Safety and Performance of a Hernia Blocking System
Not Applicable
Completed
- Conditions
- Disk Herniated Lumbar
- Registration Number
- NCT04188236
- Lead Sponsor
- NEOS Surgery
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Incidence of clinically symptomatic recurrent lumbar disc herniation 24 months
- Secondary Outcome Measures
Name Time Method 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 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 the disc degeneration (Pfirrmann scale), compared to baseline 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 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
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 endplate lesions (MODIC scale), compared to baseline 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
Trial Locations
- Locations (6)
Hospital Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital QuirónSalud Barcelona
🇪🇸Barcelona, Spain
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Hospital Universitario de Canarias
🇪🇸La Laguna, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
🇪🇸Madrid, Spain