BCH Clinical Trial Evaluates Alternative to Spinal Fusion

Recently, Dr. Alan Villavicencio of Boulder Neurosurgical and Spine Associates discussed a new clinic trial for a minimally invasive surgical procedure for the treatment of lower back using the LimiFlex™ Paraspinous Tension Band.

As we age, our spine changes due to “wear and tear” from normal, everyday activities. With spinal stenosis, aging may 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. Degenerative spondylolisthesis is a widespread problem in older adults and is one of the most common conditions for which surgery is performed in the US. Symptoms usually consist of low back and leg pain, numbness or weakness in the legs.

The symptoms of patients with lumbar spinal stenosis with or without degenerative spondylolisthesis can sometimes be successfully treated with non-operative treatments such as physical therapy, medications, or injections. Should these treatments fail to provide lasting relief, a surgical procedure to trim or remove bones and soft tissue pressing against the nerves. This process, called decompression, can relieve pain at the source, but also 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.”

Boulder Community Health is currently the only location in Colorado participating in an FDA-controlled clinical trial to evaluate a minimally invasive treatment for degenerative spinal stenosis with spondylolisthesis as an alternative to spinal fusion. LimiFlex™ is a new, investigational device used during standard spinal decompression surgery designed to stabilize the spine without fusing it, preserving the natural motion of the spine. 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 immediate benefits include a minimally invasive procedure with reduced blood loss, shorter operative time and faster recovery. The long-term benefits consist of potentially avoiding drawbacks associated with fusion.

Boulder Neurosurgical & Spine Associates is currently enrolling patients in the trial and the enrollment is expected to continue through December 2020 and then the patients will be followed for 5 years. Patients can see if they qualify for the study by visiting this link: http://www.limiflexstudy.com/ or email to get more information: info@bnasurg.com