Northern Colorado Surgeon on cutting edge as he implants his first artificial disc for the lumbar (back) spine.

Fort Collins, CO – 7/17/2003 – Dr. Kenneth Pettine of Rocky Mountain Spine Arthroplasty Associates implanted his first investigational artificial lumbar (back) disc. The disc is currently being studied in a national clinical trial. 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. Approximately 200,000 lumbar surgeries are performed in the United States 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. The disc’s design concept is based on decades of total joint arthroplasty experience.

Degenerative disc disease (DDD) is 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 also shrinks.

For those people, suffering from degenerative disc disease, who do not respond to conservative treatment, surgery may be recommended. The most common form of surgery for treating degenerative disc disease 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, a 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.

The purpose of the current clinical trial is to compare the outcomes of patients who receive an artificial disc with those of patients who have a lumbar fusion. Patients who enroll 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 866-647-9405 to find out if you are a potential candidate. Or, for more information on the clinical trail or lumbar (back) disorders, please go to www.back.com/clinicaltrial or visit the Rocky Mountain Spine Arthroplasty Specialists’ website at www.RMSAS.com.

Patients who meet specific inclusion and exclusion criteria will be considered for this study. A few of those criteria are:

Between the ages of 18-70 years, who are skeletally mature

• Not pregnant, nursing, or planning to become pregnant within a year following surgery
• Have not responded to non-operative treatment for a period of 6 months
• Diagnosed with degenerative disc disease, with degeneration confirmed by patient history
• Are willing to comply with the study plan
• Have one or more of the following conditions as documented by CT, MRI, or plain x-rays:
  • Modic changes
  • High intensity zones in the annulus
  • Loss of disc height
  • Decreased hydration

All potential candidates are subject to the above and additional non-listed list clinical trial criteria.

Caution: Investigational Device, limited by Federal (or United States) law to investigational use.