Safety and Performance of Disc Care to Prevent Lumbar Disc Herniation Recurrence

Launched by NEOS SURGERY · Sep 4, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on a new device called DISC Care, which is designed to prevent the recurrence of lumbar disc herniation in patients who have already undergone surgery for this condition. The main goals of the study are to find out if this device is effective at stopping the disc from herniating again and to ensure that it is safe for patients to use. If you are between the ages of 18 and 75 and have experienced a specific type of disc hernia confirmed by imaging tests like an MRI or CT scan, you may be eligible to participate.

Participants in the trial will receive the DISC Care device and will be monitored over a two-year period, including at least seven follow-up visits to check on their progress and safety. It's important to note that certain health conditions, such as severe osteoporosis or certain previous surgeries, may disqualify some individuals from joining the study. Overall, this trial aims to provide valuable information about a new option for preventing disc problems after surgery, which could significantly improve recovery and quality of life for many patients.

Gender

ALL

Eligibility criteria

• 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.