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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
DISC Care
DeviceMedical device to prevent disc herniation recurrence
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: DISC CareExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of clinically symptomatic recurrent lumbar disc herniation
Time frame
24 monthsSecondary outcomes
1
Incidence and type of all adverse events (AE) and serious adverse events (SAE).
Time frame
6 weeks, 6 months, 12 months, and 24 months2
Incidence of clinically asymptomatic recurrent disc herniation
Time frame
6 months, 12 months, and 24 months3
Incidence of re-interventions
Time frame
6 weeks, 6 months, 12 months, and 24 months4
Disc height maintenance [mm] related to baseline
Time frame
6 months, 12 months, and 24 monthsOther outcomes
1
Description of the impact of the procedure (implantation of the device) on the perioperative parameters
Blood loss (mL)
Time frame
Surgery2
Description of the impact of the procedure (implantation of the device) on the perioperative parameters
X-ray exposition (seconds of x-ray exposition)
Time frame
Surgery3
Description of the impact of the procedure (implantation of the device) on the perioperative parameters
Surgery duration (minutes)
Time frame
SurgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov