Lumbar Artificial Disc Clinical Trials Currently Being Performed
by Two Colorado Doctors.

Kenneth A. Pettine, M.D., Co-Inventor of the Maverick™ Artificial Disc, and E. Jeffrey Donner, M.D., to Perform Procedure on Patients with Degenerative Disc Disease

Loveland, CO. June 19, 2003 – Dr. Kenneth Pettine and Dr. Jeffrey Donner, of the Rocky Mountain Spine Arthroplasty Specialists, are now enrolling candidates for an artificial lumbar (back) disc investigational device clinical trial. The clinical trial will be used to help support an application to the U.S. Food & Drug Administration (FDA) that could allow the approved future use of the device. Approximately 200,000 lumbar surgeries are performed in the United Sates every year. These surgeries usually entail a fusion often with the use of instrumentation such as rods, screws and cages. The Maverick™ Artificial Disc could potentially offer another option to patients who suffer from degenerative disc disease (DDD). The disc’s design is based on decades of total joint arthroplasty experience. Dr. Pettine is a co-inventor of the Maverick™ that Medtronic Sofamor Danek currently holds the patent to produce and market.

DDD is a part of the natural process of growing older. As people age, their intervertebral discs lose their flexibility, elasticity and shock absorbing characteristics. Discs are gel-like cushions that act as shock absorbers between each of the bones of the spine. For approximately half of the over 40 population, this process can cause several different symptoms, including back pain, nerve root pathology and spinal cord compression. These symptoms are caused by the fact that worn out discs are a source of pain because they do not function as well as they once did, and as they shrink, the space available for the nerve roots and the spinal cord shrinks.

For those people, suffering from DDD, who do not respond to conservative treatment, surgery may be recommended. The most common form of surgery for treating DDD in the lumbar (back) spine is a spinal fusion. During a fusion procedure, the degenerated disc is removed and a bone graft, taken either from the patient’s iliac crest (hip area), a donor (cadaver) bone or a bone graft substitute is inserted in-between the two vertebrae located above and below the removed disc. Often, metal implants are then attached to the two vertebrae to stabilize the area until the bone graft can fuse to the vertebrae creating one solid piece of bone.

“I am grateful that the FDA provided me the opportunity to work with my original invention in a fashion that will allow me to see the results through in patients,” said Dr. Pettine.

The purpose of the clinical trial is to compare the outcomes of patients who receive an artificial disc with those of patients who have a lumbar fusion. Patients enrolling in the clinical study will be randomly assigned a treatment group. Approximately two-thirds of the patients will receive the Maverick™ Artificial Disc and one-third of the patients will receive the control treatment.

If you are interested in being considered a candidate for the Maverick™ Artificial Disc clinical trial, please call Rocky Mountain Spine Arthroplasty Specialists at 1-866-647-9405 to find out if you are a potential candidate. Or, for more information on the clinical trial or lumbar (back) disorders, please go to www.back.com/clinicaltrial.

The Maverick™ Artificial Disc and artificial disc implant are an investigational device and procedure, limited by Federal (or United States) law to investigational use.

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