Becker's Spine Review

Becker's Spine Review Jan/Feb 2017

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17 Executive Briefing Sponsored by Interlaminar Stabilization® Fills the Spinal Stenosis 'Transition Zone' — And Now Payment Codes Are Catching Up By Laura Dyrda L umbar spinal stenosis affects 8 percent to 11 percent of people in the United States; by 2021, around 2.4 million Americans are expected to have spinal stenosis. The typical spinal stenosis sufferer is more than 50 years old and can present with varying degrees of the disease. For years, there were two options for treating spinal stenosis patients: a simple decompression or decompression and spinal fusion. Treatment options The two most common treatment options are at the opposite ends of the spectrum. A simple decompression can provide the patient with temporary pain relief, but often eventually that patient will need additional procedures including redecompression and often the addition of spinal fusion. However, moving to a fusion too quickly limits the patient's range of motion and puts them at risk for adjacent segment disease. "Clearly lumbar spinal stenosis is very prevalent," says Hallett Mathews, MD, MBA, executive vice president and chief medical officer for Paradigm Spine. "It's a huge part of the aging population. We are healthier, more active and we want to do our athletics and aerobics. But certain people have progressive degenerative diseases, which makes it difficult to engage in everyday activities; sometimes people can't even walk to the mailbox. When conservative care fails, patients have the choice of continuing on that path or undergoing surgery. But not all patients need the most aggressive treatment; everyone needs a different thought process for stenosis management." In the article "Spine surgery for patients in the transition zone" published on the Becker's Spine Review website on Nov. 10, 2016, Todd H. Lanman, MD, of Beverly Hills, Calif.-based Lanman Spinal Neurosurgery, discussed the middle section between the decompression and fusion — the "transition zone." New solutions are emerging for patients in the transition zone: disc replacement and Interlaminar Stabilization®. Both solutions are more permanent options to alleviate the patient's pain and preserve motion. Based on his experience, Dr. Mathews sees spinal stenosis patients fall on a bell curve; around 20 percent need a simple decompression and 20 percent require fusion, but the 60 percent in the middle may be candidates for Interlaminar Stabilization®. Clinical evidence In 2012, the FDA granted pre-market approval to Paradigm Spine's coflex® Interlaminar Stabilization® device designed to fit at one or two contiguous levels in the L1-L5 interlaminar space. There is strong evidence published in the literature to support the clinical outcomes, proving equal or superior to the other available treatment options. For the pre-market approval, the company examined 344 patient outcomes, with a 90 percent follow-up rate. The data shows: 1. A 57.6 percent success rate for Interlaminar Stabilization® and 46.7 percent success rate for fusion; the study authors defined success as patients who reported Oswestry Disability Index scores of 15 or more and who didn't undergo a second intervention. 2. Important clinical success of stenosis surgical management — described as the absence of adjacent level issues and maintaining foraminal height — was 36.6 percent in the Interlaminar Stabilization® group and 35.6 percent in the fusion group. 3. When considering the lack of fusion in the Interlaminar Stabilization® cohort and successful fusion in the fusion cohort, the composite clinical success rate was 42.7 percent in the Interlaminar Stabilization® group and 33.3 percent in the fusion group. "The rules changed in 2015 and now in 2017 we can see a significant policy shift toward traditional procedures that were only being done in the inpatient setting going into the outpatient setting." -Dr. Hallett Mathews

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