Safety and Performance of a Hernia Blocking System

NCT ID: NCT04188236

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-23
• Study Completion Date: 2023-06-26

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Hernia Blocking System

Hernia Blocking System device implanted during a lumbar discectomy procedure

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Insulin-dependent diabetes mellitus.
• Peripheral neuropathy.
• Active hepatitis, AIDS or HIV.
• Rheumatoid arthritis or other autoimmune disease.
• Active or history of any invasive malignancy; patients with curatively-treated malignancies who have been disease-free for at least 5 years are eligible.
• Active tuberculosis or history of tuberculosis in the past 3 years.
• Immunologically suppressed patients.
• Current anticoagulation therapy, unless anticoagulation therapy can be suspended for surgery.
• Patients who have received medication (e.g., methotrexate, alendronate) that interferes with bone mineral metabolism within 4 weeks of the planned date of the index surgery.
• Suspected or known allergies or intolerance to the implant materials.
• Any condition that precludes the use of general anesthesia.
• Any condition that precludes the surgical procedure.
• Any contraindication for MRI or CT scan.
• Class III obesity: Body mass index ≥ 40.
• Current alcohol or recreational drug dependency.
• Pregnant or interested in becoming pregnant in the following 24 months.
• Breastfeeding.
• Life expectancy less than 2 years.
• Subject is currently participating or has participated in the previous 4 weeks in any other interventional clinical study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NEOS Surgery

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Germans Trias i Pujol

Badalona, , Spain

Hospital QuirónSalud Barcelona

Barcelona, , Spain

Hospital Universitari de Bellvitge

Barcelona, , Spain

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, , Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 39648196 (View on PubMed)

Other Identifiers

NEO-RA1-2018-01

Identifier Type: -

Identifier Source: org_study_id