Clinical Study Results Treatment Options
In two separate U.S. clinical trials, the Prestige LP™ cervical disc proved to be a safe, effective alternative to spinal fusion for patients with cervical disc disease at one or two adjacent levels.
TWO-LEVEL FDA APPROVAL
Dr. Jack Zigler explains that only two artificial discs are approved by the FDA for use at two adjacent levels. Dr. Zigler is with the Texas Back Institute in Plano, Texas.
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The Prestige LP cervical disc, used in a type of spine surgery called cervical disc replacement, has been evaluated in a clinical study for the treatment of radiculopathy (damage or trouble with nerve function that results if one of the nerve roots near the cervical vertebrae is squeezed) and/or myelopathy (disease in the spinal cord) related to single-level cervical disc disease.
This prospective (looking forward in time), non-randomized study was conducted in the United States and involved 545 patients with 280 investigational patients receiving the Prestige LP cervical disc and 265 control patients who had received anterior cervical discectomy and fusion (ACDF) in a study that had been done earlier. ACDF is a surgery from the front of the neck where a spinal disc is removed to address symptoms; the disc space may then be stabilized with a device, such as a plate, to serve as a brace while fusion occurs.
Patients in the study had to be at least 18 years of age with symptomatic, single-level cervical disc disease and were not helped by nonsurgical treatment for at least six weeks. Some of the results at 24 months after surgery are described below. Refer to the patient brochure or ask your doctor for more details about this clinical study and its results.
Risks of the Prestige LP cervical disc include, but are not limited to: neck pain and/or arm pain and development or progression of disease at other cervical levels.
|Results at 2 Years||PRESTIGE LP 1-Level||ACDF|
Surgery with the Prestige LP cervical disc may relieve the arm pain and/or neurological symptoms (such as weakness, numbness, or tingling) you are experiencing due to the damaged discs you have at two adjacent levels that are irritating your spinal cord (myelopathy) and/or spinal nerve roots (radiculopathy). In addition, the Prestige LP cervical disc is designed to allow motion at the two levels where you have surgery, unlike ACDF fusion surgery which is designed to treat symptoms by eliminating motion.
Some of the results from the clinical trial of the Prestige LP cervical disc at two years after surgery are described below. The clinical benefit beyond two years has not been fully evaluated. Refer to the patient brochure or ask your doctor for more details about this clinical trial and its results.
The trial was prospective (looking forward in time) and involved 397 patients (209 patients who received the Prestige LP cervical disc at two adjacent levels and 188 patients who underwent a fusion procedure, ACDF, at two adjacent levels).
|Results at 2 Years||PRESTIGE LP 2-Level||ACDF|
100 out of 196 (51.0%) had more than four degrees of motion at both treated levels while bending the head forward to backward (flexion-extension).
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