Elizabeth Hofheinz, M.P.H., M.Ed. • Mon, January 19th, 2015
FREE Software Accurately Predicts Surgical Outcomes 97% of the Time

“Why didn’t they do it before, ” you might think. In the words of Frank Schwab, M.D., his team succeeded by connecting the dots. Dr. Schwab, Chief of the Spinal Deformity Service at New York University’s Langone Medical Center, recently implanted the first customized osteosynthesis rod precisely designed and manufactured to properly realign the individual’s spine. Dr. Schwab is the founder/CEO, board member, and a significant equity holder of Nemaris, Inc., developer of Surgimap, the dedicated software platform used by Medicrea Group for producing this new patient specific device (UNiD rod).

Dr. Schwab told OTW, “Even in residency I was drawn to spinal deformity because there wasn’t much clarity, and thus great opportunity to optimize outcomes or standardize approaches for dealing with a wide variety of deformity problems. As data emerged from multicenter studies we began to see that there are clear patterns of deformity. I collaborated with the Scoliosis Research Society (SRS) and we developed the definitive adult deformity classification system that was based on function and pain.”

“We were able to look at patients’ progress one, two and three years after surgery and to recognize the essential drivers of what determines good outcomes. So much depends on the way we align the key components of the spine. And if we can reach a point of harmony between the shape of the pelvis, lumbar lordosis, and thoracic kyphosis then we can determine the patients’ necessary global alignment. At its core it is a mathematical equation…and our goals need to vary from patient to patient.”

And it works well enough that the SRS has adopted it. “Using this software—Surgimap, which is available for free online—we can accurately measure, simulate surgical realignment and implant needs. In addition, algorithms have been developed that let us predict outcomes in over 85% of cases. In a pre-op meeting with the patient we take the image, simulate the surgical correction, and click the patient specific rod order button. At that point Medicrea is prompted to make a custom patient specific rod in titanium or cobalt chromium alloy that is made in the exact shape needed by the patient (typically lead time 7 days). It takes a great deal of guesswork out of the OR. Ideally, surgeons don’t have to stand around saying, ‘We may need a little more curvature here…and is the rod bend in the right place?’ Up to now, surgeons had to use their hands to bend these very stiff fusion rods and just assume that they were able to form it into the correct shape—but they were never sure if that’s what the patient really needs.”

Surgimap has taken the guesswork out of the process, says Dr. Schwab, resulting in shorter OR time and sets the stage for better patient outcomes. “To date over 100 surgeries have been done using the Medicrea UNiD rod in conjunction with Surgimap, most of which have been in Europe. After the recent FDA approval, however, more and more are being performed here in the U.S. This is a major step forward. It is a translational technology that links science and patient specific planning to improved operative performance. This raises the bar substantially for surgeons and patients. What has prevented others from developing this? There was insufficient clinical data, the algorithms weren’t ready, an adapted planning software was lacking…and this all had to be combined and meet with approval by the FDA. This has finally been accomplished. And it’s a great thing for our patients”