A new hernia blocking system to prevent recurrent lumbar disc herniation: surgical technique, intraoperative findings and six-months post-operative outcomes.

Abstract

Purpose: The aim of this study was to evaluate the performance and safety of a new hernia blocking system (HBS), implanted after a limited discectomy, to prevent recurrence of lumbar disc herniation.

Methods: Prospective, multicenter (6 sites), cohort clinical investigation. Thirty patients with a postero-lateral disc herniation between L4-S1 and large annular defects (> 6 mm wide), who underwent a limited discectomy and were treated with a new HBS (DISC care, NEOS Surgery S.L.), were included. This article presents details about the investigational device, its surgical technique, intraoperative parameters, and up to 6 months follow-up outcomes. The primary endpoint of the study was to assess the incidence of early symptomatic reherniation. In addition, disc height, leg and back pain (NRS 0-10), Oswestry Disability Index (ODI), quality of life (EQ-5D-5L) and device safety, were evaluated.

Clinicaltrials: gov: NCT04188236; date: 27th November 2019.

Results: Thirty patients (43.3% female, 41.7 ± 10.9 years) were implanted with the device under evaluation in a mean of 16 ± 9.6 min. Six months after surgery, no symptomatic reherniation was detected and disc height was maintained in all patients included. All patients had a significant reduction in leg pain (> 2 points in the NRS), 92.9% improved > 15 points in the ODI and 82.6% significantly improved their quality of life (≥ 12 points in EQ VAS score). No product-related serious adverse events nor reoperations occurred.

Conclusions: The implantation of an HBS is a feasible and safe procedure that prevents early disc herniation recurrence in patients at high risk of reherniation.