Is Barricaid an option for me?
Barricaid is meant for patients at higher risk of another disc herniation and return of back and leg pain.
Your spine surgeon will be able to determine, based on your pre-operative imaging scan, if you have a disc that can be saved by performing a limited discectomy.
If you do, your hole in the disc will be measured during your discectomy surgery. If the hole is small you are considered at low risk of a recurrent herniation and thus you will not need closure with the Barricaid implant. Only in case of a large hole will you benefit from closure with Barricaid. Therefore, a final decision to implant or not is always made during the surgery. Barricaid implantation follows your standard discectomy surgery.
Barricaid surgery explained
The Barricaid device is implanted following a regular discectomy if it is needed. In this case, your surgeon may implant a Barricaid to reduce the risk of future herniations.
The surgery is guided using x-ray. Your surgeon will make a small in incision and perform a discectomy to remove disc fragments. The discectomy part of the surgery is intended to reduce the pain and restore normal motion of your back. Your surgeon will then measure the size of the hole in your disc. If the hole is the right size for Barricaid, your surgeon will then insert the implant. The small titanium (a type of metal) anchor will go into the bone, while the polymer barrier (white component) goes into the disc to block the hole. The device reduces the chance of a reherniation in the future.
What happens after my Barricaid surgery?
After your surgery, your doctor will give you a plan for your recovery as well as how to care for your incision. This may include limits for your activity or recommendation for physical therapy as well as how to change the dressing on your wound. Your doctor will perform follow-up visits at normal times to see how your wound is healing and to check to see how your recovery is going.
When should I call my doctor?
Some pain and discomfort after surgery is normal. Before surgery you should discuss with your doctor about when to call with problems after surgery. You should call your doctor immediately if you have redness or tenderness of your surgical site, or have too much pain, are sick to your stomach and vomit, or have a fever.
To learn about how patients with the device do after surgery and the use of the Barricaid, seven studies including one pivotal (major) study were performed, to show that the device is safe and is able to reduce the number of repeat herniations in the right group of patients.
The Barricaid was studied in a clinical trial in over twenty hospitals to study the safety and effects of the device in patients with herniated discs with radiculopathy (damage or trouble with nerve function that results in one or both of the nerve roots near the vertebrae pressing upon by the herniated disc).
The study was a prospective (forward looking in time) randomized controlled trial (RCT) where patients received a normal discectomy and the Barricaid device or the normal discectomy surgery alone (control group). Which treatment they got was decided randomly by a computer toward the end of the surgery, after the hole in the disc was measured. There was a total of 554 patients participating, with 276 patients in the Barricaid group and 278 patients in the control group. The trial was focused on patients with a higher risk of a new herniation.
Study results:
95% effective at preventing reoperation for reherniation. 1
References
- Thomé C et al. Annular closure in lumbar discectomy for prevention of reherniation: a randomized clinical trial. The Spine Journal 2018
See here for complete SAFETY INFORMATION.
Is Barricaid safe and does it work?
Standard discectomy surgery, with or without Barricaid, has some risks. Studies have shown that using Barricaid reduces the chance of reherniation, readmission to the hospital and repeat surgery. In the same studies, the Barricaid has shown risks such as device-related issues and development of a void in the spinal bones (vertebrae). Imaging findings showed that 1 in 5 people have these voids prior to surgery, but there is more than double the chance your spinal bones develop voids in them when using the device as compared to when only discectomy is performed. These voids may continue to grow for a few years, but the studies conducted have not shown any bad effects associated with these voids. The long-term effects of these voids have also not been studied past 5 years.
It is important that you discuss all of the risks and benefits with your surgeon. See here for complete safety information.
What are the expected outcomes of the surgery?
Your doctor will give you their expectations of your outcomes after surgery. The discectomy procedure should help improve your leg pain quickly although you may continue to have some pain after the operation. You should not be able to tell if you have a Barricaid implanted. The outcomes of your surgery may depend on how you were doing before surgery and how long you were experiencing any symptoms, among many other factors.
How do I prepare for surgery?
Your doctor will give you instructions to let you know how to prepare for your surgery. You should follow these instructions before the operation. This surgery may or may not require an overnight stay in the hospital.
Talk to your doctor
While this website is meant to provide you with additional information to aid in your discussion with your doctor to decide whether Barricaid is a good treatment option, it is not intended to replace professional medical care or provide medical advice. If you have any questions about the Barricaid, please call or see your doctor, who is the only one qualified to diagnose and treat your spinal condition. As with any surgical procedure, you should select a doctor who is experienced in performing the specific surgery that you are considering.
If you have any questions about the Barricaid treatment or how to get access to Barricaid, you may ask your doctor. See the Barricaid Introduction Guide for more information.