Comparative analysis of international standards for the fatigue testing of posterior spinal fixation systems: the importance of preload in ISO 12189

Barbera, Luigi La; Ottardi, Claudia; Villa, Tomaso

doi:10.1016/j.spinee.2015.07.461

Cited by 25 publications

(40 citation statements)

References 11 publications

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“…As regard the anterior column stiffness, few studies have investigated its contribution to the human spine in vitro [19], in vivo [20] and in silico using FE models [9,10,25,32]. Additionally, despite only La Barbera and colleagues [9,10] performed a direct comparison between the current standards and more realistic spine segments, their models hardly reproduce the loading conditions met during simple everyday life activities.…”

Section: Discussionmentioning

confidence: 99%

“…Additionally, despite only La Barbera and colleagues [9,10] performed a direct comparison between the current standards and more realistic spine segments, their models hardly reproduce the loading conditions met during simple everyday life activities.…”

Section: Discussionmentioning

confidence: 99%

“…A simple vertical load up to 2000 N was applied on each standard construct following the procedure described in [9,25]. Contacts condition between springs and blocks were defined, according to [9,26].…”

Section: Fe Models Of Current Standardsmentioning

confidence: 99%

“…Moreover, to the author's knowledge, few efforts have been made up to now to ensure that the internal loads applied to the implant during testing are representative of the in vivo clinical use [4,9,10].…”

Section: Introductionmentioning

confidence: 99%

“…stress and strain field in every component) and being more reliable, over the experimental strain-gauge approach which may be affected by significant inaccuracies and lack in repeatability [9].…”

Section: Introductionmentioning

confidence: 99%

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Preclinical evaluation of posterior spine stabilization devices: can the current standards represent basic everyday life activities?

Barbera

Galbusera

Wilke³

et al. 2016

Eur Spine J

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Fe Models Of Current Standardsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Preclinical evaluation of posterior spine stabilization devices: can the current standards represent basic everyday life activities?

Barbera

Galbusera

Wilke³

et al. 2016

Eur Spine J

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Clinically relevant finite element technique based protocol to evaluate growing rods for early onset scoliosis correction

et al. 2020

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Objective: The emergence of distraction-based growing rods has provided the means to reduce the progression of spinal deformity in early onset scoliosis (EOS). The current protocols for evaluating spinal implants (ie, ASTM-F1717 and ISO-12189) were developed for fusion/ dynamic devices. These protocols do not feature long unsupported rod lengths subjected to distraction. Due to the unsuitability of the existing guidelines for the evaluation of growing rods, a new distraction-based finite element protocol is presented herein for the first time. Method: A vertebrectomy (VO) model from current protocols was modified to accommodate multi-spinal segments (ie, MS model) in which springs with appropriate stiffness were simulated in between the plastic blocks. To assess the efficacy of the protocol, two different computational studies were conducted: (a) compression-bending (MS-CB) with no distraction, and (b) distraction followed by compression-bending (MS-D + CB). In each study, the model with no axial connector (rods-only) was modified to include a) 80-mm long tandem (LT) connectors, and b) side-by-side (SBS) connectors. Stiffness and yield loads were calculated as per ASTM-F1717 guidelines and compared with the corresponding VO models with no distraction. In the MS-D + CB models, distraction was applied at the top block, stretching the spring-block construct in a simulation of scoliosis surgery prior to locking the construct at the connector-rods' interface. Results: MS-CB models predicted higher stiffness and yield loads, compared to the VO models. The locking mechanism produced pre-existing stresses on the rod-connector interface, which caused a shift in the location of high-stress regions to the distraction site. Distraction led to a decrease in the construct's stiffness and yield load. Discussion: The proposed protocol enables the simulation of clinical parameters that are not feasible in the F1717 models and predicted stress patterns in the hardware consistent with observed clinical failures.

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Design Rationale for Posterior Dynamic Stabilization Relevant for Spine Surgery

Khandha¹,

Serhan²,

Goel³

2020

Handbook of Spine Technology

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Comparative analysis of international standards for the fatigue testing of posterior spinal fixation systems: the importance of preload in ISO 12189

Cited by 25 publications

References 11 publications

Preclinical evaluation of posterior spine stabilization devices: can the current standards represent basic everyday life activities?

Preclinical evaluation of posterior spine stabilization devices: can the current standards represent basic everyday life activities?

Clinically relevant finite element technique based protocol to evaluate growing rods for early onset scoliosis correction

Design Rationale for Posterior Dynamic Stabilization Relevant for Spine Surgery

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