The SpineMark Clinical Research
Organization at Texas Back Institute in Plano, Texas, has taken the next
step in offering patients multiple treatment options for spine care. Spinal
fusions continue to be the standard of care for treating many disabling
degenerative spinal conditions. But spinal fusions are not appropriate for
everyone. In a move to provide patients with alternative therapies,
SpineMark CRO at TBI is now enrolling patients in several clinical trials
using motion preservation spinal devices aimed at maintaining natural
movement.
Back pain has become a way of life for more than 50 million people in
the United States. In 2005, an estimated 1 million surgeries were performed
to correct spinal problems. That number exceeds the combined total of
surgeries to replace hips or knees. The growing number of people with
degenerative disc disease has created a major industry based on spinal
fusion technology and products.
Today, the treatment of back pain and spinal problems is at a major
crossroad. On one side is the public's desire to address chronic back pain
through less invasive methods. The result has put a focus on new
technologies that use smaller surgical incisions, or other methods aimed at
preserving motion of the disc space, many without the need for fusion. On
the other side, the FDA and spine surgeons in the U.S. are showing
restraint in order to properly evaluate these new techniques before
considering them a new standard of care.
The demand from patients and insurance companies for better treatment
options has persuaded surgeons to look at the alternatives as well as the
success rate for traditional fusion surgery. Data shows that the majority
of lumbar fusion patients receive benefits from surgery. Extremely high
success rates can now be attained from fusion procedures, but despite that,
only about two-thirds of patients enjoy significant relief from back pain
or regain desired function. Those published statistics are among the
reasons why surgeons and their patients are looking to emerging
technologies and new systems to deal with these spinal issues in a
different way.
Public support for these new technologies can be seen in the dramatic
growth of the industry. Sales of the emerging spinal motion preserving
devices are increasing at an annual rate of 50 percent and should exceed
$1.5 billion by 2009.
Patients with chronic back problems can access many of the leading
traditional and motion preservation spinal devices being tested in the U.S.
through SpineMark CRO at TBI in Plano, Texas. Patients are encouraged to
speak with a spine care provider to discuss which option is best for their
individual case.
Research studies for new spinal devices are directed at patients who
are looking for the latest technology to bring their lives closer to
normal. And with some of the best physicians and surgeons in the field of
spinal care conducting these studies, participants will have that
opportunity at the SpineMark CRO at TBI clinical research site.
"While fusions continue to be the gold standard, dynamic spine
stabilization is at the forefront of advances in spine care," said Marcy
Rogers, President and CEO of SpineMark Corporation. "We value the
opportunity to participate in trials that could lead to additional
treatment options for patients in search of a therapy that is right for
them."
The implant market is the fastest growing market in healthcare.
"Studies say that it will increase by 15-20 percent over the next 10
years," said Dr. Jack Zigler, president of SpineMark CRO at TBI. "In the
interest of patients, it is important to get the new devices evaluated as
efficiently as possible. The SpineMark CRO at TBI not only boasts an
extraordinary physician and surgeon investigator group, but has married it
to a clinical research organization infrastructure with solid and proven
experience in regulatory compliance, stringent data collection, and patient
safety monitoring. That combination is the ideal model for clinical
research."
About SpineMark CRO at TBI
SpineMark CRO at TBI is the research arm for Texas Back Institute
(TBI). TBI is one of the largest freestanding spine specialty clinics in
the United States. The Institute, based in Plano, Texas, was established in
1978 and provides comprehensive medical care for individuals with back and
neck pain. As an academic health care organization, TBI has trained
hundreds of physicians, scientists and allied health professionals.
SpineMark CRO at TBI employs state-of-the-art technology and research to
treat patients and is involved in the most clinical trials of artificial
discs. The professional staff there includes board-certified spine
surgeons, general surgeons, internists, chiropractors, physiatrists, pain
specialists, exercise physiologists and a team of physical and occupational
therapists. SpineMark CRO at TBI's main office is located in Plano, Texas.
SpineMark Clinical Research Organization
SpineMark Clinical Research Organization
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