Artificial disks set to revolutionize spine care

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Artificial disks set to revolutionize spine care

Rheumawire

Jul 15, 2004

Mann

Rochester, MN - An advisory panel to the federal Food and Drug

Administration (FDA) voted for the eventual commercialization of the SB

Charité III (DePuy Spine/ & , Raynham, MA), an artificial

disk consisting of a polyethylene core that slides between 2 metal end

plates, with a few stipulations regarding teaching programs and patient

follow-up. The FDA is not obligated to follow the decisions of its

advisory panel, but it usually does.

" Charité was 100% approved by a physician industry panel and with

minimal stipulations in regard to a teaching program and following up,

and now we are awaiting FDA approval, " says Dr Hochschuler

(Texas Back Institute, Plano), who conducted some of the studies on

Charité as well as other artificial disks in the pipeline. " I am very

excited about this approval, " he says. " To date, this is the most

exciting thing ever to happen in [spine care]. " He says FDA action is

expected by year-end. Currently, the Charité artificial disk is a

medical device limited by US law to investigational use, but it's

available in more than 30 countries throughout the world.

He adds that the studies in Charité that brought it to this point were

" really flawless. "

In a 2-year study, patients implanted with the Charité disk improved

more quickly than those who underwent fusion surgery. Moreover, patients

who received the artificial disk scored higher on pain and function

scores compared with fusion patients [1]. Patients in the Charité group

were also discharged form the hospital a half-day earlier than

spinal-fusion patients, and the 2 groups were comparable in terms of

complication rates. The results were presented in March 2004 at the 20th

annual meeting of the American Association of Neurological

Surgeons/Congress of Neurological Surgeons (AANS/CNS) Section on

Disorders of the Spine and Peripheral Nerves in San Diego, CA.

In this study, average range of motion in the disk group was 7.4° at 2

years, according to radiographic findings. Disk space height was

restored from an average of 5.7 mm before surgery to 12.9 mm at 2 years

after surgery. After the procedure, 88% of patients were satisfied with

the Charité disk procedure, compared with 81% of spinal-fusion patients.

In disk-replacement spinal surgery with the Charité, the collapsed

degenerated disk is removed and the Charité disk is implantedfirst the 2

end plates, and then the core in the middle, through the use of

specialized instruments. The 2 end plates (made of a cobalt chromium

alloy) are pressed into the vertebrae above and below the disk space,

and teeth along the border of the end plate grip the bone. A

polyethylene core is then placed between the end plates.

" The key to me, after having done this for 30 years, is that the spine

should be treated like the hips and knees, and instead of fusing, we

should maintain motion flexibility and balance and stability, "

Hochschuler tells rheumawire.

Artificial disks have " a lot of advantage, " he says. " It's a revolution,

not an evolution. " Previously, the thinking was that if a patient had a

painful spine, it should be fused, and now the concept is " refuse to

fuse, " he says.

Charité is not the only disk coming down the pike. Others include

PRODISC-C (Synthes-Stratec/Spine Solutions, Oberdorf, Switzerland), the

MAVERICK Artificial Disc (Medtronic Sofamor Danek, Inc, Minneapolis,

MN), and the Actipore Artificial Disc Replacement System (Biorthex,

Montreal, QC).

" Charité has the lead right now and theoretically has advantages, "

Hochschuler says. " It's supposedly biomechanically the most similar to

one's normal disk function, but you have to look at placement and

instrumentation, so there are a lot of debates that are going to arise,

but anatomically it appears that the Charité [is superior], " he says.

When asked about the future of spine surgery, he says, " the ultimate

solution is regenerating your own disk, " but that is still a way off.

Source

Geisler F. American Association of Neurological

Surgeons and Congress of Neurological Surgeons Section on Disorders of

the Spine and Peripheral Nerves; March 17-20, 2004; San Diego, CA.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org