Clinical trial NCT01283438: A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid to Discectomy for Primary Lumbar Disc Herniation
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Lumbar Disc Herniation
Lead sponsor: Intrinsic Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-01-26
Enrollment: 554
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Combined success of multiple clinical outcomes, including Oswestry disability index, Visual Analog Scale (VAS), and multiple radiographically confirmed measures
timeFrame: 24 months
measure: No radiographic evidence of recurrent disc herniation
timeFrame: 24 months
Secondary outcomes:
measure: Visual Analog Scale (VAS) Back Pain Improvement
timeFrame: 24 months
measure: Oswestry Disability Index (ODI) Improvement
timeFrame: 24 months
measure: Reoperation
timeFrame: 24 months
measure: Visual Analog Scale (VAS) LEG Pain Improvement
timeFrame: 24 months
measure: Disc Height Maintenance
timeFrame: 24 months
Other outcomes:
measure: Post 5Y device or procedure-related Serious Adverse Event (SAE)
timeFrame: Post 60 months
measure: Post 5Y secondary surgical intervention at the index level
timeFrame: Post 60 months
Locations:
city: Graz
country: Austria
facility: LKH Graz
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Aalst
country: Belgium
facility: OLV Aalst
city: Antwerp
country: Belgium
facility: ZNA Middleheim / AZ Klina
city: Sint Niklaas
country: Belgium
facility: AZ Nikolaas
city: Lille
country: France
facility: CHRU Lille, Hôpital Roger Salengro
city: Rostock
country: Germany
facility: Orthopädische Klinik und Poliklinik - Universitätsmedizin Rostock
state: Mecklenburg-Vorpommern
city: Bochum
country: Germany
facility: Neurochirurgische Universitätsklinik Knappschafts-Krankenhaus Bochum-Langendreer
state: North Rhine-Westphalia
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Deggendorf
country: Germany
facility: Klinikum Deggendorf
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Hamburg
country: Germany
facility: Asklepios Westklinikum Hamburg
city: Kiel
country: Germany
facility: UNI Kiel
city: Lingen
country: Germany
facility: St. Bonifatius Hospital GmbH
city: Mannheim
country: Germany
facility: UMM Mannheim
city: Amsterdam
country: Netherlands
facility: SLAZ Amsterdam
city: Den Haag
country: Netherlands
facility: MCH Westeinde
city: Leidschendam
country: Netherlands
facility: MCH Antoniushove
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Aarau
country: Switzerland
facility: KSA Aarau
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.