Disc HerniationACE-2NCT06023719
Safety And Performance Of Disc Care To Prevent Lumbar Disc Herniation Recurrence
A study testing DISC Care in people with Disc Herniation and Disk Herniated Lumbar, run by NEOS Surgery at 7 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Disc Herniation, Disk Herniated Lumbar
- What is being tested?
- DISC Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesSpain
- Study dates
- 30 Nov 2023to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Spain7 sites, 7 recruiting
- Recruiting
Hospital QuirónSalud Barcelona
Barcelona
Ignasi Català, MD, 0034 932 554 083
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Oscar Godino, MD, PhD
- Not yet recruiting
Hospital La Princesa
Madrid, Madrid, 28006
José Fernandez Alén, MD, PhD
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
Carlos Fernandez, MD, +34 91 586 80 00
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040
Luis Alvarez, MD, PhD, +34 91 550 48 00
- Recruiting
Hospital Universitario la Paz
Madrid, Madrid, 28046
Álvaro Gómez, MD, +34 917277000
- Not yet recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna
Hector Roldan, MD, 0034 922 678 000
About this study
Official title: 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).
- Conditions
- Disc Herniation, Disk Herniated Lumbar
- Being tested
- DISC Care
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DISC CareDevice
Also called Hernia Blocking System
Medical device to prevent disc herniation recurrence
| Study group | Role | What they receive |
|---|---|---|
| DISC Care | Experimental | DISC Care implant Receives: Device: DISC Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinically symptomatic recurrent lumbar disc herniation
Measured: 24 months
Secondary outcomes (10)
Incidence and type of all adverse events (AE) and serious adverse events (SAE).
Measured: 6 weeks, 6 months, 12 months, and 24 months
Incidence of clinically asymptomatic recurrent disc herniation
Measured: 6 months, 12 months, and 24 months
Incidence of re-interventions
Measured: 6 weeks, 6 months, 12 months, and 24 months
Disc height maintenance [mm] related to baseline
Measured: 6 months, 12 months, and 24 months
Change in leg and low back pain, related to baseline
0-10 NRS (numeric rating scale)
Measured: 6 weeks, 6 months, 12 months, and 24 months
Change in Low back related disability, related to baseline
Oswestry Disability Index (ODI)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 6 months, 12 months, and 24 months
the direct and indirect costs of the disease and the intervention.
Custom-made questionnaire
Measured: 6 weeks, 6 months, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start30 Nov 2023
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NEOS Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023719
- Sponsor's protocol ID
- NEO-RA1-2023-01
- Acronym
- ACE-2
- Status last verified
- Jan 2026
- First submitted
- 2 Aug 2023
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Clinical Investigation To Assess The Safety And Performance Of Disc Care To Prevent Lumbar Disc Herniation Recurrence
- ClinicalTrials.gov ID
- NCT06023719
- Acronym / sponsor ID
- ACE-2 / NEO-RA1-2023-01
- Conditions
- Disc Herniation, Disk Herniated Lumbar
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NEOS SurgeryIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DISC Care | Experimental | Device: DISC CareDISC Care implant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (33 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DISC CareAlso: Hernia Blocking SystemMedical device to prevent disc herniation recurrence | Device | DISC Care |
Primary outcome
Incidence of clinically symptomatic recurrent lumbar disc herniation
Time frame: 24 months
10 secondary outcomes
Incidence and type of all adverse events (AE) and serious adverse events (SAE).
Time frame: 6 weeks, 6 months, 12 months, and 24 months
Incidence of clinically asymptomatic recurrent disc herniation
Time frame: 6 months, 12 months, and 24 months
Incidence of re-interventions
Time frame: 6 weeks, 6 months, 12 months, and 24 months
Disc height maintenance [mm] related to baseline
Time frame: 6 months, 12 months, and 24 months
Change in leg and low back pain, related to baseline
Time frame: 6 weeks, 6 months, 12 months, and 24 months
Change in Low back related disability, related to baseline
Time frame: 6 weeks, 6 months, 12 months, and 24 months
The change in quality of life, compared to baseline
Time frame: 6 weeks, 6 months, 12 months, and 24 months
The change in patient neurological status, compared to baseline
Time frame: 6 weeks, 6 months, 12 months, and 24 months
The degeneration of the disc, in comparison with the preoperative state
Time frame: 6 months, 12 months, and 24 months
the direct and indirect costs of the disease and the intervention.
Time frame: 6 weeks, 6 months, 12 months, and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DISC Care in people with Disc Herniation and Disk Herniated Lumbar, run by NEOS Surgery at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laia Rofes, PhD (+34 935944726, lrofes@neosurgery.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinically symptomatic recurrent lumbar disc herniation (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.