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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Barricaid Device | Experimental | Intervention: Barricaid Device |
|
| Standard of Care | Active Comparator | Standard (Limited) Discectomy Only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Barricaid | Device | Annular closure device |
| |
| Standard of Care |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Back Pain Improvement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post 5Y device or procedure-related Serious Adverse Event (SAE) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH Graz | Graz | Austria | ||||
| Medizinische Universität Innsbruck |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29730458 | Result | 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. | |
| 30280130 |
| Label | URL |
|---|---|
| Sponsor website | View source |
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| Device |
Standard Limited discectomy |
|
| Oswestry Disability Index (ODI) Improvement |
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 | 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 | 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 | 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 |
| Post 60 months |
| Post 5Y secondary surgical intervention at the index level | 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 |
| Innsbruck |
| Austria |
| OLV Aalst | Aalst | Belgium |
| ZNA Middleheim / AZ Klina | Antwerp | Belgium |
| AZ Nikolaas | Sint-Niklaas | Belgium |
| CHRU Lille, Hôpital Roger Salengro | Lille | 59037 | France |
| Orthopädische Klinik und Poliklinik - Universitätsmedizin Rostock | Rostock | Mecklenburg-Vorpommern | D-18055 | Germany |
| Neurochirurgische Universitätsklinik Knappschafts-Krankenhaus Bochum-Langendreer | Bochum | North Rhine-Westphalia | 44892 | 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 | 8025AB | Netherlands |
| KSA Aarau | Aarau | Switzerland |
| Result |
| 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. |
| 29983583 | Result | 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. |
| 29927860 | Result | 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. |
| 29538243 | Result | 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. |
| 28894388 | Result | 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. |
| 34882183 | Derived | 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. |
| 33085021 | Derived | 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. |
| 31689835 | Derived | 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. |
| 31089894 | Derived | 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. |
| Published protocol design manuscript | View source |
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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