A new hernia blocking system prevents lumbar disc herniation recurrence and disc degeneration: 2 years results of a multicentric clinical investigation.

INTRODUCTION: Recurrent lumbar disc herniation (rLDH) is a common complication of limited discectomy for patients with large annular defects. This manuscript presents the first long-term experience with a new hernia blocking system (HBS) that aims to reduce rLDH.

RESEARCH QUESTION: Whether a new HBS, implanted after a limited discectomy, prevents rLDH.

MATERIAL AND METHODS: Thirty patients with a postero-lateral disc herniation between L4 and S1 and large annular defects, who underwent a limited discectomy and were treated with a new HBS (DISC care, NEOS Surgery S.L.), were included in the study. Patients were clinically evaluated with patient questionnaires (VAS Pain and Oswestry Disability Index - ODI) and neurological examinations and radiologically evaluated with MR, CT scan and X-Rays before surgery to assess preoperative status and at 6 weeks, 6, 12 and 24 months after surgery to assess their progression.

RESULTS: No symptomatic rLDH was detected during the 24-months follow-up. Additionally, disc height was largely preserved, and no disc degeneration was observed in the studied patients. All patients had a significant reduction in leg pain (>2 points in the NRS) and 84.6 % improved >15 points in the ODI. The implantation of the HBS was not associated with segmental instability, vertebral body fractures, heterotopic ossification or spontaneous fusion. No product-related serious adverse events nor secondary surgical interventions occurred.

DISCUSSION AND CONCLUSIONS: The implantation of this new HBS is an easy and safe procedure that prevents long-term rLDH.

CLINICALTRIALSGOV: NCT04188236.