Patients with nagging numbness or weakness in their legs caused by a herniated disk in their lower back may have access to a ground-breaking new surgical implant option, thanks to The CORE Institute’s involvement in a new clinical trial.
A “bulging,” or herniated, disk affects approximately one in 100 people at some point during their life. The condition may create severe pain in the lower back, which can radiate down the leg, causing weakness. The culprit is a tear in the fibrous outer wall, called the annulus, of the spinal disk. The annulus is spongy and acts as a cushion between the spinal vertebrae and allows for flexibility. When the annulus tears, the softer inner portion of the disk can protrude through the tear, placing pressure on important nerves of the spine.
Surgery to remove the compromised part of the disk is usually very successful for relieving pain and restoring function. However, patients with a large annulus tear are at high risk of the disk’s soft interior to once again bulge through the tear. One of the challenges with surgical correction of large herniations is closing the hole that remains in the outer wall of the disk to prevent reoccurrence. For small holes, re-herniation is very uncommon. However, for defects larger than 6mm, re-herniation can occur in up to 25% of cases.
As part of a national clinical trial, The CORE Institute’s Spine Division Director, Ali Araghi, DO, will partner with MORE Foundation — an Arizona-based nonprofit dedicated to studying musculoskeletal and neurological conditions — to help evaluate a new composite implant. This new implant could potentially reduce re-herniation and greatly improve outcomes for these high-risk patients.
The bone-disk connection
A spinal disk has the consistency of a gummy bear and creates a critical interface between its own soft material and the hard bones of the vertebrae in the spinal column. In herniated disk surgery, it’s critical that an implant be able to match the properties of both soft and hard materials.
Enter the Barricaid device, manufactured by Intrinsic Therapeutics. This composite device uses a fabric material that flexes with the soft disk materials attached to a metal anchor that can be secured to the bone. “The fabric portion is inserted into the tear in the disk and unfurls like a flag. The fabric then prevents the disk from protruding through the hole that remains in the disk’s wall,” Dr. Araghi explains.
Although much more data is needed to fully understand the potential benefits of this technology, a large clinical research study conducted in Europe found a 61% reduction in reoperations with the use of the Barricaid device. In the U.S. trial, for which The CORE Institute/MORE Foundation partnership hopes to enroll 20 patients over the course of the next year, Dr. Araghi will use the Barricaid device on a select subset of patients at highest risk of re-herniation.
“When I saw the research on this, it made me feel this really could be beneficial,” Dr. Araghi adds. “Anytime we can improve the quality of care for our patients, it’s exciting and it’s great to be at the cutting edge and forefront of medicine.”
Power of partnership
Conducting clinical research trials at multiple sites across the country comes with extremely stringent guidelines. That’s why MORE Foundation’s involvement in the trial is critical, Dr. Araghi says. MORE Foundation assures guidelines are followed and data is collected to FDA standards. Patients will be monitored closely for one year, but ultimately tracked for up to 10 years to gauge long-term success, said Marc Jacofsky, PhD., MORE Foundation’s Executive Director.
“These partnerships give patients in our community potential access to the latest and greatest cutting-edge technologies, in some cases, years before they are more widely available to the public,” Dr. Jacofsky said.