Patients with large anular defects (6mm or wider) following lumbar discectomy for disc herniation are at high risk for symptomatic recurrence and reoperation.
To determine whether a bone-anchored anular closure device (Barricaid) in addition to lumbar microdiscectomy resulted in significantly lower reherniation and reoperation rates plus increased overall success compared to lumbar microdiscectomy alone.
Barricaid demonstrated superiority in overall trial success at 2 years compared to limited discectomy alone. The difference between both groups is statistically superior on all endpoints, in favor of Barricaid.
Frequency of symptomatic reherniation was lower with Barricaid (12% vs 25%, P<0.001).
Index level reoperations were less frequent with Barricaid (9% vs 16%, P=0.01). 29 reoperations in 24 patients in Barricaid group and 61 reoperations in 45 control patients.
Frequency of reoperations to address recurrent herniation was 5% with Barricaid and 13% in controls (P=0.001).
Reoperated patients report significantly more pain, disability and work loss than non-reoperated patients at 2 years.
Frequency of serious adverse events as related to either the implant or procedure was 7% in the Barricaid group and 17% in the control group (P=0.001). This difference was primarily due to the lower incidence of reherniation in the Barricaid group.
No difference in all-cause serious adverse events was observed when comparing Barricaid to controls (25% vs 30%, P=.015).
Endplate changes were more prevalent in the Barricaid anular closure device group (84% vs 30%, P<0.001), though no correlation with any symptom or clinically adverse event was observed.
In patients at high risk of herniation recurrence following lumbar microdiscectomy, anular closure with Barricaid significantly lowers the risk of symptomatic recurrence (P<0.001) and reoperation (P=0.01).