2010 Technical Program - Mining Metallurgy and Exploration - SME

ROI-C® CeRvICal CaGe

Patient education

This patient information brochure is designed to give you some basic details on neck

anatomy and disc degeneration, and to help you better understand one treatment option for your neck pain and related problems. Your doctor has recommended that you consider surgery to relieve your pain and discomfort using the ROI-C® Cervical Cage. This brochure will help answer some of the most commonly asked questions in preparation for, and also after surgery.

This information should not be used as a substitute for talking with a doctor. Please consult your doctor with any questions about your symptoms or treatment options.

The ROI-C was cleared for use in the United States in 2008 and has been used to help more than 14,000 patients worldwide.

The cervical spine includes the bones, spinal cord, nerves, vasculature (system that carries blood), ligaments, and muscles in your neck.

More specifically, the cervical spine is made up of the first seven vertebrae (bones of the spine) and begins at the base of the skull. The cervical vertebrae help to contain and protect the spinal cord, support the skull, and allow head movement.

The most mobile region of the spine is the neck. Between each of the seven vertebrae there is a disc that acts as a cushion, absorbing the stresses that are imposed on the spine. The discs also act as joints, allowing the vertebral bodies to move with respect to one another.

Each disc has an annulus fibrosis, which is a series of strong outer rings that help keep the disc’s soft center, the nucleus propulsus, contained. Disc problems can arise in the event of over exertion, trauma, or just wear and tear of everyday life.

Basics of the cervical spine

X-ray (side-view) of a healthy cervical spine1

Vertebra (C5)DiscVertebra (C6)

Spinous Process (bone)

Spinal Cord

Vertebra (bone)Disc

Annulus FibrosisNucleus Propulsus

Nerve Root

Healthy cervical vertebra (top-down view)2

Disc degeneration has a predictable pattern. First, the nucleus, or center of the disc, begins to lose its ability to take in and retain water. This causes the disc to dehydrate and makes the nucleus unable to absorb normal movement. Tears start to form around the annulus (outer ring of disc) and the disc weakens. The disc will start to collapse and the overall alignment of the spine becomes compromised. Unnatural movement of the discs, ligaments, and facet joints (the smaller joints in the back of the spine) causes irritation and results in pain on movement.

Disc degeneration may cause:•Disc rupture or herniation (bulge of the nucleus).•Spinal canal stenosis (the spinal canal narrows and pinches the spinal cord and nerves).•Spinal instability.•Articular facet syndrome (the smaller joints in the back of the spine become irritated and cause pain on movement).•Myelopathy (a disturbance of the spinal cord that results in a loss of sensation or mobility).•Radiculopathy (irritation of the nerve roots) in the neck, can cause disabling pain or weakness and tingling in the arms and hands.

Degenerative Disc Disease

Unhealthy cervical vertebra (top-down view)3

Pinched spinal cord from unhealthy ligament

Pinched nerve from herniated disc

Pinched nerve from unhealthy facet joint

Facet

X-ray (side-view) of a cervical spine showing degeneration

What is the ROI-C Cervical Cage?

The ROI-C Cervical Cage is designed to:•Replace a worn out disc to fuse two vertebrae together to eliminate movement at a joint.•Restore normal disc height and help unpinch nerves.•Function in some cases as a stand-alone implant, without the need of additional plating on the front of the spine.

The ROI-C consists of a rectangular cage made from strong, medical grade plastic. To help make the cage more stable and prevent implant movement, the top and bottom of the implant have teeth that fit into the bone. The ROI-C cage also comes in two designs. One design has a slightly rounded shape on top to match the natural anatomy of the top vertebra. The other design is tapered to come in close contact with your bone if you have non-concave, flattened endplates on your vertebra. Your surgeon will choose between different shapes and sizes to best match your anatomy. The hollow interior of the cage is filled with bone graft from one vertebra to the other. This results in “fusion.”

The ROI-C can be used with an integrated metal plating system made from a medical grade Titanium. The plates pass through the cage and into the adjacent vertebral bone, helping to hold the cage in place until the fusion can grow. If your doctor chooses, the ROI-C can be used with an additional implant(s) for increased stability, such as an exterior plate on the front of the spine.

Plate

Anatomic Lordotic

Based on the advice from your doctor, you have likely tried to relieve your pain or dysfunction with other treatments such as physical therapy or medication for at least six weeks. Or perhaps your doctor has determined that permanent damage may occur without surgery. Your doctor has recommended that the ROI-C Cervical Cage may help relieve your symptoms.

Do I need surgery?

CagePlate

Both the ROI-C and a traditional cervical cage use the same incision location and first surgical steps; the surgeon removes the diseased disc and replaces the empty disc space with an implant (spacer) made of metal, plastic, or bone. But the traditional cervical cage requires a metal plate on the front of the cervical spine to keep the plastic or bone confined and the spine stable.

In some cases, these metal plates on the front of the spine can cause difficulty swallowing and/or difficulty producing sounds.

The ROI-C uses an innovative internal plating technology to keep the cage and bone graft in place. In most cases, no traditional plate is needed on the front face of the vertebrae.

Traditional cervical plates also require the implantation of screws in the bones both above and below the disc being replaced; the incision and retraction need to be long enough to reach both vertebrae. The ROI-C plates are inserted straight into the cage and curve upward into the bone.

How does the ROI-C compare to a traditional cervical fusion surgery with an exterior plate?

