Actively Recruiting
Multicentric Clinical Investigation To Assess The 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical investigation aims to evaluate DISC Care, a device designed to prevent lumbar disc herniation from recurring in patients who have undergone lumbar disc hernia surgery. The study focuses on assessing whether the DISC Care implant can reduce the chance of herniation recurrence and whether it is a safe device to use. Participants will be adults between 18 and 75 years old with confirmed posterolateral disc hernias and specific clinical features. Participants will receive the DISC Care implant during surgery to prevent further disc herniation. After implantation, they will be followed for two years with a total of seven visits scheduled to monitor their progress. The study includes regular assessments at 6 weeks, 6 months, 12 months, and 24 months to evaluate safety, device performance, pain levels, disability, neurological status, disc condition, and costs related to the condition and treatment. During the study, participants will undergo clinical evaluations, imaging scans such as CT or MRI, and questionnaires to assess pain and quality of life. Researchers will monitor for any adverse events or complications and measure if the disc height is maintained and if there is any recurrence of herniation. Participants will be regularly checked for leg and back pain changes, neurological health, and disability related to their back condition. The study involves detailed follow-up and safety monitoring over the full two-year period after implantation.
CONDITIONS
Brief 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
- Confirmed posterolateral disc hernia between levels L4 and S1 by CT scan or MRI
- At least six weeks of failed conservative treatment including physical therapy and/or anti-inflammatory medications and/or epidural/facet injections
- Minimum posterior disc height of 5 mm at the affected level
- Radiculopathy with positive straight leg raise test
- Oswestry Disability Index score of at least 30 out of 100
- Able to give voluntary informed consent
- Willing and able to comply with study requirements
You will not qualify if you...
- Spondylolisthesis or instability at the affected level affecting device implantation
- Central, foraminal, or extraforaminal disc hernia
- Traumatic, neoplastic, metabolic, or infectious pathology affecting vertebral bodies at the affected level
- Scoliosis greater than 20 degrees
- Congenital anatomical abnormalities causing distorted anatomy
- Deformation affecting posterior vertebral corners that may affect device implantation
- Endplate irregularities affecting device implantation
- Prior surgery at the affected lumbar level affecting device implantation
- Severe facet joint disease or degeneration
- Osteoporosis or high risk with DXA T-score less than -2.0 at index level
- Cauda equina syndrome
- Fever, leucocytosis, or active infection
- Systemic or local inflammation at implantation site
- Uncontrolled metabolic bone disease affecting spine
- Uncontrolled insulin-dependent diabetes mellitus
- Peripheral neuropathy
- Active hepatitis, AIDS, or HIV
- Rheumatoid arthritis or autoimmune spine joint disease
- Active or recent invasive malignancy within 5 years
- Uncontrolled tuberculosis or past uncontrolled tuberculosis within 3 years
- Immunosuppressed patients
- Current anticoagulation therapy unless suspended for surgery
- Recent medications interfering with bone metabolism within 4 weeks
- Allergies to device materials
- Contraindications to general anesthesia or surgery
- Contraindications to MRI or CT scan
- Body mass index 40 or higher
- Alcohol or drug dependency
- Pregnant or planning pregnancy within 24 months
- Breastfeeding
- Life expectancy less than 2 years
- Participation in another interventional clinical study within 4 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive the DISC Care implant to prevent lumbar disc herniation recurrence.
1 visit (in-person)
Duration - 24 months
Participants are monitored for safety, device performance, and recovery after implantation.
Visits at 6 weeks, 6 months, 12 months, and 24 months (in-person)
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
D
Daniel Alvarez, PhD
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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