How Well Do Closure Devices Reduce Re-Herniation Risk?
A new study tests the proposition that a disc closure device can reduce the risk of reherniation following discectomy. One of the more significant aspects of this study is that it collected 5-year follow-up data for more than 550 patients.
The findings were published (”Effectiveness of an Annular Closure Device to Prevent Recurrent Lumbar Disc Herniation A Secondary Analysis With 5 Years of Follow-up”) online on January 25, 2022 in JAMA Network Open.
Herniated lumbar discs most frequently affect young, active individuals and can lead to disability and absenteeism from work. Typically, more conservative treatments are attempted first before surgery is recommended. Almost 500,000 discectomies for a herniated lumbar disc are performed annually in the U.S. Patients who undergo it are at high risk of reherniation and/or reoperation.
The randomized superiority trial collected data from 554 patients. The closure device used was Barricaid, which had received FDA Pre-Market Approval in 2019. According to the study authors, patient treated with the Barricaid closure device experienced significantly fewer reherniations and reoperations over the five-year study period: reherniations (41% reduction; p < 0.001) and reoperations (29% reduction, p = 0.03).
The researchers say this new data confirms previous evidence including 64 peer-reviewed studies that focused on 8 unique patient populations.
"The five-year follow-up analysis makes it clear that lumbar discectomies are not as benign as we originally thought. The JAMA study results conclusively show high-risk lumbar discectomy patients treated with Barricaid are less likely to suffer reherniation and reoperation than those patients treated with discectomy alone," said Professor Claudius Thomé, head of Neurosurgery at the University of Innsbruck, Austria, and principal investigator of the trial.
The rates of serious adverse events associated with implant or procedure were also lower in the patients treated with Barricaid (12.0% vs 20.5%) (p = 0.008). And fewer complications lead to fewer hospital readmission, the researchers added.
"Not surprisingly, patients who have operations for reherniation don't generally experience the same pain and functional improvement as patients not requiring additional surgery," Dr. Pierce Nunley, Director of the Spine Institute of Louisiana, explained.
"With the proven reduction in reoperation, this large, multicenter study reaffirms and compliments a large body of published evidence supporting Barricaid's medical and economic benefits."
The Barricaid Disc Closure Device was developed by Intrinsic Therapeutics, Inc., a medical device company that specializes in preventing reherniation and reoperation following lumbar discectomy. In this study, researchers found that high-risk discectomy patients treated with Barricaid were less likely to suffer reherniation or reoperation.
For more information about Barricaid, here is a video courtesy of Intrinsic Therapeutics, Inc. which describes one patient’s experience.
Suzanne is a 46-year-old mother and passionate fitness instructor. When she suffered a dramatic disc herniation resulting in extreme sciatic pain, getting back to teaching and minimizing her risk of future problems were top priorities. Suzanne and her surgeon chose a disc closure device (Barricaid) to close the hole in the disc after her discectomy and reduce her risk of reoperation for reherniation by 81%. Five months later she is pain free and back to doing what she loves.