Annular closure in lumbar microdiscectomy for prevention of reherniation: a randomized clinical trial

Thomé, Claudius; Klassen, Peter Douglas; Bouma, Gerrit J.; Kursumovic, Adisa; Fandiño, Javier; Barth, Martin; Arts, Mark P.; Brink, Wimar van den; Bostelmann, Richard; Hegewald, Aldemar Andrés; Heidecke, Volkmar; Vajkoczy, Peter; Fröhlich, Susanne; Wolfs, Jasper F. C.; Assaker, R.; Kelft, Erik Van de; Köhler, Hans-Peter; Jadik, Senol; Eustacchio, Sandro; Hes, Robert; Martens, Frederic

doi:10.1016/j.spinee.2018.05.003

Cited by 76 publications

(96 citation statements)

References 25 publications

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“…Implants, such as Inclose or Xclose (ANULEX Technology, Minnetonka, Minnesota), have been developed, but are no longer available as they have caused several complications and clinical trials have suggested no significant benefits with regard to prevention of reherniation . At current, Barricaid (Intrinsic Therapeutics, Woburn, Massachusetts) is the only commercially available implant, for which a significant decrease in herniation recurrence risk could be observed up to 2 years after surgery . Nevertheless, Barricaid`s long‐term effects remain to be studied, in particular as Barricaid operates by bone anchors and because no in situ AF regeneration was evaluated.…”

Section: Discussionmentioning

confidence: 99%

“…30 At current, Barricaid (Intrinsic Therapeutics, Woburn, Massachusetts) is the only commercially available implant, 29 for which a significant decrease in herniation recurrence risk could be observed up to 2 years after surgery. 31 Nevertheless, Barricaid`s long-term effects remain to be studied, in for a large AF defect in bovine IVD within a bioreactor culture system, could limit the biomechanical deterioration resulting from the defect. 33 The observation period, however, was relatively short and although cell infiltration could be observed, it remains to be determined whether application of cell engraftment is required, especially considering the limited densities and potency of endemic IVD cells.…”

Section: Discussionmentioning

confidence: 99%

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Annulus fibrosus cell sheets limit disc degeneration in a rat annulus fibrosus injury model

et al. 2019

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In recent years, studies have explored novel approaches for cell transplantation to enable annulus fibrosus (AF) regeneration of the intervertebral disc in particular for lumbar disc herniation. Nevertheless, successful engraftment of cells is structurally challenging, and no definitive method has yet been established. This study investigated the potential of cell sheet technology to facilitate cell engraftment for AF repair. AF injury was induced by a 1 × 1 mm defect in rat tails after which AF cell sheets were transplanted. Its regenerative effects were compared to a nondegenerated and degeneration only conditions. Degenerative changes of the entire intervertebral disc were examined by disc height measurements, histology, and immunohistochemistry for 4‐, 8‐, and 12‐weeks post‐transplantation. Cell engraftment was confirmed by tracing PKH26 fluorescent dyed AF cells. In the transplant group, disc degeneration was significantly suppressed after 4, 8, and 12 weeks when compared with the degenerative group, as indicated by histological scoring and DHI observations. At 2 and 4 weeks after transplant, PKH26 positive cells could be detected in defect region and surrounding AF. The results suggest cell engraftment into AF tissue could be established by the cell sheet technology without additional scaffolding or adhesives. In short, AF cell sheets appear to be an effective and accessible tool for AF repair and to support intervertebral disc regeneration.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Annulus fibrosus cell sheets limit disc degeneration in a rat annulus fibrosus injury model

et al. 2019

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“…This study describes outcomes of the control group only, from a multicenter, prospective randomized trial of subjects that underwent microscopic limited lumbar discectomy (only the herniated part of the disc was removed) and were followed for 2 years [13]. This study retrospectively reviewed the prospective data to analyse the natural course of MC in serial imaging.…”

