Advice
The technology
The technology
The Neo Pedicle Screw System (PSS; Neo Medical) is a sterile, single‑use pedicle screw system designed for use during spinal fusion surgery in adults. It comprises several differently sized rods, 14 screws, 5 core instruments and several smaller tools. Two rods are used per surgery to stabilise the vertebrae. The screws are long-arm, fenestrated, polyaxial (with monoplanar conversion option), double-threaded and self-tapping as standard.
The 5 core instruments are:
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an awl for breaking the cortical bone in open surgery
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a stefi to measure which screw is needed
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a screwdriver and a T‑Handle
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a rod holder for use during minimally invasive surgery.
The system also includes:
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4 spring steel guide wires to help place the screws
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a pedicle probe
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a rod measurer
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a counter-torque to help with tightening
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a screw-tower removal tool (the rods are delivered through screw towers into the screw head deep in the tissue, and tightened in place with set screws)
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a removable screw-tower to replace an original tower if needed.
Spinal fusion surgery uses bone grafts to make a bridge between adjacent vertebrae to strengthen the spine. It is used to treat back or leg pain caused by pressure on the nerves of the spine, from conditions such as degenerative disc disease or trauma. Bone grafts can be taken from the person's own bone at the surgical site, or donated or artificial bone can be used. Screws and rods are used to strengthen the graft.
The Neo PSS allows the placement of single‑use screws into the pedicle of the vertebral body. The screws are placed at multiple spine segments around the bone graft and act as anchor points for the rods. This stabilises the segments of vertebrae that are being fused.
After the vertebrae have fused the screws and rods are normally left in place, unless the surgeon decides that removal is more beneficial. The manufacturer provides a revision kit for this additional surgery if needed, which includes 4 small revision screws, a screwdriver, a counter-torque and a removable screw-tower.
Innovations
The potential innovations are that Neo PSS contains fewer components in fewer trays than standard instrument sets. For example, some pedicle screw systems can contain over 400 screws; the Neo PSS contains only 14 screws while aiming to provide similar functionality. This is designed to take up less storage space and, by using fewer instruments and fewer screws, to potentially streamline surgery. The screws in the Neo PSS are also covered with a plastic sheath which keeps the screws sterile until contact with the pedicle. This is designed to minimise the risk of infection.
Current NHS pathway or current care pathway
Spinal fusion surgery can be used to treat low back pain caused by severe degenerative disc changes, by fusing 1 or 2 levels of the lower spine. It is usually only done after 6 to 12 months of non-surgical treatment.
The NICE guideline on low back pain and sciatica in over 16s recommends that spinal fusion surgery should not be used for this indication unless in a randomised controlled trial. NICE interventional procedure guidance on lateral interbody fusion in the lumbar spine notes that it has serious but well recognised complications, so should only be done by an experienced surgeon for people with life-limiting symptoms that have not responded to medical management.
Current spinal fusion surgery uses larger single‑use and reusable pedicle screw systems to implant the screws. The screws and instruments in reusable systems must be repeatedly sterilised and have a limited shelf-life. The Neo PSS would be used as an alternative to these single‑use or reusable systems.
NICE is aware of the following CE‑marked device that appears to fulfil a similar function to the Neo PSS:
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SteriSpine (Safe Orthopaedics).
Population, setting and intended user
The Neo PSS is intended for use during spinal fusion surgery for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, tumour, pseudoarthrosis or failed previous spinal fusion. In 2009/10, over 4,000 spinal fusion operations were done in the NHS. This was a 14% increase on the previous year (Rushton et al. 2015). By 2012/13, this had increased further to 6,500 operations (Greenwood et al. 2016).
The Neo PSS would most likely be used for skeletally mature patients over the age of 18, who need spinal fusion surgery. The system will most likely be used by spinal, orthopaedic and trauma surgeons and neurosurgeons. In‑house training is needed for both surgical and nursing staff before using the system to ensure familiarity with its use. A product specialist from the distributor provides this training as well as advice during surgery if needed.
Costs
Resource consequences
The Neo PSS would be used in the same setting by the same surgeons who use existing pedicle screw systems. No additional facilities or products are needed for Neo PSS, and it should need less storage space.
Repeatedly sterilising reusable screw systems can corrode the screws and instruments, which increases the chances of metal fracture and implant failure. A sterile single‑use system, such as the Neo PSS, could be cost saving to the NHS if there were a reduced incidence of implant fracture or failure. The screws are supplied in a protective sheath designed to keep them sterile up to the point of insertion which, if it resulted in fewer infections, could reduce the associated costs. There is currently no evidence to support these potential resource benefits.
The Neo PSS is currently being used in 2 NHS trusts.