Safety and Performance of a Hernia Blocking System

NCT04188236 | Completed

• 1 other identifier: NEO-RA1-2018-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

Brief Summary

Prospective, multi-center, single-arm clinical study to assess the performance of an Hernia Blocking System in preventing clinically symptomatic recurrent lumbar disc herniation.

Conditions

Disk Herniated Lumbar

Outcome Measures

Primary Outcomes (1)

• Incidence of clinically symptomatic recurrent lumbar disc herniation

  24 months

Secondary Outcomes (11)

• The incidence and type of all adverse events (AE) and serious adverse events (SAE).

  6 weeks, 6 months, 12 months, and 24 months

• Incidence of clinically asymptomatic recurrent disc herniation

  6 months, 12 months, and 24 months

• Disc height maintenance [mm] related to baseline

  6 weeks, 6 months, 12 months, and 24 months

• Change in leg and low back pain assessed by NRS (numeric rating scale), related to baseline

  6 weeks, 6 months, 12 months, and 24 months

• Change in Low back related disability according to the Oswestry Disability Index (ODI), related to baseline

  6 weeks, 6 months, 12 months, and 24 months

Interventions

Hernia Blocking System DEVICE

Hernia Blocking System device implanted during a lumbar discectomy procedure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is between 18 and 75 years of age.
• Posterolateral disc herniation at one level between L4 and S1 with radiographic confirmation (CT and/or MRI) of neural compression.
• At least six weeks of failed conservative treatment prior to surgery, including physical therapy, use of anti-inflammatory medications at maximum specified dosage and/or administration of epidural/facet injections.
• Minimum posterior disc height of 5 mm at the index level.
• Radiculopathy with positive straight leg raise test.
• ODI score of at least 40/100.
• Subjects who are able to give voluntary informed consent to participate in the clinical investigation and from whom consent has been obtained.
• Subject is able and willing to comply with the protocol requirements.

You may not qualify if:

• Spondylolisthesis and/or instability at the index level.
• Foraminal, extra-foraminal or central disc herniation.
• Subject has clinically compromised vertebral bodies in the lumbosacral region due to any traumatic, neoplastic, metabolic, or infectious pathology.
• Subject has scoliosis of greater than 20 degrees (both angular and rotational).
• Less than 20 mm of interpedicular distance in the spinal canal at the index level.
• Grossly distorted anatomy due to congenital abnormalities.
• Deformation that affect the posterior corners of the vertebra at the index level (e.g., osteophytes).
• Endplate irregularities that, in the judgment of the surgeon, could affect the device implantation.
• Prior surgery at the index lumbar vertebral level.
• Radiological confirmation of severe facet joint disease or degeneration.
• Patients diagnosed or at a high risk of osteoporosis (such as postmenopausal women and patients receiving long-term treatment with corticosteroids) who present a bone densitometry DXA T-score of less than -2.0 at the index level.
• Cauda equina syndrome.
• Fever, leucocytosis and/or systemic or localized active infection.
• Systemic inflammation and/or inflammation at the implantation site.
• Any metabolic bone disease.

Sponsors & Collaborators

• NEOS Surgery: lead

Study Sites (6)

Hospital Germans Trias i Pujol

Badalona, Spain

Location

Hospital QuirónSalud Barcelona

Barcelona, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Spain

Location

Related Publications (2)

• Catala I, Roldan H, Fernandez-Carballal C, Dominguez-Alonso C, Alvarez-Galovich L, Godino O. A new hernia blocking system prevents lumbar disc herniation recurrence and disc degeneration: 2 years results of a multicentric clinical investigation. Brain Spine. 2025 Dec 3;6:105898. doi: 10.1016/j.bas.2025.105898. eCollection 2026.

  PMID: 41492501 DERIVED

• Godino O, Fernandez-Carballal C, Catala I, Moreno A, Rimbau JM, Alvarez-Galovich L, Roldan H. A new hernia blocking system to prevent recurrent lumbar disc herniation: surgical technique, intraoperative findings and six-months post-operative outcomes. Eur Spine J. 2025 Mar;34(3):1123-1133. doi: 10.1007/s00586-024-08595-x. Epub 2024 Dec 8.

  PMID: 39648196 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 5, 2019
• Study Start: October 23, 2019
• Primary Completion: June 26, 2023
• Study Completion: June 26, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6)