NCT01283438

Brief 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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
554

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2010

Longer than P75 for phase_4

Geographic Reach
6 countries

21 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 26, 2011

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
8.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

5.8 years

First QC Date

January 6, 2011

Last Update Submit

September 27, 2023

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (2)

  • Combined success of multiple clinical outcomes, including Oswestry disability index, Visual Analog Scale (VAS), and multiple radiographically confirmed measures

    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

    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 Outcomes (5)

  • Visual Analog Scale (VAS) Back Pain Improvement

    24 months

  • Oswestry Disability Index (ODI) Improvement

    24 months

  • Reoperation

    24 months

  • Visual Analog Scale (VAS) LEG Pain Improvement

    24 months

  • Disc Height Maintenance

    24 months

Other Outcomes (2)

  • Post 5Y device or procedure-related Serious Adverse Event (SAE)

    Post 60 months

  • Post 5Y secondary surgical intervention at the index level

    Post 60 months

Study Arms (2)

Barricaid Device

EXPERIMENTAL

Intervention: Barricaid Device

Device: Barricaid

Standard of Care

ACTIVE COMPARATOR

Standard (Limited) Discectomy Only

Device: Standard of Care

Interventions

BarricaidDEVICE

Annular closure device

Barricaid Device
Standard of CareDEVICE

Standard Limited discectomy

Standard of Care

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

LKH Graz

Graz, Austria

Location

Medizinische Universität Innsbruck

Innsbruck, Austria

Location

OLV Aalst

Aalst, Belgium

Location

ZNA Middleheim / AZ Klina

Antwerp, Belgium

Location

AZ Nikolaas

Sint-Niklaas, Belgium

Location

CHRU Lille, Hôpital Roger Salengro

Lille, 59037, France

Location

Orthopädische Klinik und Poliklinik - Universitätsmedizin Rostock

Rostock, Mecklenburg-Vorpommern, D-18055, Germany

Location

Neurochirurgische Universitätsklinik Knappschafts-Krankenhaus Bochum-Langendreer

Bochum, North Rhine-Westphalia, 44892, Germany

Location

Klinikum Augsburg

Augsburg, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Klinikum Deggendorf

Deggendorf, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Asklepios Westklinikum Hamburg

Hamburg, Germany

Location

UNI Kiel

Kiel, Germany

Location

St. Bonifatius Hospital GmbH

Lingen, Germany

Location

UMM Mannheim

Mannheim, Germany

Location

SLAZ Amsterdam

Amsterdam, Netherlands

Location

MCH Antoniushove

Leidschendam, Netherlands

Location

MCH Westeinde

The Hague, Netherlands

Location

Isala Klinieken

Zwolle, 8025AB, Netherlands

Location

KSA Aarau

Aarau, Switzerland

Location

Related Publications (10)

  • Thome C, Klassen PD, Bouma GJ, Kursumovic A, Fandino J, Barth M, Arts M, van den Brink W, Bostelmann R, Hegewald A, Heidecke V, Vajkoczy P, Frohlich S, Wolfs J, Assaker R, Van de Kelft E, Kohler HP, Jadik S, Eustacchio S, Hes R, Martens F; Annular Closure RCT Study Group. Annular closure in lumbar microdiscectomy for prevention of reherniation: a randomized clinical trial. Spine J. 2018 Dec;18(12):2278-2287. doi: 10.1016/j.spinee.2018.05.003. Epub 2018 May 3.

    PMID: 29730458RESULT

  • Martens F, Vajkoczy P, Jadik S, Hegewald A, Stieber J, Hes R. Patients at the Highest Risk for Reherniation Following Lumbar Discectomy in a Multicenter Randomized Controlled Trial. JB JS Open Access. 2018 Apr 16;3(2):e0037. doi: 10.2106/JBJS.OA.17.00037. eCollection 2018 Jun 28.

