ArticleEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2019
Material failure in dynamic spine implants: are the standardized implant tests before market launch sufficient?
Article 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, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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.
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Who cites it
4 citing papers in PubMed, 4 citations in OpenAlex.
- From Concept to Clinic: Pre-Clinical Testing and Regulatory Considerations in Spine Implant Development.JOR spine · 2026Review
- A Review of Finite Element Analysis in Spine Surgery Decision-Making.Journal of clinical medicine · 2026Review
- Three-Dimensional Printing of a Spinal Interbody: Design Principles, Biomaterials, and Translational Considerations.Journal of functional biomaterials · 2026Review
- How to improve the mechanical safety of a novel spinal implant while saving costs and time.JOR spine · 2024Review
Corrections and comments
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Authors and funding
7 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeInternational Standards Organization (ISO) 12189 and American Society for Testing and Materials F2624 are two standard material specification and test methods for spinal implant devices. The aim of this study was to assess whether the existing and required tests before market launch are sufficient.
methodsIn three prospective studies, patients were treated due to degenerative disease of the lumbar spine or spondylolisthesis with lumbar interbody fusion and dynamic stabilization of the cranial adjacent level. The CD HORIZON BalanC rod and S
resultsA fatigue fracture of the material of the topping off system has been found in five cases (11%) for the group fitted with the CD HORIZON BalanC rod. In the group using the S
conclusionSpinal implants have to be checked by a notified body before market launch. The notified body verifies whether the implants fulfil the requirements of the current standards. These declared studies suggest that the current standards for the testing of load bearing capacity and stand ability of dynamic spine implants might be insufficient. Revised standards depicting sufficient deformation and load pattern have to be developed and counted as a requirement for the market launch of an implant. These slides can be retrieved under Electronic Supplementary Material.
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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.