Loading clinical trials...

Safety And Performance Of Disc Care To Prevent Lumbar Disc Herniation Recurrence | Clinical Trials | Clareo Health

RECRUITINGNA

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

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

NCT06023719•NEOS Surgery

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+23 more criteria

Locations (7)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital La Princesa

Madrid, Madrid, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, Spain

Hospital Universitario la Paz

Madrid, Madrid, Spain

Hospital QuirónSalud Barcelona

Barcelona, Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Spain

Key Dates

Start Date

November 30, 2023

Primary Completion Date

June 1, 2028

Completion Date

June 1, 2028

Last Updated

January 12, 2026

Enrollment

ESTIMATED participants

Conditions

Disc HerniationDisk Herniated Lumbar

Interventions

DISC Care

DEVICE

Contacts

Laia Rofes, PhD

CONTACT

+34 935944726 lrofes@neosurgery.com

Daniel Alvarez, PhD

CONTACT

+34 935944726 dalvarez@neosurgery.com

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

NCT05029726

Lumbar Spinal StenosisLumbar Disc Herniation+8 more

View study

RECRUITINGNA

Dynamic Compliance-Guided Ventilation in Lumbar Surgery

NCT07349719

Lumbar Spine StenosisLumbar Disc Herniation+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

Dynamic Compliance-Guided Ventilation in Lumbar Surgery

A Randomized Trial of Annular Repair With Discectomy Versus Discectomy Alone for Lumbar Disc Herniation

The Influence of the Timing of Postoperative Rehabilitation Intervention on the Clinical Efficacy of Unilateral Biportal Endoscopic Spine System in the Treatment of Lumbar Disc Herniation

Prediction of TEI Success in Sciatica

PREventing Pain After Surgery