Disk Herniated Lumbar Clinical Trial
Official title:
A Multi-center, Prospective Study to Evaluate the Safety and Performance of a Hernia Blocking System to Prevent Recurrent Lumbar Disc Herniation
Verified date | October 2023 |
Source | NEOS Surgery |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective, multi-center, single-arm clinical study to assess the performance of an Hernia Blocking System in preventing clinically symptomatic recurrent lumbar disc herniation.
Status | Completed |
Enrollment | 30 |
Est. completion date | June 26, 2023 |
Est. primary completion date | June 26, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | 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 |
Lead Sponsor | Collaborator |
---|---|
NEOS Surgery |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of clinically symptomatic recurrent lumbar disc herniation | 24 months | ||
Secondary | The incidence and type of all adverse events (AE) and serious adverse events (SAE). | 6 weeks, 6 months, 12 months, and 24 months | ||
Secondary | Incidence of clinically asymptomatic recurrent disc herniation | 6 months, 12 months, and 24 months | ||
Secondary | Disc height maintenance [mm] related to baseline | 6 weeks, 6 months, 12 months, and 24 months | ||
Secondary | 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 | |
Secondary | 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 | ||
Secondary | The change in quality of life according to EQ-5D-5L, compared to baseline | 6 weeks, 6 months, 12 months, and 24 months | ||
Secondary | The change in the patient work status, compared to baseline | 6 weeks, 6 months, 12 months, and 24 months | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | The change in the disc degeneration (Pfirrmann scale), compared to baseline | 6 months, 12 months, and 24 months | ||
Secondary | The change in the endplate lesions (MODIC scale), compared to baseline | 6 months, 12 months, and 24 months |
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