A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid to Discectomy for Primary Lumbar Disc Herniation
NCT ID: NCT01283438
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
554 participants
INTERVENTIONAL
2010-12-17
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Barricaid Device
Intervention: Barricaid Device
Barricaid
Annular closure device
Standard of Care
Standard (Limited) Discectomy Only
Standard of Care
Standard Limited discectomy
Interventions
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Barricaid
Annular closure device
Standard of Care
Standard Limited discectomy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
21 Years
75 Years
ALL
No
Sponsors
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Intrinsic Therapeutics
INDUSTRY
Responsible Party
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Locations
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LKH Graz
Graz, , Austria
Medizinische Universität Innsbruck
Innsbruck, , Austria
OLV Aalst
Aalst, , Belgium
ZNA Middleheim / AZ Klina
Antwerp, , Belgium
AZ Nikolaas
Sint-Niklaas, , Belgium
CHRU Lille, Hôpital Roger Salengro
Lille, , France
Orthopädische Klinik und Poliklinik - Universitätsmedizin Rostock
Rostock, Mecklenburg-Vorpommern, Germany
Neurochirurgische Universitätsklinik Knappschafts-Krankenhaus Bochum-Langendreer
Bochum, North Rhine-Westphalia, Germany
Klinikum Augsburg
Augsburg, , Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Klinikum Deggendorf
Deggendorf, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Asklepios Westklinikum Hamburg
Hamburg, , Germany
UNI Kiel
Kiel, , Germany
St. Bonifatius Hospital GmbH
Lingen, , Germany
UMM Mannheim
Mannheim, , Germany
SLAZ Amsterdam
Amsterdam, , Netherlands
MCH Antoniushove
Leidschendam, , Netherlands
MCH Westeinde
The Hague, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
KSA Aarau
Aarau, , Switzerland
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Sponsor website
Published protocol design manuscript
Other Identifiers
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EUBARD-CP-011
Identifier Type: -
Identifier Source: org_study_id
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