Vertos Medical has released the results of an independent, retrospective cohort study which found that 88% of lumbar spinal stenosis (LSS) patients avoided surgical lumbar decompression for at least five years after receiving the minimally invasive lumbar decompression (mild®) procedure.
The data which was based on procedures conducted at the Cleveland Clinic (Cleveland, USA) between 2010 and 2015, showed that nine out of 75 patients required lumbar surgical decompression at the same level during the follow-up period, making the annual incidence of same-level lumbar-decompression surgery just 2.4%.
Subjects experienced statistically significant pain relief and reduction of opioid medications utilisation at three, six and 12 months compared to baseline. There were also no major complications reported.
According to Vertos Medical, mild® is a clinically proven outpatient procedure that removes a major root cause of stenosis through a portal the size of a baby aspirin and requires no implants, no general anaesthesia, no stitches, and no overnight hospital stay.
LSS study patients had hypertrophic ligamentum flavum (HLF), a thickening of the interspinous ligament that accounts for up to 85% of spinal canal narrowing. HLF may cause neurogenic claudication symptoms involving back or leg pain when standing or walking that is relieved when sitting or bending forward, as a contributing factor.
Changes in pain level using the Numeric Rating Scale (NRS) and opioid medication utilisation using Morphine Milligram Equivalent dose per day from baseline to three, six and 12-months post-mild® procedure were also collected, along with post-procedure complications.
The study was conducted at the Cleveland Clinic by lead author Nagy Mekhail, and director of evidence-based pain management research at Cleveland Clinic.