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Anne Arundel Medical Center participates in numerous clinical trials for new patient treatments and to learn more about ways to prevent and diagnose disease. The mission of Anne Arundel Medical Center is to ensure that patients and community members have every opportunity to participate in Clinical Trials. Clinical Trials are research studies that have been approved by the hospital's Institutional Review Board (IRB) for research involving human subjects. Patients must voluntarily agree to take part in the study and will receive a copy the informed consent document that they will sign. Only through research can we learn more about disease. For questions or additional information please contact:
The IRB Office at (443) 481-1320 or
The Research Integrity Officer/ Human Protection Administrator at (443) 481-1520.
New Disc Replacement Device Provides Increased Range of Motion
Neurosurgeon Gary Dix, M.D., implants a new disc in a patient suffering from discogenic pain as part of a clinical trial to examine its efficacy and safety.
AAMC is one of only three locations in the Mid-Atlantic region conducting research into an exciting spinal disc technology that examines the efficacy and safety of a new device to alleviate discogenic pain.
AAMC neurosurgeon Gary Dix, M.D., along with his partners Brian Sullivan, M.D., and Timothy Burke, M.D., are involved in a nationwide multicenter clinical trial for the new disc replacement device, the Kineflex disc.
“We are convinced that this disc surgery can be helpful to many people with back and neck problems, and are currently evaluating patients to see if they are good candidates for this procedure,” said Dr. Dix.
The Kineflex disc implant is designed to alleviate pain in the spine caused by degenerative disc disease (DDD). DDD, a condition characterized by narrowing of the disc space between two vertebrae, is extremely common. While it is estimated that about 85 percent of the population shows some evidence of disc degeneration by age 50, only a very small percentage are symptomatic enough to warrant surgery. Aging discs can be brittle, dehydrated, and less flexible, and they also lose their ability to act as “shock absorbers.” In addition, discs can be damaged by spinal trauma.
“Disc replacement is really the first wave of innovations as we try to move away from fusion, especially in younger, more active individuals with degenerative disc disease,” explained Dr. Sullivan. “The Kineflex system built on the ideas of the first generation of disc replacements and will likely be a great addition to our armamentarium.”
In the past the most common treatment for DDD has been fusion surgery. Implantation of the Kineflex disc is a fairly new procedure in the U.S., although artificial discs have been used in Europe and South Africa for many years. More than 500 patients in South Africa have received Kineflex disc implants.
“The Kineflex disc is innovative because of the materials used, the way it is constructed, and the range of motion it allows,” said Dr. Dix. “It is especially helpful in cases where patients need help with degenerative disc problems at a relatively young age.”
The Kineflex disc is made of titanium in a cobalt chromium alloy. The metal-on-metal device is designed to potentially minimize wear on the spine and improve longevity and performance. It is constructed with scored sections called keels or fins that keep the disc positioned in the spine, and has a flexible locking mechanism that allows for bending in all planes and greater translational motion, explained Dr. Dix.
“Some devices are limited in the way they allow a person to twist, rotate, and bend forward and backward,” said Dr. Dix. “This disc is constructed to mimic the motion of the cervical and lumbar discs in their natural setting.”
The Kineflex trial includes disc devices for both cervical and lumbar replacements. For more information about the Kineflex trial and a wide range of other AAMC clinical trials, contact askAAMC at 443-481-4000.
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Spine Clinical Trials
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