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08.12.2024 | Original Article

A new hernia blocking system to prevent recurrent lumbar disc herniation: surgical technique, intraoperative findings and six-months post-operative outcomes

verfasst von: Oscar Godino, Carlos Fernandez-Carballal, Ignasi Català, Ángela Moreno, Jordi Manuel Rimbau, Luís Alvarez-Galovich, Héctor Roldan

Erschienen in: European Spine Journal

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Abstract

Purpose

The aim of this study was to evaluate the performance and safety of a new hernia blocking system (HBS), implanted after a limited discectomy, to prevent recurrence of lumbar disc herniation.

Methods

Prospective, multicenter (6 sites), cohort clinical investigation. Thirty patients with a postero-lateral disc herniation between L4-S1 and large annular defects (> 6 mm wide), who underwent a limited discectomy and were treated with a new HBS (DISC care, NEOS Surgery S.L.), were included.

This article presents details about the investigational device, its surgical technique, intraoperative parameters, and up to 6 months follow-up outcomes. The primary endpoint of the study was to assess the incidence of early symptomatic reherniation. In addition, disc height, leg and back pain (NRS 0–10), Oswestry Disability Index (ODI), quality of life (EQ-5D-5L) and device safety, were evaluated. Clinicaltrials.gov: NCT04188236; date: 27th November 2019.

Results

Thirty patients (43.3% female, 41.7 ± 10.9 years) were implanted with the device under evaluation in a mean of 16 ± 9.6 min. Six months after surgery, no symptomatic reherniation was detected and disc height was maintained in all patients included. All patients had a significant reduction in leg pain (> 2 points in the NRS), 92.9% improved > 15 points in the ODI and 82.6% significantly improved their quality of life (≥ 12 points in EQ VAS score). No product-related serious adverse events nor reoperations occurred.

Conclusions

The implantation of an HBS is a feasible and safe procedure that prevents early disc herniation recurrence in patients at high risk of reherniation.

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

Leven D, Passias PG, Errico TJ, Lafage V, Bianco K, Lee A, Lurie JD, Tosteson TD, Zhao W, Spratt KF, Morgan TS, Gerling MC (2015) Risk factors for reoperation in patients treated surgically for intervertebral disc herniation. J Bone Joint Surg 97:1316–1325. https://doi.org/10.2106/JBJS.N.01287CrossRefPubMedPubMedCentral

Miller LE, McGirt MJ, Garfin SR, Bono CM (2018) Association of annular defect width after lumbar discectomy with risk of symptom recurrence and reoperation. Spine (Phila Pa) 43:E308–E315. https://doi.org/10.1097/BRS.0000000000002501CrossRef

Watters WC, McGirt MJ (2009) 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 9:240–257. https://doi.org/10.1016/j.spinee.2008.08.005CrossRefPubMed

Barth M, Diepers M, Weiss C, Thomé C (2008) Two-year outcome after lumbar microdiscectomy versus microscopic sequestrectomy - part 2: radiographic evaluation and correlation with clinical outcome. Spine (Phila Pa 1976) 33:273–279. https://doi.org/10.1097/BRS.0b013e31816201a6CrossRefPubMed

Shepard N, Cho W (2019) Recurrent lumbar disc herniation: a review. Global Spine J 9:202–209. https://doi.org/10.1177/2192568217745063CrossRefPubMed

Thomé C, Klassen PD, Bouma GJ, Kursumovic A, Fandino J, Barth M, Arts M, van den Brink W, Bostelmann R, Hegewald A, Heidecke V, Vajkoczy P, Fröhlich S, Wolfs J, Assaker R, Van de Kelft E, Köhler H-PP, Jadik S, Eustacchio S, Hes R, Martens F, Kuršumović A, Fandino J, Barth M, Arts M, van den Brink W, Bostelmann R, Hegewald A, Heidecke V, Vajkoczy P, Fröhlich S, Wolfs J, Assaker R, Van de Kelft E, Köhler H-PP, Jadik S, Eustacchio S, Hes R, Martens F (2018) Annular closure in lumbar microdiskectomy for prevention of reherniation: a randomized clinical trial. Spine J 18:2278–2287. https://doi.org/10.1016/j.spinee.2018.05.003CrossRefPubMed

Pfirrmann CWA, Metzdorf A, Zanetti M, Hodler J, Boos N (2001) Magnetic resonance classification of lumbar intervertebral disc degeneration. Spine (Phila Pa 1976) 26:1873–1878. https://doi.org/10.1097/00007632-200109010-00011CrossRefPubMed

Modic MT, Masaryk TJ, Ross JS, Carter JR (1988) Imaging of degenerative disk disease. Radiology 168:177–186. https://doi.org/10.1148/radiology.168.1.3289089CrossRefPubMed

10.

