Data from a post-market clinical study has demonstrated that a force control technology had significant clinical benefits in spinal (thoracolumbar) fusion procedures.
Developed by Neo Medical, the company’s Force Control Technology was found to offer significant clinical benefit versus legacy surgical approaches, including a 58 per cent reduction in implant related revision surgeries.
The study also demonstrated substantial improvements in patients’ postoperative daily function.
The clinical study involved 75 patients undergoing thoracolumbar fusion surgery to treat conditions including trauma, spinal stenosis, and degenerative disc disease.
The data showed a significant reduction in screw loosening, with the Neo Pedicle Screw System (PSS) demonstrating a screw loosening rate of just 2.7 per cent after one year – 3.4 times lower than the 9.2 per cent rate seen in the control group.
The study also demonstrated substantial improvements in patients’ postoperative daily function. At one year post surgery, patients treated using Neo’s technology reported disability scores 38 per cent lower than those in the control group, indicating better daily function.
At the two-year follow-up, the ODI score dropped still further to 19, with significant reductions in back pain, from a baseline visual analogue scale score of 80.3 to 21.6 at one year.
The implant-related revision rate in the Neo group was 4.1 per cent, representing a 58 per cent reduction compared to published data (9.8 per cent).
Jointly led by Professor David Noriega, chief of the orthopaedic department at Hospital Clínico Universitario de Valladolid (Spain), and Dr. Yasser Abdalla, head of neurosurgery at Nordwest-Krankenhaus, Sanderbusch (Germany), the study demonstrated the benefits of the platform in reducing early screw loosening and improving patient outcomes by managing unintended mechanical stress during surgery.
Noriega said: “Limiting unintended stress during thoracolumbar fusion surgery is essential to reducing complications like screw loosening and implant failure.
“Optimising the fixation process with Neo’s Force Control Technology supports real improvements in clinical outcomes and patients’ quality of life.”
Dr. Yasser Abdalla said: “These results highlight how Neo’s Force Control Technology allows us to apply corrective forces effectively while minimising harmful mechanical stress. By protecting both the implants and the patient’s anatomy, we can reduce complications and achieve better outcomes in spinal fusion surgery.”
Neo’s co-founder and CEO, Vincent Lefauconnier, said: “The results of this study highlight the clinical value of our Force Control Technology in reducing some of the most common and damaging complications that too often limit the benefits patients see after surgery.
“Our goal is to move spine surgery beyond the limits of legacy systems, reimagining treatment processes to make them safer, more efficient, and more effective for every patient.”
