Expert review with meta-analysis of randomized and nonrandomized controlled studies of Barricaid annular closure in patients at high risk for lumbar disc reherniation

References

• U.S. Department of Health and Human Services. Use of complementary health approaches for musculoskeletal pain disorders among adults: United States, 2012. 2012 [cited 2019 Dec 17]. Available from: https://www.cdc.gov/nchs/data/nhsr/nhsr098.pdf
   Google Scholar
• GBD Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392:1789–1858.
   PubMed Web of Science ®Google Scholar
• Vroomen PC, de Krom MC, Knottnerus JA. Predicting the outcome of sciatica at short-term follow-up. Br J Gen Pract. 2002;52:119–123.
   PubMed Web of Science ®Google Scholar
• Vroomen PC, de Krom MC, Wilmink JT, et al. Lack of effectiveness of bed rest for sciatica. N Engl J Med. 1999;340:418–423.
   PubMed Web of Science ®Google Scholar
• Arts MP, Kursumovic A, Miller LE, et al. Comparison of treatments for lumbar disc herniation: systematic review with network meta-analysis. Medicine (Baltimore). 2019;98:e14410.
   PubMed Web of Science ®Google Scholar
• Goel VK, Goyal S, Clark C, et al. Kinematics of the whole lumbar spine. Effect of discectomy. Spine (Phila Pa 1976). 1985;10:543–554.
   PubMed Web of Science ®Google Scholar
• Mariconda M, Galasso O, Attingenti P, et al. Frequency and clinical meaning of long-term degenerative changes after lumbar discectomy visualized on imaging tests. Eur Spine J. 2010;19:136–143.
   PubMed Web of Science ®Google Scholar
• Carragee EJ, Spinnickie AO, Alamin TF, et al. 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;31:653–657.
   PubMed Web of Science ®Google Scholar
• Ambrossi GL, McGirt MJ, Sciubba DM, et al. Recurrent lumbar disc herniation after single-level lumbar discectomy: incidence and health care cost analysis. Neurosurgery. 2009;65:574–578; discussion 578.
   PubMed Web of Science ®Google Scholar
• Abdu RW, Abdu WA, Pearson AM, et al. Reoperation for recurrent intervertebral disc herniation in the spine patient outcomes research trial: analysis of rate, risk factors, and outcome. Spine (Phila Pa 1976). 2017;42:1106–1114.
   PubMed Web of Science ®Google Scholar
• Fritzell P, Knutsson B, Sanden B, et al. Recurrent versus primary lumbar disc herniation surgery: patient-reported outcomes in the Swedish spine register swespine. Clin Orthop Relat Res. 2015;473:1978–1984.
   PubMed Web of Science ®Google Scholar
• Heindel P, Tuchman A, Hsieh PC, et al. Reoperation rates after single-level lumbar discectomy. Spine (Phila Pa 1976). 2017;42:E496–E501.
   PubMed Web of Science ®Google Scholar
• Kim CH, Chung CK, Park CS, et al. Reoperation rate after surgery for lumbar herniated intervertebral disc disease: nationwide cohort study. Spine (Phila Pa 1976). 2013;38:581–590.
   PubMed Web of Science ®Google Scholar
• Suri P, Pearson AM, Zhao W, et al. Pain recurrence after discectomy for symptomatic lumbar disc herniation. Spine (Phila Pa 1976). 2017;42:755–763.
   PubMed Web of Science ®Google Scholar
• Miller LE, McGirt MJ, Garfin SR, et al. Association of annular defect width after lumbar discectomy with risk of symptom recurrence and reoperation: systematic review and meta-analysis of comparative studies. Spine (Phila Pa 1976). 2018;43:E308–E315.
   PubMed Web of Science ®Google Scholar
• Ammerman J, Watters WC, Inzana JA, et al. 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;11:e4613.
   PubMed Web of Science ®Google Scholar
• Fazzalari NL, Costi JJ, Hearn TC, et al. Mechanical and pathologic consequences of induced concentric anular tears in an ovine model. Spine (Phila Pa 1976). 2001;26:2575–2581.
   PubMed Web of Science ®Google Scholar
• Bron JL, Helder MN, Meisel HJ, et al. Repair, regenerative and supportive therapies of the annulus fibrosus: achievements and challenges. Eur Spine J. 2009;18:301–313.
   PubMed Web of Science ®Google Scholar
• Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Ann Intern Med. 2009;151:W65–94.
   PubMed Web of Science ®Google Scholar
• Higgins JP, Altman DG, Gotzsche PC, et al. The cochrane collaboration’s tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.
