BACKGROUND: Patients with large defects in the annulus fibrosus following lumbar 
discectomy have high rates of symptomatic reherniation. The Barricaid annular 
closure device provides durable occlusion of the annular defect and has been 
shown to significantly lower the risk of symptomatic reherniation in a large 
European randomized trial. However, the performance of the Barricaid device in a 
United States (US) population has not been previously reported.
DESIGN AND METHODS: This is a historically controlled post-market multicenter 
study to determine the safety and efficacy of the Barricaid device when used in 
addition to primary lumbar discectomy in a US population. A total of 75 patients 
with large annular defects will receive the Barricaid device following lumbar 
discectomy at up to 25 sites in the US and will return for clinical and imaging 
follow-up at 4 weeks, 3 months, and 1 year. Trial oversight will be provided by 
a data safety monitoring board and imaging studies will be read by an 
independent imaging core laboratory. Patients treated with the Barricaid device 
in a previous European randomized trial with comparable eligibility criteria, 
surgical procedures, and outcome measures will serve as historical controls. 
Main outcomes will include back pain severity, leg pain severity, Oswestry 
Disability Index, health utility on the EuroQol-5 Dimension questionnaire, 
complications, symptomatic reherniation, and reoperation. Propensity score 
adjustment using inverse probability of treatment weighting will be used to 
adjust for differences in baseline patient characteristics between the US trial 
participants and European historical controls.
ETHICS AND DISSEMINATION: This study was approved by a central institutional 
review board. The study results of this trial will be widely disseminated at 
conference proceedings and published in peer-reviewed journals. The outcomes of 
this study will have important clinical and economic implications for all 
stakeholders involved in treating patients with lumbar discectomy in the US.
STUDY REGISTRATION: ClinicalTrials.gov (https://clinicaltrials.gov): 
NCT03986580.
LEVEL OF EVIDENCE: 3.