Mechanical performance of lumbar intervertebral body fusion devices: An analysis of data submitted to the Food and Drug Administration

Peck, Jonathan; Kavlock, Katherine D.; Showalter, Brent L.; Ferrell, Brittany M.; Peck, Deepa G.; Dmitriev, Anton E.

doi:10.1016/j.jbiomech.2018.07.022

Cited by 41 publications

(17 citation statements)

References 15 publications

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“…In fact, initial sagittal deformity correction has been shown to decline over short-term follow-up. [18][19][20] The results of our study demonstrate significant superior immediate correction in SVA with interbody support. However, with longterm follow-up, we found no statistically significant difference in SVA between cohorts.…”

Section: Discussionmentioning

confidence: 82%

Does Interbody Support at L5-S1 Matter in Long Fusions to the Pelvis?

Lara

Chung

Lockwood

et al. 2021

Spine

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Study Design. Retrospective review of prospectively collected data. Objective. To determine if the addition of L5-S1 interbody support in long fusion deformity constructs is associated with superior long-term clinical and radiographic outcomes. To compare the 5-year clinical and radiographic outcomes and complications between long fusion constructs with L5-S1 interbody support versus posterolateral fusion (PLF) alone. Summary of Background Data. Cadaveric biomechanical studies have suggested that an interbody fusion at L5-S1 is beneficial in long fusion constructs with sacropelvic fixation. However, there is limited data reflecting the superiority of interbody support augmentation in optimizing arthrodesis and deformity correction relative to PLF alone. Methods. Eighty-eight consecutive adults with spinal deformity who underwent at minimum T11-pelvis posterior pedicle screw instrumentation with 5-year follow-up were included. Two cohorts were compared based on technique used at the lumbosacral junction (L5-S1): (A) no interbody (PLF; n ¼ 23), or (B) interbody support at L5-S1 (IB; n ¼ 65). Radiographic measurements and clinical outcome measures were compared at multiple time points. Complications were recorded and compared.Results. No differences in baseline patient characteristics between cohorts. One nonunion occurred at L5-S1 in the PLF group (P ¼ 0.091). Initial postop sagittal alignment was better in the IB group (PLF: 6.46 cm, IB: 2.48 cm, P ¼ 0.007); however, this was not maintained over long-term follow-up. No significant differences in proximal junctional kyphosis (PLF: 7/23, IB: 9/65, P ¼ 0.076). Proximal junctional failure was more frequent in the PLF group (PLF: 6/23, IB: 6/65, P ¼ 0.043). No significant differences in complications were found. Both cohorts had improvement from baseline pain and functional scores. Conclusion. There is no absolute long-term advantage for lumbar interbody support in adult spinal deformity patients undergoing spinal arthrodesis to the pelvis.

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Section: Discussionmentioning

confidence: 82%

Does Interbody Support at L5-S1 Matter in Long Fusions to the Pelvis?

Lara

Chung

Lockwood

et al. 2021

Spine

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“…A recent meta-analysis identified graft subsidence in up to 10% of patients who underwent LLIF, with a height loss of approximately 10% at one year postoperatively [2]. Biomechanical analysis, however, has suggested that LLIF grafts may be less prone to subsidence as compared to posterior or transforaminal LIF grafts due to their greater width and increased footprint in the interbody space [3]. The conforming nature of the expansile mesh portion of the Duo TM graft and the resultant wider graft footprint should, therefore, provide further protection from subsidence in our patient, who did, in fact, have durable symptom relief at one-year postoperatively.…”

Section: Discussionmentioning

confidence: 99%

Novel Application of a New Lateral System for Adjacent-level Revision Surgery: A Case Report

Kolcun

Brusko

Wang

2019

Cureus

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In recent years, lateral lumbar interbody fusion (LLIF) has grown in popularity as a minimally invasive spine surgery (MISS) approach that can be offered to patients with prior surgeries from a posterior approach. In this report, we present a patient with a focal disease and a history of multiple posterior lumbar surgeries who underwent LLIF with a novel application of the Duo TM system (Spineology Inc., MN, USA) adjacent to prior surgical levels and without posterior instrumentation. At one year postoperatively, she continued to have no back pain or complaints relating to her lumbar pathology. The case demonstrates the novel use of a new MISS LLIF system that requires minimal exposure as compared to current LLIF systems to treat a patient with adjacent segment disease and progressive symptoms following multiple posterior decompressive surgeries.

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“…Previously, a retrospective analysis of 510(k) submissions was conducted and mechanical performance of FDA‐cleared IBFDs were summarized 10,11 . In the current study, retrospective analysis of 510(k) submissions for IBFDs cleared by the FDA between 2013 and 2017 was performed and submissions containing FEA test reports were identified for further investigation.…”

Section: Methodsmentioning

confidence: 99%

Assessing the use of finite element analysis for mechanical performance evaluation of intervertebral body fusion devices

et al. 2021

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Background: Intervertebral body fusion devices (IBFDs) are a widely used type of spinal implant placed between two vertebral bodies to stabilize the spine for fusion in the treatment of spinal pathologies. Assessing mechanical performance of these devices is critical during the design, verification, and regulatory evaluation phases of development. While traditionally evaluated with physical bench testing, empirical assessments are at times supplemented with computational models and simulations such as finite element analysis (FEA). However, unlike many mechanical bench tests, FEA lacks standardized practices and consistency of implementation. Objectives: The objectives of this study were twofold. First, to identify IBFD 510(k) submissions containing FEA and conduct a comprehensive review of the elements provided in the FEA reports. Second, to engage with spinal device manufacturers through an anonymous survey and assess their practices for implementing FEA. Methods: First, a retrospective analysis of 510(k) submissions for IBFDs cleared by the FDA between 2013 and 2017 was performed. The contents of FEA test reports were quantified according to FDA guidance. Second, a survey inquiring about the use of FEA was distributed to industry and academic stakeholders. The survey asked up to 20 questions relating to modeler experience and modeling practices. Results: Significant gaps were present in model test reports that deemed the data unreliable and, therefore, unusable for regulatory decision-making in a high percentage of submissions. Nonetheless, the industry survey revealed most stakeholders employ FEA during device evaluation and are interested in more prescriptive guidelines for executing IBFD models. Conclusions: This study showed that while inconsistencies and gaps in FEA execution do exist within the spinal device community, the stakeholders are eager to work together in developing standardized approaches for executing computational models to support mechanical performance assessment of spinal devices in regulatory submissions.

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Mechanical performance of lumbar intervertebral body fusion devices: An analysis of data submitted to the Food and Drug Administration

Cited by 41 publications

References 15 publications

Does Interbody Support at L5-S1 Matter in Long Fusions to the Pelvis?

Does Interbody Support at L5-S1 Matter in Long Fusions to the Pelvis?

Novel Application of a New Lateral System for Adjacent-level Revision Surgery: A Case Report

Assessing the use of finite element analysis for mechanical performance evaluation of intervertebral body fusion devices

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