Using DISC Care to prevent recurrence of lumbar disc herniation

Multicentric Clinical Investigation To Assess The Safety And Performance Of Disc Care To Prevent Lumbar Disc Herniation Recurrence

This study is testing a new device called DISC Care to see if it can help prevent lumbar disc herniation from coming back in patients who have already had surgery for it.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: NEOS Surgery (Industry-sponsored)
• Drugs / interventions: methotrexate
• Locations: 7 sites (L'Hospitalet de Llobregat, Barcelona and 6 other locations)
• Trial ID: NCT06023719 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the safety and effectiveness of the DISC Care device, designed to prevent the recurrence of lumbar disc herniation in patients who have previously undergone surgery for this condition. Participants will receive the DISC Care implant and will be monitored over a two-year period through a series of follow-up visits. The study aims to determine if the device can effectively block herniation and ensure patient safety during the recovery process.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed posterolateral disc hernia between L4 and S1 who have not responded to conservative treatments.

Not a fit: Patients with spondylolisthesis, instability at the index level, or other specific exclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the risk of recurrent lumbar disc herniation in patients who have undergone surgery.

How similar studies have performed: While similar approaches have been explored, the specific use of the DISC Care device for this purpose is novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

L'Hospitalet de Llobregat, Barcelona and 6 other locations

• Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
• Hospital La Princesa — Madrid, Madrid, Spain (Not_yet_recruiting)
• Hospital General Universitario Gregorio Marañón — Madrid, Madrid, Spain (Recruiting)
• Hospital Universitario Fundación Jiménez Díaz — Madrid, Madrid, Spain (Recruiting)
• Hospital Universitario la Paz — Madrid, Madrid, Spain (Recruiting)
• Hospital QuirónSalud Barcelona — Barcelona, Spain (Recruiting)
• Hospital Universitario de Canarias — San Cristóbal de La Laguna, Spain (Not_yet_recruiting)

Study contacts

• Study coordinator: Laia Rofes, PhD

Conditions Disc Herniation; Disk Herniated Lumbar