NCT06023719 Safety And Performance Of Disc Care To Prevent Lumbar Disc Herniation Recurrence
| NCT ID | NCT06023719 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NEOS Surgery |
| Condition | Disc Herniation |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-11-30 |
| Primary Completion | 2028-06 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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 implanted with DISC Care and followed up for two years (7 visits).
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 b