Clinical trial NCT04188236: Safety and Performance of a Hernia Blocking System
Official title: A Multi-center, Prospective Study to Evaluate the Safety and Performance of a Hernia Blocking System to Prevent Recurrent Lumbar Disc Herniation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disk Herniated Lumbar
Lead sponsor: NEOS Surgery
Sponsor class: INDUSTRY
First posted: 2019-12-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of clinically symptomatic recurrent lumbar disc herniation
timeFrame: 24 months
Secondary outcomes:
measure: The incidence and type of all adverse events (AE) and serious adverse events (SAE).
timeFrame: 6 weeks, 6 months, 12 months, and 24 months
measure: Incidence of clinically asymptomatic recurrent disc herniation
timeFrame: 6 months, 12 months, and 24 months
measure: Disc height maintenance [mm] related to baseline
timeFrame: 6 weeks, 6 months, 12 months, and 24 months
measure: Change in leg and low back pain assessed by NRS (numeric rating scale), related to baseline
timeFrame: 6 weeks, 6 months, 12 months, and 24 months
measure: Change in Low back related disability according to the Oswestry Disability Index (ODI), related to baseline
timeFrame: 6 weeks, 6 months, 12 months, and 24 months
measure: The change in quality of life according to EQ-5D-5L, compared to baseline
timeFrame: 6 weeks, 6 months, 12 months, and 24 months
measure: The change in the patient work status, compared to baseline
timeFrame: 6 weeks, 6 months, 12 months, and 24 months
measure: The change in patient neurological status: straight leg raise test, reflexes, motor muscle strength and sensory neurological evaluations, compared to baseline
timeFrame: 6 weeks, 6 months, 12 months, and 24 months
measure: The change in the kinematics of the intervertebral disc at the index level, compared to baseline
timeFrame: 6 weeks, 6 months, 12 months, and 24 months
measure: The change in the disc degeneration (Pfirrmann scale), compared to baseline
timeFrame: 6 months, 12 months, and 24 months
measure: The change in the endplate lesions (MODIC scale), compared to baseline
timeFrame: 6 months, 12 months, and 24 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital QuirónSalud Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
Study officials:
References: