Patient

Information
Guide

Total Disc Replacement

 prodisc® L | PATIENT INFORMATION GUIDE 3

Total Disc Replacement

TABLE OF CONTENTS

Glossary 4-5 Risks Associated with Total Disc

Replacement (Including prodisc L Total 15
Introduction 6 Disc Replacement)

What is Degenerative Disc Disease? 7 What are the Potential Adverse Effects of
16
the prodisc L Total Disc Replacement?
What is the prodisc L Total Disc
8-9 The prodisc L Total Disc Replacement
Replacement? 17
U.S. Clinical Studies
Who Should Receive a prodisc L Total
10 What are the Potential Benefits of
Disc Replacement? (Indications) 17 - 18
prodisc L Total Disc Replacement?
Who Should Not Receive a
How to Choose the Correct Treatment 19
prodisc L Total Disc Replacement? 11
(Contraindications) What Happens Before Your Surgery? 20
What are the Warnings for prodisc L What Happens During Your Surgery? 20
11
Total Disc Replacement?
What Happens After Your Surgery? 21
What are the Precautions for prodisc L
12 - 13 When to Call Your Doctor? 21
Total Disc Replacement?
What are the Potential Risks and Adverse When Can I Travel After prodisc L Total
14 22
Effects of Having this Procedure? Disc Replacement Surgery?
Risks Specifically Associated with Lumbar Where Can I Find Out More Information? 22
14
Spinal Surgery Patient Information 23
4 prodisc® L | PATIENT INFORMATION GUIDE

GLOSSARY

Anterior: Front of the body.

Artificial Disc
A medical implant designed to replace a worn out disc.
Replacement Device:

Bone Graft: A transplant of bone taken from one area to another area.

Body Mass Index (BMI): An estimation of an individual’s body fat based on height and weight.

Cobalt chromium
molybdenum alloy A metallic material used in implants.
(CoCrMo):

Computerized Tomography An x-ray procedure that combines many x-ray images to create cross-sectional images (like
(CT): slices) of the body.

Degeneration: Deterioration of tissue, which may include loss of function.

Degenerative Disc Disease DDD is a condition that can occur when the spinal discs no longer function normally because of
(DDD): aging, wear, or from being injured.

Disc: The soft tissue found between the bones of the spinal column that helps cushion the spine.

Discectomy: A surgical procedure in which the soft tissue (central) portion of a disc is removed.

Extension (In the lower back): Bending backwards.

Joints that connect the vertebrae together in the back of the spine and slide against one another
Facet Joint:
during motion.

Flexion (In the lower back): Bending forwards.

Fusion: Joining two bones together so that they no longer move.

A disc that, due to use, injury or disease, bulges outside its normal area, potentially causing pain
Herniated Disc:
and limiting function.

Incision A surgical cut made in the skin.

Investigational Device Allows an investigational device to be used in a clinical study to collect safety and effectiveness
Exemption (IDE): data.

In Vitro: A biomechanical test that is conducted outside of a live human body.

 prodisc® L | PATIENT INFORMATION GUIDE 5

In Vivo: An experiment carried out in a living human.

Lateral Bending (In the lower

Bending side to side.
back):

Magnetic Resonance Imaging A radiographic (like an X-ray) procedure that uses magnets to create cross-sectional images (like
(MRI): slices) of the body.

An instrument, apparatus, or implant designed to diagnose, prevent, or treat a disease or other

Medical Device:
condition. a medical implant is a medical device placed inside the body by means of surgery.

Non-inferior: A new treatment is not unacceptably worse than the comparator treatment.

Osteoporosis: A disease in which the bones are thin or weak and become brittle and fragile.

A condition in which the bones are somewhat thin or weak, and which may develop into
Osteopenia:
osteoporosis.

A measure of consistency between the results actually obtained in a clinical trial and the “pure
P-value: chance” explanation for those results. The p-value ranges between 0 and 1 where small p-values
(p<0.05) indicate the actual results are likely not due to pure chance.

The pars is a short section of bone within a vertebra. A pars defect is a fracture (break) of the
Pars Defect:
pars.

