In a March 26, 2014 webinar titled, "Driving Value and Outcomes in the Treatment of Lumbar Spinal Stenosis," Hallett Mathews, MD, Executive Vice President and CMO of Paradigm Spine, LLC, and James Chappuis, MD, discussed the value created by the use of the coflex® Interlaminar Stabilization™ device for treating lumbar spinal stenosis.
"Value is the currency of the future healthcare system," said Dr. Mathews. "We are now moving from a quantity-based system to a quality-based system, so defining value for the treatments we provide is important."
Before approval of the coflex® device, fusion was the only option for stabilization after decompression for the treatment of lumbar spinal stenosis, which is expensive, said Dr. Chappuis. Spinal fusions are also associated with loss of movement, longer recovery times and dependency on narcotics to relieve postoperative pain. The coflex® device outperforms fusion in these areas.
In a Level 1 prospective, randomized controlled trial, Paradigm Spine proved that the coflex® device outperformed fusion in all clinical outcome measurements at two years. Of the patients receiving the coflex® device, 66.2 percent achieved composite clinical success, compared to 57.7 percent of fusion patients. Patients were deemed a clinical success if they had at least a 15-point improvement in ODI, no reoperations, revisions, removals or major device-related complications.
"I've been following this device for awhile now, and it was this study that really sold me on the fact that coflex® is comparable to spinal fusion," said Dr. Chappuis.
Another study titled, "Decompression and Coflex Interlaminar Stabilization Compared With Decompression and Instrumented Spinal Fusion for Spinal Stenosis and Low-Grade Degenerative Spondylolisthesis," published in Spine last year, also showed the benefits of the coflex® device over the use of pedicle screws.
In addition to clinical benefits, the coflex® device and procedure has cost-effectiveness data supporting its use. An analysis of Medicare data shows the potential cost-savings of more than $13,000 in the first year after the procedure and over $14,500 in the second year compared to traditional fusion.
A third study titled, "Comparative Cost-Effectiveness of coflex® Interlaminar Stabilization Versus Instrumented Posterolateral Lumbar Fusion for Treatment of Lumbar Spinal Stenosis and Spondylolisthesis," published in March 2014 in the Journal of ClinicoEconomics and Outcomes Research, showed the coflex® device significantly reduced healthcare costs over five years.
"The pain is minimal as compared to postoperative pain with fusions," said Dr. Chappuis. "In about 10 days we see the patients beginning physical therapy. It allows them to get on their feet quicker and get back to work quicker. It also results in less dependency on narcotics."
For trained spinal surgeons, the coflex® device is easy to incorporate into a medical practice. It doesn't involve trays of new instrumentation or doesn't change any post-anesthesia care unit protocols," Dr. Chappuis said.
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