Orthopedic Surgeons at Jefferson to Study Safety of Artificial Disc for Patients with Cervical Disc Degeneration
(PHILADELPHIA) Thousands of patients with chronic pain in their shoulders and arms could benefit from a study being done at
The Rothman Institute at Thomas Jefferson University Hospital, Philadelphia. Orthopedic and neurosurgeons specializing in
spinal surgery there are participating in a U.S. Food and Drug Administration-approved clinical study assessing the safety
and effectiveness of an artificial disc for use in the treatment of chronic cervical disc degeneration in the neck.
Leading this randomized, controlled study is Todd J. Albert, M.D., a spine surgeon at The Rothman Institute, and professor
and vice chair of orthopedic surgery at Jefferson Medical College. “The intent of cervical disc replacement is to offer spine
surgeons an alternative to the current standard of spinal fusion,” said Dr. Albert, who also serves as co-director of Reconstructive
Spine Surgery and the Spine Fellowship Program at Jefferson. “The goal is to offer relief from pain and other symptoms while
retaining motion at the treated joint.”
Pain associated with spinal problems is one of the most common reasons for visits to a physician in the United States, with
nearly 80 percent of all Americans suffering from at least one significant episode of neck or back pain in their lifetime.
In fact, this type of pain is the leading cause of disability among people 19 to 45 years of age and represents 16 percent
of all workers compensation claims.
For the majority of patients, pain and weakness in the arm and shoulder, caused by problems with the cervical discs, is resolved
with conservative, noninvasive treatments. When such treatments no longer provide relief, the primary solution has been the
removal of the affected discs, and fusion of the vertebral segments. Though spinal fusion surgery is highly successful in
these cases, it results in loss of motion in the fused joint. It is estimated that nearly 400,000 people in the U.S. undergo
fusion procedures each year.
The artificial disc being studied by the Rothman Institute orthopedic surgeons is constructed of the same materials used in
artificial hip and knee replacements. It comprises two cobalt chromium alloy endplates surrounding a special grade plastic
core. Together, these components could help restore--or at least maintain--motion in the affected vertebral segments after
removal of the diseased disc and bone. Doctors are increasingly interested in finding ways to relieve the pain of cervical
disc degeneration in patients without eliminating movement in the related joint.
Among other requirements that must be satisfied to participate in the study, a patient 1) should be between the ages of 18
and 65; 2) must be diagnosed with a degenerative disc in the cervical spine; 3) have been unresponsive to non-surgical treatments
for six weeks; and 4) have had no more than one previous surgical procedure.
The Rothman Institute at Jefferson is world renowned for expertise in virtually every orthopedic procedure including total
hip replacement; total knee replacement; revision hip and knee replacement; cartilage repair and transplantation; knee, shoulder,
elbow and ankle arthroscopy; anterior cruciate ligament (ACL) reconstruction; disc surgery; spinal fusion surgery; cervical
spine surgery; scoliosis surgery; shoulder rotator cuff repair; shoulder reconstruction; elbow reconstruction and epicondylitis
surgery; foot and ankle fusion; bunion surgery; and ankle ligament reconstruction.
The PCM® (Porous Coated Motion) Artificial Disc being studied is produced by Cervitech Inc., headquartered in Rockaway, N.J.
Patients who think they might qualify and who want to be considered for this study, can call Thomas Jefferson University Hospital
directly at 1-800-JEFF-NOW and request information about The Rothman Institute artificial cervical disc study.
Media Only Contact:Jeffrey A. BaxtThomas Jefferson University Hospital
Phone: 215-955-6300
Published: 1-4-2006