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A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid to Discectomy for Primary Lumbar Disc Herniation

NCT01283438 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 554

Last updated 2023-09-28

No results posted yet for this study

Summary

A randomized study to demonstrate the superiority of the Barricaid® when used in conjunction with limited discectomy, compared to limited discectomy alone, with regard to preventing reherniation and the recurrence of pain or dysfunction.

Conditions

  • Lumbar Disc Herniation

Interventions

DEVICE

Barricaid

Annular closure device

DEVICE

Standard of Care

Standard Limited discectomy

Sponsors & Collaborators

  • Intrinsic Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-17
Primary Completion
2016-10-31
Completion
2025-06-30

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Netherlands
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01283438 on ClinicalTrials.gov