Annular Closure Device Reduces Symptomatic Reherniation Rates: Results of a Meta-analysis

Abstract

Background: The scope of existing annular closure device (ACD) studies examining long-term follow-up data is limited. There is a paucity of studies that report and analyze recent outcomes data following ACD use. Purpose: We sought to summarize the available long-term follow-up data on postoperative outcomes of the Barricaid (Intrinsic Therapeutics) ACD. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, the PubMed, Cochrane, and OVID databases were searched to identify studies after 2015 that include direct evaluation of an ACD in a clinical context with a minimum of 2 years of follow-up and inclusion of reherniation and complication rates, while excluding case reports, reviews, and meta-analyses. Outcome measures included patient demographics, study characteristics, surgical technique, defect measurement technique, perioperative statistics, radiographic assessments, complications, patient-reported outcome measures (PROMs), and postoperative outcomes. Results: Five studies—2 randomized controlled trials (RCTs), 2 retrospective studies, and 1 prospective cohort study—were included. Symptomatic reherniation rates in the ACD populations ranged from 3% to 18.8%. Two studies found that control groups herniate significantly more than their ACD counterparts (ACD 18.8% vs non-ACD 31.6% and ACD 3.33% vs non-ACD 20.0%). No significant differences were found in reoperation rates. Of the 4 studies that reported PROMs data, all observed relative improvement in each cohort, although pooled analysis did not find significant differences between ACD and non-ACD groups for Oswestry Disability Index and visual analogue scale–leg pain at 2-year follow-up. Conclusions: For patients undergoing diskectomy for lumbar disk herniation, the Barricaid device is effective in reducing symptomatic reherniation but does not appear to alter postoperative PROMs or reoperation rates. Surgeons must consider that device-related complications can occur.

Keywords

annular closure device Barricaid reherniation diskectomy systematic review meta-analysis

Get full access to this article

View all access options for this article.

References

Agnol

Gonzalez Dias

Nicoletti

Falavigna

Bianchi

Polyurethane as a strategy for annulus fibrosus repair and regeneration: a systematic review. Regen Med. 2018;13(5):611–626. https://doi.org/10.2217/rme-2018-0003.

Ambrossi

GLG

McGirt

Sciubba

, et al. Recurrent lumbar disc herniation after single-level lumbar discectomy: incidence and health care cost analysis. Neurosurgery. 2009;65(3):574–578; discussion 578. https://doi.org/10.1227/01.NEU.0000350224.36213.F9.

Barth

Diepers

Weiss

Thomé

Two-year outcome after lumbar microdiscectomy versus microscopic sequestrectomy: part 2: radiographic evaluation and correlation with clinical outcome. Spine (Phila Pa 1976). 2008;33(3):273–279. https://doi.org/10.1097/BRS.0b013e31816201a6.

Bateman

Balkovec

Akens

, et al. Closure of the annulus fibrosus of the intervertebral disc using a novel suture application device-in vivo porcine and ex vivo biomechanical evaluation. Spine J. 2016;16(7):889–895. https://doi.org/10.1016/j.spinee.2016.03.005.

Bouma

Barth

Ledic

Vilendecic

The high-risk discectomy patient: prevention of reherniation in patients with large annular defects using an annular closure device. Eur Spine J. 2013;22(5):1030–1036. https://doi.org/10.1007/s00586-013-2656-1.

Brockman

P160050 Barricaid® annular closure device (ACD). Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160050A.pdf. Published February 8, 2019. Accessed November 16, 2023.

Carragee

Han

Suen

Kim

Clinical outcomes after lumbar discectomy for sciatica: the effects of fragment type and annular competence. J Bone Joint Surg Am. 2003;85(1):102–108.

Carragee

Spinnickie

Alamin

Paragioudakis

A prospective controlled study of limited versus subtotal posterior discectomy: short-term outcomes in patients with herniated lumbar intervertebral discs and large posterior annular defect. Spine (Phila Pa 1976). 2006;31(6):653–657. https://doi.org/10.1097/01.brs.0000203714.76250.68.

Cho

Shin

Park

GY.

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(6):691–699. https://doi.org/10.3340/jkns.2019.0071.

10.

Evaniew

Bogle

Soroceanu

, et al. Minimally invasive tubular lumbar discectomy versus conventional open lumbar discectomy: an observational study from the Canadian Spine Outcomes and Research Network. Global Spine J. 2023;12(5):1293–1303. https://doi.org/10.1177/21925682211029863.

11.

Fujiwara

Kobayashi

Saiki

Kitagawa

Tamai

Saotome

Association of the Japanese Orthopaedic Association score with the Oswestry Disability Index, Roland-Morris Disability Questionnaire, and short-form 36. Spine (Phila Pa 1976). 2003;28(14):1601–1607.

12.

