The purpose of the Freedom® Lumbar Disc (FLD) clinical study is to look at the result of using the FLD device as an artificial lumbar disc and to compare the results of the FLD to an already approved lumbar disc, the Synthes ProDisc™. The study will compare the safety and effectiveness of the artificial lumbar discs. An important part of this study is that you will be randomly assigned which artificial disc replacement that you will receive. If you take part in this study, you will not be able to choose which type of artificial disc replacement that you will receive.
What is a lumbar disc?
The human spine is made up of 24 spinal bones called vertebrae. Vertebrae are stacked on top of one another to form the spinal column. The spinal column gives the body its form. It is the body's main upright support. The section of the spine in the lower back is known as the lumbar spine. Lumbar disc replacement typically occurs in the lumbar spine at levels called L3 to S1 (Figure 1). A layer of tissue called an intervertebral disc sits between each pair of vertebrae. The disc normally works like a shock absorber. It protects the spine against the daily pull of gravity. It also protects the spine during hard physical activities that put strong force on the spine, such as jumping, running, and lifting. If the intervertebral disc does not work like it should due to an illness called Degenerative Disc Disease (DDD), it can cause more pain and lessen the spine’s ability to handle activities.
What is the FLD?
There are several artificial lumbar discs approved for use in the U.S. by the FDA. All of the approved artificial lumbar discs are generally called a “ball and socket joint” artificial lumbar disc. These ball and socket joints are three-piece replacement devices. They are made up of two different shaped metal pieces and a different type of hard plastic (polyethylene) or hard metal placed in between the metal. The FLD is a one-piece total disc replacement device. A special plastic (silicone polycarbonate urethane polymer) is placed in between two metal plates. A metal cap locks into each plate. The FLD is intended to relieve low back pain by replacing the parts of your lower back (the intervertebral disc) that have been damaged by degenerative disc disease.
What clinical information is already available for the FLD?
The FLD device has been used in England and Germany in 50 patients in a clinical study. Researchers are still studying the long term effects of the FLD in these patients. No clinical studies have been done on the FLD in the U.S. before this FDA study.
Who is eligible for this study?
Generally, males and females between 21 and 65 years of age who are diagnosed with single level, degenerative disc disease at L3 to S1. Other considerations, such as medical history, must be evaluated by your surgeon before offering you the choice to take part in the study.
Are there additional costs?
It is not expected there will be any added cost to you for participating in the study. The Sponsor will pay for any implant device, medical test, or medical or surgical procedures that are required by the study. The Sponsor will not pay for tests and drugs that you would normally receive as part of the regular treatment of your condition. The patient informed consent form for this study and your surgeon will have more detailed information on what is or is not paid by the study’s Sponsor. The Sponsor and the investigator will not pay you to be a part of this study.
How long will the study last?
The study is expected to last about 5 years in total, however, there is a possibility this study may last up to 10 years. The follow-up visits required by your surgeon may be the same as if you were not participating in the study. At each visit you and your condition will be evaluated by your surgeon, x-rays will be taken, and you will be asked to fill out several questionnaires about your level of pain, function and satisfaction. If the study continues after 5 years, additional follow-up will be via a mail “postcard” asking about your previous back surgery or actual clinic visits with your surgeon or some combination.
What are the risks and benefits?
The risks to you that are related to the FLD device are similar to other low back surgery and other approved artificial disc replacement devices. Potential benefits may include decreased pain, better function and the decreased use of medicines for pain. Please ask your surgeon to explain all of the risks and potential benefits to you in detail. The informed consent form for this study has much more detailed information about risks, benefits, and study requirements.
Why should I participate?
A select group of surgeons are participating as investigators in this study of the FLD. AxioMed Spine Corporation (the study Sponsor) is collecting this data in order to compare the safety and effectiveness of the FLD to other FDA approved artificial lumbar discs. If eligible and you choose to be a participant, you will be one of approximately 300 to 500 patients across the U.S. and Europe who will be selected by their surgeon to participate in this important clinical investigation.
What if I decide not to participate?
Your participation in this study is entirely voluntary. Furthermore, you may decide to withdraw from the study at any time. Regardless of your choice, the quality of care provided by your surgeon will remain the same.
Who is AxioMed Spine Corporation?
AxioMed Spine Corporation was formed in 2001 to develop products to treat patients with degenerative spine disease while delivering patient care of the highest quality and performance with sound, innovative technology. AxioMed Spine Corporation is the sponsor of this clinical study. You can find out more about the study at www.AxioMed.com.
Who do I contact to find out if I am a candidate?
Resurgens Spine Center is one of the currently participating sites that is enrolling patients in this FDA study. To learn more about scheduling an evaluation with a participating Resurgens surgeon, please send an e-mail to info@resurgensspine.com or contact Lori Ellwood, RN, at 404-531-8614.
