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Clinical Trials/NL-OMON55882
NL-OMON55882CompletedPhase 4

*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 - EUBARD*CP*011

Intrinsic Therapeutics, GmbH0 sites66 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
66
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18 to 99 (—)

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  • •Subjects who have died or withdrawn consent during follow-up of RCT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

Investigators

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*A prospective randomized multicenter... | Clinical Trial