TOPS Clinical Study
Roland Kent, MD
Daniel Blizzard, MD
Am I eligible for the TOPS study?
Radiating leg pain
Greater leg / buttock pain than back pain
Severe pain sets in when walking as little as 100 yards or 2 minutes
Pain reduces when sitting, bending forward, or leaning over a shopping cart
What is the TOPS Study?
It is a research study offered to volunteers who suffer from spondylolisthesis, spinal stenosis and additional spinal symptoms. Physicians will be comparing the TOPS to lumbar fusion in a randomized clinical trial. This pivotal study is designed to determine the safety and efficacy of the TOPS implant after which the U.S. Food and Drug Administration (FDA) will determine if the device will become available to the general public.
How are patients randomized?
If you choose to participate and you qualify for this study, you will not be able to choose the group to which you are assigned. Your treatment assignment will be made by randomization, a method similar to tossing a coin. You will have a two in three chances of receiving the TOPS System (67%) and a one in three chance of receiving posterior lumbar spinal fusion (33%).
Has this type of surgery ever been done prior to this clinical trial?
Yes. TOPS is approved and used in Europe and Australia for many years. The TOPS completed a pilot study in the United States.
What is my commitment?
You will be evaluated at regular follow-up visits. There will be one visit 6 weeks after surgery and then other visits at 3, 6, 12, and 24 month, and annually there after until the study ends. During these visits one or more medical professionals will evaluate your physical condition. Enrollment in this study requires that you complete all follow-up visits in a timely manner. This is an agreement that you make with the physician and the sponsor of the study. No matter what your assignment group is, your follow-up data is very important to help determine the safety and efficacy of the TOPS device.
Are there any risks associated with this clinical trial or the surgical procedure?
The risks are the same as those associated with fusion spine surgery. If you are interested in enrolling in the study, you will be asked to sign an Informed Consent form that contains a list of potential adverse events. The physician conducting this clinical trial will have a detailed discussion with you prior to enrollment in the study. This trial is being conducted under the auspices of FDA. Additionally the hospital's associated Institutional Review Board has approved this clinical trial.