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The Washington Hospital, February 2003

Innovative surgical procedure for treatment of degenerative disc disease
performed first time in region at The Washington Hospital
Washington only hospital in tri-state area to take part in major study; disk inventor on hand

An innovative new surgical procedure designed to treat degenerative disc disease took place Wednesday, March 5, 2003 at The Washington Hospital. Donald Whiting, M.D., a neurosurgeon at the hospital, led a surgical team in the implantation of the BryanŞ Cervical Disc prosthesis into a 44-year-old woman from Atlasburg, Washington County.

The procedure is part of a study of about 550 patients nationwide focusing on the BryanŞ Cervical Disc prosthesis, a new method of treatment for patients with neck and/or arm pain and nerve and/or spinal cord irritation due to degenerative disc disease that has not improved significantly following at least six weeks of standard conservative treatment. Dr. Whiting believes his patient is an ideal candidate for this procedure after non-surgical therapies did not relieve her symptoms.

The Washington Hospital is the only hospital in the tri-state area, one of only 21 hospitals in the United States, and the only community hospital participating in the Investigational Device Exemption (IDE) clinical study. Data from this study will be used in support of a future marketing application to the FDA.

"The Washington Hospital is honored to be included in a very select group of hospitals taking part in this study," said Telford W. Thomas, president and CEO at the hospital, who added that the hospital participates in various, selective research studies. "We are proud that Dr. Whiting's leadership and the medical excellence embodied by our neurosurgery professionals will be playing a major role in this study."

Dr. Vincent Bryan, inventor of the prosthesis, was in the operating room to observe the procedure. The purpose of the study, which compares the Bryan implant to surgical fusion--the standard way of treating this disease--is to show that the Bryan implant is safe and effective.

Cervical disc disease affects about half the U.S. population over age 40. Herniation, resulting from disc degeneration or injury, occurs when a portion of the disc bulges out between two vertebrae. This bulge may impinge on the spinal cord or nerves, resulting in irritation of the cord or nerves. The growth of bony spurs on the vertebrae can result in the same symptoms.

Each year, about 200,000 cervical spine procedures are performed to remove an impingement on the spinal cord or nerve root, and implant metal plates to rigidly fuse, or "weld," the vertebrae together. This fusion of the vertebrae limits a patient's ability to move the neck, and increases the stress on the discs above and below the fusion.

"This procedure is expected to produce early and long-term relief of neck and arm pain or nerve irritation--or stop an increase in spinal cord symptoms--by removing the diseased disc and replacing it with an artificial disc," said Dr. Whiting, principal investigator in the study.

A major benefit of artificial disc replacement is that it allows a patient to continue to have a normal range of movement in the neck This should lead to less stress on the discs above and below the ones being treated. Also, the use of the Bryan implant prevents the need to create a surgical opening in the patient's hip to get the bone graft that is used in many fusion operations.

The BryanŞ Prosthesis was previously studied in Europe and is now in use there. Last spring, Canadian surgeons implanted the first BryanŞ Prosthesis in that country. The disc is manufactured by Spinal Dynamics Corporation of Seattle, WA.

How the Bryan prosthesis works

--The Bryan cervical disc is made of two titanium shells, two titanium wires, a polyurethane nucleus, a plastic sheath, and two titanium seal plugs.

--The plastic nucleus is shaped to fit between the two dome-shaped cells. The side of the shell that rests against the bone includes a rough-textured coating to allow for potential attachment to the bone, a process called biologic ingrowth.

--The sheath is a small, strong sheet of plastic that surrounds the nucleus and is intended to hold in any particles that may wear off of the nucleus. To hold the sheath in place, the two titanium wires are placed around the sheath and then seated in grooves at the edge of the shells. When attached, the sheath and the two shells form a closed compartment.

--Holes are located at the top of each shell, through which a sterile saline lubricant is injected into the closed compartment. Seal plugs screw into the holes to seal the compartment and help to keep the lubricant in the compartment before the device is implanted.

--The implant is held between the two neck bones where the shape of the implant shells has been milled (carved) into each bone. Because of this fit, the device should have no significant sideways movement. A small part of the top shell that extends up and a small part of the bottom shell that extends down is intended to prevent it from moving backward into the spinal cord.

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