Polyethylene: A hard plastic material used in implants

Rehabilitation: The process of recovery from surgery to a more normal condition.

Spinal Arthroplasty: The reconstruction of a damaged or diseased disc. also known as Total Disc Replacement.

Narrowing inside the spinal canal, which mainly occurs from a combination of aging and
Spinal Stenosis:
degenerative changes in the spine.

A vertebrae that has slipped on the vertebrae below. This usually occurs when a vertebra has a
Spondylolisthesis:
bony defect (spondylolysis) on both sides of the bony ring.

Spondylosis: A degenerative condition in which the vertebral joints of the spine may stiffen or fuse.

Systemic: Pertaining to or affecting a particular body system.

The bones of the spine that make up the spinal column, with a hole for the spinal cord to pass
Vertebrae:
through.

X-ray: An image produced by the use of radiation waves, showing bone and other tissues in the body.
6 prodisc® L | PATIENT INFORMATION GUIDE

INTRODUCTION
After reviewing your history and x-rays, examining you,
and taking into account the results of other diagnostic
studies, your surgeon has decided that you need spine
surgery. This patient information brochure explains one CERVICAL
of your treatment options (the prodisc L Total Disc
Replacement made by Centinel Spine). This brochure may
assist you in making an informed choice regarding the
treatment of your back pain.
Your spine (Figure 1) is very important, it provides balance
and allows you to move and bend. You would be unable to
sit or stand without the support it provides to your body.
The spine is made up of twenty-four bones, called
vertebrae. Each of these bones has a hole in it, similar to a
donut. They are stacked one on top of the other, forming a THORACIC
column.
The spine is divided into four areas. The bones of your neck
are called cervical vertebrae. The middle section of your
back is the thoracic region. Your lower back is the lumbar
area. The base of your spine is made up of the sacrum and
coccyx bone, commonly called the tail bone.
The vertebrae are separated by cushioning discs. Passing
through the hole in each vertebra is the spinal cord. The
spinal cord contains nerves that carry signals from your
brain to the rest of your body. Your spine protects your
spinal cord from injury
LUMBAR

SACRUM AND COCCYX

Figure 1: The Spinal Column

 prodisc® L | PATIENT INFORMATION GUIDE 7

What Is Degenerative Disc Disease?

Normally, the disc sandwiched between each vertebra HEALTHY

provides the cushioning space that keeps the bones LUMBAR DISC
separated. Degenerative Disc Disease, or DDD, is a condition
that can occur when the discs in your spine no longer function
normally because of aging, wear, or from being injured.
This can cause pain that limits your ability to perform daily
activities. This condition can often be treated non-surgically
with medications, physical therapy, spinal injections,
chiropractic care, braces, exercise programs, or rest.
However, in some cases, the symptoms may not improve
or may get worse, and then your doctor may suggest
surgery. The traditional surgery for DDD has been spinal
fusion surgery. In spinal fusion surgery, the unhealthy disc
is removed, the bones are held in position with medical
devices, and a bone graft is placed in the area. In most
cases, the bone for the graft is obtained from the patient’s
hip bone through a separate incision. After surgery, bone is
supposed to grow between the two vertebrae, creating one
solid piece of bone. If you have fusion surgery, it may take
your pain away, but you may have less motion in your back.
HERNIATED
Another option your doctor may consider is surgery with an LUMBAR DISC
artificial disc replacement device. The prodisc L Total
Disc Replacement is one artificial disc replacement device.

Figure 2: Healthy Disc vs. Damaged Disc

8 prodisc® L | PATIENT INFORMATION GUIDE

What is the prodisc L

Total Disc Replacement?

The prodisc L Total Disc Replacement is an artificial

disc replacement device for the lower spine designed to
replace your unhealthy disc.
Expected Device Lifetime: There is no limitation of lifetime
in the implanted state, and the potential removal would be
based on your physician’s assessment, which can vary from
patient to patient.
All of the materials used to make the prodisc L Total
Disc Replacement are materials frequently used in spine
surgery. The prodisc L Total Disc Replacement is a ball
and socket implant consisting of two Cobalt Chromium
Molybdenum alloy (metal) endplates and a polyethylene
Figure 3: prodisc L Total Disc Replacement Placed
(plastic) inlay. The polyethylene inlay snap-locks into the In-Between Two Lumbar Vertebrae
lower endplate and provides the ball that rides in the
socket of the upper endplate (Figures 4 and 5).

