Trial reportActa neurochirurgica2019
Three-year results from a randomized trial of lumbar discectomy with annulus fibrosus occlusion in patients at high risk for reherniation.
Trial report in Acta neurochirurgica, 2019. 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 26 papers, 3 of them syntheses that pooled 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.
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.
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
Who cites it
26 citing papers in PubMed, 3 syntheses or guidelines pooled it, 42 citations in OpenAlex.
- Effectiveness of Microscopic Tubular Discectomy for Improved Pain and Mobility in Far Lateral Lumbar Disc Herniation: A Systematic Review.Orthopaedic surgery · 2025Pooled it
- Comparison of different treatments for lumbar disc herniation: a network meta-analysis and systematic review.BMC surgery · 2025Pooled it
- 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 · 2023Pooled it
- Risk factors for early reherniation after lumbar discectomy with or without annular closure: results of a multicenter randomized controlled study.Acta neurochirurgica · 2021Trial
- Prevalence of Symptomatic Reherniation After Lumbar Discectomy Using a Bone-Anchored Annular Closure Device and Associated Contributing Factors: A Meta-Analysis.Malaysian orthopaedic journal · 2026Article
- Mechanical and Biological Treatments for Annulus Fibrosus Repair and Closure: A Review of Clinical Studies.Neurospine · 2026Review
- ISASS Recommendations and Coverage Criteria for Bone-Anchored Annular Defect Closure Following Lumbar Discectomy: Coverage Indications, Limitations, and/or Medical Necessity-An ISASS 2025 Policy Update on the Use of Bone-Anchored Annular Closure to Prevent Reherniation in High-Risk Lumbar Discectomy Patients.International journal of spine surgery · 2025Article
- Bioactive Therapies for Degenerative Disc Disease: Current State of the Art and Clinical Applications.World neurosurgery · 2025Review
- Chitin nanocrystal-reinforced chitin/collagen composite hydrogels for annulus fibrosus repair after discectomy.Materials today. Bio · 2025Article
- Annulus Fibrosus Repair via Interpenetration of a Non-Woven Scaffold Supports Tissue Integration and Prevents Re-Herniation.JOR spine · 2025Article
- Bone anchoring annular suture technique for repairing annular defects at vertebral body edge following lumbar discectomy.Scientific reports · 2025Article
- Article
- Percutaneous endoscopic lumbar discectomy combined with platelet-rich plasma injection for lumbar disc herniation: analysis of clinical and imaging outcomes.BMC musculoskeletal disorders · 2024Article
- Decoding the annulus fibrosus cell atlas by scRNA-seq to develop an inducible composite hydrogel: A novel strategy for disc reconstruction.Bioactive materials · 2022Article
- Lumbar Intervertebral Disc Herniation: Annular Closure Devices and Key Design Requirements.Bioengineering (Basel, Switzerland) · 2022Review
- Effectiveness of an Annular Closure Device to Prevent Recurrent Lumbar Disc Herniation: A Secondary Analysis With 5 Years of Follow-up.JAMA network open · 2021Article
- Towards a More Simplified Approach for Evaluating Strength of Evidence in Health Technology Assessments.Cureus · 2021Article
- Intraoperative findings, complications, and short-term results after lumbar microdiscectomy with or without implantation of annular closure device.Acta neurochirurgica · 2021Article
- Incidence and clinical impact of vertebral endplate changes after limited lumbar microdiscectomy and implantation of a bone-anchored annular closure device.BMC surgery · 2021Article
- Annular closure device breakage due to recurrent lumbar disc herniation: a case report.Acta neurochirurgica · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 5 institutions in 4 countries.
Funding
Abstract
backgroundA larger defect in the annulus fibrosus following lumbar discectomy is a well-known risk factor for reherniation. Procedures intended to prevent reherniation by sealing or occluding the annular defect warrant study in high-risk patients. This study sought to determine 3-year results of lumbar discectomy with a bone-anchored annular closure device (ACD) or lumbar discectomy only (controls) in patients at high risk for reherniation.
methodsThis multicenter randomized trial enrolled patients with sciatica due to lumbar intervertebral disc herniation who failed conservative treatment. Patients with large annular defects after lumbar limited microdiscectomy were intraoperatively randomly assigned to receive ACD or control. Clinical and imaging follow-up was performed at routine intervals over 3 years. Main outcomes included rate of reherniations, reoperations, and endplate changes; leg and back pain scores on a visual analogue scale; Oswestry Disability Index (ODI); Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36; and adverse events adjudicated by a data safety monitoring board.
resultsAmong 554 randomized patients, the modified intent-to-treat population consisted of 272 patients in which ACD implantation was attempted and 278 receiving control; device implantation was not attempted in 4 patients assigned to ACD. Outcomes at 3 years favored ACD for symptomatic reherniation (14.8% vs. 29.5%; P < 0.001), reoperation (11.0% vs. 19.3%; P = 0.007), leg pain (21 vs. 30; P < 0.01), back pain (23 vs. 30; P = 0.01), ODI (18 vs. 23; P = 0.02), PCS (47 vs. 44; P < 0.01), and MCS (52 vs. 49; P < 0.01). The frequency of all-cause serious adverse events was comparable between groups (42.3% vs. 44.5%; P = 0.61).
conclusionsThe addition of a bone-anchored ACD in patients with large annular defects following lumbar discectomy reduces the risk of reherniation and reoperation, and has a similar safety profile over 3-year follow-up compared with lumbar limited discectomy only.
trial registrationClinicalTrials.gov NCT01283438.
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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.