Multicentric Clinical Investigation to Assess the Safety and Performance of Disc Care to Prevent Lumbar Disc Herniation Recurrence

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital QuirónSalud Barcelona
RECRUITING
Barcelona
Hospital Universitari de Bellvitge
RECRUITING
Hospitalet De Llobregat
Hospital Universitario de Canarias
NOT_YET_RECRUITING
La Laguna
Hospital General Universitario Gregorio Marañón
RECRUITING
Madrid
Hospital La Princesa
NOT_YET_RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz
RECRUITING
Madrid
Hospital Universitario la Paz
RECRUITING
Madrid
Contact Information
Primary
Laia Rofes, PhD
lrofes@neosurgery.com
+34 935944726
Backup
Daniel Alvarez, PhD
dalvarez@neosurgery.com
+34 935944726
Time Frame
Start Date: 2023-11-30
Estimated Completion Date: 2027-09
Participants
Target number of participants: 30
Treatments
Experimental: DISC Care
DISC Care implant
Related Therapeutic Areas
Sponsors
Leads: NEOS Surgery

This content was sourced from clinicaltrials.gov