SUPERIOR (TOP)
ENDPLATE

INLAY

INFERIOR
(BOTTOM) ENDPLATE

Figure 4: prodisc L Implant

SOCKET

BALL

Figure 5: Ball and Socket

 prodisc® L | PATIENT INFORMATION GUIDE 9

There are also keels (fins) on both endplates that are

designed to help hold them in the vertebral bone (Figure KEEL
6). The metal surfaces that are in contact with the bone are
also coated with titanium (a metal). This coating is designed
to help the bone attach to the metal endplates.
The prodisc L Total Disc Replacement is designed to
allow motion in flexion and extension (bending forward and
backward, Figure 8) as well as lateral bending (bending
side to side, Figure 7); however, not all patients will achieve
motion after treatment with the prodisc L Total Disc KEEL
Replacement.

Figure 6: Assembled Version with Keels

Figure 7: Illustrated Lateral Bending Motion of

prodisc L Total Disc Replacement

Figure 8: Illustrated Flexion/Extension Motion of

prodisc L Total Disc Replacement
10 prodisc® L | PATIENT INFORMATION GUIDE

Who Should Receive a prodisc L

Total Disc Replacement (Indications)?

Your doctor has diagnosed that the pain in your lower back
is coming from the bottom of the lumbar area and, possibly,
L3
the top of the sacrum. You may hear your doctor refer to the
involved lumbar areas as L3, L4, and L5 and the sacrum as
S1 (Figure 9). L4
Your doctor may recommend the prodisc L Total Disc
Replacement because it is designed to allow some motion L5
in the disc space. The prodisc L Total Disc Replacement
surgery does not require bone graft. This means that you
would not need to have bone taken from your hip.
S1
You should discuss the options available to you with your
doctor. Only your doctor can decide whether you are a
candidate for the prodisc L Total Disc Replacement.
In order to be a candidate, you must meet the following
requirements:
• Have a diagnosis of degenerative disc disease (DDD) at
only one or two levels between L3 and S1.
• Have had at least six months of non-surgical treatment
without relief of your symptoms (e.g., medications, Figure 9: Levels of the Lower Spine
physical therapy, etc.).
• Have specific findings on imaging studies such as X-ray, CT,
or MRI.
• Be old enough so that your bones are mature and are no
longer growing.
 prodisc® L | PATIENT INFORMATION GUIDE 11

Who Should Not Receive a prodisc L What are the Warnings for
Total Disc Replacement (Contraindications)? prodisc L Total Disc Replacement?

You should not have surgery with the prodisc L Total Disc Correct placement of the device is very important for
Replacement if you have any of the following conditions: the device to work properly. Use of the prodisc L
Total Disc Replacement should only be undertaken by
• Active whole body (systemic) infection or an infection at the experienced surgeons who have had hands-on training
surgery site, such as a skin rash or infected cut because undergoing in the use of this specific device. A lack of experience may
surgery could interfere with your ability to heal and could increase lead to a higher number of complications.
the chance of spreading or worsening the infection.
• Osteopenia or osteoporosis. These conditions could increase the
risk of your bone breaking or could cause your implant to loosen.
• Narrowing inside your spinal canal (spinal stenosis) because you
may still have pain when moving even after surgery.
• Known allergy or sensitivity to the implant materials (cobalt,
chromium, molybdenum, polyethylene, titanium, and tantalum).
Talk to your doctor if you have a metal allergy because use of the
prodisc L Total Disc Replacement could cause an allergic
reaction.
• Low back and/or leg pain caused by single nerve root compression
(“pinched nerve”), because your pain may be treated with a
different surgical procedure.
• A fracture (break) in a specific location within your vertebrae
(referred to as a pars defect) which could cause instability within
your spine.
• Vertebral bodies smaller than the smallest implant size
available. Correct sizing of the implant is necessary for the device
to function.
• Damaged lumbar vertebral bodies at the affected levels. This
may lead to poor performance of the device.
• Too much forward slippage of your upper vertebral body with
respect to your lower vertebral body (spondylolisthesis) as
determined by your doctor which could cause instability in your
spine.
12 prodisc® L | PATIENT INFORMATION GUIDE

What are the Precautions for

prodisc L Total Disc Replacement?

