Life Spine, Emerge Diagnostics, and Oklahoma Spine & Brain Institute Announced Today That They Received Approval from the Western Institutional Review Board to Conduct a Study Utilizing Electrodiagnostic Functional Assessment (EFA)
Study to Determine Outcomes for Open (PLIF) vs Minimally Invasive (MIDLINE) Posterior Lumbar Spine Surgery
HUNTLEY, Ill.--(BUSINESS WIRE)--Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, is pleased to announce the approval of the study to help determine outcomes for Open vs. Minimally Invasive Posterior Lumbar Spine Surgery.
The purpose of this study is to determine which procedure, open PLIF or MIDLIF, using Life Spine’s NAUTILUS® Thoracolumbar Pedicle Screw System and CENTERLINE® Thoracolumbar Cortical Screw System hardware, is less traumatic to the patient, produces better functional outcomes, and to evaluate if a patient type is better suited for a particular surgery. 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,” said Frank Tomecek, MD FAANS, Principle Investigator.
MaryRose Reaston, Ph.D. CSO Founder Emerge Diagnostic and a Co-Investigator, said, “We are pleased to take part in a ground breaking research study by being able to document muscle pathology and improve patient care.”
“The study provides a comparative platform to help determine which technique demonstrates faster muscular recovery and better functional outcomes. This is an exciting opportunity for use of both Life Spine’s cortical bone screw and traditional pedicle screw systems,” said Mariusz Knap, Vice President of Marketing for Life Spine. “We continue to focus on advancements that strive to improve surgical efficiencies, ease of use and reliability of PLIF and MIDLINE systems, thus providing the highest value of care to our customers and patients.”
About Life Spine
Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.
About Emerge Diagnostics
Headquartered in Carlsbad, CA Emerge Diagnostics is delivering a new way to determine the location and age of soft tissue injuries. The Company provides comprehensive technology and Emerge is leading the way with technological development and ongoing innovation to improve patient outcomes and provide better care. For more information, visit emergedx.com.
About Oklahoma Spine and Brain Institute
Oklahoma Spine and Brain is a Tulsa, OK based neurosurgery group focused on care of the spine and brain. Oklahoma Spine & Brain Institute is a private practice neurosurgical group, dedicated to delivering the highest quality neurosurgical (spine and brain) care possible. We provide this level of care through compassion, technology, education and quality neurosurgical health care to each person we serve. By concentrating on our special areas of interest and expertise, we can fulfill our goal of becoming the leading provider of neurosurgical services in northeast Oklahoma. In this age of "Managed Care", we always place quality of care above cost considerations. We pay close attention to patient confidentiality. Our physicians are some of the most experienced, well-trained neurosurgeons in this part of the country. http://www.oksbi.com/
Life Spine is a registered trademark.
Mr. Omar Faruqi
Chief Financial Officer