For Back, Neck Pain, Artificial Disc Replacement Has Cost, Outcome Advantages Over Fusion Surgery

ScienceDaily (Mar. 22, 2011) —

When physical therapy and drugs fail to relieve back or neck pain, patients often turn to spinal fusion surgery as a last resort, but two new studies show that in certain situations, especially when several discs are involved, artificial disc replacement may give better long-term results at lower cost.

Hospital costs for artificial disc replacement were 49 percent lower, and four years out from surgery, artificial disc patients were four times less likely to need additional surgery than those who had fusion operations, according to two recently published studies.

"Back pain is the fifth leading cause of hospital admission and the third most common reason for surgery," said orthopaedic surgeon Rick B. Delamarter, M.D., co-director of the Cedars-Sinai Spine Center. "Estimates vary and are probably understated, but health care expenditures for back pain top $91 billion a year, not including indirect and societal costs such as time lost from work and worker's compensation.It is crucial that we develop surgical procedures that are cost effective without sacrificing high-quality results."

Delamarter is a lead author of the two studies, which were published recently in the SAS Journal of the International Society for the Advancement of Spine Surgery and the Society for Minimally Invasive Spine Surgery.

Both studies compared disc replacement surgery with the more common fusion operation to treat degenerative disc disease -- deterioration caused by aging and wear and tear. One study looked at 209 patients with damaged neck discs who received either minimally invasive disc replacement or the more complex spinal fusion surgery. These patients were followed at regular intervals for four years. A separate group of 136 who received an artificial disc two years after the first group also were part of the study. All patients were assessed on their satisfaction with the results of the procedure. The other study focused on 53 patients suffering from three-level, lower back disc disease and looked at cost comparisons for length of hospital stay, resources used and other factors

Discs act as cushions between the bones (vertebrae) of the spine. When healthy, the discs have enough "give" to allow the back to be flexible but are firm enough to provide stability. With age or injury, they lose their pliability and density. Nerves may become pinched between the bones, causing pain not just in the spine but in other parts of the body.

Fusion surgery seeks to relieve symptoms of the degenerative disease by removing the damaged disc and replacing it with bone. Studies show this procedure often can be effective but there can be drawbacks: in some cases, fused spinal sections can lose flexibility, impeding normal movement and stressing adjacent discs, often leading later to more fusion surgery. Artificial disc replacement, which has been performed in the United States since 2000, tends to cause less tissue injury than fusion surgery, and the discs are designed to maintain natural spine movement and reduce need for follow-up surgery.

In their study of patients suffering neck (cervical) disc disease, Delamarter and his colleagues found both disc replacement and fusion surgery acceptable options providing good long-term outcomes. But four years out from surgery, fusion patients were four times more likely to need more surgery. Half of these secondary operations were needed to treat new disc problems occurring adjacent to fused sections.

Patients in the study had imaging scans to measure before-and-after flexibility and range of motion; were evaluated for physical and neurological improvement; and completed self-assessment questionnaires on neck disability, neck and arm pain intensity. Improvements were seen in all categories, regardless of the surgical procedure, but results tended to be at least slightly better in patients with disc replacements.

An important area, according to Delamarter, was patient satisfaction with the procedure. Four years after surgery, nearly 88 percent of disc replacement patients reported that they were very to completely satisfied, compared with 76 percent of fusion patients. When asked if they would undergo the same surgery again, 89 percent of disc replacement patients and 81 percent of fusion patients said yes.

"While the results of this 13-center study are preliminary, it appears that artificial disc replacement surgery compares favorably as an effective procedure, is preferred by patients and slows the rate of adjacent-level disease," Delamarter said.

Spinal fusion has been recognized as one of the more expensive surgical procedures. The second study looked at costs and is believed to be the first to compare those of three-level disc replacement with three-level fusion. It evaluated itemized billing records of 53 patients undergoing surgery for three consecutive discs of the low back (lumbar spine) at St. John's Health Center in Santa Monica, Calif., where Delamarter practiced before joining Cedars-Sinai.

Total hospital costs for patients undergoing disc replacement surgery averaged 49 percent lower than those for fusion patients.

The number of fusions for low back pain is rising rapidly, but Delamarter urges hospitals, insurers and surgeons to consider alternatives, including total disc replacement.

"After safety and effectiveness of a procedure have been documented, cost is an important consideration," he said. "Artificial disc replacement technology appears to offer a promising, cost-saving alternative to fusion, especially for patients with disease at three levels."

The artificial discs implanted in these studies -- the ProDisc-C and ProDisc-L -- were manufactured by Synthes USA Products. Delamarter and his colleagues have evaluated outcomes and written about the devices since the FDA approved them for research and limited use in the United States. Delamarter is a consultant for Synthes and receives royalties on the ProDisc devices. However, he does not receive royalties on devices used for his patients or any other patients at Cedars-Sinai Medical Center.

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Spinal fusion surgery: The science behind Manning's life changing operation

By Christi Sodano | Feb 02, 2012 | Medill Reports Chicago

With his home turf the epicenter of the Super Bowl buzz this season, his younger brother in contention for the NFL championship and a potentially life-changing contract decision only one month away, it is little wonder why Peyton Manning’s recovery is at the forefront of Indianapolis conversation.

Last September, Manning underwent his third neck surgery in two years. The controversial spinal-fusion surgery aimed to correct a cervical disc herniation in his neck has been associated with declines in his on-field performance.

Cervical disc herniation occurs when the cushioned discs, which act as shock absorbers between the vertebrae, bulge and pinch the spinal cord or nerve root that are encased in the spine.

This is generally caused by repeated neck motion or trauma and can result in loss of motor function and numbness or sharp pain, said Dr. Selene Parekh, associate professor of orthopedic surgery at Duke University.

Typically surgery is considered only after the patient has endured prolonged pain of up to six weeks, said Dr. Wellington Hsu, assistant professor of orthopedic surgery at the Feinberg School of Medicine at Northwestern University.

In Manning’s case, disc fragments pinching the nerve root in his cervical spine likely caused acute pain and decreased arm strength.

During the September operation, doctors removed a single disc through a small incision in the front of the neck, alleviating pressure on the nerve root and replacing the disc with bone grafts or a plastic implant. Once the new disc is set into place, the surrounding vertebrae are fused using a titanium plate and screws in the upper and lower vertebrae.

Prior to Manning’s spinal-fusion surgery, he underwent two microdiscectomies in an attempt to correct the problem. After a series of diagnostic tests in September showed his recovery was not on track, spinal-fusion surgery became the next step.

Although the surgery is touted by many industry professionals as more than 95 percent successful, Dr. Kenneth Pettine, an American Academy of Orthopedic Surgeons member, said in a 2010 report, “The perception is that this is a great operation. I’m not saying it’s an awful operation. We’re just presenting the data that it’s certainly not 95 percent.”

“When you get one level fused, the next level up and down has to take all the motion. This very often accelerates into adjacent level dysfunction. That can happen two years later, that can happen 10 years later,” said Shaeffer Bannigan, development engineer at NuVasive, Inc., a spinal surgery technology company.

Hsu, who published a study in 2010 about the likelihood of athletes to return to the NFL after spinal- fusion surgery said, “For a player like Manning, the time frame to play football is closing in and when his arm strength was not improving fast enough, he elected to have the fusion.”

In his study, Hsu analyzed 99 players, some of whom are still on the field, and found on average players treated surgically had a higher return-to-play rate and longer career than players who are treated nonsurgically and position was a key factor in success after surgery.

Performance after surgery largely depends on the player's position and is particularly relevant for quarterbacks, Parekh said.

“Loss of function, even if only by a few degrees, is significant because if neck rotation is inhibited, that can affect your ability to assess what is happening on the field,” he said.

Recovery plans after surgery vary depending on the patient.

According to Parekh’s medical-information blog, the bone usually takes 12 weeks to fuse and after fusion, “a prolonged course of therapy will be needed to regain some of the loss of function, mobility and strength.”

Despite a lengthy recovery process, Hsu speculated that, “Manning will be able to come back to the NFL next year. What his level of play will be after he returns is still yet to be determined.”

However, Hsu’s opinion is not shared by all.

“My personal opinion was that there wasn’t an entirely honest view of what was happening him, there is a real chance that he may never return to play in the NFL,” Parekh said.

View this article in its original publication.