Medical Update: FDA Approves Innovative New Treatment for Neck Pain

33-year old Tina Cockrell couldn't cuddle her child. Nor could she lift a bowling ball, walk her two rambunctious dogs or get through a workday without going home sick.

"Life was miserable," she said.

But now, thanks to a titanium implant device recently approved by the Food and Drug Administration (FDA), Cockrell's routine has changed, and her life has changed. After years of suffering the debilitating pain of degenerative disc disease, she's among a growing number of patients who've benefited from a new surgical treatment option: the BAK/C Cervical Interbody Fusion System.

In addition to offering a better chance of recovery and fewer complications than other surgeries, the system has an added benefit: "I'm freed from painkillers," she said.

Designed for patients like Cockrell who have severe neck, arm or shoulder pain caused by degenerative disc disease, the procedure involves implanting a cylindrical, titanium alloy device in the cervical (neck) portion of the spine to relieve pain.

Sulzer Spine-Tech (www.spinetech.com) developed the BAK/C system in 1994 and tested it for seven years under clinical supervision by some of the nation's leading neurosurgeons and orthopedic surgeons. Now that it has received FDA approval, the BAK/C system offers new hope to a growing number of people with degenerative disc disease.

Degenerative disc disease

Originating in the neck but affecting other parts of the body as well, degenerative disc disease typically is associated with aging, injuries or trauma from accidents or athletics, smoking and poor diet. If untended, it can gradually immobilize a person, stripping the ability to work and enjoy many outside activities.

Those who suffer from it often undergo a series of treatments to relieve their pain, including physical therapy and chiropractic treatments. When they've exhausted those options, patients often elect to have spinal fusion surgery, a procedure that uses bone material to replace a degenerated spinal disc and literally fuses two vertebra together to stop them from pinching sensitive nerves.

In 1999, 118,000 people had some form of cervical spine fusion surgery to correct degenerative disc disease. That number is expected to increase more than 20 percent over the next few years, according to a recent report by brokerage Merrill Lynch.

Pain in the neck ... and beyond

Pain associated with degenerative disc disease is rooted in the cervical region of the spinal column. This area consists of seven bones, or vertebrae. Located between each vertebra is an elastic-like ring containing a small mass of tissue that has the consistency of crab meat. These discs act as a kind of shock absorber as the spine moves.

When the disc between two vertebrae degenerates, the vertebrae may grate against each other. Also, with movement, the vertebrae may pinch or rub on sensitive nerves that lead to the arms and hands. This can cause symptoms such as shaking in the arms or hands, numbness, severe to immobilizing neck pain, severe migraine-like headaches, decreased strength, abnormal sensations or altered reflexes.

In Cockrell's case, a whiplash injury from an auto accident at 17 started her on the road to the disease. Over time, pain prevented Cockrell from taking part in many activities at home and at work, including her favorite activity, bowling, which she has been enjoying since she was 5 years old. After sitting at a computer four to six hours a day for her job, often, Cockrell's pain would intensify to the point where, upon arriving at home at the end of the day, she would simply need to rest on the sofa or bed for the rest of the evening.

"The headaches made me so snappy," said Cockrell, "that people would steer clear of me. It got to the point where I didn't want to go to work because I'd come home sick."

Eventually, Cockrell took the advice of her physician and opted for surgery using the BAK/C system to relieve the pain.

A new treatment option

"The BAK/C system is a different way to do traditional cervical fusion surgery that has unique benefits," said Cockrell's physician, Michael Copeland, M.D., Ph.D., an attending neurosurgeon at Independence Regional Hospital, North Kansas City Hospital and Liberty Hospital in the Kansas City area.

In traditional cervical spine surgery, the space between the vertebrae, where the degenerated disc once was, is refilled with a small piece of bone taken from the patient's hip or from a bone bank. In time, the vertebrae may fuse, or join together. In addition to the piece of bone, some surgeons may place a metal plate at the fusion site to strengthen it. With such surgery, the patient may wear a neck brace for a few weeks or longer.

The new BAK/C system minimizes the need for a separate operation to harvest bone from the patient's hip or to use donor bone. Because of the BAK/C device's unique design, bone material is scraped from the vertebrae as the BAK/C is implanted. This bone material rotates into the center of the BAK/C device where it begins to grow and fuse the two vertebrae together. In addition, because the BAK/C device is made of titanium, it provides instant stability, which in turn, improves the fusion process and provides improved use of the neck.

"The remarkable thing is how much less pain there is, versus typical procedures," said Copeland, who performs up to 100 such operations per year. "Patients are often leaving the hospital the next day and many don't have to wear a neck brace because the BAK/C device provides instant stability."

Because it is placed between the vertebrae, a stabilizing plate is generally not required, which further reduces or eliminates a patient's discomfort, Copeland said. "Procedures like this have the potential to alter the way we practice medicine."

A new outlook on life

Six weeks after her surgery, Cockrell said she feels very good. "With the old procedure, I would have been in a neck brace for weeks. This way, I was home the next day. And while I can't lift a bowling ball yet, I can now turn my neck without discomfort, and I'm not tossing and turning in bed like I used to."

The BAK/C system and the surgical procedure are generally reimbursed by most healthcare plans.

Courtesy of ARA Content, www.ARAcontent.com, e-mail: info@ARAcontent.com