Section: Methodsmentioning

confidence: 99%

New insights into the natural course and clinical relevance of Modic changes over 2 years following lumbar limited discectomy: analysis of prospective collected data

et al. 2019

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Purpose Few retrospective studies have addressed Modic changes (MC) following lumbar spine surgery, though it is usually assumed that MC increase in grade and incidence. To test this conventional wisdom, we investigated the natural course of MC following primary lumbar limited discectomy with two-year follow-up. In addition, a possible clinical relevance to those changes was assessed. Methods The data of the control group (278 subjects) of a prospective randomized, controlled trial (RCT) were evaluated retrospectively. Results We did not observe a simple increase in MC with regard to grade. There is variable activity observed in Type 2 (at 12 months) and in Type 1 (at 24 months). Conversion from one grade to another may occur and may be upward or downward. The incidence of MC increased slightly over time, as after surgery a decreasing percentage of the study group remained without MC over two years (1 year: 34% (85/250); 2 years: 30% (72/237)). Radiological parameters (rotation, translation, and spondylolisthesis) had no significant correlation to MC or MC subtypes. Lastly, we found that neither the different MC types nor their changes were correlated with clinical parameters (VAS back, VAS leg, ODI score) preoperatively or during follow-up. Conclusion The pattern of Modic changes following lumbar limited discectomy is complex, not simply increasing. There is variable activity in MC Types 1 and 2 at the different time points of follow-up, and conversion from a higher grader to a lower one or vice versa is possible. Graphical abstractThese slides can be retrieved under Electronic Supplementary Material. Key points 1. Although Modic changes (MC) have widely investigated in conservative treatment, few retrospective studies have addressed Modic changes following lumbar spine surgery. 2. Usually it is assumed, that Modic changes should increase in quality and quantity.Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Affiliations

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“…For the generation of random sequences, seven articles provide computer-generated random numbers or similar methods. Only one article in randomization hiding provides specific details (NCT01283438), 16 and six articles indicate the use of random number table or other random allocation scheme, but did not provide details. Two articles mentioned the article used blind, 12,16 and the other five articles do not mentioned the blind method; all articles describe the number and reasons for withdrawal.…”

Section: Quality Assessmentmentioning

confidence: 99%

“…Six studies provided available data in reoperation rate. [12][13][14][15][16]18 There was no significant heterogeneity (P > 0.1, I 2 = 7%), the fixed effect model was used for analysis. The pooled outcomes demonstrated that a 1.74fold higher risk of reoperation rate in the AF unrepaired group than in the repair group [RR = 1.74, 95% CI (1.22, 2.49), P = 0.002; Fig.…”

Section: Reoperation Ratementioning

confidence: 99%

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

Bai

Shi

et al. 2020

Preprint

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ObjectiveTo investigate clinical effects of discectomy combined with annulus fibrosus (AF) repair for the treatment of lumbar disc herniation. MethodsWe searched PubMed, Embase, Web of science, CNKI and WanFang data for studies evaluating discectomy combined with AF repair and discectomy for the treatment lumbar disc herniation. Two reviewers selected studies, assessed quality and extracted data. This meta-analysis was performed to calculate weighted mean difference (WMD), risk ratios (RRs), and 95% confidence intervals (CIs). ResultsSeven randomized controlled trials (RCTs) were included in the meta-analysis. The pooled results suggested that the recurrence rate and reoperation rate in the non-repair group higher than those in the repair group [RR= 2.16, 95% confidence interval (CI) 1.50, 3.10], [RR=1.74, CI 1.22, 2.49], respectively. The rate of Visual analogue scale (VAS) relief in the repair group was significantly better than in non-repair group [WMD=0.22, CI 0.06, 0.37], and did not increase the incidence of postoperative complications. There were no significant differences between the two surgical procedures in the Oswestry disability index (ODI) reduction [WMD=0.36, CI -0.79, 1.50], intraoperative blood loss [WMD = -1.23, CI -4.46, 2.00] and the length of the surgical incision [WMD = 0.08, CI -0.01, 0.18]. However, the operation time of the repair group was slightly longer than nonrepair group [WMD =6.73, CI 2.80, 10.66]. ConclusionDiscectomy combined with AF repair is superior to discectomy regarding postoperative recurrence rate, reoperation rate and postoperative pain relief, but the operation time is slightly longer than the latter. There is no significant difference in intraoperative blood loss, length of surgical incision, postoperative complication rate and reduction in ODI between the two surgical procedures.

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Annular closure in lumbar microdiscectomy for prevention of reherniation: a randomized clinical trial

Cited by 76 publications

References 25 publications

Annulus fibrosus cell sheets limit disc degeneration in a rat annulus fibrosus injury model

Annulus fibrosus cell sheets limit disc degeneration in a rat annulus fibrosus injury model

New insights into the natural course and clinical relevance of Modic changes over 2 years following lumbar limited discectomy: analysis of prospective collected data

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

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