MAVERICK™
Clinical Trials
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 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 866-548-7425 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. |
