Trial reportMedicine2019
Lumbar disc reherniation prevention with a bone-anchored annular closure device: 1-year results of a randomized trial.
Trial report in Medicine, 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 12 papers, 1 of them a synthesis 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
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.
- 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
- A new hernia blocking system to prevent recurrent lumbar disc herniation: surgical technique, intraoperative findings and six-months post-operative outcomes.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 · 2025Trial
- 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
- Lumbar disc herniation: Prevention and treatment of recurrence: WFNS spine committee recommendations.World neurosurgery: X · 2024Review
- Lumbar Discectomy With Bone-Anchored Annular Closure Device in Patients With Large Annular Defects: One-Year Results.Cureus · 2023Article
- Complications associated with lumbar discectomy surgical techniques: a systematic review.Journal of spine surgery (Hong Kong) · 2022Review
- Is surgery for recurrent lumbar disc herniation worthwhile or futile? A single center observational study with patient reported outcomes.Brain & spine · 2022Article
- Article
- 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
- Adverse events associated with the Barricaid annular closure device: An analysis of the FDA MAUDE Database.Journal of craniovertebral junction & spineArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe risk of recurrent herniation after lumbar discectomy is highest during the first postoperative year. The purpose of this study was to determine whether implantation of a bone-anchored annular closure device (ACD) following limited lumbar discectomy reduced the risk of recurrent herniation and complications during the first year of follow-up compared to limited lumbar discectomy alone (Controls) and whether this risk was influenced by patient characteristics.
methodsIn this randomized multicenter trial, patients with symptomatic lumbar disc herniation and with a large annular defect following limited lumbar discectomy were randomized to bone-anchored ACD or Control groups. The risks of symptomatic reherniation, reoperation, and device- or procedure-related serious adverse events were reported over 1 year of follow-up.
resultsAmong 554 patients (ACD 276; Control 278), 94% returned for 1-year follow-up. Bone-anchored ACD resulted in lower risks of symptomatic reherniation (8.4% vs. 17.3%, P = .002) and reoperation (6.7% vs. 12.9%, P = .015) versus Controls. Device- or procedure-related serious adverse events through 1 year were reported in 7.1% of ACD patients and 13.9% of Controls (P = .009). No baseline patient characteristic significantly influenced these risks.
conclusionsAmong patients with large annular defects following limited lumbar discectomy, additional implantation with a bone-anchored ACD lowered the risk of symptomatic reherniation and reoperation over 1 year follow-up. Device- or procedure-related serious adverse events occurred less frequently in the ACD group. These conclusions were not influenced by patient characteristics. ClinicalTrials.gov (NCT01283438).
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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.