Ireland
--:--IST
Recruiting Not applicable

Safety And Performance Of Disc Care To Prevent Lumbar Disc Herniation Recurrence

NCT06023719 · tracked via the Priya Life Science Spain tracker
Sponsor
NEOS Surgery
Phase
Not applicable
Started
2023-11-30
Last updated
2026-01-12

Condition(s) studied

Disc HerniationDisk Herniated Lumbar

Investigational drug(s) / intervention(s)

DISC Care

DISC Care: Medical device to prevent disc herniation recurrence

Study summary

The goal of this clinical investigation is to learn about DISC Care, an Hernia Blocking System, in patients who have undergone lumbar disc hernia surgery. The main questions it aims to answer are:

* if the implant (DISC Care) prevents disc herniation recurrence
* if DISC Care is a safe device

Participants will be implanted with DISC Care and followed up for two years (7 visits).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Subject is between 18 and 75 years old. * Posterolateral disc hernia between levels L4 and S1 with radiological (CT scan or MRI) confirmation 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 30/100. * 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 that, in the judgement of the surgeon, could affect the device implantation. * Central, foraminal or extraforaminal disc hernia. * Subject has vertebral bodies of the index level affected by any traumatic, neoplastic, metabolic, or infectious pathology. * Subject has scoliosis of greater than 20 degrees (both angular and rotational). * Grossly distorted anatomy due to congenital abnormalities. * Deformation that affects the posterior corners of the vertebra at the index level (e.g., osteophytes) that, in the judgment of the surgeon, could affect the device implantation. * Endplate irregularities that, in the judgment of the surgeon, could affect the device implantation. * Prior surgery at the index lumbar vertebral level that, in the judgment of the surgeon, could affect the device implantation. * 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 (dual energy x-ray absorptiometry) 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 uncontrolled metabolic bone disease that affects the spine. * Uncontrolled insulin-dependent diabetes mellitus. * Peripheral neuropathy. * Active hepatitis, AIDS or HIV. * Rheumatoid arthritis or other autoimmune disease that affects the spine joints. * Active or history of any invasive malignancy; patients with curatively-treated malignancies who have been disease-free for at least 5 years are eligible. * Uncontrolled active tuberculosis or history of uncontrolled 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 device materials: titanium, nitinol, stainless steel, polyetheretherketone and polyethylene terephthalate. * Any condition that precludes the use of general anaesthesia. * 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 outcome measure(s)

  • Incidence of clinically symptomatic recurrent lumbar disc herniation — 24 months

Trial sites (7)

FacilityCityRegionStatus
Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Barcelona Recruiting
Hospital La Princesa Madrid Madrid Not Yet Recruiting
Hospital General Universitario Gregorio Marañón Madrid Madrid Recruiting
Hospital Universitario Fundación Jiménez Díaz Madrid Madrid Recruiting
Hospital Universitario la Paz Madrid Madrid Recruiting
Hospital QuirónSalud Barcelona Barcelona Spain Recruiting
Hospital Universitario de Canarias San Cristóbal de La Laguna Spain Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06023719 on ClinicalTrials.gov ↗ ← All trials in Spain