Safety and Performance of a Hernia Blocking System

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

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

Conditions
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Disk Herniated Lumbar

Intervention / Treatment
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* Device: Hernia Blocking System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Hernia Blocking System|Hernia Blocking System device implanted during a lumbar discectomy procedure|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |