Safety And Performance Of Disc Care To Prevent Lumbar Disc Herniation Recurrence (ACE-2)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Disk Herniated Lumbar; Disc Herniation
• Intervention / Treatment: Device: DISC Care

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laia Rofes, PhD; Phone Number: +34 935944726; Email: lrofes@neosurgery.com
• Study Contact Backup: Name: Daniel Alvarez, PhD; Phone Number: +34 935944726; Email: dalvarez@neosurgery.com

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Quironsalud Barcelona
    • Contact: Ignasi Català, MD; Phone Number: 0034 932 554 083
  • San Cristóbal de La Laguna, Spain
    • Not yet recruiting
    • Hospital Universitario de Canarias
    • Contact: Hector Roldan, MD; Phone Number: 0034 922 678 000
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Recruiting
      • Hospital Universitari de Bellvitge
      • Contact: Oscar Godino, MD, PhD
  • Madrid
    • Madrid, Madrid, Spain, 28046
      • Recruiting
      • Hospital Universitario La Paz
      • Contact: Álvaro Gómez, MD; Phone Number: +34 917277000
    • Madrid, Madrid, Spain, 28007
      • Recruiting
      • Hospital General Universitario Gregorio Marañon
      • Contact: Carlos Fernandez, MD; Phone Number: +34 91 586 80 00
    • Madrid, Madrid, Spain, 28040
      • Recruiting
      • Hospital Universitario Fundacion Jimenez Diaz
      • Contact: Luis Alvarez, MD, PhD; Phone Number: +34 91 550 48 00
    • Madrid, Madrid, Spain, 28006
      • Not yet recruiting
      • Hospital La Princesa
      • Contact: José Fernandez Alén, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DISC Care; DISC Care implant	Device: DISC Care; Medical device to prevent disc herniation recurrence; Other Names: Hernia Blocking System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of clinically symptomatic recurrent lumbar disc herniation	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of clinically asymptomatic recurrent disc herniation		6 months, 12 months, and 24 months
Incidence and type of all adverse events (AE) and serious adverse events (SAE).		6 weeks, 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	0-10 NRS (numeric rating scale)	6 weeks, 6 months, 12 months, and 24 months
Change in Low back related disability, related to baseline	Oswestry Disability Index (ODI)	6 weeks, 6 months, 12 months, and 24 months
The change in quality of life, compared to baseline	EQ-5D-5L (5-level EQ-5D version)	6 weeks, 6 months, 12 months, and 24 months
The change in patient neurological status, compared to baseline	straight leg raise test, reflexes, motor muscle strength and sensory neurological evaluations, classified as normal or abnormal	6 weeks, 6 months, 12 months, and 24 months
The degeneration of the disc, in comparison with the preoperative state	Pfirrmann intervertebral disc degeneration scale (I, II, III, IV, V)	6 months, 12 months, and 24 months
the direct and indirect costs of the disease and the intervention.	Custom-made questionnaire	6 weeks, 6 months, 12 months, and 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the impact of the procedure (implantation of the device) on the perioperative parameters	Blood loss (mL)	Surgery
Description of the impact of the procedure (implantation of the device) on the perioperative parameters	X-ray exposition (seconds of x-ray exposition)	Surgery
Description of the impact of the procedure (implantation of the device) on the perioperative parameters	Surgery duration (minutes)	Surgery

Collaborators and Investigators

• Sponsor: NEOS Surgery

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: September 4, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Hernia; Pathological Conditions, Signs and Symptoms; Intervertebral Disc Displacement
• Other Study ID Numbers: NEO-RA1-2023-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No