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Tests treatment safety and results for Disc Herniation
Official title Safety And Performance Of Disc Care To Prevent Lumbar Disc Herniation Recurrence
ClinicalTrials.gov ID: NCT06023719
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Minimum posterior disc height of 5 mm at the index level.
- Radiculopathy with positive straight leg raise test.
You likely can't join if
- 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...
See the full eligibility criteria
Who can 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.
- people 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.
What rules you out
- 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)...
- 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 treatment clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- L'Hospitalet de Llobregat, Barcelona, Spain
- Madrid, Madrid, Spain
- Barcelona, Spain
- San Cristóbal de La Laguna, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include L'Hospitalet de Llobregat, Barcelona, Spain; Madrid, Madrid, Spain; Barcelona, Spain; San Cristóbal de La Laguna, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.