Ament JD, Thaci B, Yang Z, Kursumovic A, Bostelmann R, Lanman T, Patrick Johnson J, Fröhlich S, Kim KD (2019) Postoperative direct health care costs of lumbar discectomy are reduced with the use of a novel annular closure device in high-risk patients. Spine J 19:1170–1179. https://doi.org/10.1016/j.spinee.2019.02.010CrossRefPubMed

11.

ICH Harmonised Tripartite Guideline (1999) Statistical principles for clinical trials. International Conference on Harmonisation E9 Expert Working Group. Stat Med 18:1905–42

12.

Klassen PD, Hes R, Bouma GJ, Eustacchio S, Barth M, Kursumovic A, Jadik S, Heidecke V, Bostelmann R, Thomé C, Vajkoczy P, Köhler HP, Fandino J, Assaker R, van de Kelft E, Fröhlich S, van den Brink W, Perrin J, Wolfs J, Arts M, Martens F (2016) 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 3:120. https://doi.org/10.18203/2349-3259.ijct20162794CrossRef

13.

Joelson A, Nerelius F, Sigmundsson FG, Karlsson J (2022) The minimal important change for the EQ VAS based on the SF-36 health transition item: observations from 25772 spine surgery procedures. Qual Life Res 31:3459–3466. https://doi.org/10.1007/s11136-022-03182-3CrossRefPubMedPubMedCentral

14.

McGirt MJ, Eustacchio S, Varga P, Vilendecic M, Trummer M, Gorensek M, Ledic D, Carragee EJ (2009) 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) 34:2044–2051. https://doi.org/10.1097/BRS.0b013e3181b34a9aCrossRefPubMed

15.

Kim HS, Park JY (2013) Comparative assessment of different percutaneous endoscopic interlaminar lumbar discectomy (PEID) techniques. Pain Phys 16:359–367

16.

Atlas S, Keller R, Wu Y, Deyo R, Singer D (2005) Long-term outcomes of surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: 10 year results from the maine lumbar spine study. Spine (Phila Pa 1976) 30:927–935. https://doi.org/10.1097/01.brs.0000158954.68522.2aCrossRefPubMed

17.

Liu C, Ferreira GE, Abdel Shaheed C, Chen Q, Harris IA, Bailey CS, Peul WC, Koes B, Lin C-WC (2023) Surgical versus non-surgical treatment for sciatica: systematic review and meta-analysis of randomised controlled trials. BMJ. https://doi.org/10.1136/bmj-2022-070730CrossRefPubMedPubMedCentral

18.

Weinstein JN, Lurie JD, Tosteson TD, Tosteson ANA, Blood EA, Abdu WA, Herkowitz H, Hilibrand A, Albert T, Fischgrund J (2008) Surgical versus nonoperative treatment for lumbar disc herniation. Spine (Phila Pa 1976) 33:2789–2800. https://doi.org/10.1097/BRS.0b013e31818ed8f4CrossRefPubMed

19.

Kienzler JC, Heidecke V, Assaker R, Fandino J, Barth M (2021) Intraoperative findings, complications, and short-term results after lumbar microdiscectomy with or without implantation of annular closure device. Acta Neurochir (Wien) 163:545–559. https://doi.org/10.1007/s00701-020-04612-2CrossRefPubMed

20.

United Nations Scientific Committee on the Effects of Atomic Radiation (2021) UNSCEAR 2020/2021 Report. SOURCES, EFFECTS AND RISKS OF IONIZING RADIATION. United Nations Publication I

21.

Arts M, Brand R, van der KallenNijeholt BG, Peul W (2011) Does minimally invasive lumbar disc surgery result in less muscle injury than conventional surgery? A randomized controlled trial. Eur Spine J 20:51–57. https://doi.org/10.1007/s00586-010-1482-yCrossRefPubMed

22.

