TOPS Clinical Study

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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.

Degenerated Spine

Healthy Spine

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.

Innovation for Mobility

© 2017 by The Lyman Medical Research Foundation, Inc. | ABN Institute for Orthopedic Research & Innovation