Pivotal clinical trial demonstrates superiority of anular closure compared to standard lumbar discectomy

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Barricaid anular closure device (Intrinsic Therapeutics)

The use of a bone-anchored anular closure device following discectomy is superior to treating high-risk patients with discectomy alone, a two-year study recently published in The Spine Journal reports. The landmark, randomised superiority clinical trial investigated the Barricaid anular closure device (Intrinsic Therapeutics) in comparison to today’s gold standard of discectomy without anular closure for patients at higher risk of recurrent lumbar disc herniation.

The clinical trial included 554 randomised patients. Its purpose was to determine whether a microdiscectomy with a bone-anchored anular closure device resulted in lower reherniation and reoperation rates and increased overall patient clinical success, when compared to traditional lumbar discectomy without defect closure.

The group treated with Barricaid had significantly lower rates of reherniation (12% vs. 25%, P <0.001), reoperations to address recurrent herniation (5% vs. 13%, P=0.001), and index-level reoperations (9% vs. 16%, P =0.01).

“In order to fully comprehend the benefit of treating these patients with an implant, it is important to realise that patients who are reoperated generally do not reach the same pain and functional improvement of patients who did not have additional surgery. The odds of not returning to work were nearly three times higher after a revision surgery. Barricaid cuts the rate of reoperations in half at two years, preventing chronic disability and improving quality of life,” explains Matthew McGirt (adjunct research associate professor, University of North Carolina, USA), who was not involved in the study.

In addition, the rates of serious adverse events related to either the implant and/or procedure was 7% in the Barricaid group and 17% in the control group (P=0.001), indicating that use of the Barricaid lowers the incidence of hospital readmissions.

“These study results shine a spotlight on the fact that if we add a device to a procedure that doesn’t otherwise have one, the treatment cohort experiences fewer related hospital readmissions, with a 40% reduction at two years. According to current follow-up data of up to five years this differential is maintained,” says Claudius Thomé (Department of Neurosurgery, University of Innsbruck, Austria), one of the principal investigators of this trial. “Moreover, if a reoperation needs to be considered in a patient later on, the same revision strategies are possible with this implant as after microdiscectomy alone.”

Within the discectomy population, patients with large defects in their anulus following lumbar discectomy are at high risk of symptomatic recurrence and reoperation. According to literature, 30–40% of all discectomy patients fall into this group. With almost 500,000 discectomies performed annually in the USA alone, this poses a significant problem not only for the patients affected, but also for society as a whole, Intrinsic Therapeutics say in a press release.

The company currently markets and sells the Barricaid in Europe, Australia, Mexico, the Middle East and selected countries in other regions around the world. In the USA, Intrinsic Therapeutics is seeking regulatory approval of the Barricaid Anular Closure device.

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