Benefits and Risks – Artificial Disc Replacement Surgery

Benefits

The Prestige^® Cervical Disc as an alternative to spinal fusion was evaluated in a clinical study that involved 541 patients – the largest clinical study of its kind ever conducted and completed for the cervical spine.

Some key findings of the clinical study include:

• The group of patients receiving the Prestige Cervical Disc had a median return to work that was 26.2% earlier than the median in the spinal fusion treatment group.
• Patients in the Prestige Cervical Disc group experienced no device failures (breakages).
• Fewer patients in the Prestige Cervical Disc group required revision surgical procedures than those in the spinal fusion treatment group. A revision surgery was defined as a procedure that adjusts or in any way modifies the original implant configuration.

Risks

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.

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