Spine Surgeons Speak Out About Artificial Disc Replacement

CHARITÉ™ Artificial Disc
DePuy Spine, Inc.

Rick Delamarter, MD Orthopaedic Surgeon The Spine Institute at Saint John's Health Center Santa Monica, CA

In my opinion, the artificial disc is the most revolutionary technology to hit spine surgery ever. It relieves pain while retaining motion, all without the need for fusion. It's easier on patients and the recovery is quicker. I am very encouraged.

Michael Fehlings, MD Professor, Division of Neurosurgery Krembil Chair in Neural Repair & Regeneration University of Toronto Toronto, Ontario, Canada

Disc replacement represents an exciting new treatment option for back pain associated with lumbar degenerative disc disease. The recent clinical trial with the CHARITÉ™ Artificial Disc appears promising. There are a few potential concerns, however. While artificial discs appear safe when used in experienced hands, they are not for everyone. Patients with multi-level lumbar pathology are less likely to benefit than patients with one-level of lumbar disc degeneration.

There are potentially serious operative risks that the patient needs to consider before opting for an artificial disc. No patient should consider this option without first trying high-quality non-operative treatments for at least six months. Patients should also be aware that the long-term outcomes of artificial discs are still not well-known and that revision surgery may be required down the road.

Richard G. Guyer, MD Orthopaedic Surgeon Co-Founder and Fellowship Director Texas Back Institute Plano, TX

Disc replacement is the most significant advancement since the modern treatment of spinal disorders began 70 years ago. Further, disc replacement introduces a new era of motion preserving surgeries that will include facet joint replacement, nucleus replacement, and minimally invasive motion preservation devices.

The lives of millions of patients will change for the better. Having been one of the original United States (US) investigators during the Food and Drug Administration (FDA) study of the CHARITÉ™ Artificial Disc during the last four and one-half years, I can honestly say that this is one of the most satisfying operations that I perform. To see patients who have suffered with chronic back pain for years only to return to normal pain free lives is truly amazing.

But the patient must be wary, because not all patients can expect to be "normal". The FDA study of the CHARITÉ™ Artificial Disc showed that patients had less pain and better function than the fusion patients and that they were happier. They were not however totally pain-free. In my personal series, about 40% of patients were pain-free while the others were improved. The challenge for the patient is to have realistic expectations. Not every patient will be able to be pain free or "hit the home run", as I explain to my patients.

We have learned through our studies that patient selection is extremely important and proper placement of the artificial disc is important to obtain the best possible results. The challenge for the surgical community is to select patients by adhering to the same strict criteria of the study, obtain proper training in the implantation of these devices, and perform the surgery properly to maximize the results.

Isador Lieberman, MD, MBA, FRCS(C) Orthopaedic and Spinal Surgeon The Cleveland Clinic Foundation Cleveland, OH

A few points to make regarding artificial disc technology:

• Disc replacement represents a whole new spectrum of treatments for patients suffering from degenerative discs.

• The indications for disc replacement are limited - this will not be the absolute cure for all that ails the spine.

• Surgeons who perform this surgery must be trained and should have past experience with anterior spine surgery.

• The risks include misplacement, dislodgement, injury to surrounding organs and vessels during implantation, as well as all of the usual risks of spinal surgery.

• The longevity of artificial discs is yet known. If it only lasts 10 years, the patient will definitely need further surgery.

• Revision disc replacement surgery will be a life-threatening operation.

• As of now, insurance reimbursement for this procedure has not been verified.

• Patients need to remember that back pain is not life threatening, but spinal surgery can be.