Safety And Performance Of Disc Care To Prevent Lumbar Disc Herniation Recurrence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNEOS Surgery
About this trial
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
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- DISC Care
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov