New Procedure May Offer Alternative to Spine Surgery
Up until recently, patients suffering from severe back pain who didn't respond to the usual treatments of rest, medications or physical therapy, have been left with one final alternative. You guessed it -- surgery. In many cases, spinal fusion was the preferred procedure.
According to Dr. Kevin Pauza -- a spine specialist in Texas -- patients undergoing the spinal fusion procedure did well for only one or two years before needing more help. But Pauza -- a renowned interventional spine specialist, and co-founder and co-owner of the Texas Spine and Joint Hospital -- may be changing that. He invented a procedure that's performed as an outpatient surgery, is minimally invasive, requires no more than a local anesthetic -- and takes about 5 minutes to complete.
Spine problems account for more than 1.2 million surgeries each year in the United States. Of these, about 300,000 are spinal fusion. But spinal fusion is a mixed blessing, at best. It involves the permanent joining of two or more vertebrae -- the bones that compose the spinal column -- so that they don't move. Sometimes this requires metal rods or screws. The only problem with fusion is the spine wasn't created to be rigid, but flexible and pliable. In order to maintain the condition, the vertebrae must have free movement. So the fusion procedure solved one problem, but often created a set of others.
Pauza's solution was to take two components of blood plasma -- thrombin and fibrinogen, which combine to make fibrin -- and inject it into the damaged disc. The substance is applied in what amounts to a caulking gun -- and, like glue, acts like a sealant as it enters the crevices of the bone.
The disc begins to regrow, becoming healthy and normal. However, this method is not available nationally -- yet. Pauza's fibrin solution will be marketed as the Biostat System, which is composed of the Biostat BiologX Fibrin Sealant and an application device. It is currently in the third phase of clinical trials through the Food and Drug Administration.
Meanwhile, Pauza, himself, claims a roughly 86 percent success rate with the more than 1,000 patients he has treated through his private practice.
If all goes according to plan, many back pain sufferers who are facing surgery may have a less invasive, less uncomfortable and more permanent alternative by 2015.
That's when the FDA should be able to render its approval, and the procedure becomes available for public use.