Barricaid Annular Closing Device case series

Kienzler et al. published a multicenter randomized controlled trial in Europe. Patients included underwent standard lumbar discectomy-with or without implantation of an annular closure device (ACD). Enrollment of 554 patients in 21 centers in Europe (Germany, Switzerland, Austria, Belgium, The Netherlands, and France) started in 2010 and was completed in October 2014. A total of 276 patients were randomized to the ACD group (ACG) and 278 patients to the control group (CG).

Four (1.5%) symptomatic reherniations occurred in the ACG and 18 (6.5%) in the CG. In the overall population, a significant correlation was found with recurrent herniation for disc degeneration (Pfirrmann p = 0.009) and a trend for current smoker status (p = 0.07). In CG, age ≥ 50 years (p = 0.05) and disc degeneration (Pfirrmann p = 0.026, Kellgren and Lawrence p = 0.013) were predictive factors for reherniation.

In the current study, risk factors for early recurrent lumbar disc herniation after lumbar discectomy were age ≥ 50 years and moderate disc degeneration. The annular closure device reduced the risk of early reherniation 1).

Sixty patients (30 CLD, 30 ACD) were enrolled in this study. At 24-month follow-up, the disc height in the annular closure device (ACD) group was significantly greater than that in the CLD group (11.4±1.5 vs. 10.2±1.2 mm, p=0.006). Re-herniation occurred in one patient in the ACD group versus six patients in the CLD group (χ2=4.04, p=0.044). Back and leg VAS scores, ODI scores, and SF-12 scores improved significantly in both groups compared with preoperative scores in the first 7 days following surgery and remained at significantly improved levels at a 24-month follow-up. However, no statistical difference was found between the two groups.

Conclusion: Lumbar discectomy with the Barricaid® (Intrinsic Therapeutics, Inc.) ACD is more effective at maintaining disc height and preventing re-herniation compared with conventional discectomy. Our results suggest that adoption of ACD in lumbar discectomy can help improve the treatment outcome 2).

a multicenter, randomized superiority study.

Patient sample: Patients with symptoms of lumbar disc herniation for at least 6 weeks with a large annular defect (6-10 mm width) after lumbar microdiscectomy were included in the study.

Outcome measures: The co-primary end points determined a priori were recurrent herniation and a composite end point consisting of patient-reported, radiographic, and clinical outcomes. Study success required superiority of annular closure on both end points at 2-year follow-up.

Methods: Patients received lumbar microdiscectomy with additional bone-anchored annular closure device (n=276 participants) or lumbar microdiscectomy only (control; n=278 participants). This research was supported by Intrinsic Therapeutics. Two authors received study-specific support morethan $10,000 per year, 8 authors received study-specific support less than $10,000 per year, and 11 authors received no study-specific support.

Results: Among 554 randomized participants, 550 (annular closure device: n=272; control: n=278) were included in the modified intent-to-treat efficacy analysis and 550 (annular closure device: n=267; control: n=283) were included in the as-treated safety analysis. Both co-primary end points of the study were met, with recurrent herniation (50% vs. 70%, P<.001) and composite end point success (27% vs. 18%, P=.02) favoring annular closure device. The frequency of symptomatic reherniation was lower with annular closure device (12% vs. 25%, P<.001). There were 29 reoperations in 24 patients in the annular closure device group and 61 reoperations in 45 control patients. The frequency of reoperations to address recurrent herniation was 5% with annular closure device and 13% in controls (P=.001). End plate changes were more prevalent in the annular closure device group (84% vs. 30%, P<.001). Scores for back pain, leg pain, Oswestry Disability Index, and health-related quality of life at regular visits were comparable between groups over 2-year follow-up.

Conclusions: In patients at high risk of herniation recurrence after lumbar microdiscectomy, annular closure with a bone-anchored implant lowers the risk of symptomatic recurrence and reoperation. Additional study to determine outcomes beyond 2 years with a bone-anchored annular closure device is warranted 3).

Forty-six consecutive patients undergoing lumbar discectomy for single-level herniated disk at 2 institutions were followed prospectively with clinical and radiographic evaluations at 6 weeks and 3, 6, 12, and 24 months (control cohort). A second consecutive cohort of 30 patients undergoing 31 lumbar discectomies with implantation of an annular closure device was followed similarly. Incidence of recurrent disk herniation, disk height loss, the leg and back pain visual analog scale (VAS), and the Oswestry Disability Index were assessed at each follow-up.

Cohorts were well matched at baseline. By 2 years of follow-up, symptomatic recurrent same-level disk herniation occurred in 3 (6.5%) patients in the control cohort versus 0 (0%) patients in the annular repair cohort (P=0.27). A trend of greater preservation of disk height was observed in the annular repair versus the control cohort 3 months (7.9 vs. 7.27 mm, P=0.08), 6 months (7.81 vs. 7.18 mm, P=0.09), and 12 months (7.63 vs. 6.9 mm, P=0.06) postoperatively. The annular closure cohort reported less leg pain (VAS-LP: 5 vs. 16, P<0.01), back pain (VAS-BP: 13 vs. 22, P<0.05), and disability (Oswestry Disability Index: 16 vs. 22, P<0.05) 1 year postoperatively.

