PoSTuRE (Patient Specific Scoliosis Treatment) offers a solution for people with scoliosis, a curvature of the spine. In the Netherlands, 4 in 1000 people have scoliosis, with serious cases requiring surgery. This involves correcting the spine and securing it with metal screws and rods. Says Paul: ‘Initially, we were looking for a solution for very young children. Because they're still growing, you can’t set the spine. This will impede the development of the chest, which can lead to lung problems. So rather than setting, you want to correct and allow growth. To do this, we used DSM’s ultra-strong Dyneema fibres to develop flexible cables that slide over metal rods. This corrects the back while allowing children to continue growing.’
These GEM power cables (named after the work location of the partners involved from Geleen, Exton (US) and Maastricht) were also found to be very effective in adults with a distortion of the spine and of particular benefit to people aged 50-plus, whose bones lose density due to osteoporosis. Says Paul: ‘In this age group, stress often occurs at the point where the rigidly fixed section meets the rest of the spine, which is still flexible, causing screws to come loose and vertebra to sometimes collapse or fracture. One in three patients will end up needing further surgery. Fixing the spine with the slightly springy cables eases this stress at the point of transition, potentially avoiding further surgery.’
‘We’ve done a lot of work in four years’, says Paul. ‘There are lots of steps to go through in getting a product to the market, and every last detail has to be registered in order to meet the requirements. In our case, we had to do this not just for the cables, but also for the leader (a thick needle that allows us to attach the cable around the vertebral arch), and the tensioning device used to adjust the tension of the screws. We couldn't have done this without our partners, including the Eindhoven University of Technology, DSM, and MDProjects. It's a question of pioneering, making connections, and establishing a network in which you share knowledge and strengthen each other. InSciTe certainly helped us here. To get from bench to bedside, you have to deal with so many layers, authorities, and companies. You can’t do it alone.’
‘In our hospital, we're the first department to conduct a First in Man trial with our own product,’ explains Paul. ‘Being a co-product developer is something new for our hospital. So this project is a learning curve for us and the rest of the hospital. Because of this, we’ve also worked closely with our own clinical trial center (CTCM). They will soon be able to make sure that other departments benefit from the knowledge we’ve gained and the network we've built.’
The first patient results are still some way off. Says Paul: ‘We’ve been ready for four months, but elective care has been scaled back due to COVID. It will be July 2021 before we can operate on the first patients. For these patients, the expected benefit is a greatly reduced likelihood of repeat surgery. The test data in the laboratories are encouraging, now we have to back this up in clinical practice.’
Reoperation is now needed for one in three patients who have undergone a traditional spine correction. The new scoliosis treatment aims to reduce complications that require further surgery. This single treatment would improve the quality of life of many patients , reduce the number of clinical treatments and improve patients’ participation in work. That spine correction surgery has a major positive impact, both on personal lives as on employability, is illustrated by one of Paul’s patients:
"Before the operation, I could hardly stand for 10 minutes or I had the feeling that my back was just collapsing and I couldn't stop it. I also had to rest in the afternoon to recover. In addition, I had a numb, painful feeling in my right leg, as if it were constantly asleep. After the operation, I am much straighter and can work for hours during the day without having to rest. That annoying pain in my leg is also gone. I have my life back.
Paul Willems was trained as an orthopaedic surgeon with an additional 1-year certified AO-Spine Fellowship at the Sint Maartenskliniek, Nijmegen. He has devoted his clinical and research practice to Spine Surgery at the Maastricht University Medical Center (MUMC+). Paul is leader of the Spine Center Maastricht, a multidisciplinary setting for evaluation and treatment of patients with spinal disorders, and his clinical practice is devoted to the whole spectrum of instrumented spine surgery in first, second and third line of care. Scientifically he has a special interest in deformity and degeneration of the spine, osteoporotic fractures and translational research in scoliosis. Since December 2016 he has been active as project leader of Posture, a translational InSciTe project that aims to improve and renew surgical techniques for the treatment of early onset scoliosis and adult spinal deformity with the use of Dyneema® sublaminar wires.