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

NCT06023719 | Recruiting

• 1 other identifier: NEO-RA1-2023-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (1)

• Incidence of clinically symptomatic recurrent lumbar disc herniation

  24 months

Secondary Outcomes (10)

• Incidence and type of all adverse events (AE) and serious adverse events (SAE).

  6 weeks, 6 months, 12 months, and 24 months

• Incidence of clinically asymptomatic recurrent disc herniation

  6 months, 12 months, and 24 months

• Incidence of re-interventions

  6 weeks, 6 months, 12 months, and 24 months

• Disc height maintenance [mm] related to baseline

  6 months, 12 months, and 24 months

• Change in leg and low back pain, related to baseline

  6 weeks, 6 months, 12 months, and 24 months

Other Outcomes (3)

• Description of the impact of the procedure (implantation of the device) on the perioperative parameters

  Surgery

• Description of the impact of the procedure (implantation of the device) on the perioperative parameters

  Surgery

• Description of the impact of the procedure (implantation of the device) on the perioperative parameters

  Surgery

Study Arms (1)

DISC Care

EXPERIMENTAL

DISC Care implant

Device: DISC Care

Interventions

DISC Care DEVICE

Medical device to prevent disc herniation recurrence

Also known as: Hernia Blocking System

DISC Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NEOS Surgery: lead

Study Sites (7)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Hospital La Princesa

Madrid, Madrid, 28006, Spain

NOT YET RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

RECRUITING

Hospital Universitario la Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Hospital QuirónSalud Barcelona

Barcelona, Spain

RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Laia Rofes, PhD

CONTACT

+34 935944726; lrofes@neosurgery.com

Daniel Alvarez, PhD

CONTACT

+34 935944726; dalvarez@neosurgery.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: September 5, 2023
• Study Start: November 30, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

ES (7)