fractures varied.
4.5 The Committee noted that treatment with EXOGEN is self-administered, and therefore some patients may need help when using the device. The Committee was told by the patient expert and clinical experts that the device is easy to use and can be administered by a carer instead of the patient.