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CLINICAL RESULTS

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Clinical experience with Barricaid spans over 8 years, including one of the largest level I superiority RCTs in spine, where Barricaid has been compared to the gold standard, discectomy alone.

21 European hospitals have enrolled 554 patients (276 Treatment versus 278 Control) in this 1:1 landmark randomized trial. Patient enrollment was completed in October 2014.

Click here to learn which hospitals participate in the Anular Closure RCT Study Group.

Enrolled patients are those with maximum potential to benefit from preservation of their remaining disc by implanting Barricaid anular closure (i.e. those having a minimum posterior disc height of 5mm, as well as a minimum defect size of 4-6mm tall, 6-10mm wide). 

To be judged a success, Barricaid patients will need to demonstrate statistical superiority in the study’s two co-primary endpoints:

  • Reherniation free survival
  • A composite endpoint of patient outcomes including improvement in leg pain, Oswestry Disability Index (ODI), maintenance of disc height, and lack of a reoperation at the target level.

All patients have been followed at 6 weeks, 3 months, 6 months, 1 year and 2 years.

FOLLOW-UP TABLE
  PRE-OP INTRA-OP 6 WEEKS 3 MONTHS 6 MONTHS 1 YEAR 2 YEARS
Neurological Evaluation
VAS Leg  
VAS Back  
ODI  
SF-36  
Defect Size            
Nucleus Removed            
X-Ray  
MRI        
Low-dose CT        

 

Click here to learn more about the peer-reviewed publications from this level 1b RCT.

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BARRICAID PUBLICATIONS

 

PROVIDING THE CLINICAL PROOF

Performance of an Annular Closure Device in a ‘Real-World’, Heterogeneous, At-Risk, Lumbar Discectomy Population
Cureus 9(11): e1824. DOI 10.7759/cureus.1824, Kursumovic A, Rath S
Bone-anchored annular closure following lumbar discectomy reduces risk of complications and reoperations within 90 days of discharge
Journal of Pain Research 2017:10 2047–2055, Klassen PD , Bernstein DT, Köhler H-P, Arts MP, Weinder B, Miller LE, Thomé C
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, PD Klassen, R Hes, GJ Bouma, S Eustacchio, M Barth, A Kursumovic, S Jadik, V Heidecke, R Bostelmann, C Thomé, P Vajkoczy, HP Köhler, J Fandino, R Assaker, E Van de Kelft, S Fröhlich, W van den Brink, J Perrin, J Wolfs, M Arts, F Martens
Use of Annular Closure Device (Barricaid®) for Preventing Lumbar Disc Reherniation: One-Year Results of Three Cases
Korean J Neurotrauma 2014;10(2):119-122, BS Hahn, GY Ji, B Moon, DA Shin, Y Ha, KN Kim, DH Yoon
Effect Of A Novel Annular Closure Device (Barricaid) On Same Level Recurrent Disc Herniation And Disc Height Loss After Primary Lumbar Discectomy: Two-Year Results Of A Multi-Center Prospective Cohort Study
Clin Spine Surg. 2016 Dec;29(10):454-460, SL Parker, G Grahovac, D Vukas, M Vilendecic, D Ledic, MJ McGirt, EJ Carragee
Effect of Anular Closure on Disk Height Maintenance and Reoperated Recurrent Herniation Following Lumbar Diskectomy: Two-Year Data
J Neurol Surg A 2015;76:211-218., D Ledic, D Vukas, G Grahovac, M Barth, GJ Bouma, M Vilendecic
Clinical Outcomes In Patients After Lumbar Disc Surgery With Anular Reinforcement Device; Two-Year Follow Up
Acta Clin Croat (2013) 52:87-91, D Vukas, D Ledić, G Grahovac, Z Kolić, K Rotim, M Vilendečić
Protecting Facet Joints Post-Lumbar Discectomy: Barricaid Annular Closure Device Reduces Risk of Facet Degeneration
Clin Neurol Neurosurg. 2013 Aug;115(8):1440-5, M Trummer, S Eustacchio, M Barth, PD Klassen, S Stein
Primary Limited Lumbar Discectomy with an Annulus Closure Device: One-Year Clinical and Radiographic Results from a Prospeective, Multi-Center Study
Korean J Spine (2012) 9(4):340-347, M Lequin, M Barth, C Thomé, GJ Bouma
The High-Risk Discectomy Patient: Prevention Of Reherniation In Patients With Large Anular Defects Using An Anular Closure Device
Eur Spine J (2013) 22:1030–1036, GJ Bouma, M Barth, D Ledic, M Vilendecic

 

DEMONSTRATING THE ECONOMIC BENEFIT

Cost Savings Associated with Prevention of Recurrent Lumbar Disc Herniation: A Multi-Center Prospective Cohort Study
J Neurol Surg A Cent Eur Neurosurg. 2013 Sep;74(5):285-9, SL Parker, G Grahovac, D Vukas, D Ledic, M Vilendecic, MJ McGirt

 

PRECLINICAL VALIDATION

Effect of Annular Defects on Intradiscal Pressures in the Lumbar Spine: An in Vitro Biomechanical Study of Diskectomy and Annular Repair
J Neurol Surg A 2015, DOI: 10.1055/s-0035-1570344, R Bostelmann, H-J Steiger, JF Cornelius
Can Prevention of A Re-Herniation Be Investigated?: Establishment Of A Herniation Model And Experiments With An Anular Closure Device
Spine (2013) 38(10) E587–E593, HJ Wilke, L Widmann, F Heuer, N Graf, S Rath

