Guidance
3 Committee considerations
The evidence
3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 4 sources, which was discussed by the committee. The evidence included 2 retrospective case series, 1 retrospective cohort study and 1 prospective cohort study. It is presented in the summary of key evidence section in the interventional procedures overview. The committee also considered data available from the US Food and Drug Administration website. Other relevant literature is in the appendix of the overview.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: correction of the scoliosis, maintenance of spinal mobility and quality of life.
3.3 The professional experts and the committee considered the key safety outcomes to be: osteolysis, pain, infection, metallosis and damage to adjacent structures.