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Why are you doing a study? Why can't my surgeon
just implant the device?
The FlexiCore™ Intervertebral Disc is an investigational device.
The government requires that new devices be investigated for safety
and effectiveness before they can be made generally available. This
study is designed to determine if symptom relief provided by the
FlexiCore disc is better, worse, or the same as a fusion surgery.
We also want to determine if patients with the FlexiCore disc still
have motion of their vertebrae, compared with patients undergoing
fusion (who should have very little or no motion at the fusion site).
Why am I being invited to participate in this study?
The hospital stay is usually from two to five days. Before release
you may see a nurse or physical therapist who will teach you how
to care for your incisions and your back during your recovery.
How will I know if I am to receive the disc or fusion surgery?
Patients will be selected at random to receive the FlexiCore disc
or fusion surgery (control). For every three patients, two will
be selected randomly to receive the FlexiCore disc. In other words,
you have a greater chance to receive the FlexiCore disc compared
to fusion surgery. Your surgeon will discuss with you the treatment
you will receive.
What is the control procedure?
The fusion surgery involves making an incision in your abdomen and
removing a single damaged or worn disc between the vertebrae. The
disc tissue is replaced with allograft bone (from a bone bank).
Another incision will be made in your lower back to implant pedicle
screws and rods. Bone may be taken from your hip and placed near
the screws. The allograft bone and hipbone will help the vertebrae
fuse together. The pedicle screws and rods will help stabilize your
spine and hold the allograft tightly in place while the vertebrae
fuse.
What is the experimental procedure?
The disc replacement procedure involves making an incision in your
abdomen and removing a single damaged or worn disc between the vertebrae.
The disc tissue is replaced with a FlexiCore Intervertebral Disc.
The FlexiCore disc is made up of two metal plates that make contact
with the vertebrae, with a ball and socket between them. The vertebrae
are not fused in this procedure.
Which operation will relieve my pain and restore function?
The fusion surgery procedures have been used since the late 1950's.
The FlexiCore disc has not been used in humans before this clinical
trial. Both surgical procedures are expected to relieve pain and
the symptoms of nerve irritation caused by the damaged disc, and
stop progression of spinal cord-related symptoms (if they are present).
Either surgery may not relieve pain and other symptoms for everyone.
The surgery associated with the FlexiCore disc is expected to allow
motion at the operated disc space.
What should I do to prepare for surgery?
You may be told to see your general practitioner before surgery
to check your overall health. Tell your surgeon what medications
you are taking, and ask if you should stop taking any medications
before surgery. You may be asked to donate blood for your own surgery,
although this is uncommon. If you smoke, stop smoking, as this slows
the ability of bone to grow and repair adequately. To make your
recovery easier, prepare your home for life after surgery. Place
often-used items in easy reach. Remove safety hazards that might
cause you to lose your balance. Arrange for someone to help you
at home after surgery.
You'll most likely be told not to eat or drink the night before
the surgery. Be sure you read, understand and sign an Informed Consent
Form before surgery. Your surgeon is required to let you know of
the potential risks as well as the benefits of this surgery.
What can I expect after the operation?
After surgery, you will experience some pain at the site of the
surgery. Your surgeon may prescribe pain or anti-inflammatory medication.
Take it as directed.
Your surgeon will prescribe a plan for your physical rehabilitation.
Your surgeon may encourage short walks to speed your body's recovery
from surgery. Your surgeon may place limits on sitting, lifting,
bending, and twisting, and may require that you wear a corset or
a brace for a few weeks. Follow the plan your surgeon prescribes
for your recovery.
When will I be able to leave the hospital?
The hospital stay is usually from two to five days. Before release
you may see a nurse or physical therapist who will teach you how
to care for your incisions and your back during your recovery.
When should I call my surgeon?
You should notify your surgeon if you notice any of the following:
- More back or leg pain, numbness, tingling or
weakness that does not
decrease with rest.
- Swelling in your legs.
- Increased pain, redness or drainage from your
incision(s).
- Temperature over 100ºF.
- You experience chest pain.
How soon can I return to work, drive a vehicle,
or operate equipment?
Your surgeon will answer these questions based on your individual
case. Although full recovery from back surgery usually takes about
6-12 weeks, it is likely you will be able to return to work in as
little as 4 weeks. Try to avoid long travel, as sitting for long periods
of time places strain on your back. And remember never to drive or
operate machinery when taking pain medication.
When can I engage in normal activities?
It is important to follow your surgeon's instructions about lifting
and twisting your back. It is advisable to quit smoking, as it interferes
with the healing process. You may be advised to avoid sports and recreational
activities for 8-12 weeks. If your surgeon is satisfied with your
progress at the 6 week or 3 month follow-up visit, then restrictions
on your activities will probably be removed.
What follow-up visits are required?
Whether your surgery is the FlexiCore disc or fusion, you will need
to return for a physical evaluation at 6 weeks, 3 months, 6 months,
1 year, 2 years and then annually until the study is completed. At
each of these visits you will be required to undergo a physical examination
(including x-rays) and complete a questionnaire that measures your
comfort and ability to perform daily activities. It is very important
for the study and your continued care that you return on schedule
to provide this information.
How am I protected as a study patient?
There are several procedures in place to protect your rights and safety
in a clinical study:
- Your surgeon is required to
explain the study procedures, benefits and risks, and answer all
your questions. When you are satisfied that the study is for you,
you will sign an informed consent form. Your surgeon cannot
include you in the study without your written, voluntary consent.
- This study has been approved
by the review board of your surgeon's institution (IRB). The IRB
includes consumers, physicians, other health care providers, and
sometimes members of the clergy, who have no personal interest in
the results of the study. As neutral reviewers, they ensure that
the study is conducted fairly and that there is not a high risk of
harm for participants.
- An independent safety
monitor (a physician experienced with this type of study),
monitors the ongoing safety of the participants.
- The company sponsoring the
study is required to let you and your surgeon know if any new
information becomes available during the study that might impact
your safety or influence your decision to continue to participate.
- Your decision to participate is voluntary.
You may withdraw your decision at any time without loss of benefits
to which you are otherwise entitled, and without affecting your
relationship with your surgeon.
Patient Checklist
Before Surgery
- Stop Smoking
- Remove Hazards at home and
put items within reach.
- Stop taking aspirin and ibu
profen several days before surgery.
- Donate your own blood, if
requested.
- Don't eat or drink after
midnight before surgery
After Surgery
- Take your pain medication as
directed
- Walk daily to speed your
recovery.
- Follow physical
rehabilitation plan as prescribed
- Do not drive until your
surgeon approves.
- Schedule your post-operative
6 weeks exam.
Long-Term Recovery
- Ask your surgeon about resuming work and other
activities.
Attend follow-up exams at 6 weeks, 6, 12 and 24 months after surgery.
Attend follup-up exams annually up to
post-operative year 5 if required.
Contact
Dr. Gil Tepper, M.D., F.A.C.S.,
info@valleyspinecenter.com
Valley Spine Center
Call: (866) DISC - DOC
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PBS
Special
Phone:
866-DISC-DOC
Email:
info@valleyspine.com
Surgeon Highlights
Dr. Gil Tepper
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