FlexiCore™ Intervertebral Disc for the Treatment of Degenerative Disc Disease

Overview
The purpose of this clinical trial is to compare the safety and effectiveness of treatment with the FlexiCore™ artificial disc to treatment with the current standard of care, spinal fusion.

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?
You and your surgeon have tried other treatments for at least six months now, which have not adequately relieved your pain or dysfunction. Your surgeon has recommended that you consider surgery. You are being invited to participate in this clinical study because you are a good candidate for surgery and you met the study's eligibility criteria.

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.
• Read, understand, and sign the informed consent form.
• Stop taking aspirin and ibuprofen 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.
• Talk 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.

Location & contact
Charles Kuntz, MD (Principal investigator)
William Tobler, MD (Co-investigator)
Robert Bohinski, MD (Co-investigator)
Suzanne Kempisty-Cliver, RN (Study coordinator)

University of Cincinnati & Mayfield Clinic
Telephone: 513-558-3590
Fax: 513-558-7702
Email: suzanne.kempisty-cliver@uc.edu 

More information
Start date: 6/2004
Close date: 11/2004
Sponsor: SpineCore

Understanding clinical trials