We are in partnership with a team from UCL to research the design and development of surgical guides for spinal surgery for the treatment of scoliosis, especially for young children.
Scoliosis, or curvature of the spine, affects 1-3% of children under the age of 10. It requires a highly complex surgical procedure that involves placing screws into the spine to an extremely high level of accuracy. Even when undertaken by very experienced consultant surgeons, the risks of spinal cord damage are significant, especially when operating on children whose vertebrae are so small.
The UCL team of material engineers, clinicians and radiologists is developing a bespoke surgical guide customised to the body shape of each patient, to help spinal surgeons achieve a high level of accuracy when placing screws into the spine. The design of the surgical guide begins with a preoperative C.T. scan of a patient, which the surgeon uses to determine the precise placement and trajectory of the spinal screws. This is then 3D printed to create a bespoke polymer guide for each patient. It has the potential to benefit many patients, not just in the UK but around the world and especially in developing countries where surgeons may be less experienced.
This use of the guide will also reduce the number of x-rays or C.T. scans required to check every stage of the procedure – these are currently undertaken preoperatively, intraoperatively and postoperatively to check the accuracy of each screw placement, leading to high level of intraoperative radiation. Studies have indicated that children undertaking these procedures are at a very high risk of cancer because of this heavy exposure to radiation.
The interdisciplinary project team is working with clinicians and patients, to ensure its real-world application and has reached the pre-clinical stage, gathering the data required prior to the first in human clinical trial. If successful, it will be the first time that such a product has been available for UK patients with highest level of safety and efficacy data. The team is also developing advanced imaging techniques based on MRI (black MRI) rather than C.T scans, reducing still further the risk of radiation, working with the artificial intelligence team within UCL.
Dr Deepak Kalaskar, Associate Professor of Bioengineering at UCL, who is leading the project says,
‘Without the seed funding from ORUK we would not have got to the stage when we are thinking about getting or first in-man trial or secured a second round of funding. It is playing a big role in the development process and connecting us to sources of funding with the aim of ultimately sharing in our success when, as we hope, the product is clinically validated.’