Goel

Goyal

Clark

Nishiyama

Nye

Kinematics of the whole lumbar spine. Effect of discectomy. Spine (Phila Pa 1976). 1985;10(6):543–554. https://doi.org/10.1097/00007632-198507000-00008.

13.

Gray

Deyo

Kreuter

, et al. Population-based trends in volumes and rates of ambulatory lumbar spine surgery. Spine (Phila Pa 1976). 2006;31(17):1957–1963; discussion 1964. https://doi.org/10.1097/01.brs.0000229148.63418.c1.

14.

Kienzler

Fandino

Van de Kelft

Eustacchio

Bouma

; Barricaid® 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;163(1):259–268. https://doi.org/10.1007/s00701-020-04505-4.

15.

Klassen

Lesage

Miller

, 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. https://doi.org/10.1016/j.wneu.2019.07.038.

16.

Kuršumović

Rath

Performance of an annular closure device in a “real-world,” heterogeneous, at-risk, lumbar discectomy population. Cureus. 2017;9:e1824. https://doi.org/10.7759/cureus.1824.

17.

Lequin

Barth

Thomė

Bouma

GJ.

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(4):340–347. https://doi.org/10.14245/kjs.2012.9.4.340.

18.

Yuan

, et al. A novel full endoscopic annular repair technique combined with autologous conditioned plasma intradiscal injection: a new safe serial therapeutic model for the treatment of lumbar disc herniation. Ann Palliat Med. 2021;10(1):292–301. https://doi.org/10.21037/apm-20-2257.

19.

Dou

Kong

Repair and regenerative therapies of the annulus fibrosus of the intervertebral disc. J Coll Physicians Surg Pak. 2016;26(2):138–144. https://doi.org/02.2016/JCPSP.138144.

20.

Loupasis

Stamos

Katonis

Sapkas

Korres

Hartofilakidis

Seven- to 20-year outcome of lumbar discectomy. Spine (Phila Pa 1976). 1999;24(22):2313–2317. https://doi.org/10.1097/00007632-199911150-00005.

21.

Mariconda

Galasso

Attingenti

Federico

Milano

Frequency and clinical meaning of long-term degenerative changes after lumbar discectomy visualized on imaging tests. Eur Spine J. 2010;19(1):136–143. https://doi.org/10.1007/s00586-009-1201-8.

22.

Martens

Lesage

Muir

Stieber

JR.

Implantation of a bone-anchored annular closure device in conjunction with tubular minimally invasive discectomy for lumbar disc herniation: a retrospective study. BMC Musculoskelet Disord. 2018;19(1):269. https://doi.org/10.1186/s12891-018-2178-4.

23.

Miller

Allen

Duhon

Radcliff

KE.

Expert review with meta-analysis of randomized and nonrandomized controlled studies of Barricaid annular closure in patients at high risk for lumbar disc reherniation. Expert Rev Med Devices. 2020;17(5):461–469. https://doi.org/10.1080/17434440.2020.1745061.

24.

Miller

McGirt

Garfin

Bono

CM.

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(5):E308–E315. https://doi.org/10.1097/BRS.0000000000002501.

25.

Munn

Stone

Aromataris

, et al. Assessing the risk of bias of quantitative analytical studies: introducing the vision for critical appraisal within JBI systematic reviews. JBI Evid Synth. 2023;21(3):467–471. https://doi.org/10.11124/JBIES-22-00224.

26.

Parker

Grahovac

Vukas

, 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(10):454–460. https://doi.org/10.1097/BSD.0b013e3182956ec5.

27.

Sobottke

Schlüter-Brust

Kaulhausen

, et al. Interspinous implants (X Stop, Wallis, Diam) for the treatment of LSS: is there a correlation between radiological parameters and clinical outcome? Eur Spine J. 2009;18(10):1494–1503. https://doi.org/10.1007/s00586-009-1081-y.

28.

Strenge

DiPaola

Miller

Hill

Whitmore

RG.

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(35):e16953. https://doi.org/10.1097/MD.0000000000016953.

29.

Thomé

Klassen

Bouma

, et al. Annular closure in lumbar microdiscectomy for prevention of reherniation: a randomized clinical trial. Spine J. 2018;18(12):2278–2287. https://doi.org/10.1016/j.spinee.2018.05.003.

30.

Thomé

Kuršumović

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. https://doi.org/10.1001/jamanetworkopen.2021.36809.

31.

Watters

McGirt

MJ.

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;9(3):240–257. https://doi.org/10.1016/j.spinee.2008.08.005.

32.

Yorimitsu

Chiba

Toyama

Hirabayashi

Long-term outcomes of standard discectomy for lumbar disc herniation: a follow-up study of more than 10 years. Spine (Phila Pa 1976). 2001;26(6):652–657. https://doi.org/10.1097/00007632-200103150-00019.

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.03 MB

0.02 MB

0.01 MB

0.13 MB

0.03 MB