   PubMed Web of Science ®Google Scholar
• Higgins JP, Thompson SG, Deeks JJ, et al. Measuring inconsistency in meta-analyses. BMJ. 2003;327:557–560.
   PubMed Web of Science ®Google Scholar
• Barth M, Fontana J, Thome C, et al. Occurrence of discal and non-discal changes after sequestrectomy alone versus sequestrectomy and implantation of an anulus closure device. J Clin Neurosci. 2016;34:288–293.
   PubMed Web of Science ®Google Scholar
• Cho PG, Shin DA, Park SH, et al. Efficacy of a novel annular closure device after lumbar discectomy in Korean patients: a 24-month follow-up of a randomized controlled trial. J Korean Neurosurg Soc. 2019;62:691–699.
   Web of Science ®Google Scholar
• Thome C, Klassen PD, Bouma GJ, et al. Annular closure in lumbar microdiscectomy for prevention of reherniation: a randomized clinical trial. Spine J. 2018;18:2278–2287.
   PubMed Web of Science ®Google Scholar
• Vukas D, Ledic D, Grahovac G, et al. Clinical outcomes in patients after lumbar disk surgery with annular reinforcement device: two-year follow up. Acta Clin Croat. 2013;52:87–91.
   PubMed Web of Science ®Google Scholar
• Kienzler JC, Klassen PD, Miller LE, et al. 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;161:1389–1396.
   PubMed Web of Science ®Google Scholar
• Klassen PD, Bernstein DT, Kohler HP, et al. Bone-anchored annular closure following lumbar discectomy reduces risk of complications and reoperations within 90 days of discharge. J Pain Res. 2017;10:2047–2055.
   PubMed Web of Science ®Google Scholar
• Kursumovic A, Kienzler JC, Bouma GJ, et al. Morphology and clinical relevance of vertebral endplate changes following limited lumbar discectomy with or without bone-anchored annular closure. Spine (Phila Pa 1976). 2018;43:1386–1394.
   PubMed Web of Science ®Google Scholar
• van den Brink W, Fluh C, Miller LE, et al. Lumbar disc reherniation prevention with a bone-anchored annular closure device: 1-year results of a randomized trial. Medicine (Baltimore). 2019;98:e17760.
   PubMed Web of Science ®Google Scholar
• Trummer M, Eustacchio S, Barth M, et al. Protecting facet joints post-lumbar discectomy: Barricaid annular closure device reduces risk of facet degeneration. Clin Neurol Neurosurg. 2013;115:1440–1445.
   PubMed Web of Science ®Google Scholar
• Ardeshiri A, Miller LE, Synowitz M, et al. Surgical experience and complications in 50 patients treated with an anular closure device following lumbar discectomy. Orthop Surg. 2019;11:431–437.
   PubMed Web of Science ®Google Scholar
• Kursumovic A, Rath SA. Effectiveness of an annular closure device in a “real-world” population: stratification of registry data using screening criteria from a randomized controlled trial. Med Devices (Auckl). 2018;11:193–200.
   PubMedGoogle Scholar
• Ledic D, Vukas D, Grahovac G, et al. Effect of anular closure on disk height maintenance and reoperated recurrent herniation following lumbar diskectomy: two-year data. J Neurol Surg A Cent Eur Neurosurg. 2015;76:211–218.
   PubMedGoogle Scholar
• Lequin MB, Barth M, Thome C, et al. Primary limited lumbar discectomy with an annulus closure device: one-year clinical and radiographic results from a prospective, multi-center study. Korean J Spine. 2012;9:340–347.
   PubMedGoogle Scholar
• Parker SL, Grahovac G, Vukas D, et al. Effect of an annular closure device (Barricaid) on same-level recurrent disk herniation and disk height loss after primary lumbar discectomy: two-year results of a multicenter prospective Cohort study. Clin Spine Surg. 2016;29:454–460.
   PubMed Web of Science ®Google Scholar
• Martens F, Vajkoczy P, Jadik S, et al. Patients at the highest risk for reherniation following lumbar discectomy in a multicenter randomized controlled trial. JB JS Open Access. 2018;3:e0037.
   PubMedGoogle Scholar
• Barth M, Weiss C, Bouma GJ, et al. Endplate changes after lumbar discectomy with and without implantation of an annular closure device. Acta Neurochir (Wien). 2018;160:855–862.
   PubMed Web of Science ®Google Scholar
• Bouma GJ, Barth M, Miller LE, et al. Challenges in the analysis of longitudinal pain data: practical lessons from a randomized trial of annular closure in lumbar disc surgery. Pain Res Treat. 2019;2019:3498603.
