Options for Cervical Disc Degeneration A Guide to the M6-C

WIRB 20101066 #7976750.0

Options for Cervical Disc Degeneration A Guide to the M6-C?

clinical study

Each year,

hundreds of thousands of adults are diagnosed with Cervical Disc Degeneration, an upper spine condition that can cause pain and

numbness in the neck, shoulders, arms, and even hands. This guide is intended to provide you with a better understanding of Cervical Disc Degeneration as well as an overview of certain treatment options. Additionally, this guide will introduce you to the M6-C

rently being o ered in select Spine Centers throughout the country.

This guide is not intended as a substitute for an informed discussion with your physician. If you have questions regarding this booklet, please write them down in the notes section on page 10 so that your doctor or other health care professional can

answer them for you.

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The Cervical Spine

Intervertebral disc

Nerve Vertebrae

The Cervical Spine

The cervical spine is a complex system of bones, muscles, cartilage, and nerves designed to support the weight of the head while allowing movement in multiple directions. The cervical spine begins at the base of the skull and is made up of seven small bones called vertebrae. These vertebrae are stacked on top of one another to form a protective pathway for the spinal cord and its nerve roots, which carry signals to the shoulders, arms, and hands.

Spinal cord

Nerve Root

Annulus Fibrosus

Nucleus Pulposus

Top view of cervical vertebra and its structures

The Cervical Intervertebral Disc

Between each vertebra is a disc; a shock-absorbing pillow that helps maintain proper spacing, stability, and motion within the cervical spine. Each disc has a fibrous, tire-like outer band (called the annulus fibrosus) that encases a central gel-like substance (called the nucleus pulposus). The nucleus and annulus work together to absorb shock, help stabilize the spine, and provide a controlled range of motion between each vertebra.

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Nerve

Herniated Discs

Herniated discs shown impinging on adjacent nerves and spinal cord

Ruptured Disc

Impinged Nerve

Cervical Disc Degeneration

As we age, the discs in our cervical spine begin to atten and wear down. When a disc ens, it forces

the vertebrae closer together, which can put added stress not only on the disc itself, but also on the surrounding joints, muscles, and nerves. This process is called Cervical Disc Degeneration, and can lead to several painful conditions.

Conditions Caused By Cervical Disc Degeneration

Herniated Disc

A Herniated Disc, known as a Herniated Nucleus Pulposus (HNP), occurs when the outer layer of the disc (the annulus brosus) tears or ruptures due to stress from the surrounding vertebrae. These tears can cause the disc's soft central core (the nucleus pulposus) to bulge out or even detach completely, putting pressure on the nearby nerves or spinal cord. This nerve pressure can cause symptoms of pain or weakness in sp c parts of the body, depending on which nerves are being compressed.

Bone Spurs (Osteophytes)

Bone spurs, also called osteophytes, are small bony ridges that form on vertebrae as a result of increased stress on these bones. Usually, these spurs cause nothing more than an occasional sti or sore neck. However, as with a HNP, bone spurs may press against nearby nerves or the spinal cord, causing symptoms of pain or weakness in spec c parts of the body.

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Symptoms of Cervical Disc Degeneration

Although many people experience Cervical Disc Degeneration as a result of aging, few people experience severe symptoms. Typically, Cervical Disc Degeneration symptoms are mild such as aches or stiffness in the neck and shoulder, as well as occasional headaches. However, Cervical Disc Degeneration symptoms can become severe when nerves are pinched due to a herniated disc or bone spurs. This can lead to a painful condition known as Cervical Radiculopathy.

Cervical Radiculopathy - When spinal nerves are pinched, it can lead to pain, weakness, or numbness in the neck, shoulder, arms, and hands. Oftentimes, this feels like a shooting pain traveling down the arm.

Diagnosis

Your physician will conduct a history and physical examination to understand your symptoms and to determine if you have any nerve or spinal cord impairment caused by conditions related to Cervical Disc Degeneration.

