Galaxy UNYCO for temporary stabilisation of lower limb fractures

The technology described in this briefing is Galaxy UNYCO. It is a single-use device used for temporary stabilisation of lower limb fractures of the femur, tibia, ankle and foot.

The innovative aspects are that Galaxy UNYCO is claimed to be less invasive than other external fixation devices. This is designed to reduce procedure time and the risk of deep bone infection.

The intended place in therapy would be in place of current external fixation devices for people with complex lower limb fractures needing temporary stabilisation. This is likely to be a clinically rare scenario in current NHS practice.

The main points from the evidence summarised in this briefing are from 5 studies (including a total of 13 adults) in a hospital setting (in France, Germany, Italy and Switzerland), 4 case studies and 1 observational study, only 1 of which has been published in a peer-reviewed journal. The studies suggest that Galaxy UNYCO can provide effective temporary fixation for tibial and ankle fractures.

Key uncertainties around the low quantity of evidence are that there is no direct comparative evidence to determine if patient outcomes would be different to those having other forms of fixation, such as bicortical fixation.

The cost of Galaxy UNYCO is £1,600 to £2,000 per unit. The cost of standard external fixation (reusable) is about £2,400. The resource impact would be an increase in costs compared with standard care.