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

NCT ID: NCT06023719

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2028-06-30

Brief 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).

Conditions

Disc Herniation; Disk Herniated Lumbar

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

DISC Care

DISC Care implant

Group Type: EXPERIMENTAL

DISC Care

Intervention Type: DEVICE

Medical device to prevent disc herniation recurrence

Interventions

DISC Care

Medical device to prevent disc herniation recurrence

Intervention Type: DEVICE

Other Intervention Names

Hernia Blocking System

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NEOS Surgery

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status: RECRUITING

Hospital La Princesa

Madrid, Madrid, Spain

Site Status: NOT_YET_RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Site Status: RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, Spain

Site Status: RECRUITING

Hospital Universitario la Paz

Madrid, Madrid, Spain

Site Status: RECRUITING

Hospital QuirónSalud Barcelona

Barcelona, , Spain

Site Status: RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, , Spain

Site Status: NOT_YET_RECRUITING

Countries

Spain

Central Contacts

Laia Rofes, PhD

Role: CONTACT

lrofes@neosurgery.com

+34 935944726

Daniel Alvarez, PhD

Role: CONTACT

dalvarez@neosurgery.com

+34 935944726

Facility Contacts

Oscar Godino, MD, PhD

Role: primary

José Fernandez Alén, MD, PhD

Role: primary

Carlos Fernandez, MD

Role: primary

+34 91 586 80 00

Luis Alvarez, MD, PhD

Role: primary

+34 91 550 48 00

Álvaro Gómez, MD

Role: primary

+34 917277000

Ignasi Català, MD

Role: primary

0034 932 554 083

Hector Roldan, MD

Role: primary

0034 922 678 000

Other Identifiers

NEO-RA1-2023-01

Identifier Type: -

Identifier Source: org_study_id