Your posture, neck motion, reflexes, muscle strength, and areas of pain are all evaluated during the examination. If Cervical Disc Degeneration is suspected, your doctor may order an X-ray or MRI to evaluate your discs, nerves and spinal cord to help outline a course of treatment.

MRI helps your physician detect any degeneration that

could be causing pain

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Single level Anterior Cervical Discectomy with Fusion (ACDF)

Treating Cervical Disc Degeneration

Non-Surgical Treatments

For many patients, non-surgical or conservative treatments will e ectively relieve symptoms of Cervical Disc Degeneration. These treatments may include a combination of rest, physical therapy, or the use of painkillers or anti-in ammatory medications. If pain or numbness persists despite these treatments, surgical treatment options are considered.

Surgical Treatments

Fusion

The most common surgical procedure for treating Cervical Disc Degeneration is spinal fusion, also known as ACDF (Anterior Cervical Discectomy with Fusion). During this procedure, the attened disc is removed (called a discectomy) along with any bone spurs that are pinching against nerves. This process of relieving pressure on spinal nerves is called decompression. Once the disc is removed, the space between the vertebrae is ed in with a bone graft. Typically, a small titanium plate is also used to help stabilize the vertebrae. Over time, this bone graft will join together with the vertebrae to form one column of bone. This process is known as fusion. The goal of spinal fusion is to eliminate pain while restoring proper spacing between vertebrae.

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Recently, a new surgical procedure has been introduced

calle

al cervical disc replacement, which may o er

some advantages over traditional spinal fusion. cial

disc replacement surgery is very similar to Anterior

Cervical Discectomy with Fusion. However, when

the damaged disc is removed, the space between

with a specialized implant called

an cial disc instead of a bone graft. The cial

disc is designed to restore proper spacing between

the vertebrae while preserving motion associated with

a healthy disc.

Single level artificial disc replacement

The M6-C is an advanced generation cial cervical disc

developed to replace an intervertebral disc damaged by

degenerative disc disease. The M6-C is the only cial

disc that replicates the anatomic structure of a natural

disc by incorporating

into

its design. Together

re

designed to provide the same motion characteristics

of a natural disc.

The M6-C's compressible a al nucleus made of a

polycarbonate urethane polymer is designed to simulate

the function of the native nucleus. Surrounding this nucleus is

a multi-layer

er annulus made of high tensile

strength, ultra-high molecular weight polyethylene. This

annulus is intended to facilitate a controlled range

of motion in multiple directions. A polyurethane sheath

(plastic covering), designed to capture any particles that

may develop as a result of device wear, surrounds the

nulus. This sheath is also designed to prevent

body tissue from growing into the device.

The M6-C has two titanium outer plates with keels for

anchoring the disc into the bone of the vertebral body.

These outer plates are coated with a titanium plasma

spray that promotes bone growth onto the metal plates,

providing long term

n and stability of the disc in

the bone.

M6-C artificial cervical disc Keel

Sheath

Annulus Nucleus

The arti cial annulus and nucleus

of the M6-C a

cervical disc

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clinical study

Herniated Disc Removed

Cervical Disc Study

The purpose of this study is to show whether the M6-C a al cervical disc is saf symptoms that result from Cervical Disc Degeneration.

If you qualify and choose to participate in this study, the damaged disc in your upper spine will be removed and replaced with the M6-C disc. The M6-C is intended to act as a replacement for your natural disc.

Study Follow-Up

To evaluate your progress, you will be asked to return to the doctor's o ce at the following times after surgery; 6-weeks, and 3, 6, 12, and 24 months. During the return visits, your doctor will do the following:

t Physical Exam related to your neck problem t Test your re exes t Test the strength of your arm muscles t Test your ability to feel touch on di erent

areas of your neck and arms t Take X-rays of your neck t Provide questionnaires about your pain and your

ability to do daily activities, about your overall health, how you feel and how you think you are getting along

Each visit should typically last 1-2 hours. Completing the questionnaire should take about 10-20 minutes. After the 24 month visit following your procedure, you may be asked to return annually for additional follow-up visits.

Final M6-C Cervical Disc Placement

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