Evidence map›Paper›PMID 33085021›Full record

Trial reportActa neurochirurgica2021

Risk factors for early reherniation after lumbar discectomy with or without annular closure: results of a multicenter randomized controlled study.

Jenny C Kienzler, Javier Fandino, Erik Van de Kelft, Sandro Eustacchio, Gerrit Joan Bouma, Barricaid® Annular Closure RCT Study Group

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Acta neurochirurgica, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01283438 (A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid® to Discectomy for Primary Lumbar Disc Herniation), which is not on this map. Cited by 11 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 3 pooled it
2.3field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01283438 phase4unknown statusnot on this map

A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid® to Discectomy for Primary Lumbar Disc Herniation: Extended Follow-Up of the Barricaid® Annular Closure Device (ACD) Randomized Control Trial (RCT) Postmarket Cohort for Lumbar Disc Herniation and Interaction With Other Risk Factors

TypeinterventionalSponsorIntrinsic TherapeuticsRan2010 to 2025Enrolled554ConditionsLumbar Disc HerniationArmsBarricaid, Standard of Care
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 3 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. The effectiveness and safety of annulus closure device implantation in lumbar discectomy for patients with lumbar disc herniation: a systematic review and meta-analysis.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2023
    Pooled it
  3. Pooled it
  4. Review
  5. Article
  6. Annular Closure Device Reduces Symptomatic Reherniation Rates: Results of a Meta-analysis.HSS journal : the musculoskeletal journal of Hospital for Special Surgery · 2025
    Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 4 countries.

Jenny C KienzlerDepartment of Neurosurgery, Kantonsspital Aarau, Tellstrasse, 5001, Aarau, Switzerland.
Javier FandinoDepartment of Neurosurgery, Kantonsspital Aarau, Tellstrasse, 5001, Aarau, Switzerland. fandino@neurochirurgie-ag.ch.ORCID http://orcid.org/0000-0002-5375-3087
Erik Van de KelftDepartment of Neurosurgery, AZ Nikolaas, Sint-Niklaas and Faculty of Medicine and Health Sciences, University of Antwerp, Antwerpen, Belgium.
Sandro EustacchioDepartment of Neurosurgery, University Hospital Graz, Graz, Austria.
Gerrit Joan BoumaDepartment of Neurosurgery, OLVG Locatie West, Amsterdam, The Netherlands.
Barricaid® Annular Closure RCT Study Group
Kantonsspital Aarau · CHGraz University Hospital · ATOLVG · NLUniversity of Antwerp · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundReherniation after lumbar discectomy is classified as a failure and occurs in 3 to 18% of cases. Various risk factors for reherniation such as age, sex, body mass index, smoking, and size of annular defect have been reported. The aim of this study was to identify risk factors for early reherniation after one-level lumbar discectomy with or without annular closure within 3 months after surgery.

methodsThis study is based on data analysis of a prospective, 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).

resultsFour (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.

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

trial registrationClinicaltrials.gov NCT01283438.

Indexed as

DiskectomyFemaleHumansIntervertebral Disc DegenerationIntervertebral Disc DisplacementLumbar VertebraeMaleMiddle AgedPostoperative ComplicationsReoperationRisk FactorsAnnular closure deviceAnnulus fibrosusDisc herniationLumbar discectomyReherniationRisk factors

Identifiers

PMID33085021
OpenAlexW3094324363

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.