Cervical Disc Arthroplasty

Cervical artificial disc replacement surgery is a joint replacement procedure that involves inserting an artificial disc, such as the PRESTIGE® Cervical Disc, between the vertebrae to replace a natural spinal disc after it has been removed. This prosthetic device is designed to maintain motion in the treated vertebral segment.

What Is Cervical Artificial Disc Surgery?

Cervical artificial disc surgery is a type of joint replacement procedure, or arthroplasty, which involves inserting a cervical artificial disc into the intervertebral space after a natural cervical disc has been removed.

A cervical artificial disc is a prosthetic device designed to maintain motion in the treated vertebral segment. A cervical artificial disc essentially functions like a joint, allowing for flexion, extension, side bending and rotation. The PRESTIGE® Cervical Disc is the first artificial disc to be approved by the U.S. Food and Drug Administration for use in the cervical spine.

Why Do I Need This Procedure?

The intervertebral discs of the cervical spine are very important for the normal mobility and function of your neck. When healthy, they act as “cushions” for the individual bones of the spine, or vertebrae. Each disc is made up of two parts:

  • The nucleus pulposus – the soft, gel-like center of the disc.
  • The annulus fibrosis – strong, fibrous outer ring that surrounds and supports the nucleus pulposus.

Prestige Cervical Disc Surgery

Over time, discs can become dried out, compressed or otherwise damaged, due to age, genetics and everyday wear-and-tear. When this happens, the nucleus pulposus may push through the annulus fibrosis. Disc degeneration also may result in bone spurs, also called osteophytes. If disc or bone material pushes into or impinges on a nearby nerve root and/or the spinal cord, it may result in pain, numbness, weakness, muscle spasms and loss of coordination, both at the site of the damage and elsewhere in the body, since most the nerves for rest of the body (e.g., arms, chest, abdomen and legs) pass from the brain through the neck. Similar symptoms, however, may occur suddenly if the disc nucleus dislodges acutely and causes nerve root compression, a condition referred to as a herniated disc.

When non-surgical therapies fail to provide relief from your symptoms, your doctor may recommend spine surgery. The goal of cervical artificial disc surgery is to remove all or part of a damaged cervical disc (discectomy), relieve pressure on the nerves and/or spinal cord (decompression) and to restore spinal stability and alignment after the disc has been removed.

A spinal fusion with an anterior cervical plate currently is a very good surgical option for many patients, leaving most symptom-free and able to return to their normal activities within a short period of time. Using bone grafts and instrumentation, such as metal plates and screws, this procedure fuses, or creates a bond between, two or more adjacent cervical vertebrae, ideally stabilizing the segment and providing relief.

Cervical artificial disc replacement surgery, also referred to as spinal arthroplasty or just disc replacement, is another potential treatment option for patients with this condition.

Cervical artificial disc replacement surgery may be an appropriate treatment option for you if:

  • You have been diagnosed with cervical radiculopathy, myelopathy or both with the presence of disc herniation and/or bone spurs.
  • Your symptoms did not improve after conservative treatment measures, such as exercise, pain relievers, physical therapy and/or chiropractic care.
  • You require treatment at only one cervical level.
  • You are at least 18 years of age with skeletal maturity.
  • Are not pregnant or nursing at the time of surgery.

To determine whether cervical artificial disc replacement surgery is the right treatment for you, your physician will perform a physical exam and other diagnostic testing, such as a spinal X-ray; magnetic resonance imaging (MRI), computed tomography (CT) scan, myelogram and/or a bone scan.

It is important that you discuss the potential risks, complications, and benefits of cervical artificial disc replacement surgery with your doctor prior to receiving treatment, and that you rely on your physician’s judgment. Only your doctor can determine whether you are a suitable candidate for this treatment.

How Is Cervical Artificial Disc Replacement Surgery Performed?

Through a small incision made near the front of your neck (a surgical approach called the anterior approach) your surgeon will:

  • Gently pull aside the soft tissues – skin, fat and muscle – as well as the trachea, or windpipe, to access the cervical spine
  • Expose the area where disc fragments and/or bone spurs are pressing against the neural structures (nerve roots and/or spinal cord);
  • Remove the disc and bone material from around the neural structures to give them more space (discectomy and decompression);
  • Insert and secure the artificial disc into the intervertebral space, using specialized instruments;
  • Ease the soft tissues of the neck and other structures back into place; and
  • Close the incision.

Knowing what to expect during your procedure can help you face your surgery with confidence. Your doctor can give you additional details about the procedure specific to your condition.

How Long Will It Take Me To Recover?

Your surgeon will have a specific post-operative recovery plan to help you return to your normal activity level as soon as possible. Your length of stay in the hospital will depend on your treatment and physical condition. You typically will be up and walking by the end of the first day after the surgery. Your return to work will depend on how well your body is healing and the type of work/activity level you plan to return to.

Work closely with your spinal surgeon to determine the appropriate recovery protocol for you, and follow his or her instructions exactly to optimize your healing process.

Are There Any Potential Risks Or Complications?

As with any spine surgery, surgical treatment with the PRESTIGE® Cervical Disc is not without risk. A variety of complications may occur, either alone or in combination.

