Disk Herniated Lumbar
Conditions
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.
Interventions
DEVICEHernia Blocking System
Hernia Blocking System device implanted during a lumbar discectomy procedure
Sponsors
NEOS Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of clinically symptomatic recurrent lumbar disc herniation | 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 0-10 NRS |
| 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 incidence and type of all adverse events (AE) and serious adverse events (SAE). | 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 | — |
| The change in the patient work status, compared to baseline | 6 weeks, 6 months, 12 months, and 24 months | — |
Countries
Spain
Outcome results
None listed