Safety and Performance of a Hernia Blocking System

A Multi-center, Prospective Study to Evaluate the Safety and Performance of a Hernia Blocking System to Prevent Recurrent Lumbar Disc Herniation

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

Study Overview

• Status: Completed
• Conditions: Disk Herniated Lumbar
• Intervention / Treatment: Device: Hernia Blocking System

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Badalona, Spain
    • Hospital Germans Trias i Pujol
  • Barcelona, Spain
    • Hospital Universitari de Bellvitge
  • Barcelona, Spain
    • Hospital Quironsalud Barcelona
  • La Laguna, Spain
    • Hospital Universitario de Canarias
  • Madrid, Spain, 28040
    • Hospital Universitario Fundación Jiménez Díaz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of clinically symptomatic recurrent lumbar disc herniation	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0-10 NRS	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
The change in quality of life according to EQ-5D-5L, compared to baseline		6 weeks, 6 months, 12 months, and 24 months
The change in the patient work status, compared to baseline		6 weeks, 6 months, 12 months, and 24 months
The change in patient neurological status: straight leg raise test, reflexes, motor muscle strength and sensory neurological evaluations, compared to baseline		6 weeks, 6 months, 12 months, and 24 months
The change in the kinematics of the intervertebral disc at the index level, compared to baseline		6 weeks, 6 months, 12 months, and 24 months
The change in the disc degeneration (Pfirrmann scale), compared to baseline		6 months, 12 months, and 24 months
The change in the endplate lesions (MODIC scale), compared to baseline		6 months, 12 months, and 24 months

Collaborators and Investigators

• Sponsor: NEOS Surgery

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2019
• Primary Completion (Actual): June 26, 2023
• Study Completion (Actual): June 26, 2023

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: NEO-RA1-2018-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No