Published Clinical Evidence

Overview

Publication Synopsis

Barricaid evidence-based value proposition in 5 steps.

Published Evidence Overview

Full listing of peer-reviewed journal articles. Updated: 3/2021

Levels of Evidence Table

Level 1 RCT

PD Klassen, DT Bernstein, H-P Köhler, MP Arts, B Weiner, LE Miller, C Thomé, Bone-anchored annular closure following lumbar discectomy reduces the risk of complications and reoperations within 90 days of discharge, Journal of Pain Research 2017:10 2047-2055

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

C Thomé, A Kuršumović, PD Klassen et al. 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;4(12):e2136809. doi:10.1001/jamanetworkopen.2021.36809

C Thomé, PD Klassen, GJ Bouma, A Kuršumović, J Fandino, M Barth, M Arts, W van den Brink, R Bostelmann, A Hegewald, V Heidecke, P Vajkoczy, S Fröhlich, J Wolfs, R Assaker, E Van de Kelft, S Jadik, S Eustacchio, R Hes, F Martens, Annular closure in lumbar microdiscectomy for prevention of reherniation: a randomized clinical trial, The Spine Journal 18 (2018) 2278-2287

JC Kienzler, PD Klassen, LE Miller, R Assaker, V Heidecke, S Fröhlich, C Thomé, Three-year results from a randomized trial of lumbar discectomy with annulus fibrosus occlusion in patients at high risk for reherniation, Acta Neurochirurgica 2019 https://doi.org/10.1007/s00701-019-03948-8

D Nanda, MP Arts, LE Miller, H-P Köhler, JM Perrin, C Flüh, P Vajkoczy, Annular closure device lowers reoperation risk 4 years after lumbar discectomy, Medical Devices: Evidence and Research 2019: 12 327-335

PD Klassen, R Hes, GJ Bouma, S Eustacchio, M Barth, A Kuršumović, S Jadik, V Heidecke, R Bostelmann, C Thomé, P Vajkoczy, H-P Köhler, J Fandino, R Assaker, E Van de Kelft, S Fröhlich, W van den Brink, J Perrin, J Wolfs, M Arts, F Martens, A multicenter, prospective, randomized study protocol to demonstrate the superiority of a bone-anchored prosthesis for anular closure used in conjunction with limited discectomy to limited discectomy alone for primary lumbar disc herniation, Int J Clin Trials. 2016 Aug;3(3):120-131

GJ Bouma, W van den Brink, LE Miller, JFC Wolfs, MP Arts, Does patient blinding influence clinical outcomes after annular closure device implantation? A propensity score-matched analysis, Orthopedic Research and Reviews, Volume 2019:11 Pages 177-182; doi.org/10.2147/ORR.S216980

PD Klassen, G Lesage, LE Miller, R Hes, J Wolfs, S Eustacchio, P Vajkoczy, Reoperation after primary lumbar discectomy with or without implantation of a bone-anchored annular closure device: Surgical strategies and clinical outcomes, World Neurosurg. (2019)

PD Klassen, WK Hsu, F Martens, JA Inzana, WA van den Brink, MW Groff, C Thomé, 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, ClinicoEconomics and Outcomes Research 2018:10 349-357

GJ Bouma, M Barth, LE Miller, S Eustacchio, C Flüh, R Bostelmann, S Jadik, Challenges in the analysis of longitudinal pain data: Practical lessons from a randomized trial of annular closure in lumbar disc surgery, Pain Research and Treatment Volume 2019, Article ID 3498603, 6 pages

M Barth, J Fontana, C Thomé, GJ Bouma, K Schmieder, Occurrence of discal and non-discal changes after sequestrectomy alone versus sequestrectomy and implantation of an anulus closure device, Journal of Clinical Neuroscience 34 (2016) 288-293

M Barth, C Weiß, GJ Bouma, R Bostelmann, A Kuršumović, J Fandino, C Thomé, Endplate changes after lumbar discectomy with and without implantation of an annular closure device, Acta Neurochirurgica 2017

A Kuršumović, JC Kienzler, GJ Bouma, R Bostelmann, M Heggeness, C Thomé, LE Miller, M Barth, Morphology and clinical relevance of vertebral endplate changes following limited lumbar discectomy with or without bone-anchored annular closure, Spine 2018

