A prospective randomized multicenter study to demonstrate the superiority of the Barricaid® to discectomy for primary lumbar disc herniation: Extended Follow-Up of the Barricaid® Annular Closure Device (ACD) Randomized Control Trial (RCT) Postmarket Cohort for Lumbar Disc Herniation and Interaction with Other Risk Factors

Phase 4

Completed

Conditions: lumbar disc herniation
sciatica
10043237
10041543
10009720

Registration Number: NL-OMON55882

Lead Sponsor: Intrinsic Therapeutics, GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 66

Inclusion Criteria

Only subjects enrolled in the original RCT protocol EUBARD-CP-001 will be
eligible for long-term follow-up.
Original inclusion criteria included: subjects with radiculopathy (with or
without back pain), a positive straight leg raise (L4-5, L5-S1) or femoral
stretch test (L1-2, L2-3, L3-4), and a posterior or posterolateral herniation
at one level between L1 and S1 with radiographic confirmation of neural
compression using MRI who are found to have an anular defect (post discectomy)
which measures between 4mm and 6mm tall and between 6mm and 10mm wide, with a
minimum posterior disc height of 5mm, and failed at least 6 weeks of
conservative treatment.

Exclusion Criteria

Only subjects enrolled in the original RCT protocol EUBARD-CP-001 will be
eligible for long-term follow-up.
Subjects who have died or withdrawn consent during follow-up of RCT
EUBARD-CP-001 will not be included in the patient population eligible for this
long-term evaluation.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary hypotheses of this extended follow-up post approval study extension<br /><br>are:<br /><br>• The Barricaid® ACD remains safe and effective at 10 years.<br /><br>• The Barricaid® ACD subjects do not have late or continued slow growth of<br /><br>lesions that lead to new or unexpected AEs or<br /><br>adverse clinical outcomes.<br /><br>• Development of osteoporosis does not negatively impact the progression of<br /><br>lesions observed and does not lead to new or<br /><br>unexpected AEs or adverse clinical outcomes.<br /><br>Sample size: This study extension is not powered to demonstrate statistical<br /><br>conclusions, but rather the sample size is based on<br /><br>the subjects from the original 2-year study who agree to participate in<br /><br>longer-term follow-up.</p><br>

Secondary Outcome Measures