Bhatia P, Chhabra H, Mohapatra B, Nanda A, Sangodimath G, Kaul R (2016) Microdiscectomy or tubular discectomy: Is any of them a better option for management of lumbar disc prolapse. J Craniovertebr Junction Spine 7:146. https://doi.org/10.4103/0974-8237.188411CrossRefPubMedPubMedCentral

23.

van den Brink W, Flüh C, Miller LE, Klassen PD, Bostelmann R (2019) Lumbar disc reherniation prevention with a bone-anchored annular closure device. Medicine 98:e17760. https://doi.org/10.1097/MD.0000000000017760CrossRefPubMedPubMedCentral

24.

Lebow RL, Adogwa O, Parker SL, Sharma A, Cheng J, McGirt MJ (2011) Asymptomatic same-site recurrent disc herniation after lumbar discectomy: Results of a prospective longitudinal study with 2-year serial imaging. Spine (Phila Pa 1976) 36:2147–2151. https://doi.org/10.1097/BRS.0b013e3182054595CrossRefPubMed

25.

Wilke H-J, Ressel L, Heuer F, Graf N, Rath S (2013) Can prevention of a reherniation be investigated? Establishment of a herniation model and experiments with an anular closure device. Spine (Phila Pa 1976) 38:E587–E593. https://doi.org/10.1097/BRS.0b013e31828ca4bcCrossRefPubMed

26.

Sin AH, Caldito G, Smith D, Rashidi M, Willis B, Nanda A (2006) Predictive factors for dural tear and cerebrospinal fluid leakage in patients undergoing lumbar surgery. J Neurosurg Spine 5:224–227. https://doi.org/10.3171/spi.2006.5.3.224CrossRefPubMed

27.

Wang JC, Bohlman HH, Riew KD (1998) Dural tears secondary to operations on the lumbar spine. management and results after a two-year-minimum follow-up of eighty-eight patients. J Bone Joint Surg 80:1728–1732. https://doi.org/10.2106/00004623-199812000-00002CrossRefPubMed

28.

Guerin P, El Fegoun AB, Obeid I, Gille O, Lelong L, Luc S, Bourghli A, Cursolle JC, Pointillart V, Vital J-M (2012) Incidental durotomy during spine surgery: incidence, management and complications. A retrospective review. Injury 43:397–401. https://doi.org/10.1016/j.injury.2010.12.014CrossRefPubMed

29.

Smorgick Y, Baker KC, Herkowitz H, Montgomery D, Badve SA, Bachison C, Ericksen S, Fischgrund JS (2015) Predisposing factors for dural tear in patients undergoing lumbar spine surgery. J Neurosurg Spine 22:483–486. https://doi.org/10.3171/2015.1.SPINE13864CrossRefPubMed

30.

Intrinsic Therapeutics I (2019) Barricaid. FDA summary of safety and effectiveness data (SSED). 1–71

31.

Bostelmann R, Petridis A, Fischer K, Vajkoczy P, Bostelmann T, Barth M (2019) New insights into the natural course and clinical relevance of Modic changes over 2 years following lumbar limited discectomy: analysis of prospective collected data. Eur Spine J 28:2551–2561. https://doi.org/10.1007/s00586-019-05988-1CrossRefPubMed

32.

Kienzler JC, Rey S, Wetzel O, Atassi H, Bäbler S, Burn F, Fandino J (2021) Incidence and clinical impact of vertebral endplate changes after limited lumbar microdiscectomy and implantation of a bone-anchored annular closure device. BMC Surg 21:1–11. https://doi.org/10.1186/s12893-020-01011-3CrossRef

33.

Häkkinen A, Ylinen J, Kautiainen H, Airaksinen O, Herno A, Kiviranta I (2003) Does the outcome 2 months after lumbar disc surgery predict the outcome 12 months later? Disabil Rehabil 25:968–972. https://doi.org/10.1080/0963828031000122258CrossRefPubMed

Titel: A new hernia blocking system to prevent recurrent lumbar disc herniation: surgical technique, intraoperative findings and six-months post-operative outcomes
verfasst von: Oscar Godino
Carlos Fernandez-Carballal
Ignasi Català
Ángela Moreno
Jordi Manuel Rimbau
Luís Alvarez-Galovich
Héctor Roldan
Publikationsdatum: 08.12.2024
Verlag: Springer Berlin Heidelberg
Erschienen in: European Spine Journal
Print ISSN: 0940-6719
Elektronische ISSN: 1432-0932
DOI: https://doi.org/10.1007/s00586-024-08595-x

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