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

September 27, 2023 updated by: Intrinsic Therapeutics

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The Barricaid is indicated for patients with radiculopathy (with or without back pain), a positive Straight Leg Raise (L45, L5S1) or femoral stretch test (L12, L23, L34), 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 annular defect (post discectomy) which measures between 4mm and 6mm tall and between 6mm and 10mm wide, have a minimum posterior disc height of 5mm, and have failed at least 6 weeks of conservative treatment including a post-approval amendment with follow-up visits at 7 & 10 years for eligible subjects.

Study Type

Interventional

Enrollment (Actual)

554

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • LKH Graz
      • Innsbruck, Austria
        • Medizinische Universität Innsbruck
  • Belgium
      • Aalst, Belgium
        • OLV Aalst
      • Antwerp, Belgium
        • ZNA Middleheim / AZ Klina
      • Sint Niklaas, Belgium
        • AZ Nikolaas
  • France
      • Lille, France, 59037
        • CHRU Lille, Hôpital Roger Salengro
  • Germany
      • Augsburg, Germany
        • Klinikum Augsburg
      • Berlin, Germany
        • Charité - Universitätsmedizin Berlin
      • Deggendorf, Germany
        • Klinikum Deggendorf
      • Düsseldorf, Germany
        • Universitatsklinikum Dusseldorf
      • Hamburg, Germany
        • Asklepios Westklinikum Hamburg
      • Kiel, Germany
        • UNI Kiel
      • Lingen, Germany
        • St. Bonifatius Hospital GmbH
      • Mannheim, Germany
        • UMM Mannheim
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, D-18055
        • Orthopädische Klinik und Poliklinik - Universitätsmedizin Rostock
    • North Rhine-Westphalia
      • Bochum, North Rhine-Westphalia, Germany, 44892
        • Neurochirurgische Universitätsklinik Knappschafts-Krankenhaus Bochum-Langendreer
  • Netherlands
      • Amsterdam, Netherlands
        • SLAZ Amsterdam
      • Den Haag, Netherlands
        • MCH Westeinde
      • Leidschendam, Netherlands
        • MCH Antoniushove
      • Zwolle, Netherlands, 8025AB
        • Isala Klinieken
  • Switzerland
      • Aarau, Switzerland
        • KSA Aarau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 21 to 75 years old and skeletally mature (male or female).
  • Patients with posterior or posterolateral disc herniations at one level between L1 and S1 with radiographic confirmation of neural compression using Magnetic Resonance Imaging (MRI).
  • At least six (6) weeks of failed, conservative treatment prior to surgery
  • Oswestry Disability Index (ODI) Questionnaire score of at least 40/100 at baseline.
  • Visual Analog Scale (VAS) leg pain (one or both legs) of at least 40/100 at baseline.
  • Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.

Exclusion Criteria:

  • Spondylolisthesis Grade II or higher (25% slip or greater).
  • Prior surgery at the index lumbar vertebral level.
  • Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).
  • Any metabolic bone disease.
  • Subject has insulin-dependent diabetes mellitus.
  • Subject has been diagnosed with active hepatitis, acquired immunodeficiency syndrome (AIDS), or Human immunodeficiency virus (HIV).
  • Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease.
  • Subject has a known allergy to titanium, polyethylene or polyester materials.
  • Any subject that cannot have a baseline MRI taken.
  • Subject is pregnant or interested in becoming pregnant in the next three (3) years.
  • Subject has active tuberculosis or has had tuberculosis in the past three (3) years.
  • Subject is currently involved in another investigational study.
  • Any contraindication for MRI or Computed tomography CT scan (e.g. claustrophobia, contrast allergy).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Barricaid Device
Intervention: Barricaid Device
Device: Barricaid
Annular closure device
Active Comparator: Standard of Care
Standard (Limited) Discectomy Only
Device: Standard of Care
Standard Limited discectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined success of multiple clinical outcomes, including Oswestry disability index, Visual Analog Scale (VAS), and multiple radiographically confirmed measures
Time Frame: 24 months

To be considered a success, a patient will have achieved success in each of the following outcomes:

  • 15 point (out of 100 point scale) improvement in Oswestry compared to pre-op
  • 20 point (on a 100 point scale) improvement in VAS Leg (based on the primary leg complaint; if both legs have a minimum of 40/100 pre-operatively, the average leg score will be used)
  • Maintenance of average disc height (75% or greater of preoperative disc height) compared to pre-op
  • No deterioration of neurological status at the index level measured by motor function
  • Device integrity and lack of implant migration (radiographic, implanted patients only)
  • No radiographically confirmed spontaneous fusion
  • No radiographically or surgically confirmed reherniation at the index level (on either side)
  • No secondary surgical interventions at the index level
24 months
No radiographic evidence of recurrent disc herniation
Time Frame: 24 months
To be considered a success, a patient will have no evidence of recurrent disc herniation at the index level at any time up to and including the 24-month follow-up. Recurrent herniation may be confirmed surgically, or radiographically as determined by an independent review (unless surgically confirmed that the suspected herniation is not a herniation, e.g. scar tissue or residual nucleus material).
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) Back Pain Improvement
Time Frame: 24 months
Change in back pain as measured using a Visual Analog Scale (VAS), on a scale of 0-100, with lower values representing better outcome. A subject is a success if there is at least a 20 point improvement on the VAS back at 24 months, relative to baseline.
24 months
Oswestry Disability Index (ODI) Improvement
Time Frame: 24 months
Change in function as measured using the Oswestry Disability Index (ODI). The ODI is scored on a scale from 0% to 100%, with higher scores indicating higher levels of disability. A subject is a success if there is at least a 15 point improvement (decrease) in the ODI at the 24 month visit relative to baseline.
24 months
Reoperation
Time Frame: 24 months
A subject will be deemed a success if they have not had a second operation at the index level by the 24 month visit. Rates of subject success in treatment and control will be compared at 24 months. A subject is a success if there is at least 75% of the pre-op disc height preserved at the 24 month visit.
24 months
Visual Analog Scale (VAS) LEG Pain Improvement
Time Frame: 24 months
Change in leg pain as measured using a Visual Analog Scale (VAS), on a scale of 0-100, with lower values representing better outcome. A subject is a success if there is at least a 20 point improvement on VAS leg pain in the ipsilateral leg at 24 months, relative to baseline.
24 months
Disc Height Maintenance
Time Frame: 24 months
A subject is a success if there is at least 75% of the pre-op disc height preserved as measured on MRI, at the 24 month visit.
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post 5Y device or procedure-related Serious Adverse Event (SAE)
Time Frame: Post 60 months
Adverse events will be categorized as device-related and/or procedure-related and will be assigned severity or seriousness. Safety will be determined by evaluating the type, frequency, severity, and relationship to device and/or procedure of adverse events through the 10 year time point or until stabilization of the endplate lesions, whichever is longer.
Post 60 months
Post 5Y secondary surgical intervention at the index level
Time Frame: Post 60 months
The safety will be supported if the incidence of secondary surgical interventions (SSIs) and the incidence SAEs related to either the device or procedure is not greater in the Barricaid® annular closure device than in the Control cohort.
Post 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intrinsic Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2010

Primary Completion (Actual)

October 1, 2016

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

January 6, 2011

First Submitted That Met QC Criteria

January 25, 2011

First Posted (Estimated)

January 26, 2011

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUBARD-CP-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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