There was a clinical study in the United States to evaluate Your occupation, activity level, weight, overall health, the
patients treated with the prodisc L Total Disc condition of other levels of your spine, whether or not you
Replacement. are pregnant, and any allergies you have may influence
whether or not you should have the prodisc L Total
Because the clinical study of the prodisc L Total Disc Disc Replacement surgery. Please inform your doctor if any
Replacement only evaluated patients who met certain of these factors apply to you or if you think you have any
criteria, the safety and effectiveness of the prodisc L special health issues.
Total Disc Replacement has not been tested in patients with
the following conditions: This device is placed close to major blood vessels and nerves.
There is a risk of nerve damage and/or serious or fatal
• More than two consecutive vertebral levels with DDD or bleeding if these structures are damaged during surgery.
levels outside L3-S1.
• Prior fusion surgery at any vertebral level. It is very important that you carefully follow your doctor’s
instructions after surgery. Extreme activities like lifting very
• Facet joint disease or degeneration. heavy weights may result in failure of the device.
• Back or leg pain of unknown cause.
During the postoperative phase, in addition to mobility
• Diseases of the bone caused by low mineral levels or and muscle training, it is of particular importance that your
genetic problems (Paget’s disease, osteomalacia, or other physician keeps you well informed.
metabolic bone diseases).
• Very overweight (BMI greater than 40 or weight more Under no circumstances may implant components from
than 100 lbs. over ideal body weight). different suppliers be combined.
• Pregnancy. The manufacturer is not responsible for any complications
• Taking medications (such as steroids) which are known to arising from incorrect diagnosis, choice of incorrect implant,
get in the way of bone or soft tissue healing. incorrectly com­bined implant components and/or surgical
techniques, the limita­ tions of treatment methods, or
• Diseases that cause the vertebrae to swell or grow together inadequate asepsis.
and limit movement, such as rheumatoid arthritis or other
autoimmune diseases.
• Whole body (systemic) disease including AIDS, HIV, and
hepatitis.
• Active malignancy (cancer).
prodisc® L | PATIENT INFORMATION GUIDE 13
14 prodisc® L | PATIENT INFORMATION GUIDE

What are the Potential Risks and Adverse

Effects of Having This Procedure?

As with any surgery, there are possible complications that can Risk specifically associated with lumbar spinal
occur. Although many of the major risks are covered in this surgery:
patient information, a comprehensive list is provided in the
package insert for the device, which your doctor has received. • Injury to surrounding organs and structures including
Please ask your doctor for more information about any the spinal cord, nerves, lymphatic vessels (thin walled
additional risks that could be related to your planned surgery. structures that carry lymph), soft tissue, dura (membrane
that surrounds the spinal cord), intestines, kidneys, and
ureters.
Risks associated with any surgical procedure:
• Neurological difficulties, including trouble with bowel
• Allergic reaction to anesthesia. and/or bladder function, impotence or other issues
• Infection (wound, local and/or systemic) or abscess (a with sexual function, muscle weakness or paralysis,
localized collection of pus surrounded by inflamed tissue). paresthesias (a sensation of tingling, tickling, prickling,
pricking, or burning of the skin) or other changes in
• Problems with the wound including wound dehiscence
sensation, or pain.
(opening of the wound along the surgical suture line) or
wound necrosis (dead tissue within the wound). • Broken vertebrae (bones that make up the spinal
column).
• Edema (abnormal excess accumulation of fluid in soft
tissues). • Hematoma (collection of clotted blood in tissue as a
result of a broken blood vessel) in the epidural space
• Heart and vascular (relating to the blood vessels)
(the space inside the spinal canal but just outside of the
complications including bleeding, ischemia (a deficient
dura) or the retroperitoneal space (the space between
supply of blood to a body part), abnormal blood pressure,
the space where the abdominal organs are located and
hematoma (collection of clotted blood in tissue as a result
the back abdominal wall).
of a broken blood vessel), thrombosis (formation of a
blood clot within a blood vessel), and embolism (sudden • Scarring, adhesions, or swelling including in the
obstruction of a blood vessel by a clot or abnormal particle peritoneum (the membrane that lines the abdominal
circulating in the blood). cavity).
• Pulmonary (relating to the lungs) complications. • Hernia (the bulge of an organ through the structure or
muscle that usually contains it).
• Gastrointestinal complications including ileus (blockage
of the intestines).
• Genitourinary (relating to the genital or urinary organs)
complications.
• Neurological complications including nerve damage,
paralysis (loss of movement), seizures, changes to mental
status, and reflex sympathetic dystrophy (a painful
disorder marked by burning pain, swelling, and motor and
sensory disturbances especially of an extremity).
• Complications of pregnancy including miscarriage and
congenital defects.
• Inability to resume activities of daily living.
• Death.
 prodisc® L | PATIENT INFORMATION GUIDE 15