    PMID: 30280130RESULT

  • Klassen PD, Hsu WK, Martens F, Inzana JA, van den Brink WA, Groff MW, Thome C. Post-lumbar discectomy reoperations that are associated with poor clinical and socioeconomic outcomes can be reduced through use of a novel annular closure device: results from a 2-year randomized controlled trial. Clinicoecon Outcomes Res. 2018 Jun 26;10:349-357. doi: 10.2147/CEOR.S164129. eCollection 2018.

    PMID: 29983583RESULT

  • Ament J, Thaci B, Yang Z, Kulubya E, Hsu W, Bouma G, Kim KD. Cost-effectiveness of a Bone-anchored Annular Closure Device Versus Conventional Lumbar Discectomy in Treating Lumbar Disc Herniations. Spine (Phila Pa 1976). 2019 Jan 1;44(1):5-16. doi: 10.1097/BRS.0000000000002746.

    PMID: 29927860RESULT

  • Kursumovic A, Kienzler JC, Bouma GJ, Bostelmann R, Heggeness M, Thome C, Miller LE, Barth M; Annular Closure RCT study group. Morphology and Clinical Relevance of Vertebral Endplate Changes Following Limited Lumbar Discectomy With or Without Bone-anchored Annular Closure. Spine (Phila Pa 1976). 2018 Oct 15;43(20):1386-1394. doi: 10.1097/BRS.0000000000002632.

    PMID: 29538243RESULT

  • Klassen PD, Bernstein DT, Kohler HP, Arts MP, Weiner B, Miller LE, Thome C. Bone-anchored annular closure following lumbar discectomy reduces risk of complications and reoperations within 90 days of discharge. J Pain Res. 2017 Aug 26;10:2047-2055. doi: 10.2147/JPR.S144500. eCollection 2017.

    PMID: 28894388RESULT

  • Thome C, Kursumovic A, Klassen PD, Bouma GJ, Bostelmann R, Martens F, Barth M, Arts M, Miller LE, Vajkoczy P, Hes R, Eustacchio S, Nanda D, Kohler HP, Brenke C, Fluh C, Van de Kelft E, Assaker R, Kienzler JC, Fandino J; Annular Closure RCT Study Group. Effectiveness of an Annular Closure Device to Prevent Recurrent Lumbar Disc Herniation: A Secondary Analysis With 5 Years of Follow-up. JAMA Netw Open. 2021 Dec 1;4(12):e2136809. doi: 10.1001/jamanetworkopen.2021.36809.

    PMID: 34882183DERIVED

  • Kienzler JC, Fandino J, Van de Kelft E, Eustacchio S, Bouma GJ; Barricaid(R) Annular Closure RCT Study Group. Risk factors for early reherniation after lumbar discectomy with or without annular closure: results of a multicenter randomized controlled study. Acta Neurochir (Wien). 2021 Jan;163(1):259-268. doi: 10.1007/s00701-020-04505-4. Epub 2020 Oct 21.

    PMID: 33085021DERIVED

  • van den Brink W, Fluh C, Miller LE, Klassen PD, Bostelmann R. Lumbar disc reherniation prevention with a bone-anchored annular closure device: 1-year results of a randomized trial. Medicine (Baltimore). 2019 Nov;98(44):e17760. doi: 10.1097/MD.0000000000017760.

    PMID: 31689835DERIVED

  • Kienzler JC, Klassen PD, Miller LE, Assaker R, Heidecke V, Frohlich S, Thome C; Annular Closure RCT Study Group. Three-year results from a randomized trial of lumbar discectomy with annulus fibrosus occlusion in patients at high risk for reherniation. Acta Neurochir (Wien). 2019 Jul;161(7):1389-1396. doi: 10.1007/s00701-019-03948-8. Epub 2019 May 15.

    PMID: 31089894DERIVED

Related Links

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2011

First Posted

January 26, 2011

Study Start

December 17, 2010

Primary Completion

October 1, 2016

Study Completion

June 1, 2025

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations

BE(3)DE(10)AU(2)CH(1)FR(1)NL(4)