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

N

NEOS Surgery

Status

Enrolling

Conditions

Disc Herniation
Disk Herniated Lumbar

Treatments

Device: DISC Care

Study type

Interventional

Funder types

Industry

Identifiers

NCT06023719
NEO-RA1-2023-01

Details and patient eligibility

About

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).

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.
  • 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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

DISC Care
Experimental group
Description:
DISC Care implant
Treatment:
Device: DISC Care

Trial contacts and locations

0

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Central trial contact

Laia Rofes, PhD; Daniel Alvarez, PhD

Data sourced from clinicaltrials.gov

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