Leo
07-12-2003, 06:03 PM
WMC chosen for study
By TARA WESTREICHER Star-Tribune staff writer
The Wyoming Medical Center is one of 27 sites in the U.S. recently chosen to participate in a study of the effectiveness of an artificial cervical disc, the hospital announced this week.
The product, called the Prestige Artificial Cervical Disc, is manufactured by Medtronic Sofamore Danek USA, of Memphis, Tenn.
WMC says 550 patients nationwide will be chosen to participate in the study, which will compare the long-term surgery results of those who get the artificial implant and those who undergo the standard surgery that implants human bone and fuses two vertebrae.
"The study imposes several restrictions to keep results 'pure,'" said Joseph Sramek, M.D., of Central Wyoming Neurosurgery, CWN.
The implant is designed to closely match the function of a normal spinal disc space and intended to provide patients with more normal neck movements after surgery, the hospital reported.
Other surgeons participating in the study are Robert Narotzky, M.D., also of CWN, and Clayton Turner, M.D., of Casper Orthopedics.
To qualify as a candidate, a patient may not have scheduled surgery. A patient also cannot sign up specifically to get the artificial implant, Sramek says.
"Recipients must be chosen randomly from the study group," he explains.
In addition, a patient cannot have had any previous cervical spine surgery and the patient's cervical disease can only be present in one "level," or site, of the cervical spine to be considered for the study.
The hospital says patients who are accepted into the study will be required to get periodic checkups for two years after their surgery.
Medtronic says it will pay participants $300 and provide the device if a patient's insurance won't cover it.
Beyond that, the patient is responsible for the cost of the surgery.
The actual price of the device has not been determined, corporate officials say, because the product is not yet on the market.
Once the study is complete, Sramek says it could take two or more years before the Federal Drug Administration approves the disc for public use.
By TARA WESTREICHER Star-Tribune staff writer
The Wyoming Medical Center is one of 27 sites in the U.S. recently chosen to participate in a study of the effectiveness of an artificial cervical disc, the hospital announced this week.
The product, called the Prestige Artificial Cervical Disc, is manufactured by Medtronic Sofamore Danek USA, of Memphis, Tenn.
WMC says 550 patients nationwide will be chosen to participate in the study, which will compare the long-term surgery results of those who get the artificial implant and those who undergo the standard surgery that implants human bone and fuses two vertebrae.
"The study imposes several restrictions to keep results 'pure,'" said Joseph Sramek, M.D., of Central Wyoming Neurosurgery, CWN.
The implant is designed to closely match the function of a normal spinal disc space and intended to provide patients with more normal neck movements after surgery, the hospital reported.
Other surgeons participating in the study are Robert Narotzky, M.D., also of CWN, and Clayton Turner, M.D., of Casper Orthopedics.
To qualify as a candidate, a patient may not have scheduled surgery. A patient also cannot sign up specifically to get the artificial implant, Sramek says.
"Recipients must be chosen randomly from the study group," he explains.
In addition, a patient cannot have had any previous cervical spine surgery and the patient's cervical disease can only be present in one "level," or site, of the cervical spine to be considered for the study.
The hospital says patients who are accepted into the study will be required to get periodic checkups for two years after their surgery.
Medtronic says it will pay participants $300 and provide the device if a patient's insurance won't cover it.
Beyond that, the patient is responsible for the cost of the surgery.
The actual price of the device has not been determined, corporate officials say, because the product is not yet on the market.
Once the study is complete, Sramek says it could take two or more years before the Federal Drug Administration approves the disc for public use.