Implantation of a novel annular repair device was associated with greater maintenance of disk height and improved 1-year leg pain, back pain, and low-back disability. Recurrent disk herniation did not occur in any patient after annular repair. Closure of annular defect after lumbar discectomy may help preserve the physiological disk function and prevent long-term disk height loss and associated back and leg pain 4).

Hahn et al., demonstrated the preliminary reports of Barricaid® insertion in 3 patients who underwent surgery for lumbar disc herniation.

The early experience of Barricaid® implantation showed preserved disc heights and delayed disc degeneration, and improved leg and back pain. However, greater number of cohort and longer duration of follow-up would be necessary in the future study to estimate the effectiveness and safety of this device. We hope our experience to be shared with others and helpful to future trial of Barricaid® insertion. 5).

While widely perceived as a successful procedure, discectomy surgery has a high failure rate over time. The overall risk of recurrent disc herniation varies between 2-18% in reported literature. The Barricaid® anular closure device was designed as an adjunct to lumbar limited microdiscectomy to block large anular defects while maintaining as much native nucleus within the disc space. Patients that are considered for anular closure have a minimum posterior disc height of 5mm, and an intra-operatively measured anular defect between 5mm and 12mm wide. The aim of this study was determined as to assess the cost effectiveness of the use of Barricaid® in this group of patients in Turkey. Methods: A simple decision analysis model was used to assess the cost effectiveness of the use of Barricaid®. The primary clinical endpoint was determined as the number of prevented reherniations. According to the literature, the use of Barricaid® reduced the number of reherniations by 18%. Resource utilization data were obtained via expert clinical opinion and included pre-op, post-op and follow-up costs, etc. Unit costs were taken from the Social Security Institution’s official price list. Results were presented as incremental cost/number of prevented reherniations. The comparison was made between using and not using the Barricaid®. Results: According to the results of the cost effectiveness analysis, the incremental number of prevented reherniation was 4.398 with Barricaid® and incremental cost was 119.343.000 TL. The ICER was within the limits of the threshold recommended by the World Health Organization with 27.136 TL. Conclusions: Use of Barriciad® in lumbar discectomy surgery is a cost-effective treatment option in Turkey 6).

Trummer et al., investigated whether implantation with the Barricaid annular closure device (ACD) during discectomy reduced the rate of facet degeneration. Inclusion criteria were primary lumbar disc herniation failing conservative treatment, Visual Analog Scale (VAS) Leg≥40/100, Oswestry Disability Index (ODI)≥40/100 and defects that were ≤60 mm2 (Barricaid arm only), and patient age 18-75. CT interpretations were collected preoperatively and 12 months post-discectomy. Patients implanted with Barricaid had significantly reduced rates and grades of facet degeneration than patients without Barricaid. Reinforcing the annulus fibrosus with Barricaid during lumbar discectomy may slow the progression of facet joint degeneration 7).

Kienzler JC, Fandino J, Van de Kelft E, Eustacchio S, Bouma GJ; 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 Jan;163(1):259-268. doi: 10.1007/s00701-020-04505-4. Epub 2020 Oct 21. PMID: 33085021.
Cho PG, Shin DA, Park SH, Ji 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 Nov;62(6):691-699. doi: 10.3340/jkns.2019.0071. Epub 2019 Oct 30. PMID: 31679318; PMCID: PMC6835150.
Thomé C, Klassen PD, Bouma GJ, 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 HP, Jadik S, Eustacchio S, Hes R, Martens F; Annular Closure RCT Study Group. Annular closure in lumbar microdiscectomy for prevention of reherniation: a randomized clinical trial. Spine J. 2018 Dec;18(12):2278-2287. doi: 10.1016/j.spinee.2018.05.003. Epub 2018 May 3. PMID: 29730458.
Parker SL, Grahovac G, Vukas D, Vilendecic M, Ledic D, McGirt MJ, Carragee EJ. 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 Dec;29(10):454-460. PubMed PMID: 27879508.
Hahn BS, Ji GY, Moon B, Shin DA, Ha Y, Kim KN, Yoon do H. Use of Annular Closure Device (Barricaid®) for Preventing Lumbar Disc Reherniation: One-Year Results of Three Cases. Korean J Neurotrauma. 2014 Oct;10(2):119-22. doi: 10.13004/kjnt.2014.10.2.119. Epub 2014 Oct 31. PubMed PMID: 27169045; PubMed Central PMCID: PMC4852609.
Tatar M, Senturk A, Dalgali Y. Cost-Effectiveness of Use of Barricaid® In Lumbar Discectomy Surgery in Turkey. Value Health. 2014 Nov;17(7):A380. doi: 10.1016/j.jval.2014.08.2614. Epub 2014 Oct 26. PubMed PMID: 27200843.
Trummer M, Eustacchio S, Barth M, Klassen PD, Stein S. Protecting facet joints post-lumbar discectomy: Barricaid annular closure device reduces risk of facet degeneration. Clin Neurol Neurosurg. 2013 Aug;115(8):1440-5. doi: 10.1016/j.clineuro.2013.01.007. Epub 2013 Mar 6. PubMed PMID: 23473658.
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