Clinical experience with Barricaid spans over 8 years, including one of the largest level I superiority RCTs in spine, where Barricaid has been compared to the gold standard, discectomy alone.
21 European hospitals have enrolled 554 patients (276 Treatment versus 278 Control) in this 1:1 landmark randomized trial. Patient enrollment was completed in October 2014.
Click here to learn which hospitals participate in the Anular Closure RCT Study Group.
Enrolled patients are those with maximum potential to benefit from preservation of their remaining disc by implanting Barricaid anular closure (i.e. those having a minimum posterior disc height of 5mm, as well as a minimum defect size of 4-6mm tall, 6-10mm wide).
To be judged a success, Barricaid patients will need to demonstrate statistical superiority in the study’s two co-primary endpoints:
All patients have been followed at 6 weeks, 3 months, 6 months, 1 year and 2 years.
|PRE-OP||INTRA-OP||6 WEEKS||3 MONTHS||6 MONTHS||1 YEAR||2 YEARS|
Click here to learn more about the peer-reviewed publications from this level 1b RCT.