   PubMed Web of Science ®Google Scholar
• Bouma GJ, van den Brink W, Miller LE, et al. Does patient blinding influence clinical outcomes after annular closure device implantation? A propensity score-matched analysis. Orthop Res Rev. 2019;11:177–182.
   PubMed Web of Science ®Google Scholar
• Kursumovic A, Bouma GJ, Miller LE, et al. Clinical implications of vertebral endplate disruptions after lumbar discectomy: 3-year results from a randomized trial of a bone-anchored annular closure device. J Pain Res. 2020;13. In press.
   PubMed Web of Science ®Google Scholar
• Ament J, Thaci B, Yang Z, et al. Cost-effectiveness of a bone-anchored annular closure device versus conventional lumbar discectomy in treating lumbar disc herniations. Spine (Phila Pa 1976). 2019;44:5–16.
   PubMed Web of Science ®Google Scholar
• Ament JD, Thaci B, Yang Z, et al. Postoperative direct healthcare costs of lumbar discectomy are reduced with the use of a novel annular closure device in high-risk patients. Spine J. 2019;19:1170–1179.
   PubMedGoogle Scholar
• Bostelmann R, Petridis A, Meder A, et al. Who benefits from medical technical innovations? A medical and medical economic analysis using the example of lumbar disc surgery. Orthopade. 2019;49:32–38.
   Web of Science ®Google Scholar
• Klassen PD, Hsu WK, Martens F, et al. 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;10:349–357.
   PubMed Web of Science ®Google Scholar
• Parker SL, Grahovac G, Vukas D, et al. Cost savings associated with prevention of recurrent lumbar disc herniation with a novel annular closure device: a multicenter prospective cohort study. J Neurol Surg A Cent Eur Neurosurg. 2013;74:285–289.
   PubMedGoogle Scholar
• Thaci B, McGirt MJ, Ammerman JM, et al. Reduction of direct costs in high-risk lumbar discectomy patients during the 90-day post-operative period through annular closure. Clinicoecon Outcomes Res. 2019;11:191–197.
   PubMed Web of Science ®Google Scholar
• Barth M, Weiss C, Bouma GJ, et al. Reply to the letter to the editor of E. Shiban and B. Meyer regarding “Endplate changes after lumbar discectomy with and without implantation of an annular closure device” by Barth M et al., (Acta Neurochir (Wien) 2018 Apr;160(4):855-862). Acta Neurochir (Wien). 2018;160:1611–1612.
   PubMed Web of Science ®Google Scholar
• Bouma GJ. Answer to the letter to the editor of Dr. Yusuf Izci entitled “anular closure device: is it necessary after discectomy?” concerning “the high-risk discectomy patient: prevention of reherniation in patients with large anular defects using an anular closure device” by G. J. Bouma, M. Barth, D. Ledic, M. Vilendecic (2013) Eur Spine J; 22(5):1030-1036. Eur Spine J. 2014;23:485.
   PubMed Web of Science ®Google Scholar
• Grasso G. Reoperations after first lumbar disk herniation surgery with or without implantation of mechanical annular closure device. World Neurosurg. 2019;131:217–219.
   PubMed Web of Science ®Google Scholar
• Izci Y. Anular closure device: is it necessary after discectomy? Eur Spine J. 2014;23:483–484.
   PubMed Web of Science ®Google Scholar
• Klassen PD, Bernstein DT, Kohler HP, et al. Erratum: bone-anchored annular closure following lumbar discectomy reduces risk of complications and reoperations within 90 days of discharge [Corrigendum]. J Pain Res. 2017;10:2739.
   PubMed Web of Science ®Google Scholar
• Lange N, Meyer B, Shiban E. Low-grade infection due to annular closure device. Acta Neurochir (Wien). 2018;160:1867.
   PubMed Web of Science ®Google Scholar
• Shiban E, Meyer B. Letter to the editor of Acta Neurochirurgica: endplate changes after lumbar discectomy with and without implantation of an annular closure device. Acta Neurochir (Wien). 2018;160:1609.
   PubMed Web of Science ®Google Scholar
• Gautschi OP, Corniola MV, Schaller K. Risk of recurrence and postoperative intervertebral disc degeneration after lumbar intervertebral disc operation - is an anulus closure prosthesis the solution?. Praxis (Bern 1994). 2014;103:775–779.
