 The Charité Artificial Disc is an investigational
device limited by US (Federal) law to investigational
use in the USA.
The US Food and Drug Administration (FDA) is currently
allowing a small number of selected doctors to use
the Charité on a limited number of patients
in the United States. The doctor must check each patient
that is selected for the study at specific intervals
for at least two years after surgery to monitor their
progress. This is called a Clinical Investigation and
it is hopeful that when all of the patient data is
submitted, the FDA will allow the Charité to
be available for general use in the United States.
The US Clinical Study is a prospective, randomized
(blind) study in which two-thirds of the patients in
the study will receive the Charité Artificial
Disc and one-third of the patients will receive an
alternative treatment. The patients do not know which
procedure they will receive prior to surgery but are
informed as such afterwards.
Inclusion Criteria Include:
-
Suffer from low back pain
-
Be between 18 and 60 years of age
-
Have a diagnosis of Degenerative Disc Disease at
the L4/L5 or L5/S1 level
-
Have had at least six months of prior conservative
treatment
Exclusion Criteria Include:
-
Any previous back fusion surgery
-
Multiple levels of degenerative disc disease
-
Osteoporosis, osteopenia or other metabolic bone
disease
-
Infection, spinal stenosis, spondylolisthesis,
scoliosis or spinal tumor
-
History of chronic steroid use
-
Pregnancy or morbid obesity
If you would like more information about the U.S.
Clinical Study, please contact DePuy
Spine.
The Charité Artificial Disc is an investigational
device limited by US (Federal) law to investigational
use in the USA.
The US Food and Drug Administration (FDA) is currently
allowing a small number of selected doctors to use
the Charité on a limited number of patients
in the United States. The doctor must check each patient
that is selected for the study at specific intervals
for at least two years after surgery to monitor their
progress. This is called a Clinical Investigation and
it is hopeful that when all of the patient data is
submitted, the FDA will allow the Charité to
be available for general use in the United States.
The US Clinical Study is a prospective, randomized
(blind) study in which two-thirds of the patients in
the study will receive the Charité Artificial
Disc and one-third of the patients will receive an
alternative treatment. The patients do not know which
procedure they will receive prior to surgery but are
informed as such afterwards.
Inclusion Criteria Include:
-
Suffer from low back pain
-
Be between 18 and 60 years of age
-
Have a diagnosis of Degenerative Disc Disease at
the L4/L5 or L5/S1 level
-
Have had at least six months of prior conservative
treatment
Exclusion Criteria Include:
-
Any previous back fusion surgery
-
Multiple levels of degenerative disc disease
-
Osteoporosis, osteopenia or other metabolic bone
disease
-
Infection, spinal stenosis, spondylolisthesis,
scoliosis or spinal tumor
-
History of chronic steroid use
-
Pregnancy or morbid obesity
If you would like more information about the U.S.
Clinical Study, please contact DePuy
Spine.
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