The surgery is guided using x-ray. Once you and your surgeon decide that this device may be good for your situation, your surgeon measures the size of the hole to see if you qualify as a higher risk patient. If so he/she will choose the correct size of the implant. Your surgeon will then insert the small titanium (a type of metal) anchor into the bone, while the polymer (a type of plastic) flap forms a barrier to try to block the hole. The discectomy part of the surgery is supposed to reduce the pain and restore normal motion of your back. The device is supposed to help reduce the potential for a future herniation to occur again.
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.
- Symptomatic reherniation: Symptomatic reherniations result in increased pain, functional loss, and increased hospital visits or additional surgeries. Patients treated with the Barricaid had a statistically superior treatment differential with respect to symptomatic reherniation rates over discectomy alone. In other words, patients treated with the Barricaid had fewer reherniations that caused symptoms such as pain and additional surgeries. This benefit was maintained through 5 years.
- Additional Surgery: Patients treated with the Barricaid had fewer reoperations that patients treated with discectomy alone. 39 Barricaid patients had reoperations and 10 went on to have subsequent reoperations, two patients had a third reoperation, and none had a fourth. 57 discectomy-only patients (no Barricaid) had reoperations and 18 went on to have a total of 24 subsequent reoperations. Four patients went on to have a third reoperation, and two had a fourth reoperation. For additional surgeries specifically for reherniation, 24 Barricaid patients had a total of 33 reoperations following reherniation compared to 62 such reoperations in 47 Control patients.
- Device issues: There were a total of 51 device issues reported, 27 of these caused the patient any symptoms. Of the total issues reported, 7 were related to the metal anchor (breaking and/or moving), and 44 were related to the polymer (moving and/or detaching).
- VAS (leg pain) improved due to discectomy: As expected, both the patients treated with the Barricaid and those who weren’t showed the same improvement of pain scores because of the discectomy procedure. Low rates of post-operative pain are because of the discectomy procedure, and not the Barricaid.
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.