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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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