Paradigm Spine published new results from a clinical trial examining the coflex Interlainar Stabilization after decompression for lumbar spinal stenosis.
"Surgeons appreciate the effectiveness of providing stabilization after decompression for advanced degenerative lumbar spinal stenosis," said Hallett Mathews, MD, MBA, EVP & CMO of Paradigm Spine. "The long-term results discussed in this article provide Level 1 evidence that fusion stabilization may no longer be the gold standard for spinal stenosis patients."
The authors examined patients for four years to report long-term results. There were 344 patients enrolled and randomized in the study with an 85 percent follow-up rate at four years. The researchers found:
1. The success rate, described as no second intervention and an ODI of 15 points or more, was 57.6 percent of the interlaminar stabilization patients and 46.7 percent of the fusion patients.
2. When adding adjacent level success to both cohorts, and maintaining foraminal height in the coflex cohort showed a CCS of 36.6 percent in the interlaminar stabilization group and 35.6 percent in the fusion group.
3. At the five-year follow-up in the United States PMA study, the trends are expected to continue to show interlaminar stabilization provides superior outcomes to posterolateral fusion after decompression for spinal stenosis.
4. Adding the lack of fusion in the interlaminar stabilization cohort and successful fusion in the fusion cohort there was a CCS of 42.7 percent in the interlaminar stabiliziton group and 33.3 percent in the fusion group.
5. Dr. Mathews anticipates payers will embrace the findings as evidence of interlaminar stabilization's ability to provide durable and sustained therapeutic benefits for patients.
"All interested stakeholders, including patients, physicians, payers, providers and policy makers are critically focused on long-term data and sustainability of therapeutic treatment effects and we are pleased to see this study provide definitive long-term evidence of the positive clinical attributes of coflex Interlaminar Stabilization," said Marc Viscogliosi, Chairman and CEO of Paradigm Spine.