Trial reportEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2020
Two-level ACDF with a zero-profile stand-alone spacer compared to conventional plating: a prospective randomized single-center study.
Trial report in 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, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 3 of them syntheses that pooled it.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 3 syntheses or guidelines pooled it, 25 citations in OpenAlex.
- Zero-profile anchored spacer versus conventional plate-cage construct in bilevel anterior cervical discectomy and fusion: a systematic review and meta-analysis.Journal of orthopaedic surgery and research · 2023Pooled it
- Comparison of outcomes between Zero-p implant and anterior cervical plate interbody fusion systems for anterior cervical decompression and fusion: a systematic review and meta-analysis of randomized controlled trials.Journal of orthopaedic surgery and research · 2022Pooled it
- Anterior Cervical Discectomy and Fusion Using Zero-P System for Treatment of Cervical Spondylosis: A Meta-Analysis.Pain research & managementPooled it
- Zero-profile interbody fusion in single and two-level anterior cervical discectomy and fusion: a novel surgical system and its indications.Journal of spine surgery (Hong Kong) · 2026Article
- Biomechanical effect of cage size in single-level anterior cervical discectomy and fusion: a finite element analysis.BMC musculoskeletal disorders · 2025Article
- Three-Dimensional Printed Anterior Cervical Standalone Combined Cage-Plate-300 Consecutive Medical Implants.Journal of the American Academy of Orthopaedic Surgeons. Global research & reviews · 2025Article
- A retrospective comparative analysis of anterior cervical discectomy and fusion using stand-alone titanium cage versus cage and plate fixation in two-level cervical disc herniation.Journal of orthopaedic surgery and research · 2025Article
- Article
- [Comparison of effectiveness between zero-profile anchored cage and plate-cage construct in treatment of consecutive three-level cervical spondylosis].Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery · 2025Article
- Does the Angulation of the Screws in the Zero-P Implant Affect the Clinical and Radiological Outcomes of Patients?Orthopaedic surgery · 2024Article
- Review
- Clinical and radiographic outcomes after index anterior cervical discectomy and fusion with interbody spacer with integrated anchor fixation: a single-surgeon case study.Journal of spine surgery (Hong Kong) · 2024Article
- Review
- Evaluation of outcome measures for post-operative dysphagia after anterior cervical discectomy and fusion.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2023Review
- Article
- Clinical and imaging outcomes of self-locking stand-alone cages and anterior cage-with-plate in three-level anterior cervical discectomy and fusion: a retrospective comparative study.Journal of orthopaedic surgery and research · 2023Article
- Biomechanical evaluation of a novel individualized zero-profile cage for anterior cervical discectomy and fusion: a finite element analysis.Frontiers in bioengineering and biotechnology · 2023Article
- Follow-up of a new titanium cervical plate for fusion of the cervical spine.Orthopedic reviews · 2023Article
- Clinical and radiological comparison of the zero-profile anchored cage and traditional cage-plate fixation in single-level anterior cervical discectomy and fusion.European journal of medical research · 2022Article
- 2-Level Anterior Cervical Arthrodesis With Integrated Spacer and Plate vs Traditional Anterior Spacer and Plate System.International journal of spine surgery · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeStand-alone zero-profile devices have already proven safety, and a reduced dysphagia rate was assumed. So far, no level-one evidence is available to prove the proposed advantages of zero-profile implants in multilevel procedures. The aim of this RCT was to compare the clinical and radiological outcome of a zero-profile spacer versus cage + plate in two-level ACDF.
methodsConsecutive patients with contiguous two-level cDD were randomly assigned either to the interventional group (zero-profile device) or to the control group (cage + plate). Primary endpoint of the study was the prevalence of dysphagia at 24 months. Disability, progress of adjacent segment degeneration, fusion status and loss of correction were analyzed as secondary outcome measure. Primary outcome parameter was statistically analyzed by Chi-square test.
resultsForty-one patients met inclusion criteria and were randomly assigned to the interventional and the control group. Dysphagia was frequent in either group at 3 months FU favoring interventional group (p = 0.078). At final FU, less patients of the interventional group complained about dysphagia, but the difference was not significant. No relevant differences at final FU were recorded for NPDI, loss of correction and adjacent-level degeneration. Fusion rate was slightly lower in the interventional group. DISCUSSION: Two-level ACDF either by a stand-alone zero-profile spacer or cage + plate is safe. Using a zero-profile cage dysphagia was infrequent at 24 months, but the value did not reach statistical significance in comparison with the cage + plate. Hence, this randomized trial was not able to prove the proposed clinical superiority for dysphagia rates for zero-profile anchored spacer in two-level cDD.
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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.