The LimiFlex™ Clinical Trial is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of decompression and stabilization with the Empirical Spine LimiFlex™ Paraspinous Tension Band compared to decompression and transforaminal lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) for the treatment of lumbar degenerative spondylolisthesis (Grade I per Meyerding classification) with spinal stenosis. Clinical trial sites will enroll solely LimiFlex subjects or solely TLIF/PLF subjects.
Principal Investigator: Alan T. Villavicencio, MD
Sub-Investigators: Sharad Rajpal, MD, Kara Beasley, DO, Andrew Bauer, MD
Sponsor: Empirical Spine, Inc.
Status: Enrolling patients
Spondylolisthesis & Spinal Stenosis
As we age, our spine changes due to “wear and tear” from normal, everyday activities. Spine ligaments thicken and widen, spinal discs lose height, joints get bigger and your bones may grow spurs. With Spinal stenosis, these changes cause spaces in the spine to narrow and press against spinal nerves. Many people with spinal stenosis also have spondylolisthesis, a type of instability where one spine bone “slips” forward over the one below. Nerve pressure from these conditions can result in leg pain, tingling, or numbness that gets worse when walking or standing and improves when sitting or bending forward.
What is Surgical Decompression & Fusion?
When medications and injections fail to provide lasting relief, a surgical procedure is known as “decompression” is often recommended. This procedure involves trimming or removing the bones and soft tissue pressing against your nerves – thereby relieving pain at the source. However, removing bone increases spinal instability. To compensate for this, surgeons often use screws and implants to “fuse” together segments of the spine to help stabilize them, a process known as “spinal fusion.” Although spinal fusion helps keep the spine stable following decompression, it also eliminates natural motion between spinal bones, which can lead to further problems.
What is LimiFlex?
LimiFlex™ is a new, investigational device used during standard spinal decompression surgery. LimiFlex is designed to stabilize the spine without fusing it, thereby preserving motion in the spine. LimiFlex does not involve any screws or bone grafts, which eliminate the natural motion between spine segments. Rather, LimiFlex is made of two spring-like titanium rods that are wrapped around the back of two spine segments – this provides stability to the spine while also allowing the spine to move in a controlled manner. The LimiFlex device is placed following a standard decompression surgery, typically in less than 30 minutes.