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ROI-C® CERVICAL CAGE
Patient Education
T
his 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.
Basics of the cervical spine
The cervical spine
includes the bones,
spinal cord, nerves,
vasculature (system that
carries blood),
ligaments, and muscles
in your neck.
Vertebra (C5)
Disc
Vertebra (C6)
More specifically, the
cervical spine is made
up of the first seven
vertebrae (bones of the
X-ray (side-view) of a healthy
spine) and begins at
cervical spine1
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
pulposus, contained. Disc problems can arise in the event of
over exertion, trauma, or just wear and tear of everyday life.
Healthy cervical vertebra
(top-down view)2
Spinous Process
(bone)
Spinal Cord
Nerve Root
Vertebra (bone)
Disc
Annulus Fibrosis
Nucleus Pulposus
Degenerative Disc Disease
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
X-ray (side-view) of a cervical
spine showing degeneration
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.
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
Do I need surgery?
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.
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.
Lordotic
Anatomic
Plate
Cage
Plate
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.
(front of neck)
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
screws4
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.
(front of neck)
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.
X-ray of ROI-C cervical fusion
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.
Expectations for after surgery
Expectations for after surgery
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.
What will my incision look like?
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.
When can I start driving and moving my neck
normally?
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.
Will my ROI-C affect travel through airport
security?
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.
•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.
Who should avoid having cervical cage
surgery?
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: PEEKOptima®, 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.
What are the risks associated with cervical cage
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.
What considerations must my surgeon make
when imaging my spine post-operatively?
Non-clinical testing has demonstrated that the Interbody Cage
Systems are MR-Conditional. Patients can be scanned safely
immediately after implantation under the following
conditions:
· Static magnetic field of 1.5 Tesla (1.5T) or 3.0-Tesla (3.0T)
only.
· Maximum spatial gradient field of 3000 G/cm (30 T/m) or
less.
· Normal Operating Mode: Maximum whole-body specific
absorption rate (SAR) of 4.0 W/kg.
· When other methods of supplemental fixation are used,
also follow the MR conditional labeling for the additional
components.
Under the scan conditions defined above, the ROI-C Implant
System is expected to produce a maximum temperature rise
of <maximum observed either 1.5T or 3T after 15 minutes of
continuous scanning at 4W/kg>ºC after 15 minutes of
continuous scanning.
In non-clinical testing, the image artifact caused by the device
extends approximately 0.8cm from the ROI-C Implant when
imaged with a gradient echo pulse sequence in either a 1.5T or
3T MRI system.
For additional information please visit:
www.ldr.com
Indications:
NOTE: VerteBRIDGE® Plating is the supplemental fixation designed specifically
for the ROI-C cage and can be used in applications where a stand-alone cervical
interbody fusion construct is appropriate. Additional supplemental fixation options that can be used with the ROI-C cage (with or without VerteBRIDGE Plating)
include anterior vertebral plating and other fixation devices cleared by the FDA
in the cervical spine.
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.
References
1. boneandspine.com 2. wikimedia.org 3. spineuniverse.com 4.spineuniverse.com
LDR, LDR Spine, LDR Médical, a passion for innovation, Avenue, BF+, BF+(Ph),
Bi-Pack, C-Plate, Easyspine, FacetBRIDGE, InterBRIDGE, Laminotome, L90, MC+,
MIVo, 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.
Ref #: IR-C PF 2 REV C 03.2016
The ROI-C Implant System and LDR Spine ROI-C Titanium-Coated Implant System
are 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 or allogenic bone graft composed of cancellous
and/or corticocancellous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.