A Kuršumović, GJ Bouma, LE Miller, R Assaker, E Van de Kelft, R Hes, J Kienzler, Clinical implications of vertebral endplate disruptions after lumbar discectomy: 3-year results from a randomized trial of a bone-anchored annular closure device, Journal of Pain Research 2020:13 1-7

US Study

Nunley PD, Strenge KB, Huntsman K, Bae H, DiPaola C, Allen R. T, Shaw A, Sasso RC, Araghi A, Staub B, Chen S, Miller LE, Musacchio M. Lumbar Discectomy With Barricaid Device Implantation in Patients at High Risk of Reherniation: Initial Results From a Postmarket Study, Cureus 13(12): e20274. doi:10.7759/cureus.20274

Health economics

Ammerman JM, Wind JJ, Goldsmith ME, Inzana JA. Lumbar Discectomy and Reoperation Among Workers’ Compensation Cases in Florida and New York: Are Treatment Trends Similar to Other Payer Types? J Occup Environ Med. 2020 Sep;62(9):e478-e484.

B Thaci, MJ McGirt, JM Ammerman, C Thomé, KD Kim, JD Ament, Reduction of direct costs in high-risk lumbar discectomy patients during the 90-day post-operative period through annular closure, ClinicoEconomics and Outcomes Research 2019:11 191-197

JD Ament, B Thaci, Z Yang, E Kulubya, W Hsu, G Bouma, KD Kim, Cost-effectiveness of a bone-anchored annular closure device versus conventional lumbar discectomy in treating lumbar disc herniations, Spine 2019;44:5-16

JD Ament, B Thaci, Z Yang, A Kuršumović, R Bostelmann, T Lanman, JP Johnson, S Fröhlich, KD Kim, Postoperative direct health care costs of lumbar discectomy are reduced with the use of a novel annular closure device in high-risk patients, The Spine Journal 19 (2019) 1170-1179

Professional society policy guidance

M Lorio, C Kim, A Araghi, J Inzana, J Yue
International Society for the Advancement of Spine Surgery Policy 2019— Surgical Treatment of Lumbar Disc Herniation with Radiculopathy
International Journal of Spine Surgery, Vol. 14, No. 1, 2020, pp. 1–17

Biomechanics

H-J Wilke, L Ressel, F Heuer, N Graf, S Rath, Can prevention of a reherniation be investigated? Establishment of a herniation model and experiments with an anular closure device, Spine 2013 Volume 38, Number 10, pp E587-E593

R Bostelmann, H-J Steiger, JF Cornelius, Effect of annular defects on intradiscal pressures in the lumbar spine: An in vitro biomechanical study of discectomy and annular repair, J Neurol Surg A 2015.

Defining the need

EJ Carragee, MY Han, PW Suen, D Kim. Clinical outcomes after lumbar discectomy for sciatica: the effects of fragment type and anular competence. J Bone Joint Surg Am. 2003;85(1):102-108.

BI Martin, SK Mirza, DR Flum, TM Wickizer, PJ Heagerty, AF Lenkoski, RA Deyo. Repeat surgery after lumbar decompression for herniated disc: the quality implications of hospital and surgeon variation. Spine J. 2012;12(2):89-97.

LE Miller, MJ McGirt, SR Garfin, CM Bono, Association of annular defect width after lumbar discectomy with risk of symptom recurrence and reoperation: Systematic review and meta-analysis of comparative studies, Spine Volume 43, Number 5, pp E308-E315

F Martens, P Vajkoczy, S Jadik, A Hegewald, J Stieber, R Hes, Patients at the highest risk for reherniation following lumbar discectomy in a multicenter randomized controlled trial, JBJS 2018:e0037.

MP Arts, A Kuršumović, LE Miller, J Wolfs, JM Perrin, E Van de Kelft, V Heidecke, Comparison of treatments for lumbar disc herniation: Systematic review with network meta-analysis, Medicine (2019) 98:7(e14410)

J Ammerman, WC Watters, JA Inzana, E Carragee, MW Groff, Closing the treatment gap for lumbar disc herniation patients with large annular defects: A systematic review of techniques and outcomes in this high-risk population, Cureus 2019 DOI 10.7759/cureus

A Kuršumović, JM Muir, J Ammerman, R Bostelmann, The disability cascade: A preventable consequence of the loss of disc height following lumbar microdiscectomy, Cureus 11(7): e5169.DOI 10.7759/cureus.5169

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