Reoperation After Primary Lumbar Discectomy with or without Implantation of a Bone-Anchored Annular Closure Device: Surgical Strategies and Clinical Outcomes

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

“…Additionally, this systematic review utilized 2-year followup data, but the publication of longer-term comparative data is encouraged. In the pivotal trial of the Barricaid device, clinical results through 4 years of follow-up confirm there are no excess clinically important patient risks with Barricaid treatment relative to lumbar discectomy only [74] and that the Barricaid device does not interfere with reoperations should a patient require one in the future [70]. The final 5-year followup data from the pivotal trial of the Barricaid device will be available in late 2020 and dissemination of these results will be helpful to clarify the long-term clinical outcome among patients with large annular defects treated with lumbar discectomy and the Barricaid device.…”

“…Controlled study (3) Barth, 2016 [22] 85-patient retrospective study Clinical outcomes with vs. without Barricaid over~2 years Trummer, 2013 [30] 75-patient retrospective study Facet degeneration with vs. without Barricaid over 1 year Vukas, 2013 [25] 102 [72] 554-patient RCT (NCT01283438) Clinical outcomes with Barricaid in older adults Bouma, 2019b [38] 554-patient RCT (NCT01283438) Analysis of failure-adjusted pain outcomes with vs. without Barricaid Bouma, 2019 c [39] 554-patient RCT (NCT01283438) Influence of patient blinding in an RCT with vs. without Barricaid Klassen, 2019 [70] 554-patient RCT (NCT01283438) Reoperation strategies with vs. without Barricaid Kursumovic, 2020 [40] 554-patient RCT (NCT01283438) Clinical implications of endplate changes with vs. without Barricaid over 4 years Health economics (6) Ament, 2019 [41] 554-patient RCT (NCT01283438) Direct & indirect costs of discectomy with vs. without Barricaid over 5 years Ament, 2019 [42] 554-patient RCT (NCT01283438) Direct costs of discectomy with vs. without Barricaid over 5 years Bostelmann, 2019 [43] 554-patient RCT (NCT01283438) Direct & indirect costs of discectomy with vs. without Barricaid over 2 years Klassen, 2018 [44] 554-patient RCT (NCT01283438) Costs of reoperation with vs. without Barricaid over 2 years Parker, 2013 [45] 76-patient comparative study Direct & indirect costs of discectomy with vs. without Barricaid over 1 year Thaci, 2019 [46] 554-patient RCT (NCT01283438) Direct costs of discectomy with vs. without Barricaid over 90 days Letters (7) Barth, 2018 [47] 554-patient RCT (NCT01283438) Letter re: endplate changes with vs. without Barricaid over 1 year Bouma, 2014 [48] 75-patient case series Letter re: clinical outcomes with Barricaid over 2 years Grasso, 2019 [49] 554-patient RCT (NCT01283438) Letter re: reoperation strategies with vs. without Barricaid Izci, 2014 [50] 75-patient case series Letter re: clinical outcomes with Barricaid over 2 years Klassen, 2017 [51] 554-patient RCT (NCT01283438) Erratum re: clinical outcomes with vs. without Barricaid over 90 days Lange, 2018 [52] Case report Letter re: case report of 1 patient who underwent Barricaid revision Shiban, 2018 [53] 554-patient RCT (NCT01283438) Letter re: endplate changes with vs. without Barricaid over 1 year Case reports (4) Gautschi, 2014 [54] Case report Case report of 1 patient successfully treated with...…”

“…Despite the efficacy of the Barricaid device in reducing the risk of future reoperation, it is prudent to consider the possible influence of the implant in patients who require future lumbar surgery. In the study of Klassen et al [70], it was shown that among patients undergoing a reoperation, patients with an existing Barricaid device were treated with similar reoperation techniques, experienced comparable surgical risks, and reported comparable post-revision outcomes relative to patients without the Barricaid device. Further, there were no instances in which the presence of the Barricaid device was reported to complicate a reoperation or interfere with execution of the planned surgical approach.…”

Effectiveness of an Annular Closure Device to Prevent Recurrent Lumbar Disc Herniation

“… 28 It should also be noted that the presence of the device does not interfere with standard reoperation strategies should one be indicated in the future. 29 Patients who successfully received the annular closure device and underwent reoperation were treated with similar reoperation techniques as patients in the control group. Additionally, there were no reported cases where the device complicated a reoperation procedure or altered the planned reoperative approach.…”

Discectomy Combined with Annulus Fibrosus Repair for the Treatment of Lumbar Disc Herniation: A Bayesian analysis of Random Controlled Trials

“…Many factors are affecting the recurrence of LDH, such as postoperative defect of the annulus fibrosus, the degree of disc degeneration, obesity, smoking, and other factors. 4,7,[21][22][23][24][25] Lebow et al found that recurrence after nucleus pulposus removal occurred mostly in the original nucleus. 26 Rupture of AF around with high level of phospholipase A 2 , which aggravates the hyperplasia of scar tissue.…”