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 - EUBARDCP011

Intrinsic Therapeutics, GmbH0 sites66 target enrollmentTBD

Conditionslumbar disc herniation sciatica 10043237 10041543 10009720

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: lumbar disc herniation
Sponsor: Intrinsic Therapeutics, GmbH
Enrollment: 66
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Observational invasive

Investigators

Sponsor

Intrinsic Therapeutics, GmbH

Eligibility Criteria

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•Subjects who have died or withdrawn consent during follow\-up of RCT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.

Outcomes

Primary Outcomes

Not specified

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