Advice
The technology
The technology
The Galaxy UNYCO (Orthofix) is a single-use, modular bar-clamp, external fixation system. It is designed for temporary stabilisation of complex lower limb fractures of the femur, tibia, ankle and foot, including peri-articular fractures, in trauma procedures before definitive treatment.
Screws are drilled into the near cortex only and stay anchored because of the design of the screw tips, which are conical shaped, self-drilling and self-tapping. As the screw tip is inserted into the near cortex, radial preload exerts radial pressure on the cortex, holding the screws in place. A torque limiter supplied with the system makes sure screws are inserted into the near cortex only and do not enter the medullary canal. The fixation is made stable by using the specific large multiscrew clamp for UNYCO screws with 4 UNYCO screws in the same bone fragment.
Galaxy UNYCO is supplied as a sterile, single-use system and the key components include UNYCO screws (designed for diaphyseal bone), UNYCO cancellous screws (designed for metaphyseal bone), UNYCO cancellous screws long (designed for both femoral diaphyseal and metaphyseal area), a large multiscrew clamp for the standard cancellous screws (tibia clamp) and one for the long screws (femur clamp), a 400 mm carbon rod (12 mm diameter), a 350 mm carbon rod (12 mm diameter), a radiolucent hinged foot unit and the power drill torque limiter. The long cancellous screws and the multiscrew clamp for UNYCO cancellous screws long are used for femur fixation. The standard cancellous screws and the related multiscrew clamp can be used for fixing the tibia, foot or ankle.
Innovations
The potential innovation is that the Galaxy UNYCO system is less invasive than other external fixation devices, because it is anchored into the near cortex of the person's bone and the screws do not penetrate the medullary canal or the far cortex of the bone on the opposite side. Instead, the screws are inserted using a torque limiter power drill and are clustered using a dedicated multiscrew clamp to provide stability. The company claims that this will reduce procedure time and the risk of deep bone infection compared with standard care.
Current care pathway
An external fixator is used in 2 main instances: as damage control in patients who are too ill to have definitive treatment and in whom rapid stabilisation of the fracture is needed; and as a treatment option in open fractures with severe soft tissue injury.
NICE's guideline on complex fractures does not give specific guidance on the type of stabilisation or fixation to use (external or internal) for open and pilon fractures. The British Orthopaedic Association's audit standards for ankle trauma (BOAST 12: management of ankle fractures) state that early fixation (on the day or day after injury) is recommended in most patients under 60 years when the ankle mortise is unstable. The use of external fixation may be indicated in the presence of gross instability associated with soft tissue compromise (with or without a fracture), but specialist commentators stated that this type of injury is quite rare.
The British Orthopaedic Association's audit standards for the management of severe open lower limb fractures recommend that centres that cannot provide combined plastic and orthopaedic surgical care for severe open tibial fractures have protocols in place for the early transfer of the patient to an appropriate specialist centre. The primary surgical treatment (wound excision and fracture stabilisation) of severe open tibial fractures should only take place in a non-specialist centre if the patient cannot be transferred safely. The wound, soft tissue and bone excision (debridement) should be done by senior plastic and orthopaedic surgeons. They should work together on scheduled trauma operating lists within normal working hours and within 24 hours of the injury unless there is marine, agricultural or sewage contamination. The 6‑hour rule (to prevent infection, open fractures should be fully managed within a 6‑hour time frame) does not apply for solitary open fractures.
Population, setting and intended user
The Galaxy UNYCO is designed to be used in secondary and tertiary care for both adults and children with lower limb fractures of the femur, tibia, ankle or foot who need temporary stabilisation with an external fixator, and who are likely to be managed in a major trauma centre. Temporary fixation could be a treatment option for patients being transferred to specialist treatment centres for primary surgical treatment (wound excision and fracture stabilisation) of severe open tibial fractures. Specialist commentators have stated that this is likely to be a clinically rare scenario in current NHS practice. When converting to definitive fixation, the Galaxy UNYCO device can be left in place, holding the bone ends in alignment while definitive fixation with a nail or plate is done.
Training is offered by the company during the adoption phase and, according to the company, no advanced surgical training is needed.
Costs
Technology costs
According to the company, the cost of the Galaxy UNYCO system is about £1,600 to £2,000 and it may be procured under NHS England's high-cost tariff-excluded devices scheme. Galaxy UNYCO is a single-use device.
Resource consequences
Galaxy UNYCO would represent an additional cost compared with standard care. There is no evidence to judge the likelihood of claimed potential savings from a reduction in theatre time, the number of X‑rays needed to place the system when compared with bicortical systems or a reduction in infection risk.
Galaxy UNYCO is compatible with the TL‑HEX system and can be used in computer hexapod-assisted orthopaedic surgery.
The Galaxy UNYCO system is currently used in 4 NHS hospitals, 1 of which is a major trauma centre. The company states that it is included in NHS England's high-cost tariff-excluded devices scheme.