Most people don't enjoy spring cleaning. Barbara Mulville does. For seven months, Barbara lived with severe pain in her back and shooting down her leg.
"People would look at me and say, 'Barb, you can just see the pain in your face.' And I'd say, 'Well, I hurt,'" said Barbara.
Barbara had spinal stenosis, which is a common arthritic condition in the spine. Doctor Antonio Castellvi says typically he would do a fusion surgery, putting two rods in her back. But there's a new option called the Total Facet Arthroplasty System (TFAS) device.
"It reproduces normal to near-normal motion, as compared to some of the other devices we are seeing out there," said orthopedic surgeon Dr. Antonio Castellvi.
The TFAS device allows movement, compared to a rigid spinal fusion surgery.
"We are able to stabilize the spine -- eliminate the pain that comes from the facet joints and still allow motion," said Dr. Castellvi.
Dr. Castellvi has performed 15 TFAS surgeries. Only 150 have been done worldwide. Results have been excellent.
"We know how it works. We know why it works. What we don't know with certainty is, will it be functioning and doing very well 10 years from now, or 15 years from now," explained Dr. Castellvi.
Barbara says the implant allowed her to get back to life without pain.
"I was just so glad, I thought, 'Woo, look at this. I can move. I can walk. It doesn't hurt me,'" said Barbara.
And that means she can also get back to her favorite hobby -- piddling in her garden.
The TFAS device is still in clinical trials, and isn't yet FDA approved. The current study will compare the results of patients who get the TFAS to those that have the standard fusion surgery.
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Background: More than 65 million Americans live daily with chronic back or leg pain, resulting in more than 14 million annual visits to specialists. Many of these patients suffer from spinal stenosis. Spinal stenosis is a condition that commonly affects people over the age of 50 where the joints of the spine, called the facets, can enlarge due to arthritic degeneration. This increase in the size of the facets is often combined with an age-related reduction in the height of the discs between the vertebrae resulting in the compression and irritation of the nerve roots and/or the spinal cord. Patients complain of back pain but especially leg pain when they have spinal stenosis. The pain starts gradually and becomes worse and worse over time.
Standard surgery: Typically, patients with spinal stenosis undergo a spinal fusion surgery. The procedure involves the removal of the disc and the implementation of rods in the spinal area. The surgery does improve the pain the patient had, but it also permanently eliminates the motion of the affected area. Recovery for a spinal fusion surgery can take up to three months. Another concern with this type of surgery is the pressure shifts to discs above and below where the rods are implanted. This has proven to cause problems in those areas over time in 80 percent of patients. Doctors hope a new implant will help avoid these future problems.
TFAS trial: TFAS stands for Total Facet Arthroplasty System. This implant is under clinical study to compare the safety and effectiveness of TFAS to spinal fusion surgery in patients with leg and back pain caused by spinal stenosis. The main difference in TFAS is the design of the implant. It allows near normal movement for the patient after the surgery. The TFAS also allows for a complete removal of the degenerated facets and other spinal structures which can result in a more complete relief of pressure on the affected spinal nerves. The TFAS also eliminates the need to harvest the bone from a patient's hip, which is often done during a standard fusion surgery. By eliminating this, the patient has fewer surgery complications and a faster recovery time. Most patients are back on their feet the day after surgery.
Where it's being studied: TFAS is a new device currently limited by United States law to investigational use within the United States. About 150 TFAS procedures have been done worldwide. There are more than 20 locations in the United States that are part of the clinical trial. For a complete listing of participating surgeons, please visit www.archusorthopedics.com/clinical-trial-sites-c.html
University Community Hospital