EN | DE

CLINICAL RESULTS

SHARE THIS PAGE:

The Barricaid® device has been successfully implanted in patients since 2008. As part of its clinical introduction, the Barricaid has been studied in several clinical trials, which have led to a series of publications in leading medical journals and over ninety scientific presentations at international medical conferences. In December 2010, over twenty European hospitals initiated a randomized controlled trial, looking to demonstrate the clear benefit of Barricaid Anular Closure compared to the gold standard procedure (discectomy alone), in patients at highest risk of a new herniation. Two-year clinical results from 554 patients are expected to get published soon.

$contentBlock.alt

TWO PRIOR PROSPECTIVE STUDIES

  • A prospective study is characterized by having its study objectives set out prior to start of the trial, and patient outcomes are captured at the time of the desired follow up point (versus being asked after the desired follow up time point, e.g. asking a patient how much pain he had 1 year ago)
  • Two groups of 75 patients in total were treated with Barricaid and followed for two years (coming back for regular check-ups) to check initial performance of the Barricaid® implant and its safety.
  • The results of those studies have been published in peer-reviewed medical journals.
  • Summary of the results:
    • Only 1 of 68 patients who came in for the two-year follow-up had a symptomatic recurrent herniation.
    • The device did not move inside the bone (vertebrae) and the metal anchor didn’t break
    • In two cases mesh separated from the anchor and patients were reoperated with full patient recovery in both cases.
    • 2 years after the surgery, >90% of the patients maintained more than ¾ of the height of their discs, as measured before surgery.
    • Significant improvements in function and leg pain were reported.
    • No unanticipated adverse device effects occurred in either study.

J Neurol Surg A 2015;76:211-218. Effect of Anular Closure on Disk Height Maintenance and Reoperated Recurrent Herniation Following Lumbar Diskectomy: Two-Year Data. D Ledic, D Vukas, G Grahovac, M Barth, GJ Bouma, M Vilendecic

RANDOMIZED, CONTROLLED TRIAL

  • A Randomized, controlled trial (RCT) is a study where the people being studied are randomly allocated to one or other of the different treatments under trial, in this case one group of patients would receive Barricaid and the other discectomy surgery only.
  • The Barricaid RCT has finished patient enrolment. With 554 patients included in the trial, it is one of the largest studies ever performed on patients undergoing discectomy surgery.
  • The goal of this study is to prove superiority of Barricaid. That means the study should prove that patients treated with Barricaid are significantly better off than those treated with discectomy surgery only. In real life it means that the patient group treated with Barricaid should see fewer new herniations and fewer reoperations, hence demonstrating the implant to be safe and effective.
  • Two-year follow up on these 554 patients has now been completed. First publications about the study results can be found here.

STUDIES BASED ON REAL-WORLD CLINICAL EXPERIENCE

  • A growing list of hospitals performing spine surgery is collecting real-world clinical data on Barricaid and discectomy surgery alone. In the near future more scientific publications on Barricaid are to be expected from these initiatives.