Risks associated with a total disc replacement device In addition to the risks listed, there is also the risk that the
(including the prodisc L Total Disc Replacement: surgery may not be effective in relieving your symptoms, or
may cause worsening of your symptoms. If this occurs, you
• An issue with the device including poor positioning of may need another surgery in order to help you feel better.
the device, movement of the device out of place, sinking
of the device into the adjacent bone resulting in loss of
disc height, device breakage, device disassembly (coming
apart), or early or late loosening of the device. Any of
these issues may cause pain or injury to surrounding
organs and structures including nerve or spinal cord
compression or damage (which could cause paralysis)
or damage to blood vessels (which could cause a lot of
bleeding).
• The need for additional surgery which could include
removal of the prodisc L Total Disc Replacement.
• Deterioration (worsening) in neurologic status.
• Failure of the device to improve symptoms and function.
• Problems during placement of the device including
trouble sizing the device or issues with the device
instruments including the possibility that part of an
instrument may remain in your body.
• Reaction of your body to wear debris from the device
(particles of either plastic or metal that come off the
device) or the entire device which may lead to loosening
of the device, tumor formation, autoimmune disease,
metallosis (an inflammatory reaction that can occur
around metal implants), scarring, or other symptoms.
• A change in the alignment or curvature of your spine
including spondylolisthesis (movement of one vertebra
compared to the vertebra below it), a change in lordosis
(change in the normal curvature of the spine), or
instability of the spine.
• Degeneration of other parts of your spine including the
facet joints (joints that connect the vertebrae together in
the back of the spine) or adjacent discs.
• Spinal stenosis (narrowing of the spinal canal causing
symptoms)
• Loss of bone or formation of extra bone including the
potential for unintended fusion at either the treated level
or another level.
16 prodisc® L | PATIENT INFORMATION GUIDE

What are the Potential Adverse Effects of

the prodisc L Total Disc Replacement?

One-Level Study Two-Level Study

During the prodisc L Total Disc Replacement (One Level) During the prodisc L Total Disc Replacement (Two
FDA clinical trial, patients in the study experienced various Levels) FDA clinical trial, patients in the study experienced
health-related problems that could be attributed to either various health-related problems that could be attributed
the surgical procedure, the patient’s physical health or the to either the surgical procedure, the patient’s physical
prodisc L Total Disc Replacement itself. Some of these health or the prodisc L Total Disc Replacement itself.
problems were identified earlier in the Risk of Surgery section Some of these problems were identified earlier in the
of this pamphlet. Listed below are various adverse event Risk of Surgery section of this pamphlet. Listed below are
rates from the US trial that occurred in both the prodisc various adverse event rates from the US trial that occurred
L Total Disc Replacement and fusion patient groups. For the in both the prodisc L Total Disc Replacement and
safety analysis, there were 162 patients in the prodisc L fusion patient groups. For the safety analysis, there were
Total Disc Replacement patient group and 80 in the fusion 165 patients in the prodisc L Total Disc Replacement
patient group. patient group and 72 in the fusion patient group.

