Artificial Disc Clinical Trial to Study Alternative to Spine Fusion.

Approximately 30 spine surgeons throughout the country are now enrolling candidates for an artificial lumbar (back) disc investigational device clinical trail. 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 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.

The artificial disc being studied in the clinical trail, the Maverick™ Artificial Disc has been previously studied in Europe. The Maverick™ Artificial Disc features a metal on metal design with a posterior center of rotation.

While a fusion remains the standard of care, and allows most patients to return to symptom-free normal activities within a very short period of time, the artificial disc clinical trial will study an alternative potential solution for those patients suffering from Degenerative Disc Disease.

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 candidate.

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
• Not pregnant 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. 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.

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

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