Cervical and lumbar disc replacements have been determined by the United
States Food and Drug Administration (FDA) to be "significant risk
devices," requiring both preclinical and clinical evaluations to
determine their safety and effectiveness. Although they have been used in
Europe for decades, recent interest in the devices in the United States has
resulted in increasing numbers of ongoing FDA-sponsored clinical evaluations.
The historical role of fusion serves as the concurrent control in these
studies. The clinical investigative process has proved to be both arduous and
costly, and it is influenced by the familiarity of the FDA reviewer with the
device, surgeon investigator compliance, patient selection, and the complexity
of the surgical approach, as well as an early appreciation of laboratory
testing requirements. To date, two lumbar disc replacements have been cleared
for marketing and one cervical disc replacement has been recommended for
approval, with clearance expected during 2007 (Figs.
4,
5, and
6). All three have demonstrated
that the clinical use of these articulations is "non-inferior" to
their fusion control.
"Necessary and sufficient" is an apt descriptor of the dual
interactions a manufacturer must consider when embarking on the development of
an artificial disc device. While the demonstration of safety and effectiveness
is an FDA requisite for gaining entry into the marketplace, it is not
sufficient for ensuring reimbursement. In the United States, the Center for
Medicaid and Medicare Services (CMS) must further determine that artificial
disc devices are "necessary and beneficial" for the majority of
patients with degenerative disc disease. As of this writing, the
noninferiority level of FDA approval has led CMS to a noncoverage decision for
the Charité lumbar disc replacement (DePuy Spine, Raynham,
Massachusetts) for patients over sixty years of age. Such decisions by CMS
influence third-party payers.
The FDA-CMS approval process is arduous and costly.Both lumbar and cervical disc arthroplasty designs fit the criteria of a
significant risk device as defined by the FDA and require both preclinical and
clinical evaluation.The peer-reviewed literature describes clinical complications arising from
the use of the spinal disc arthroplasty devices, which are suggestive of a
steep learning curve.The current clinical indications for cervical and lumbar disc arthroplasty
are limited, with application emphasis on the former.To date, long-term outcome reports from the United States are lacking. This
is a factor in the reimbursement decision of CMS.Rational, clinical diagnostic judgments by both orthopaedic surgeons and
neurosurgeons are paramount in patient selection: One size does not fit all,
nor should it!The ability to do something is not always an indication for doing it.Spinal disc replacement will define its niche in the paradigm of available
treatments for degenerative disc disease as experience is gained from its
application. ?
The FDA-CMS approval process is arduous and costly.
Both lumbar and cervical disc arthroplasty designs fit the criteria of a
significant risk device as defined by the FDA and require both preclinical and
clinical evaluation.
The peer-reviewed literature describes clinical complications arising from
the use of the spinal disc arthroplasty devices, which are suggestive of a
steep learning curve.
The current clinical indications for cervical and lumbar disc arthroplasty
are limited, with application emphasis on the former.
To date, long-term outcome reports from the United States are lacking. This
is a factor in the reimbursement decision of CMS.
Rational, clinical diagnostic judgments by both orthopaedic surgeons and
neurosurgeons are paramount in patient selection: One size does not fit all,
nor should it!
The ability to do something is not always an indication for doing it.
Spinal disc replacement will define its niche in the paradigm of available
treatments for degenerative disc disease as experience is gained from its
application. ?