A comprehensive list of risks is provided in the package insert for the device, which your doctor has received. Please ask your
doctor for more information about any additional risks that could be related to your planned surgery.

ADVERSE EVENTS ONE-LEVEL STUDY TWO-LEVEL STUDY

prodisc L Fusion Patient prodisc L Fusion Patient

ADVERSE EVENT CATEGORY Patient Group Group Patient Group Group
N=162 N=80 N=165 N=72
Pain in the back or legs 79.0% 75.0% 73.3% 87.5%
Neurological (events related to the
21.0% 13.8% 23.6% 26.4%
nervous system)
Degenerative disease progression 10.5% 6.3% 7.3% 11.1%

Additional surgery at treated level 8.0% 15.0% 3.0% 16.7%

Incision site related 6.2% 20.0% 21.8% 27.8%

Infection, not index level related 8.6% 10.0% 9.1% 9.7%

Musculoskeletal spasms 8.0% 7.5% 20.6% 16.7%

Dermatological (events associated with
14.2% 12.5% 9.7% 15.3%
the skin) or drug allergy
Vascular injury 4.3% 8.8% 6.1% 9.7%
Other events not associated with any
70.4% 75.0% 81.8% 80.6%
previously identified categories
 prodisc® L | PATIENT INFORMATION GUIDE 17

The prodisc L Total Disc Replacement What are the Potential Benefits of the
U.S. Clinical Studies prodisc L Total Disc Replacement?

The prodisc L Total Disc Replacement was evaluated In the U.S. clinical studies, the potential benefits of the
in United States clinical trials for the safe and effective prodisc L Total Disc Replacements were also evaluated
treatment of single-level and two-level degeneration of the through five years post-surgery. Some of the study results at
cervical spine that causes problems with nerve function due are described below. A comprehensive list of study results
to pressure on the spinal cord and/or nerve roots. The one- is provided in the package insert for the device, which your
level clinical trial involved a total of 162 patients who received doctor has received. Ask your doctor for more details about
the prodisc L Total Disc Replacement compared to the clinical study and its results.
80 who received a lumbar fusion procedure. The two-level
clinical trial involved a total of 161 patients who received the For those patients that are candidates, the prodisc L
prodisc L Total Disc Replacement compared to 68 who
Total Disc Replacement surgery offers another option of
received a lumbar fusion procedure. In lumbar fusion surgery, treatment that may help stop the pain and other problems
the unhealthy disc is removed, the bones are fixed in position associated with a damaged lumbar disc at two levels.
with implants, and bone graft is placed in the area. In most Artificial lumbar disc replacement with the prodisc L
cases, the bone for the graft is obtained from the patient’s Total Disc Replacement is expected to relieve symptoms of
hip bone through a separate incision. spinal cord and/or nerve root compression resulting from
In both studies, patients participating in the prodisc L lumbar disc degeneration at two levels. Additionally, it may:
Total Disc Replacement study had to be between 18 and 60 • Help movement of your back in all directions (forward,
years old and not responsive to non-surgical treatments, backwards, side to side, rotating)
such as physical therapy, for at least six months. A brief
• Minimize your back and/or leg pain
summary of some of the 24-month benefits and adverse
effects from the prodisc L Total Disc Replacement • Minimize tingling in your leg
clinical trial appear below. The clinical benefit of the • Help you return to your normal activities of work, family,
prodisc L Total Disc Replacement beyond five years and recreation
has not been measured.
18 prodisc® L | PATIENT INFORMATION GUIDE

Below are various outcomes and results from the prodisc L Total Disc Replacement (one- and two-level) U.S.
clinical studies two and five years after surgery. Please ask your doctor for more details regarding this clinical trial
and its associated clinical outcomes and results:

One-Level Study Two-Level Study

Two years after surgery, 80 out of 143 prodisc L Total Disc
Clinical Improvement Maintained After Five Years
Replacement patients (55.9%) achieved overall study success,
Patients in both treatment groups experienced significant compared to 28 out of 60 fusion patients (46.7%).
improvements in clinical outcomes at all postoperative
Other key results from the study at two and five years after
follow up visits (including pain, function, and quality of life
surgery include:
questionnaires). The improvements were similar in both
treatment groups and were maintained through five years • The number of prodisc L Total Disc Replacement
after surgery in both patients who received prodisc patients who experienced a severe of life-threatening adverse
L Total Disc Replacement and those who underwent a event through five years was 41 out of 165 (24.8%) patients
fusion procedure. compared to 26 out of 72 (36.1%) patients in the fusion group.
Of those, 13 out of 165 (7.9%) in the prodisc L patients
More prodisc L Total Disc Replacement Patients compared to 16 out of 72 (22.2%) in the fusion patients were
Would Have the Same Surgery Again considered either device or procedure related.
• At two years, 133 out of 147 prodisc L patients (81.8%)
Patients were asked at each follow up visit whether they
demonstrated meaningful improvement in the Oswestry
would have the same surgery again. At five years, 81%
Disability Index (ODI), an outcome measure designed to
(99/122) of patients in the randomized prodisc L
evaluate patient function, compared to 43 out of 61 fusion
Total Disc Replacement group responded “yes” compared
patients (70.5%).
to 68% (34/50) of patients in the fusion group.
• In addition, at two years a meaningful decrease in low back
and leg pain was seen in 105 out of 142 prodisc L patients
Motion
(73.9%) compared to 37 out of 61 fusion patients (60.7%).
At two years after surgery, 66% (98/149) of randomized • At two years, 131 prodisc L patients were evaluated for
prodisc L Total Disc Replacement patients had range of motion (ROM) in flexion and extension (forward/
more than five degrees of motion in flexion and extension backward) at the operative levels compared to their pre-
(bending forward and backward). Similarly, at five years operative motion. In this measurement, 97 of 131 prodisc
after surgery, 67% (83/123) of randomized prodisc L patients (74.0%) had either the same or more motion in
L Total Disc Replacement patients had more than five flexion-extension at two years as before they were treated
degrees of motion in flexion and extension. based on the combined motion at both operated levels.
• Prior to the study surgery, 111 out of 161 (68.9%) of the
prodisc L patients compared to 42 of 68 (61.8%) of the
fusion patients were taking narcotic pain medication.
• At two years, 50 of 141 (35.5%) prodisc L patients were
still taking narcotic pain medication compared to 33 of 57
(57.9%) of the fusion patients.
• At two years, 139 prodisc L patients and 56 fusion
patients were asked if they would have surgery again. The
majority of patients in both arms responded “Yes”.
 prodisc® L | PATIENT INFORMATION GUIDE 19

How to Choose the

Correct Treatment

Spinal fusion and the prodisc L Total Disc Replacement

both treat DDD. Consult with your doctor about your options
and the best course of treatment for you.
20 prodisc® L | PATIENT INFORMATION GUIDE

What happens before your surgery? What happens during your surgery?

Your medical history is extremely important to the success Your doctor will remove the prodisc L Total Disc
of the operation. Before surgery, your doctor will consider Replacement implant pieces from their inner packaging,
your occupation and activity level, your overall health, the being careful to keep them clean (sterile) and undamaged.
condition of other levels of your spine, any medications you
are taking, and any allergies you have to determine the best You will be placed under general anesthesia. Even though
course of treatment for you. Your doctor will also discuss the you are having lower back surgery, your surgery will be
procedure at length as well as its potential risks and benefits. performed through an incision in your abdomen. You will be
lying on your back.
In order to be adequately prepared for your recovery
following surgery, it may be necessary to make some minor During your surgery, the doctor will remove the unhealthy
adjustments within your home and arrange for someone to disc. Trials will be used to determine the appropriate
help you. This includes moving any overhead items to an implant size and your unhealthy disc will be replaced with
area that can be easily reached and moving items that could the prodisc L Total Disc Replacement device. After
potentially cause you to lose your balance or fall. insertion, your incision will be closed.
 prodisc® L | PATIENT INFORMATION GUIDE 21