Potential risks associated with any surgery include anesthesia complications, blood clots, allergic reactions and adverse effects due to undiagnosed medical problems, such as silent heart disease. Potential complications associated with spine surgery and the PRESTIGE® Cervical Disc may include:

  • Allergic reaction to the implant material
  • Implants bending, breaking, loosening, or moving
  • Instruments bending or breaking
  • Wound, local, and/or bodily (systemic) infections
  • Neck and/or arm pain
  • Difficulty swallowing
  • Impairment of or change in speech
  • Nerve or spinal cord injury, possibly causing impairment or paralysis
  • Numbness or tingling in extremities
  • Tear in the protective membrane (dura) covering the spinal cord
  • Loss of motion or fusion at the treated cervical level
  • Development or progression of disease at other cervical levels
  • Bleeding or collection of clotted blood (hematoma)
  • Blood clots and blood flow restrictions, possibly resulting in stroke
  • Tissue swelling
  • Reactions to anesthesia
  • Changes in mental status
  • Complications of pregnancy, including miscarriage and fetal birth defects
  • Inability to resume activities of normal daily living, including sexual activity
  • Death

There is also the risk that this surgical procedure will not be effective, and may not relieve or may cause worsening of preoperative symptoms.

In the US clinical study, there were a number of adverse events. Some of the most common were trauma, difficulty swallowing, impairment of speech, and infection. There may be other risks associated with treatment using the PRESTIGE® device. Although many of the major risks are listed on this website, a more comprehensive list is provided in the physician’s package insert for the product. Please consult your doctor for more information and an explanation of these risks.

Prior to treatment, please discuss the risks associated with cervical artificial disc surgery thoroughly with your doctor.

It is important that you discuss the potential risks, complications and benefits of the PRESTIGE® Cervical Disc with your doctor prior to receiving treatment, and that you rely on your doctor’s judgment. Only your doctor can determine whether you are a suitable candidate for this treatment.

About The PRESTIGE® Cervical Disc

The PRESTIGE® Cervical Disc is an artificial disc replacement which is designed to maintain motion for patients suffering from the symptoms of degenerative cervical disc disease or acute unresolved cervical disc herniation.

The PRESTIGE® Cervical Disc offers patients with radiculopathy and myelopathy related to degenerative cervical disc disease (DDD) in the cervical spine an alternative to spinal fusion surgery. Constructed of stainless steel in a unique, two-piece ball-and-trough configuration, the device is designed to maintain motion at the treated vertebral segment.

Each vertebra in the spine is separated by a shock absorbing disc, which is made up largely of water. As discs lose water content because of disease, injury or age, they compress, or lose height, which causes the vertebrae to move closer together. This reduces the disc’s shock absorbing qualities, which may lead to bone spurs and narrowing of the nerve openings. If a disc ruptures, it can place pressure on the surrounding nerve roots and the spinal cord, resulting in pain, numbness and/or weakness.

Your doctor may recommend surgery if non-surgical treatment fails to provide relief from these symptoms. Traditionally, a procedure called an anterior cervical discectomy with fusion (ACDF) has been the “gold standard” for surgically treating DDD in the cervical spine. Using bone grafts and instrumentation such as metal plates and screws, this procedure fuses, or creates a bond between, two or more adjacent vertebrae, ideally stabilizing the segment and providing relief. Many patients have achieved excellent results with ACDF; however, a potential disadvantage associated with spinal fusion is the loss of motion and flexibility in the treated vertebral segment.

The PRESTIGE® Cervical Disc replaces a diseased or damaged disc and is designed to maintain motion. Made of stainless steel, the device has two articulating components (a ball on top and a trough on the bottom) that are inserted into the disc space and attached to the vertebral bodies on either side. The PRESTIGE® Cervical Disc was designed to allow for the following motions of a natural intervertebral disc: flexion, extension, side bending and rotation.

The PRESTIGE® Cervical Disc is available in a variety of sizes that allow surgeons to closely match a patient’s anatomy.

While many factors contribute to the longevity of an artificial disc, the PRESTIGE® Cervical Disc has undergone significant testing to verify the safety and adequate durability of the device.

The PRESTIGE® Cervical Disc is indicated in skeletally mature patients for reconstruction of the disc from levels C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy. The PRESTIGE® device is implanted via an open anterior approach. Intractable radiculopathy and/or myelopathy should present with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by patient history (e.g., pain [neck and/or arm pain], functional deficit, and/or neurological deficit), and radiographic studies (e.g., CT, MRI, x-rays, etc.): 1) herniated disc, and/or 2) osteophyte formation.

The PRESTIGE® Cervical Disc should not be implanted in patients with an active infection or with an allergy to stainless steel.

The PRESTIGE® Cervical Disc should only be used by surgeons who are experienced in the surgical procedure and have undergone adequate training with the device. A lack of adequate experience and/or training may lead to a higher incidence of adverse events, such as neurological complications.

The safety and effectiveness of this device has not been established in patients with the following conditions: more than one cervical level with DDD; not skeletally mature; clinically significant cervical instability; prior fusion at adjacent cervical level; severe facet joint pathology of involved vertebral bodies; prior surgery at treated level; osteopenia, osteomalacia, or osteoporosis as defined by bone mineral density T-score of -3.5, or -2.5 with vertebral crush fracture; spinal metastases; chronic or acute renal failure or history of renal disease; taking medications known to potentially interfere with bone/soft tissue healing (e.g. steroids); pregnant; cervical instability; severe insulin dependent diabetes; and were not refractory to at least six weeks of unsuccessful conservative treatment or had signs of progression or spinal cord/nerve root compression with continued non-operative care.

Implanted metal alloys release metallic ions into the body (especially those devices with metal-on-metal articulating surfaces). The long term effect of these ions on the body is not known.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician with appropriate training or experience.

Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.

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