   PubMedGoogle Scholar
• Hahn BS, Ji GY, Moon B, et al. Use of annular closure device (Barricaid(R)) for preventing lumbar disc reherniation: one-year results of three cases. Korean J Neurotrauma. 2014;10:119–122.
   PubMedGoogle Scholar
• Krutko AV, Baykov ES, Sadovoy MA. Reoperation after microdiscectomy of lumbar herniation: case report. Int J Surg Case Rep. 2016;24:119–123.
   PubMed Web of Science ®Google Scholar
• Lange N, Meyer B, Shiban E. Symptomatic annulus-repair-device loosening due to a low-grade infection. Acta Neurochir (Wien). 2018;160:199–203.
   PubMed Web of Science ®Google Scholar
• Klassen PD, Hes R, Bouma GJ, et al. 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;3:120–131.
   Google Scholar
• Strenge KB, DiPaola CP, Miller LE, et al. Multicenter study of lumbar discectomy with Barricaid annular closure device for prevention of lumbar disc reherniation in US patients: a historically controlled post-market study protocol. Medicine (Baltimore). 2019;98:e16953.
   PubMed Web of Science ®Google Scholar
• Bostelmann R, Steiger HJ, Cornelius JF. 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 Cent Eur Neurosurg. 2017;78:46–52.
   PubMedGoogle Scholar
• Wilke HJ, Ressel L, Heuer F, et al. Can prevention of a reherniation be investigated? Establishment of a herniation model and experiments with an anular closure device. Spine (Phila Pa 1976). 2013;38:E587–593.
   PubMed Web of Science ®Google Scholar
• Choy WJ, Phan K, Diwan AD, et al. Annular closure device for disc herniation: meta-analysis of clinical outcome and complications. BMC Musculoskelet Disord. 2018;19:290.
   PubMed Web of Science ®Google Scholar
• Ardeshiri A, Miller LE, Thome C. Two-year real-world results of lumbar discectomy with bone-anchored annular closure in patients at high risk of reherniation. Eur Spine J. 2019;28:2572–2578.
   PubMed Web of Science ®Google Scholar
• Kursumovic A, Rath S. Performance of an annular closure device in a ‘real-world’, heterogeneous, at-risk, lumbar discectomy population. Cureus. 2017;9:e1824.
   PubMed Web of Science ®Google Scholar
• Bouma GJ, Barth M, Ledic D, et al. 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.
   PubMed Web of Science ®Google Scholar
• Sanginov AJ, Krutko AV, Baykov ES, et al. Outcomes of surgical treatment of lumbar disk herniation using an annular closure device. Coluna/Columna. 2018;17:188–194.
   Google Scholar
• Carragee EJ, Han MY, Suen PW, et al. Clinical outcomes after lumbar discectomy for sciatica: the effects of fragment type and anular competence. J Bone Joint Surg Am. 2003;85-A:102–108.
   PubMedGoogle Scholar
• Kim KT, Lee DH, Cho DC, et al. Preoperative risk factors for recurrent lumbar disk herniation in L5-S1. J Spinal Disord Tech. 2015;28:E571–577.
   PubMedGoogle Scholar
• Zhou C, Tian YH, Zheng YP, et al. Mini-invasive transforaminal lumbar interbody fusion through wiltse approach to treating lumbar spondylolytic spondylolisthesis. Orthop Surg. 2016;8:44–50.
   PubMed Web of Science ®Google Scholar
• Klassen PD, Lesage G, Miller LE, et al. Reoperation after primary lumbar discectomy with or without implantation of a bone-anchored annular closure device: surgical strategies and clinical outcomes. World Neurosurg. 2019;130:e926–e932.
   PubMed Web of Science ®Google Scholar
• Jia H, Lubetkin EI, Barile JP, et al. Quality-adjusted Life Years (QALY) for 15 chronic conditions and combinations of conditions among US adults aged 65 and older. Med Care. 2018;56:740–746.
   PubMed Web of Science ®Google Scholar
• Bouma GJ, Ardeshiri A, Miller LE, et al. Clinical performance of a bone-anchored annular closure device in older adults. Clin Interv Aging. 2019;14:1085–1094.
   PubMed Web of Science ®Google Scholar
• Lorio M, Kim C, Araghi A, et al. ISASS policy 2019 - Surgical treatment of lumbar disc herniation with radiculopathy. Int J Spine Surg. 2020;14:1–7.
   Google Scholar
• Nanda D, Arts MP, Miller LE, et al. Annular closure device lowers reoperation risk 4 years after lumbar discectomy. Med Devices (Auckl). 2019;12:327–335.
   PubMedGoogle Scholar