Institutional review board approves Life Spine’s electrodiagnostic functional assessment study

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A study to help determine outcomes for open vs. minimally invasive posterior lumbar spinal surgery has been approved by the Western Institutional Review Board. The study is being run by LifeSpine and the Oklahoma Spine and Brain Institute (Tulsa, USA).

The purpose of this study is to determine whether open posterior lumbar interbody fusion (PLIF) or midline lumbar interbody fusion (MIDLIF)—using Life Spine’s Nautilus thoracolumbar pedicle screw system and Centerline thoracolumbar cortical screw system hardware—is less traumatic to the patient, if it produces better functional outcomes, and if certain patients are better suited for particular surgeries.

The goal of this study is to better quantify the approach and outcomes by demonstrating muscular injury and recovery by comparing a baseline pre-operative EFA (Electrodiagnostic functional Assessment) to post-operative EFA tests obtained at specified times, and thus comparing two surgical techniques to determine which demonstrates faster muscular recovery and better functional outcomes.

“This study is unique because for the first time ever, in addition to using questionnaires, surgical outcomes are being assessed by the EFA which measures soft tissue, muscular injury, and recovery. To date there is substantial expense for ongoing treatment and narcotic use to control pain. Under these complicated circumstances medical providers are challenged to find treatments that are less invasive and traumatic that lead to quicker and better recovery time,” says Frank Tomecek, principal investigator.

Co-investigator MaryRose Reaston, says, “We are pleased to take part in a ground-breaking research study by being able to document muscle pathology and improve patient care.”

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