Artificial Disc Replacement

Charité Artificial Disc Replacement Surgery

spine-health — Wed, 12 Dec 2007 00:00:24 -0800

Patients who fit specific criteria may be good candidates for the Charité artificial disc replacement surgery. Other criteria to assess whether or not a patient is a good candidate for the procedure is more subjective and should be discussed with the patient’s treating physician.

Total Disc Replacement—Charite™ Artificial Disc

spine-health — Wed, 12 Dec 2007 00:00:27 -0800

The Charité Artificial Disc is a total disc replacement technology that uses two metal alloy endplates and its unique sliding core. This offers the theoretical advantage of allowing the spacer to shift dynamically within the disc space during spinal motion, moving posteriorly with flexion and anteriorly in lumbar extension. Some experts feel this may improve the segmental rotation and decrease the possibility of facet impingement at extremes of motion. This has not yet been clinically demonstrated.

Total Disc Replacement—Maverick

spine-health — Wed, 12 Dec 2007 00:00:27 -0800

The Maverick is a two piece metal-on-metal design that incorporates a more posterior center of rotation. Maverick began a multicenter clinical trial in the United States in the Spring of 2003. Maverick is randomized to an anterior fusion using rectangular LT cages with Infuse (BMP-soaked sponges).

The US FDA study is now in Continued Access mode, the randomized portion having been completed. Maverick is currently being utilized in Europe where clinical series are now also being studied. A large number of implantations have been performed in Europe.

Lumbar Artificial Disc Surgery for Chronic Back Pain

spine-health — Wed, 12 Dec 2007 00:00:27 -0800

Artificial disc introduction

The use of an artificial disc to replace a damaged spinal disc that is generating chronic back pain has been practiced in a number of European countries for many years and is currently in various phases of development and clinical trials in the U.S. The Charité was FDA-approved in October 2004 and the PRODISC-L was approved in August 2006.

Deciding on Artificial Disc Replacement Surgery

spine-health — Wed, 12 Dec 2007 00:00:27 -0800

Justin Tortolani, MD

Summary of Lumbar Artificial Disc Development

spine-health — Wed, 12 Dec 2007 00:00:27 -0800

There are a number of disc replacement and other arthroplasty technologies in various stages of development and clinical trials in the US, including:

More Disc Replacement Info

Lumbar Disc Replacement

Cervical Disc Replacement

Spinal Disc Pain

Back and Neck Surgery

Total Disc Replacement—FlexiCore

spine-health — Wed, 12 Dec 2007 00:00:27 -0800

FlexiCore is a metal-on-metal device that is inserted as a single unit. The superior and inferior portions are linked by a captured ball-and-socket joint. The FlexiCore can be implanted from a straight anterior or an anterolateral direction, and offers the ability to manipulate the position of the implant within the intervertebral space. Unique domed baseplate surfaces are shaped to approximate the concavities of the vertebral body endplates, and are coated with titanium plasma spray to assist bone ongrowth fixation.

Total Disc Replacement—ProDisc

spine-health — Wed, 12 Dec 2007 00:00:27 -0800

Several manufacturers are currently researching, developing and testing total disc replacement in the US. The Charite has been approved by the FDA for the surgical treatment of single-level disease at the L4-5 or L5-S1 levels. Four other lumbar devices currently in clinical trials in the US are:

ProDisc (Spine Solutions/Synthes)
Maverick (Medtronic Sofamor Danek)
Flexicore (SpineCore)
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Pain Generated by the Spinal Disc

spine-health — Wed, 12 Dec 2007 00:00:27 -0800

Before discussing how the spinal disc can cause back pain and/or leg pain (sciatica), it is useful to first understand the role of a healthy disc in the spine and the anatomy.

The intervertebral disc has several important functions, including functioning as a spacer, as a shock absorber, and as a motion unit:

Disc Nucleus Replacement

spine-health — Wed, 12 Dec 2007 00:00:25 -0800

A disc nucleus replacement device is designed to replace only the inner portion of the disc (the nucleus).

A variety of disc nucleus replacement technologies are currently being investigated in the laboratory, and some have been implanted in countries outside the US. Various materials are utilized in these implants, including metals and ceramics, injectable fluids, hydrogels, inflatables, and elastic coils.

