A team of surgeons and researchers from Curtin University, Royal Perth Hospital and St John of God Subiaco Hospital are developing an innovative new device to assist the recovery of people with severe bone fractures and those with weak bones due to osteoporosis, particularly in trauma and complex spinal surgery.
In current spinal fusion surgery, two or more vertebrae are fused together to keep the spine stable after injury, infection or removal of a tumour. The procedure requires the use of bone screws to keep plates and bone grafts in place and is a complex process due to the risk of a screw damaging surrounding tissues. In cases of a particularly severe injury or weakened bone, these screws are prone to loosening or un-fastening completely, causing worsened pain and damage and requiring revision surgery.
St John of God Subiaco Hospital Head of Department Neurosurgery Dr Gabriel Lee said using 3D printing, the group had created a titanium expandable bone screw, which allows stronger bone fixation than a traditional screw.
“When people break their bones surgeons can use implants such as plates or rods to attach the bones back together. These implants are attached to bone using conventional screws during surgery,” Dr Lee said.
“However, if the bone is weak due to osteoporosis in older patients or the fracture is particularly severe then these screws may loosen or pull-out. This may re-injure the patient and require them to undergo a repeat surgery, which is not only a poor outcome for an individual but also an additional burden to the healthcare system.”
“Unfortunately, this happens more often than we would like. With shoulder fractures, repeat surgery is required for more than 1 in 7 people and complications leading to ongoing problems can be present in more than half of people aged over 60.”
Curtin biomedical engineer for the project, Matthew Oldakowski, is also a faculty member for the 2017 SPARK Co-Lab Design Course in which aspiring medtech innovators design new medical devices. Fellow biomedical engineer, Intan Oldakowska, who is also working on the project, was a participant in the Design Course in 2016 and is a mentor for one of this year’s groups.
Matthew says his experiences in developing the product have allowed him to help the Design course teams on their own innovation journeys.
“The best way to understand a complicated and nuanced process like inventing and commercialising a medical device is to do it, which is exactly what we have the SPARK teams do from investigating unmet clinical needs all the way to pitching to investors for funding. Having been through the same process so recently means I understand the mindset of the teams I’m guiding, which I think is a big help in giving them good advice.”
Matthew says the patented design is the key to the screws functionality and has been made possible in part by the development of 3D printing with titanium which has been investigated in collaboration with Professor Tim Sercombe from University of Western Australia.
“Our early work demonstrated that our expandable screws attach more strongly to the bone and so may prevent the screw from loosening or pulling out.” he said.
“The novel design allows the screw to be easily expanded and able to be safely removed if required, which sets them apart from other expandable screws currently in the market.”
Recently the NHMRC provided a $414,000 Development Grant to the team, led by orthopaedic surgeon Professor Markus Kuster, to take the research to the next stage of development. The funding will allow additional safety testing in the laboratory to strengthen its commercial potential, with the hope that a clinical trial will start in three years.
The work has been made possible in part by financial support from St John of God Subiaco Hospital and Curtin University, who are co-funding Matthew Oldakowski’s postdoctoral research fellowship, Kickstart funding from Curtin University as well as in-kind support from the Medical Engineering and Physics Department at Royal Perth Hospital. Collaborators at the University of Western Australia and University College London are also assisting with developing the expandable screw.
Matthew Oldakowski and Intan Oldakowska, Curtin Biomedical engineers who are working on the device.