X-ray of a traditional cervical fusion: Bone spacer with exterior metal plate and

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X-ray of ROI-C cervical fusion

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Preparing for your ROI-C surgery

Follow your doctor’s specific instructions regarding surgery preparation. The following are standard pre-surgery instructions; however, your doctor’s recommendations may vary: •Verify that any medications that you are taking are compatible with cervical fusion surgery.•Take time before going to the hospital to arrange your life to help with recovery, such as moving any frequently used items so they can be easily reached and arranging to have family or friends available for help immediately after surgery.•Likely you will be told not to eat or drink the night before the surgery. •Ask your doctor to tell you of the risks, as well as the potential benefits, of this surgery and other surgical or non-surgical options.

Ask your doctor for specific information about your recovery plan. Implantation of the ROI-C is considered major surgery; recovery will be an ongoing process. How fast you recover depends on your age, general health, reason for the operation, your commitment to following your doctor’s instructions, and exercise with the help of a physical therapist.

The following care guidelines are common after a cervical fusion surgery; however, your doctor’s recommendations may vary:•Stay approximately one night in the hospital, although it can be longer.•Sit, stand, and walk the evening after surgery. •Use oral medication for pain and nausea control as needed.•Use a neck collar to prevent neck movement for up to a few weeks after the operation.•Apply a new, sterile wound dressing five days after surgery; the doctor or nurse may show you how to change the dressing.•Care for your wound if a drainage tube is present: the wound must be kept dry for around five days after surgery. The doctor or nurse may show you how to take care of the drainage tube.•Care for your wound if a drainage tube was not used: you may shower while wearing the neck collar. The collar may be removed after showering to sponge-bath the neck area. Support your head on a chair back or pillow and avoid extending your neck. •Discuss a physical therapy regimen with your surgeon to gradually increase your activity.•Schedule office visits to check on your surgical recovery and rehabilitation. X-rays may be taken to check the position and integrity of the cage following the surgery and in the months to follow to confirm bone growth through the cage.

Expectations for after surgeryExpectations for after surgery

The incision is usually about one inch long and is commonly made in an existing crease in the skin on your neck. The cut usually heals so that it is barely noticeable.

What will my incision look like?

When can I start driving and moving my neck normally?

Will my ROI-C affect travel through airport security?

Use of a neck collar is common for a period of time after surgery. Ask your doctor for his or her recommendation on returning to your normal life activities.

It is very unlikely that the metal in the ROI-C plates will trigger airport security detectors. However, according to the TSA (Transportation Security Administration), “TSA Security Officers will need to resolve all alarms associated with metal implants. ”

Who can receive a ROI-C Cervical Cage?

The ROI-C is a cervical fusion cage for:•Adults: the skeleton must be mature or full grown.•The replacement of a degenerated disc causing disc pain and radicular symptoms (pain running down the arm and sometimes into the hands) confirmed by patient history and the study of X-ray or MRI images. •Replacing a diseased disc at level C2-T1; the ROI-C should not be used to replace the top disc in the neck.•A one level fusion.•Patients who have already undergone at least six weeks of conservative (non-operative) treatment from the beginning of their symptoms and are still experiencing symptoms.

If you are experiencing any of the following conditions you should not have cervical cage surgery:•Presence of fever or acute, chronic, systemic, or localized infection.•Metal sensitivity or allergies to the implant materials: PEEK- Optima®, tantalum alloy, or titanium.•Severe osteopenia (low bone mineral density).•Pregnancy.•Prior fusion at the level to be treated. •Patients unwilling or unable to follow post-operative care instructions.•Other medical risks, anesthetics risks, or surgical conditions which would prevent the potential benefit of spinal implant surgery.

Patients are encouraged to discuss potential complications with their physician. As with any surgical treatment, there are inherent risks associated with a cervical fusion. These complications include, but are not limited to:•Implant fracture.•Loss of implant fixation, dislocation, and/or movement.•Neurological complication, paralysis, abnormal soft tissue formation (lesion), or pain due to the surgical procedure.•Injury to vessels, nerves, and organs.•Neurological and spinal dura matter abnormal tissue formation (lesion) from surgical trauma.•Superficial or deep-set infection or inflammation.•Blood clot in a vein (venous thrombosis), blockage of the main artery of the lung or one of its branches (pulmonary embolism), and cardiac arrest. •Pocket of blood outside the blood vessels (hematoma) and slower wound healing. •Further surgical treatment due to side effects. •The need for additional implants on the front or back of the cervical spine. •Pain and/or infection at the bone graft harvest site.

Who should avoid having cervical cage surgery?

What are the risks associated with cervical cage surgery?

For additional information please visit:www.ldrmedical.com

References1. boneandspine.com 2. wikimedia.org 3. spineuniverse.com 4.spineuniverse.com

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Indications: When used as an intervertebral body fusion device, the ROI-C® Implant System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2–T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. The ROI-C Implant System implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.

This information should not be used as a substitute for talking with a doctor. Please consult your doctor with any questions about your symptoms or treatment options.

LDR, LDR Spine, LDR Médical, Avenue, BF+, BF+(ph), Bi-Pack, C-Plate, Easyspine, Laminotome, L90, MC+, Mobi, Mobi-C, Mobi-L, Mobidisc, ROI, ROI-A, ROI-C, ROI-MC+, ROI-T, SpineTune and VerteBRIDGE are trademarks or registered trademarks of LDR Holding Corporation or its affiliates in France, the United States and other countries.