The following is a brief history of early evolution of artificial disc technologies:

Disc Replacement Case Example

spine-health — Wed, 12 Dec 2007 00:00:25 -0800

The following profiles one patient’s experience with the CHARITÉ Artificial Disc. This patient was a participant in the U.S. multi-center clinical trial to study the effectiveness and safety of the device.

FDA Approves the ProDisc Lumbar Artificial Disc

spine-health — Wed, 12 Dec 2007 00:00:25 -0800

PRODISC-L is second artificial disc approved

On August 14, 2006, the PRODISC-L Total Disc Replacement was approved by the U.S. Food and Drug Administration for use as a treatment for functionally disabling pain from lumbar degenerative disc disease.

The PRODISC is made by Synthes Spine. It is in the same class of devices as Johnson & Johnson's Charite lumbar artificial disc, which was approved for use in the U.S.

Facet Technologies

spine-health — Wed, 12 Dec 2007 00:00:25 -0800

Facet arthritis (degeneration of the facet joint) is currently a contraindication for any type of disc replacement. Proper spinal motion requires normal function of both the disc and facet joints. Therefore, there is an opportunity for facet technologies to provide an adjunct to anterior column disc replacement, or as a stand-alone treatment for patients with isolated posterior column disease.

Spinal Disc Replacement with the CHARITÉ Artificial Disc

spine-health — Wed, 12 Dec 2007 00:00:25 -0800

Introduction to artificial discs

In October 2004 the CHARITÉ™ Artificial Disc was the first disc approved for disc replacement use in the general population of back pain patients in the U.S. There is a great deal of interest in the medical community and among back pain patients regarding the potential of artificial discs for lumbar disc replacement. But despite all the publicity, it’s important to remember that artificial discs are not a miracle cure.

Artificial Disc Replacement Candidates

spine-health — Wed, 12 Dec 2007 00:00:24 -0800

The overall indications for a CHARITÉ Artificial Disc are similar to that for an anterior lumbar interbody fusion (ALIF) using BAK interbody cages. Currently, the CHARITÉ Artificial Disc is only available for use for one-level disc replacement, so it is not indicated for patients with symptomatic multi-level disc disease.

All About the Charité Artificial Disc: Now Approved for Use in the U.S.

spine-health — Wed, 12 Dec 2007 00:00:24 -0800

The Charité artificial disc

On October 26, 2004 the U.S. Food and Drug Administration (FDA) approved the Charité™ artificial disc for use in the US. This device treats severe, chronic low back pain by replacing the damaged or worn out spinal disc in the lower back with an artificial disc. The device is made by DePuy Spine, a division of Johnson and Johnson, Inc.

Issues to Consider Before Having Artificial Disc Surgery

spine-health — Wed, 12 Dec 2007 00:00:24 -0800

More Disc Replacement Info

Lumbar Disc Replacement

Cervical Disc Replacement

Spinal Disc Pain

Back and Neck Surgery

Artificial Disc Replacement Surgery

spine-health — Wed, 12 Dec 2007 00:00:24 -0800

The goal of the CHARITÉ Artificial Disc procedure is to restore the intervertebral disc height and neuroforaminal height while restoring physiologic motion (similar to that of a healthy disc) in that segment of the spine. The surgery requires complete removal of the unhealthy disc in order to implant the new artificial disc.

The CHARITÉ Artificial Disc surgery is approached from the front, with a relatively small incision in the abdomen (usually below the belly button).
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Cervical Disc Replacement Update (Research Article)

spine-health — Wed, 12 Dec 2007 00:00:24 -0800

Cervical artificial disc

The cervical intervertebral disc is an amazing mechanical structure from an engineering perspective. It has the ability to absorb a large compressive load while still providing adequate motion between two adjacent bony vertebrae. Duplicating the disc’s form and function with a synthetic disc is challenging.

Artificial Disc for Cervical Disc Replacement

spine-health — Wed, 12 Dec 2007 00:00:23 -0800

An artificial cervical disc is a device inserted between two cervical vertebrae after an intervertebral disc has been surgically removed in the process of decompressing the spinal cord or a nerve root. The intent of the device is to preserve motion at the disc space. It is an alternative to the use of bone grafts, plates and screws in pursuit of a fusion following such a disc removal, which necessarily eliminates motion at the operated disc space in the neck.

Cervical Artificial Disc Replacement Technologies

spine-health — Wed, 12 Dec 2007 00:00:23 -0800

A number of disc arthroplasties are currently in various phases of development and clinical testing in the United States. These devices use a variety of materials and design concepts. At the time of the compilation of this manuscript, all cervical disc replacements in the US are available for investigational use only. As of August 2006, the FDA has approved two artificial discs for use in the general patient population for lumbar artificial disc replacement: the Charite disc (made by DePuy) and the ProDisc-L (made by Synthes).

Artificial Discs vs. Spinal Fusion for Pain Relief - Patients' Advice: Part I

spine-health — Wed, 12 Dec 2007 00:00:23 -0800

Back-to-Back

Patients share advice about artificial discs and spine fusion surgery
In this section, patients share their insights about how they made the decision to have an artificial disc replacement or spine fusion surgery.

More Disc Replacement Info

Lumbar Disc Replacement

Cervical Disc Replacement

Spinal Disc Pain

Artificial Cervical Discs

spine-health — Wed, 12 Dec 2007 00:00:23 -0800

Artificial cervical disc technologies are being developed in an effort to treat symptomatic degenerative disc disease more effectively. The main goal of this type of technology is to maintain spinal motion following anterior discectomy, to reduce the incidence of degeneration of adjacent disc levels of the spine (adjacent-segment disease), and to permit more rapid return to normal activity.

Considerations for a Cervical Disc Replacement Surgery

spine-health — Wed, 12 Dec 2007 00:00:23 -0800

There are a number of factors that are important in considering cervical disc replacement vs. a traditional decompression and fusion surgery. Perhaps the most important consideration is that longer term studies and follow-up will be needed to fully understand the potential risks and benefits of cervical disc replacement. At present, most of the information on the discs remains theoretical.

Artificial Discs and Disc Replacement - Patients' Advice: Part II

spine-health — Wed, 12 Dec 2007 00:00:23 -0800

Patients share advice about artificial disc clinical trials and disc replacement surgery
In this section, patients share their insights about why they decided to have disc replacement, challenges and successes with recovery and advice for others who are considering an artificial disc.

Artificial Discs vs. Spinal Fusion for Pain Relief - Patients' Advice: Part II

spine-health — Wed, 12 Dec 2007 00:00:23 -0800

Back-to-Back

Artificial disc was a temporary fix for my back pain

After trying all non surgical treatments to no avail my Dr. discussed with me the options of back surgery. After looking into my options I chose the disc replacement.
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Artificial Disc and Disc Replacement - Patients' Advice: Part I

spine-health — Wed, 12 Dec 2007 00:00:22 -0800

Update on Artificial Disc Replacement (Research Article)

spine-health — Wed, 12 Dec 2007 00:00:22 -0800

The main objective of an artificial disc replacement is to replace a painful disc while maintaining the natural anatomical structure of the spine. The procedure is being developed as an alternative to lumbar spine fusion.

In the U.S., clinical trials for use of artificial discs have just started and the FDA approval process is expected to take approximately two to four years.

What Is the Make-Up of Artificial Discs?

spine-health — Wed, 12 Dec 2007 00:00:22 -0800

In general, there are several types of artificial discs:

Total disc prosthesis – designed to replace a full disc
Nuclear prosthesis – designed to replace the soft inner core of a disc.

These artificial discs are manufactured using man-made materials, such as:

Metal part of the disc
Rubber polyethylene of a hidrosel for the soft inner core.
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What Are the Indications for Artificial Disc Replacement?

spine-health — Wed, 12 Dec 2007 00:00:22 -0800

Artificial disc products that are in development or in use are typically intended for use in patients with the following indications:

Diagnosis of degenerative disc disease (typically at a single level)
Are between the ages of 18 and 60
Suffer from low back pain as the major complaint (rather than leg pain)
Have not responded to a minimum of six months of conservative treatments (such as physical therapy, pain medications)
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