Does Artificial Cervical Disc Equate To Lower Treatment Costs In Patients With Degenerative Cervical Disc Disease?

Main Category: Neurology / Neuroscience
Also Included In: Clinical Trials / Drug Trials
Article Date: 29 Apr 2008 - 0:00 PDT

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Currently, the most common form of surgery for treating cervical degenerative disc disease is an anterior cervical discectomy and fusion (ACDF). More than 200,000 cervical procedures are performed each year in the United States to relieve compression on the spinal cord or nerve roots. Spinal fusion surgery creates a solid union between two or more vertebrae to help strengthen the spine and alleviate chronic neck pain. There are several types of spinal fusion surgery, as well as varied instrumentation used to secure the fusion.

The solid union created between the vertebrae stops the movement between the bones. While this treatment is effective in helping to reduce pain from motion and nerve root inflammation, the limited mobility of the neck may lead to the herniation of other discs over time.

In July 2007, the PRESTIGE ® cervical disc, a product of Medtronic, became the first and only artificial disc to date approved by the Food and Drug Administration (FDA) for use in the cervical spine. The PRESTIGE cervical disc underwent an FDA-approved multicenter clinical trial in the United States, concluding in 2005.

The PRESTIGE cervical disc is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease at one level from C3 to C7, for intractable radiculopathy and/or myelopathy. This is a stainless-steel device with a ball-in-trough design, held in place with bone screws.

While cervical artificial discs have been shown to preserve motion at the operated segment in most patients, their effectiveness in reducing the rate symptomatic adjacent disc problems has not been established; and although this technology is promising, the long-term safety and effectiveness of implanted metal alloys is unknown. Not all patients with symptomatic degenerative cervical disc disease are candidates, and as with all surgeries, there are related risks.

Researchers recently analyzed data on 541 patients who received either the PRESTIGE cervical disc or fusion. The results of this study, The Economic Impact of the Prestige® Cervical Disc System: Results from a Randomized Clinical Trial, will be presented by Vincent C. Traynelis, MD, (the University of Iowa), 9:45 to 9:59 a.m. on Tuesday, April 29, 2008, during the 76th Annual Meeting of the American Association of Neurological Surgeons in Chicago. Co-authors are Joseph Menzin, PhD (primary author), Bin Zhang, MD, Lisa M. Lines, BS (Boston Health Economics, Inc), Peter J. Neumann, ScD (Tufts Medical Center), and David W. Polly Jr., MD (the University of Minnesota).

Direct costs in 2006 US dollars, were defined as the sum of the costs of the initial surgery, secondary procedures, and medical devices. Based on the human capital approach, work productivity was estimated by multiplying the average daily wage by days of work after surgery. Net benefit was calculated as the gains in work productivity minus incremental medical costs. The following results were noted:

Overall, from a societal perspective, the net benefit of arthroplasty versus fusion was $5,988 at 2 years postsurgery.

-- The total direct cost per patient was $380 higher for arthroplasty patients than for fusion patients.

-- The mean initial procedure cost for the arthroplasty group was $947 higher than for the fusion group.

-- Because of fewer secondary procedures, the mean secondary procedure cost for arthroplasty patients was $567 lower than for fusion patients.

-- Arthroplasty patients returned to work following surgery an average of 38 days sooner than fusion patients, yielding a gain in work productivity of $6,368.

Arthroplasty patients had fewer secondary procedures and returned to work earlier than fusion patients. "From a societal perspective, the economic benefits associated with these outcomes may offset the increased device costs associated with arthroplasty therapy," stated Dr. Tryanelis.

Founded in 1931 as the Harvey Cushing Society, the American Association of Neurological Surgeons (AANS) is a scientific and educational association with more than 7,200 members worldwide. The AANS is dedicated to advancing the specialty of neurological surgery in order to provide the highest quality of neurosurgical care to the public. All active members of the AANS are certified by the American Board of Neurological Surgery, the Royal College of Physicians and Surgeons (Neurosurgery) of Canada or the Mexican Council of Neurological Surgery, AC. Neurological surgery is the medical specialty concerned with the prevention, diagnosis, treatment and rehabilitation of disorders that affect the entire nervous system, including the spinal column, spinal cord, brain and peripheral nerves.

Boston Health Economics, Inc. (BHE) is an independent research firm located in Waltham, Massachusetts. BHE was responsible for leading the economic evaluation for this clinical trial.

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