Clinical Trials

Cervical Artificial disc Clinical trial (Kineflex-C)

Design of the study

The purpose of this study is to assess the ability of an artificial disc: the Kineflex-C to safely relieve the symptoms associated with the neck ailment known as degenerative disc disease (DDD). A total of approximately three hundred and thirty seven (337) patients will participate in the study. The purpose of the study is to compare the outcome of this disc replacement to spinal fusion surgery.

Currently, spinal fusion is the standard treatment for someone who has DDD. The cervical column is made up of many joints, which allow the body to bend, twist and move. Pain often results when there is something wrong with these joints. These types of neck problems may require the spine surgeon to remove the disc, which is between the vertebrae bones, and fuse the two bones together.

This fusion often relieves the symptoms of pain, but makes the joint incapable of normal movement. Artificial discs such as the Kineflex-C have been proposed to offer potential improvements in function while also relieving pain.

Who can participate?

The replacement of damaged cervical disc by the Kineflex-C is not FDA approved. Only patients enrolled in the study can have it. The indications are very strict and by no means can be negotiated. Only patients between 18 and 60 years old, suffering from a single-level disc disease in the cervical spine, can be considered candidates. An extensive evaluation is required as the list of contraindications is long (osteoporosis, for example). Patients should understand that these restrictions are not meant to restrict the access to the study but to insure patient safety with regard to a new surgical device. No enrollment (or assurance of enrollment) will be made before you have been examined in our office and passed all the required tests. If you don't qualify for this specific study, we will certainly offer you other alternatives adapted to your condition.

What is a Clinical Trial?

A clinical trial is a research study designed to answer specific questions about new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people.

Participation in the trial will be for at least 24 months or until the last patient enrolled has reached his or her 24-month anniversary. Patients may be contacted after that time to provide longer-term information about the Kineflex-C, including x-ray information as required by the FDA.

Half of the patients enrolled in the study will receive the Kineflex artificial disc. The other half will be randomized to the fusion technique. You may not choose the group to which you are assigned. Your treatment assignment will be made by randomization, a method similar to tossing a coin. Randomization is a method based on chance by which study participants are assigned to a treatment group. Randomization minimizes the differences among groups by equally distributing people with particular characteristics. You will not know which group you have been assigned to before the surgery is performed.

Surgery

Surgery will be performed by two experts in cervical spine diseases at Lenox Hill Hospital in New York City:

• Dr. Fabien Bitan, Orthopedic surgeon, Chief of the Spine Department at Lenox Hill Hospital. He has 15years of experience in Cervical Spinal Surgery and has been a pioneer in the U.S. for the introduction and development of the Charite artificial disc for the lumbar spine. To date, he has experienced more than 350 cases.
  
  
• Dr. Fred Noban a Neurosurgeon, is in charge of Neurosurgery Services at Lenox Hill Hospital. Dr. Dr. Bitan and Dr. Noban will be performing your procedure together.
  
  

Procedure

Whichever group you are assigned to, the procedure is very similar. The only main technical difference is the nature of what is inserted in the space at the end of the procedure. The surgical approach is made through the front of your neck. After a meticulous dissection, the anterior (front) aspect of your spine is exposed and the disc is identified using an intra-operative x-ray. The disc is then removed and the nerves decompressed.

If you are assigned to the fusion group, the space is then filled with a piece of bone, which is acquired from a bone bank. This bone is then secured by a small metallic plate with screws. This construct is intended to fuse the adjacent vertebrae together. This is, to date, the standard treatment for your condition.

If you are assigned to the artificial disc group, then an appropriately sized device will be implanted. This implantation is well codified by the manufacturer. Your surgical procedure may be observed by a Sponsor representative (SpinalMotion Inc.) and/or a teaching surgeon investigator, especially for the first few surgeries done at Lenox Hill Hospital. In both cases, you will stay in the hospital for 1-2 days.

The risks of the procedures will be explained to you in detail at the time of your visit.

Who will pay for your procedure?

As with any spinal procedure, your insurance company will be contacted ahead of time for pre-certification. If there are problems; for example, if either that the surgeons don't participate to your plan or if your insurance denies the procedure or even if you have no insurance, don't hesitate to contact us. We can work with you and try to help you get enrolled anyway.

Contacts:
For Questions regarding the trial call Tom Ross at 212-744-8114 ext 238.

For medical Questions or to enroll:
Please call Dr Iris Yaron (212-744-8114 Tuesday and Thursday)

For more information regarding the artificial disc, go to: www.spinal-motion.com/kineflex_cervical_disc.htm

Current research notification.