Actively Recruiting
Safety And Performance Of Disc Care To Prevent Lumbar Disc Herniation Recurrence
Led by NEOS Surgery · Updated on 2026-01-12
30
Participants Needed
7
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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).
CONDITIONS
Official Title
Safety And Performance Of Disc Care To Prevent Lumbar Disc Herniation Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Posterolateral disc hernia between levels L4 and S1 confirmed by CT scan or MRI with neural compression
- At least six weeks of failed conservative treatment before surgery, including physical therapy, anti-inflammatory medications at maximum dosage, or epidural/facet injections
- Minimum posterior disc height of 5 mm at the treated disc level
- Radiculopathy with positive straight leg raise test
- Oswestry Disability Index (ODI) score of at least 30 out of 100
- Ability to give voluntary informed consent and willingness to follow the study protocol
You will not qualify if you...
- Spondylolisthesis or instability at the treated disc level that might affect device implantation
- Central, foraminal, or extraforaminal disc hernia
- Vertebral body affected by trauma, cancer, metabolic or infectious disease at the treated level
- Scoliosis greater than 20 degrees (angular or rotational)
- Congenital anatomical abnormalities causing significant distortion
- Vertebral deformities like osteophytes affecting device implantation
- Endplate irregularities affecting device implantation
- Previous surgery at the treated lumbar level affecting device implantation
- Severe facet joint disease or degeneration confirmed by imaging
- High risk or diagnosis of osteoporosis with bone density T-score below -2.0 at treated level
- Cauda equina syndrome
- Fever, high white blood cell count, or active infection (systemic or local)
- Systemic or local inflammation at the implantation site
- Uncontrolled metabolic bone disease affecting the spine
- Uncontrolled insulin-dependent diabetes mellitus
- Peripheral neuropathy
- Active hepatitis, AIDS, or HIV infection
- Rheumatoid arthritis or autoimmune diseases affecting spine joints
- Active or recent invasive cancer (disease-free for less than 5 years)
- Uncontrolled active tuberculosis or history of uncontrolled tuberculosis in past 3 years
- Immunosuppressed patients
- Current anticoagulation therapy unless it can be stopped for surgery
- Recent use (within 4 weeks) of medications affecting bone mineral metabolism
- Allergies or intolerance to device materials (titanium, nitinol, stainless steel, PEEK, PET)
- Conditions preventing general anesthesia or surgery
- Contraindications for MRI or CT scan
- Class III obesity (BMI 40 or higher)
- Current alcohol or recreational drug dependency
- Pregnancy, breastfeeding, or planning pregnancy within 24 months
- Life expectancy less than 2 years
- Participation in another interventional clinical study within past 4 weeks
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Actively Recruiting
2
Hospital La Princesa
Madrid, Madrid, Spain, 28006
Not Yet Recruiting
3
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain, 28007
Actively Recruiting
4
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain, 28040
Actively Recruiting
5
Hospital Universitario la Paz
Madrid, Madrid, Spain, 28046
Actively Recruiting
6
Hospital QuirónSalud Barcelona
Barcelona, Spain
Actively Recruiting
7
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Spain
Not Yet Recruiting
Research Team
L
Laia Rofes, PhD
CONTACT
D
Daniel Alvarez, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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