Coflex Device Shows ‘Similar to Superior’ Rates Compared to Fusion Surgery for Lumbar Stenosis
5-year study results about a motion-preserving stabilization device used to treat spinal stenosis in the low back
For people with moderate to severe lumbar stenosis in 1 or 2 vertebral segments, use of a motion-preserving stabilization device called coflex® (Paradigm Spine, LLC) appears to be as effective as fusion when used in combination with decompression, according to a recent study published in the International Journal of Spine Surgery.
“The coflex® procedure is intended to help patients with moderate to severe lumbar stenosis with back pain in addition to leg pain, ” said lead author Michael J. Musacchio, MD, neurosurgeon at NorthShore University HealthSystem, Evanston, IL. The device is approved for use in people with spinal stenosis (a narrowing of the passageway for the spinal cord or spinal nerves) in 1 or 2 adjacent vertebral segments in the lower back (lumbar region).
The coflex® device is placed between two bones in the low back (lumbar spine). The device is designed to stabilize your spine while allowing the bones to move in a controlled manner following a procedure called decompression (relief of pressure on the spinal cord and/or nerves).
“The 5-year results of this study show coflex® to be a durable and lasting procedure for patients with lumbar stenosis, and with low risk and complications,” Dr. Musacchio said. “In fact, in this study, the need for reoperation after fusion increases with time while the need for reoperation after coflex® decreases. There also were fewer major complications that were device related in the coflex® group compared to fusion.”
Study Design and Findings
The study included people (ages 40 to 80) with moderate to severe lumbar stenosis in 1 or 2 spinal segments and up to Grade I spondylolisthesis (meaning that one of the vertebrae being treated had slipped forward no more than 25% of where it normally should be). The patients were randomly assigned to decompression and interlaminar stabilization (D+ILS; n=215) using the coflex® device or decompression and fusion with pedicle screws (D+PS; n=107).
The treatment was successful in a similar percentage of the study groups at 5 years (50.3% of the D+ILS group and 44% of the D+PS group). In addition, a similar percentage of the groups needed a second surgery for stenosis or a revision to the first surgery (16.3% of the D+ILS group and 17.8% of the D+PS group). Both groups showed improvements in disability as well as pain and other symptom scores.
This study confirms that the coflex® device is safe, commented Lali Sekhon, MD, PhD, FACS, FAANS a neurosurgeon with Sierra Neurosurgery Group in Reno, NV, and Adjunct Associate Professor, Department of Physiology and Cell Biology, at the University of Nevada, School of Medicine in Reno and Las Vegas.
Dr. Sekhon wondered whether people in this study could have been treated with decompression alone (because their spines were relatively stable), and suggested the need to compare the effects of decompression plus coflex® with decompression alone. Dr. Sekhon added that the coflex® device should not be used in people with instability (a vertebra that has slipped forward more than 25% of where it should be), and that fusion surgery is necessary for people with true instability in their spine.
Potential Benefits of the Device
“The primary benefits of the coflex® device over fusion are that coflex® is less invasive with shorter recovery times, less risk, and quicker return to normal activities,” Dr. Musacchio said. “Additionally, coflex® preserves the natural motion of the spine while fusion eliminates motion.” Fusion sometimes causes disease in vertebrae around the area that is fused, Dr. Musacchio explained.
“Patients can expect improved back pain and less risk for recurrent spinal disease after coflex®,” Dr. Musacchio said. “This means there will be less need for subsequent treatments and surgeries when coflex is included in the treatment.”
“The coflex® device is not suitable for patients with spinal deformity or instability, those with osteoporosis, or those who have had previous back surgery at the affected level,” Dr. Musacchio said. “It also is not intended for patients with mild disease or without stenosis.”
“The coflex® device is an option that offers patients tremendous benefit with very little risk. Many patients with stenosis are candidates for coflex®, so it is important to ask your spine surgeon if this is right for you,” Dr. Musacchio concluded.