Clinical Trials - Spineology OLIF

Spineology OLIF (OptiMesh® for Lumbar Interbody Fusion (OLIF) Clinical Investigation

Your doctor has determined that you have a condition were one of your discs between the large bones (vertebrae) of your spine has been damaged. This often occurs following an injury or as a natural part of the aging process. For some people, this causes pain. The discs may tear and small bone spurs may form. Both of these things can pinch nerves and cause pain in the legs and back. Doctors may try several treatments such as exercise, bracing, and physical therapy to treat this problem. For some people these treatments do not relieve the pain. In these cases the doctor may recommend surgery to fuse the spine. Spinal fusion surgery is designed to stop the painful motion in the spine after removing tissues that are pressing on nerves. The kind of fusion surgery that will be used in this study is called interbody spinal fusion with posterior fixation. Part of your disc will be taken out and bone graft material will be put in that space to fuse the spine. A posterior spinal fixation system is also used. The fixation system is used to provide more stability while the bone graft heals. You are being asked to take part in a clinical research study which will compare a new device called the OptiMesh 1500S to a standard treatment for spine fusion. OptiMesh 1500S is the investigational device made by Spineology, Inc., a medical device manufacturer located in St. Paul, MN. The device has not yet been approved by the U.S. Food and Drug Administration (FDA) for commercial use. In order for this study to start, it is necessary for the FDA to review and approve the study procedures and other materials related to the device being studied. An ethical review committee called an Institutional Review Board (IRB) must also review and approve the study. Both the FDA and the IRB will oversee the study in order to ensure that the rights of the study patients are protected.