What happens after your surgery? When to Call Your Doctor

Surgery with the prodisc L Total Disc Replacement Contact your doctor immediately if you:
is considered major surgery. As with any major surgery,
you should expect some discomfort as well as a period of • Have a fever or chills
rehabilitation. Your doctor may prescribe medicines to help • Notice fluid draining from your incision
you manage any pain or nausea you may experience. You • Have trouble swallowing or breathing
should expect to stay in the hospital for at least a few days.
• Have trouble urinating
The average hospital stay for disc replacement surgery
patients in the clinical study for the prodisc L Total Disc • Have new or increased back or leg pain
Replacement was about 3.5 days (range: 1.0–10.0 days). • Have numbness
Prior to going home, you will be taught how to care for your
• Have weakness
incision, and you and your doctor should discuss a plan to
gradually bring you back to your normal activity level. Your
doctor may carry out follow-up examination of your lumbar
disc prosthesis at regular intervals. It is very important that
you follow your surgeon’s instructions. Try not to do too
much, too soon.

WARNING: Extreme activities like lifting very heavy CAUTION: Please be sure to tell your doctor that
weights may result in failure of the device. Call your you had surgery with the prodisc L Total Disc
doctor immediately if you have any new or increased Replacement before you have magnetic resonance
pain, numbness, or weakness in your back or legs. imaging (MRI) taken. The metal in the prodisc L
Total Disc Replacement can affect the quality of the
images taken.
22 prodisc® L | PATIENT INFORMATION GUIDE

When Can I Travel After prodisc L Where Can I Find Out

Total Disc Replacement Surgery? More Information?

Ask your doctor when you can start driving after surgery. CENTINEL SPINE has provided this brochure in an effort
The amount of time needed to recover from surgery differs to inform you about your treatment options. If you would
from patient to patient. like additional information or have more questions about
artificial disc surgery, please contact your doctor.
Contact your local airport if you will be traveling following
implantation of your device. Due to increased security,
airport personnel will be able to provide appropriate
guidance on passing through security with a metallic device
in your spine. CALL CENTINEL SPINE AT:
+1 (484) 887-8810
OR VISIT OUR WEBSITE AT:
www.rediscovermylife.org

PLEASE NOTE: This patient information brochure is not a replacement for

professional medical advice. Only your surgeon is qualified to diagnose and
treat your spine-related pain.

If you experience any serious incident in relation to prodisc L, please report

to the manufacturer, Centinel Spine ([email protected]).

If you are a resident in Australia, please also report to the Therapeutic Goods
Administration (https://www.tga.gov.au/reporting-problems).
 prodisc® L | PATIENT INFORMATION GUIDE 23

PATIENT INFORMATION

You may wish to record important information

regarding your prodisc L Total Disc Replacement.
Please ask your surgeon for this information.

Lot #

Superior Plate

Inlay

Inferior Plate

Warning: This product has labeling limitations. See package insert for complete information.

Caution: International law restricts this device to sale by or on the order of a physician (or properly licensed
practitioner) that has appropriate training experience.

Magnetic Resonance Imaging: The prodisc L Total Disc Replacement is labeled

MR conditional, where it has been demonstrated to pose no known hazards in a specified
MR environment with specified conditions of use. For more information, please refer to
the product package insert.
 Only
US Headquarters: 900 Airport Rd, Ste. 3B, West Chester, PA 19380 USA Email (US): [email protected] Centinel Spine® and prodisc® are registered trademarks
of Centinel Spine®, LLC. All rights reserved.
EMEA Office: Grafenauweg 8, 6300 Zug, Switzerland Email (Int’l): [email protected]
MKT0626 Rev 1 (03/2022)
Web: www.centinelspine.com 2797
Australian Sponsor:
Centinel Spine Australia Pty Ltd
Level 16 Tower 2 Darling Park 201 Sussex Street
Sydney NSW 2000
T: (61) 0292212099