Abstract
Background: The scope of existing annular closure device (ACD) studies examining long-term follow-up data is limited. There is a paucity of studies that report and analyze recent outcomes data following ACD use. Purpose: We sought to summarize the available long-term follow-up data on postoperative outcomes of the Barricaid (Intrinsic Therapeutics) ACD. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, the PubMed, Cochrane, and OVID databases were searched to identify studies after 2015 that include direct evaluation of an ACD in a clinical context with a minimum of 2 years of follow-up and inclusion of reherniation and complication rates, while excluding case reports, reviews, and meta-analyses. Outcome measures included patient demographics, study characteristics, surgical technique, defect measurement technique, perioperative statistics, radiographic assessments, complications, patient-reported outcome measures (PROMs), and postoperative outcomes. Results: Five studies-2 randomized controlled trials (RCTs), 2 retrospective studies, and 1 prospective cohort study-were included. Symptomatic reherniation rates in the ACD populations ranged from 3% to 18.8%. Two studies found that control groups herniate significantly more than their ACD counterparts (ACD 18.8% vs non-ACD 31.6% and ACD 3.33% vs non-ACD 20.0%). No significant differences were found in reoperation rates. Of the 4 studies that reported PROMs data, all observed relative improvement in each cohort, although pooled analysis did not find significant differences between ACD and non-ACD groups for Oswestry Disability Index and visual analogue scale-leg pain at 2-year follow-up. Conclusions: For patients undergoing diskectomy for lumbar disk herniation, the Barricaid device is effective in reducing symptomatic reherniation but does not appear to alter postoperative PROMs or reoperation rates. Surgeons must consider that device-related complications can occur.