Key Evidence
Clinical Need
A – Poor Outcomes After Discectomy
- Martin et al – Reop after discectomy in WA state – SpineJ 2012.pdf
- Osterman article.pdf
- Watters and McGirt – Aggressive vs. Conservative Discectomy – The Spine Journal 2009.pdf
B – Defect Size Significantly Correlates with Reherniation
Primary
A – Level 1A Meta Analysis
- Miller LE – Association_of_Annular_Defect_Width_Following – Spine 2018.pdf
- Wang Meta-Analysis.pdf
- Acta Orthop. Belg., 2022, 88, 491-504.pdf
- Dalal et al. Annular Closure Device Reduces Symptomatic Reherniation.pdf
- Wei-Shang et al. The Effectiveness Safety of Annulus Closure Device.pdf
B – Intrinsic Level 1B FDA PMA RCT Study
- i – Study Design
- ii – Study Endpoint 2 Year Report
- iii – Early Term Results
- iv – Mid Term Results
- v – Long Term Results
- vi – Post Hoc Analyses
- a. Blinding
- b. Reoperations
- c. Barricaid through Tubular Retractors
- d. Older Patients
- e. Discectomy Alone Risk Factors
- f. Radiographic Changes with no Clinical Significance
- g. Longitudinal Pain Analyses
C – RCT Study – Unsponsored
D – Intrinsic US Postmarket Confirmation of Effectiveness
- i. Study Design
- ii. 3 Month Results
- iii. One Year Results
Secondary
A – Intrinsic Sponsored Clinical Studies
- i. Two Year Results – Historical Control
- ii. Two Year Reherniation Rate
- iii. Disc Height Mainenance in Barricaid Patients
- iv. Less Facet Degeneration in Barricaid Patients – Historical Control
- v. One Year Results
B – Clinical Studies – Unsponsored
- 3 – Kurzbuch, et al., Lumbar discectomy with annulus fibrosus closure (53 patients).pdf
- 010_Attachment B6_Literature Kienzler – Original.pdf
- 011_Attachment B7_Literature Krutko – Original.pdf
- Ardeshiri A et al_Two-yearReal-worldResultsOfLum – ESJ 2019.pdf
- Kursumovic A_Effectiveness of ACD in real world against RCT criteria_Med Dev Evidence & Research May 2018.pdf
- Kursumovic – Performance of an annular closure device in a real-world, heterogeneous, at-risk lumbar discectomy population – Cureus 2017.pdf
- Orthopaedic Surgery – 2019 – Ardeshiri – Surgical Experience and Complications in 50 Patients Treated with an Anular.pdf
- Sanginov.pdf
- Sagninov, et al., 8 year follow-up.pdf
C – Intrinsic FDA PMA RCT Health Economics
- i. Reoperations and Disability
- ii. Direct Medical Costs
- iii. Cost Effectiveness
D – Systematic Reviews
Preliminary Safety Data
i. Biomechanics
- i. Pressure Restoration and Maintained ROM
- ii. Verification of Effectiveness in Cadaver Model
- iii. Design Priniciples of Annular Closure
ii. Case Reports
- 006_Attachment B2_Literature Burkhardt and Oertel – Original.pdf
- Grasso, Giovanni-Reoperations after first lumbar disk herniation – commentary on Klassen.pdf
- Hahn et al – Barricaid case series – KorJNeurotrauma 2014.pdf
- Krutko et al – Reoperation after Microdiscectomy of Lumbar Herniation- Case Report – IJSCR 2016.pdf
iii. Health Economics – Other
- Ammerman Workers Comp.pdf
- Parker et al – Barricaid cost reduction – CENS 2013.pdf
- Thaci 2019 – Reduction of direct costs in high-risk lumbar discectomy patients during the 90-day post‑operative period through annular closure.pdf
iv. Perspectives
- Bostelmann2019_Article_WerProfitiertVonMedizinisch-te-2.pdf
- Golish Superiority.pdf
- Kursumovic et al 2019_The disability cascade.pdf
v. Letters to Editors
- 1 -Kienzler, et al., Reply to letter – The annular closure device.pdf
- 2 – Kurzbuch, et al., The Annular Closure Device – panacea of lumbar disc herniation.pdf
- 007_Attacment B3_Literature Castro and Cunha – Original.pdf
- Bouma et al – reherniations with Barricaid – ESJ 2013 – response to letter.pdf
- Gautschi et al – Barricaid – Anulus Verschluss Prothese – Praxis 2014.pdf
- Izci Eur Spine J.pdf
- Klassen Erratum.pdf
- Lange – Low-grade Infection.pdf
- Shiban E – Letter to Editor Acta Neurochirurgica – EPC after lumbar discectomy with and without ACD – June 2018.pdf
- Shiban E – Reply to letter to Editor by Barth M – EPC after lumbar discectomy with and without ACD – Acta Neurochirurgica – June 2018.pdf