First Ever Multi-Level Artificial Disc Clinical Trial for the Treatment of
Cervical (neck) Conditions Available at Northside Hospital
Local Atlanta surgeon is now enrolling patients in Prestige®
LP Cervical Artificial Disc Clinical Trial
October 26 , 2006
Christopher R. Tomaras, M.D., neurosurgeon, in cooperation with Northside Hospital, is currently enrolling patients in a clinical trial designed to assess the outcomes of patients who receive the PRESTIGE® LP Cervical Disc. The results of the clinical trial will be used to help support an application to the U.S. Food and Drug Administration (FDA) that could allow the approved future use of the device. This is the first multi-level artificial disc study in the United States and, in North Georgia, it is only available at Northside Hospital.
Northside Hospital-Atlanta is home to many of Atlanta's finest surgeons and is equipped with innovative technology including integrated OR suites with robotic and image guided systems for many clinical specialties. The Hospital is one of only two facilities in Georgia, and the only site in North Georgia, to participate in the clinical investigation studying the safety and effectiveness of the PRESTIGE® LP disc.
"We are very excited about the potential for the treatment of our cervical spine patients," said Dr. Tomaras. "The possibility of retaining range of motion represents what could be a substantial advance in the standard of care."
About 200,000 cervical fusion procedures are performed each year in the United States, often to treat painful degenerative disc disease (DDD). Although a natural part of growing older, DDD occurs as people age and their intervertebral discs lose their flexibility, elasticity and shock absorbing characteristics. For approximately half of the population over 40, this process can cause chronic pain, nerve root pathology and spinal cord compression. During a fusion procedure, the degenerated disc is removed and replaced with a bone graft. In time, the bone graft fuses to the vertebrae, creating one solid piece of bone. Many patients become most symptom-free and go back to their normal activities within a very short period of time after surgery.
The PRESTIGE® LP Cervical Artificial Disc Clinical Trial examines the use of an artificial disc - another potential treatment option - at two vertebral levels (C3-C4 to C6-C7).
"Spinal disc replacement offers patients an alternative to spinal fusion," says Dr. Tomaras. "By replacing the diseased disc with an artificial disc, we can hopefully maintain the patient's flexibility and range of motion."
Who is eligible for the study? Patients 18-60 years old who:
- Are not pregnant at the time of surgery
- Have been diagnosed with cervical degenerative disc disease
- Have not responded to non-operative treatment for a period of 6 weeks
- Meet the following conditions as documented by CT, MRI, or plain x-rays: radiculopathy and/or myelopathy with the presence of disc herniation and/or osteophytes
- Require treatment at only two adjacent cervical levels
- Are willing to comply with the study plan
All potential candidates are subject to the above and additional non-listed clinical trial criteria. Patients enrolled in the study must be evaluated by their surgeon at regular intervals for a minimum of two years following the surgery.
In addition to the multi-level study, Dr. Tomaras also is taking patients for a single-level trial to evaluate the safety and effectiveness of the SECURE(tm)-C Cervical Artificial Disc for the treatment of symptomatic cervical disc disease (SCDD) at one cervical level between C3 and C7. Northside Hospital is the only facility in Georgia participating in both single level and multi-level studies.
Northside Hospital is a leader in providing state-of-the-art surgical services. In 2006/07, in the National Research Corporation's annually conducted Healthcare Market Guide study, consumers ranked Northside Hospital number one in Outpatient/Same Day Surgery in the Atlanta Metropolitan Statistical Area. Surgeons on staff at Northside Hospital perform more than 35,000 surgical cases annually for outpatients and inpatients in multiple, specialized operating room suites. New advances in surgical technology allow us to stay at the forefront of the medical field and devote more time to providing the best patient care possible.
For more information about the clinical trial, please contact Dr. Christopher Tomaras,
Peachtree Neurosurgery, at 404-256-2633.
