ArticleInternational journal of spine surgery2020
Critical Evaluation of Biomechanical Principles and Radiographic Indicators for Fusion Assessment in a Novel Conformable Porous Mesh Implant.
Article in International journal of spine surgery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 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
2 citing papers in PubMed.
- Mechanical performance of porous biomimetic intervertebral body fusion devices: an in vitro biomechanical study.Journal of orthopaedic surgery and research · 2023Article
- Two-Year Outcomes From a Prospective Multicenter Investigation Device Trial of a Novel Conformal Mesh Interbody Fusion Device.International journal of spine surgery · 2021Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe objectives of this paper were to identify and explain specific design factors for lumbar interbody fusion (IBF) devices that can influence bone exchange and stability at the vertebral endplate interface and to provide supporting evidence of these factors through both laboratory and clinical data. The laboratory study (Part 1) compared the pressure profiles and contact areas for a minimally invasive, expandable, and conformable porous mesh (CPM) IBF device and a rigid monolithic lateral PEEK cage (LPC). Furthermore, to demonstrate how these laboratory results translate clinically, a quantitative and qualitative assessment of subject x-rays and computed tomography (CT) scans from a US Food and Drug Administration (FDA) investigational device exemption (IDE) trial of the CPM was performed (Part 2).
methods
resultsCPM demonstrated significant direct loading on the bone graft across all tested loading conditions, while the LPC graft registered a negligible amount of pressure at only the extreme load of 3000 N. Contact area was in turn statistically greater (
conclusionsCPM allows for an optimized contact area for bone exchange and graft incorporation. The load profiles demonstrate widespread load sharing across the device. The expandable, compliant, porous mesh provides a unique area for bone exchange, contributing to qualitative biomechanical radiographic evidence of bone healing that ultimately leads to clinically acceptable fusion rates as observed in the FDA IDE trial.
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Registered trials
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