More than 60 million Americans suffer from some type of chronic back or leg pain. And for those who can’t find relief among conservative care options, surgical treatment may be required. A new spinal motion-preservation device is currently in clinical trial across the United States for patients suffering from chronic lower back and leg pain caused by spinal stenosis and/or spondylolisthesis.

This clinical trial is investigating the effects of the Total Facet Arthroplasty System (TFAS®), a motion-restoring implant suggested as an alternative to instrumented fusion after complete facetectomy. Instrumented fusion has been the surgical standard of care for spinal stenosis because of its effectiveness in stabilizing the spine and reducing pain. But the elimination of motion at the fusion level has often been implicated in further degeneration of the spine at adjacent levels. Additionally, fusion requires prolonged patient immobility and a lengthened time for healing of the bony fusion.

“TFAS is a great device because it allows a relatively rapid healing time and maintains natural motion,” says Barton Sachs, MD, board-certified orthopedic spine surgeon and physician executive at the Plano-based Texas Back Institute. “Patients are recovering quickly, and we’ve seen excellent results so far. We’re excited about the future of the trial.”

TFAS® treats lower back and leg pain caused by moderate to severe spinal stenosis and/or grade one spondylolisthesis. Degenerative spinal stenosis is the term describing a narrowing of the spaces in the spine that can lead to spinal cord or nerve root compression. Degenerative spondylolisthesis is the slippage of one vertebra relative to another that’s caused by facet deterioration and arthritis. This new implant system has the potential to stabilize the affected vertebra without rigidly fusing the bones and without completely removing the intervertebral disc. TFAS is designed to allow patients to maintain a quality of motion similar to what they had before the onset of debilitating back and leg pain.


“The Total Facet Arthroplasty System is a breakthrough device. It’s the most advanced system for treating facet joint degenerative disease that preserves motion with a reconstructive operation. The concept for this surgery is consistent with standards of treatment for degenerative hip and knee-joint-advanced arthritis,” says Sachs.

Chronic pain in the lower back region, along with the radiating leg pain that often accompanies it, is usually initially treated with physical therapy and other noninvasive therapies for as long as possible. When such treatments no longer provide relief, the current standard of care is removal of the overgrown bone and facets, and fusion of the vertebral segments. The intent of TFAS is to provide patients with an alternative to fusion that will reduce the pain without permanently restricting the motion of the spine.

The trial is a U.S. IDE, multicenter, prospective, randomized trial. Dr. Sachs recently spoke about the TFAS clinical trial at the 2008 North American Spine Society’s annual meeting. Sachs presented the midterm results from the U.S. IDE, which involved 104 patients undergoing lumbar decompression and facetectomy. The average age of the patients is 65 years old and ranges from 51 to 85 years. Follow-up is 24 months. Only patients meeting strict inclusion are enrolled.

The device is implanted via an open posterior surgical approach, is fixed within the spinal pedicles, and is intended to provide immediate alignment and stabilization of the spinal segment at a single spinal level. The device is modular, so it can be individually constructed for each participant to compliment his or her unique anatomy. Facet arthroplasty, as nonfusion restabilization of the spine, is a relatively new concept in spinal surgery.

Clinical evaluation included the Zurich Claudication Questionnaire and Visual Analog Scale for back and leg pain. Neurologic status was assessed pre-operatively and at one, three, six, 12, and 24 months, postoperatively. Range of motion via flexion-extension radiographs and freedom from complications are also assessed.

This early data suggests that the device successfully restores motion, provides stability and allows for clinically significant reduction of preoperative symptoms. Noteworthy is the reduction in back pain, which may be attributed to the motion-preservation properties of TFAS.

Patients who have received TFAS through the trial are already speaking its praises. Sachs performed the TFAS procedure on patient Ron Kaipus in September 2006. The Richardson, Texas-resident was one of the first 40 people worldwide to receive TFAS. He is now back on the golf course and enjoying his life to the fullest. At age 67, he doesn’t “miss a beat” and is grateful for being virtually pain-free.

“I’m back to my old self,” says Kaipus. “It truly gave me my life back. I can sum it up in one word: wonderful!”

Before Kaipus received TFAS, he was diagnosed with a L4-L5 degeneration and arthritis. He visited various chiropractors for years before seeking the help of Sachs at the Texas Back Institute. His condition prevented him from enjoying many parts of his life, including his biggest passion: golf. Sachs first tried injections to relieve his pain before weighing the options of spinal fusion and TFAS.

“I was walking the day after surgery,” Kaipus says. “I’d recommend it to anyone in a situation like mine.”

Sachs was involved with the early device design and development back in 2004, and he explains that Texas Back Institute was chosen to conduct this branch of the clinical trial because of its strong history and experience with successful IDE-FDA studies. “TBI’s track record for conducting a clinical trial study was, and remains, extremely attractive for any company desiring to advance new technology into clinical applications,” Sachs adds.

“I expect the pace of patient enrollment to increase during 2009. Based on personal experience and early observations, I anticipate continued help for more patients with degenerative lumbar disease that causes neurologic pain and disability,” says Sachs.

The study is expected to finish enrollment in 2009. However, with the usual approval process, the final approval for use by physicians may not occur until 2011 or 2012.

– Texas Back Institute