Clinical Trials
A Randomized Study Evaluating Anular Repair Utiliizing the Xclose Tissue Repair System versus Discectomy Without Anular Repair
(Note: This study is closed for enrollment and awaiting completion of 2 year followup.)
Dr. Gerdes and Central Minnesota Neurosciences are currently participating in a multi-center randomized study involving anular closure with the XClose TM Tissue Repair System. There were 750 patients enrolled in the study. Follow-up will continue for a minimum of 2 years following the completion of enrollment and study results will be published at that time.
The purpose of this study is to evaluate the effects of anular closure following lumbar discectomy. Because the study is randomized, some patients receive the device during surgery and some don’t. In the past, it has been standard practice to not close the anulus following discectomy because of the difficulty involved. This new device uses a unique suture anchoring system that makes a quick and simple closure of the anulus possible in most cases. It is hoped that by repairing the anulus during discectomy surgery, we can reduce the risk of re-herniation and possibly preserve more of the health and function of the disc by slowing the rate of degenerative changes that commonly occur following disc herniation. Studies such as this can help us to reduce the cost of medicine by advancing medical science and innovation.
As with all clinical trials, we must keep an open mind about the products we are evaluating. We have good reason to suspect that anular closure will have positive benefits and is unlikely to cause harm.
We will know more following the completion of this study. The information is valuable in any event and we are excited to be participants in this study and to be able to offer 
the opportunity of participation to our patients as well.
Currently the final data is being compiled.
The following information regarding the Anulex product is provided by the manufacturer for patient educational purposes. For further information regarding the study, please feel free to contact our clinic.
Click on the links below for
information from the manufacturer.