 

DISCECTOMY PUBLICATIONS

 

THE REALITY OF DISCECTOMY OUTCOMES

Repeat Surgery After Lumbar Decompression For Herniated Disc: The Quality Implications Of Hospital And Surgeon Variation
Spine J. 2012 Feb;12(2):89-97. doi: 10.1016/j.spinee.2011.11.010. Epub 2011 Dec 21, BI Martin, SK Mirza, DR Flum, TM Wickizer, PJ Heagerty, AF Lenkoski, RA Deyo
Reoperations After Lumbar Disc Surgery: A Population-Based Study Of Regional And Interspecialty Variations
Spine (2000) Jun 15;25(12):1500-8, I Keskimäki, S Seitsalo, H Osterman, P Rissanen
Risk Of Multiple Reoperations After Lumbar Discectomy: A Population-Based Study
Spine (2003) Mar 15;28(6):621-7, H Osterman, R Sund, S Seitsalo, I Keskimäki
The Swedish Spine Register: development, design and utility
Eur Spine J. (2009) Aug;18 Suppl 3:294-304, Strömqvist, et al.
Reoperation Rate After Surgery For Lumbar Herniated Intervertebral Disc Disease: Nation-Wide Cohort Study
Spine 2(013) Apr;38(7): 581–590, CH Kim, CK Chung, CS Park, B Choi, MJ Kim, BJ Park
Long-term outcomes of standard discectomy for lumbar disc herniation: a follow-up study of more than 10 years
Spine (Phila Pa 1976). 2001 Mar 15;26(6):652-7, E Yorimitsu, K Chiba, Y Toyama, K Hirabayashi

 

CONFIRMATION OF THE AT RISK PATIENT

Clinical outcomes after lumbar discectomy for sciatica: the effects of fragment type and anular competence
J Bone Joint Surg Am. 2003 Jan;85-A(1):102-8, EJ Carragee, MY Han, PW Suen, D Kim D.
Preoperative Risk Factors for Recurrent Lumbar Disk Herniation in L5–S1
J Spinal Disord Tech. 2015 Dec;28(10):E571-7, KT Kim, DH Lee, DC Cho, JK Sung, YB Kim
A prospective cohort study of close interval computed tomography and magnetic resonance imaging after primary lumbar discectomy: factors associated with recurrent disc herniation and disc height loss.
Spine (Phila Pa 1976). 2009 Sep 1;34(19):2044-51. doi: 10.1097/BRS.0b013e3181b34a9a., MJ McGirt, S Eustacchio, P Varga, M Vilendecic, M Trummer, M Gorensek, D Ledic, EJ Carragee 
 

IMPACT OF SURGICAL TECHNIQUE ON OUTCOMES

A prospective controlled study of limited versus subtotal posterior discectomy: short-term outcomes in patients with herniated lumbar intervertebral discs and large posterior anular defect
Spine (Phila Pa 1976). 2006 Mar 15;31(6):653-7., Carragee EJ, Spinnickie AO, Alamin TF, Paragioudakis S.
An evidence-based review of the literature on the consequences of conservative versus aggressive discectomy for the treatment of primary disc herniation with radiculopathy
Spine J. 2009 Mar;9(3):240-57. doi: 10.1016/j.spinee.2008.08.005. Epub 2008 Sep 21., Watters WC 3rd, McGirt MJ.
Outcome after lumbar sequestrectomy compared with microdiscectomy: a prospective randomized study
J Neurosurg Spine. 2005 Mar;2(3):271-8., Thomé C, Barth M, Scharf J, Schmiedek P.
Two-year outcome after lumbar microdiscectomy versus microscopic sequestrectomy: part 1: evaluation of clinical outcome
Spine (Phila Pa 1976). 2008 Feb 1;33(3):265-72. doi: 10.1097/BRS.0b013e318162018c, Barth M, Weiss C, Thomé C.
Is sequestrectomy a viable alternative to microdiscectomy? A systematic review of the literature
Clin Orthop Relat Res. 2015 Jun;473(6):1957-62. doi: 10.1007/s11999-014-3904-3., Fakouri B1, Shetty NR, White TC.
 

COST OF FAILURE

Recurrent lumbar disc herniation after single-level lumbar discectomy: incidence and health care cost analysis
Neurosurgery. 2009 Sep;65(3):574-8; discussion 578. doi: 10.1227/01.NEU.0000350224.36213.F9.,Ambrossi GL, McGirt MJ, Sciubba DM, Witham TF, Wolinsky JP, Gokaslan ZL, Long DM.
Long-term back pain after a single-level discectomy for radiculopathy: incidence and health care cost analysis
J Neurosurg Spine. 2010 Feb;12(2):178-82. doi: 10.3171/2009.9.SPINE09410., Parker SL, Xu R, McGirt MJ, Witham TF, Long DM, Bydon A.
Economic impact of improving outcomes of lumbar discectomy
The Spine Journal 10 (2010) 108–116, J Sherman, J Cauthen, D Schoenberg, M Burns, N L Reaven, S.L Griffith