From ideas to long-term studies: 3D printing clinical trials review

Witowski, Jan; Sitkowski, Mateusz; Zuzak, Tomasz; Coles‐Black, Jasamine; Chuen, Jason; Major, Piotr; Pdziwiatr, Michał

doi:10.1007/s11548-018-1793-8

Cited by 48 publications

(32 citation statements)

References 20 publications

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“…According to IDEAL framework (framework describing the stages of innovation in surgery), we are leaving development and exploration phases and starting the assessment and long-term studies (28,29). It can be expected that by 2020-2022 a number of studies will discuss clinical utility and impact on perioperative outcomes (30).…”

Section: Discussionmentioning

confidence: 99%

Investigating accuracy of 3D printed liver models with computed tomography

Witowski

Wake

Grochowska

et al. 2019

Quant. Imaging Med. Surg

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Background: The aim of this study was to evaluate the accuracy of three-dimensional (3D) printed liver models developed by a cost-effective approach for establishing validity of using these models in a clinical setting.Methods: Fifteen patients undergoing laparoscopic liver resection in a single surgical department were included. Patient-specific, 1-1 scale 3D printed liver models including the liver, tumor, and vasculature were created from contrast-enhanced computed tomography (CT) images using a cost-effective approach. The 3D models were subsequently CT scanned, 3D image post-processing was performed, and these 3D computer models (MCT) were compared to the original 3D models created from the original patient images (PCT).3D computer models of each type were co-registered using a point set registration method. 3D volume measurements of the liver and lesions were calculated and compared for each set. In addition, Hausdorff distances were calculated and surface quality was compared by generated heatmaps. Results:The median liver volume in MCT was 1,281.84 [interquartile range (IQR) =296.86] cm 3 , and 1,448.03 (IQR =413.23) cm 3 in PCT. Analysis of differences between surfaces showed that the median value of mean Hausdorff distances for liver parenchyma was 1.92 mm. Bland-Altman plots revealed no significant bias in liver volume and diameters of hepatic veins and tumor location. Median errors of all measured vessel diameters were smaller than CT slice height. There was a slight trend towards undersizing anatomical structures, although those errors are most likely due to source imaging. Conclusions:We have confirmed the accuracy of 3D printed liver models created by using the low-cost method. 3D models are useful tools for pre-operative planning and intra-operative guidance. Future research in this field should continue to move towards clinical trials for assessment of the impact of these models on pre-surgical planning decisions and perioperative outcomes.

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Section: Discussionmentioning

confidence: 99%

Investigating accuracy of 3D printed liver models with computed tomography

Witowski

Wake

Grochowska

et al. 2019

Quant. Imaging Med. Surg

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“…Predictive validity is a much more objective and desirable goal, and involves an assessment of patient outcomes ( 44 ) as a result of the simulation. As previously discussed, there are clinical trials underway exploring if 3D printed anatomical models for presurgical planning do indeed improve patient outcomes ( 1 ), but none on the topic of endovascular intervention.…”

Section: Discussionmentioning

confidence: 99%

“…3D printing is anticipated to represent the next step in personalized medicine. Despite the nascence of the technology, its utility as a tool in presurgical planning and intraoperative visualization is currently being examined via clinical trials ( 1 ). In addition, its potential in other settings is being explored, such as for patient education and engagement and trainee education.…”

Section: Introductionmentioning

confidence: 99%

Accessing 3D Printed Vascular Phantoms for Procedural Simulation

2021

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Introduction: 3D printed patient-specific vascular phantoms provide superior anatomical insights for simulating complex endovascular procedures. Currently, lack of exposure to the technology poses a barrier for adoption. We offer an accessible, low-cost guide to producing vascular anatomical models using routine CT angiography, open source software packages and a variety of 3D printing technologies.Methods: Although applicable to all vascular territories, we illustrate our methodology using Abdominal Aortic Aneurysms (AAAs) due to the strong interest in this area. CT aortograms acquired as part of routine care were converted to representative patient-specific 3D models, and then printed using a variety of 3D printing technologies to assess their material suitability as aortic phantoms. Depending on the technology, phantoms cost $20–$1,000 and were produced in 12–48 h. This technique was used to generate hollow 3D printed thoracoabdominal aortas visible under fluoroscopy.Results: 3D printed AAA phantoms were a valuable addition to standard CT angiogram reconstructions in the simulation of complex cases, such as short or very angulated necks, or for positioning fenestrations in juxtarenal aneurysms. Hollow flexible models were particularly useful for device selection and in planning of fenestrated EVAR. In addition, these models have demonstrated utility other settings, such as patient education and engagement, and trainee and anatomical education. Further study is required to establish a material with optimal cost, haptic and fluoroscopic fidelity.Conclusion: We share our experiences and methodology for developing inexpensive 3D printed vascular phantoms which despite material limitations, successfully mimic the procedural challenges encountered during live endovascular surgery. As the technology continues to improve, 3D printed vascular phantoms have the potential to disrupt how endovascular procedures are planned and taught.

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“…The existing AM processes are classified into seven main categories: binder jetting; directed energy deposition; material extrusion; material jetting; powder bed fusion; sheet lamination; and vat photopolymerization [3]. Within these AM categories, the most used AM systems in the biomedical industry are stereolithography, selective laser sintering, Inkjet 3D printing, electron beam melting, polyjet photopolymer, and fused deposition modeling [4,5], especially in orthopedics, dentistry, and maxillofacial surgery [6,7].…”

Section: Introductionmentioning

confidence: 99%

Development of 18 Quality Control Gates for Additive Manufacturing of Error Free Patient-Specific Implants

et al. 2019

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Unlike subtractive manufacturing technologies, additive manufacturing (AM) can fabricate complex shapes from the macro to the micro scale, thereby allowing the design of patient-specific implants following a biomimetic approach for the reconstruction of complex bone configurations. Nevertheless, factors such as high design variability and changeable customer needs are re-shaping current medical standards and quality control strategies in this sector. Such factors necessitate the urgent formulation of comprehensive AM quality control procedures. To address this need, this study explored and reported on a variety of aspects related to the production and the quality control of additively manufactured patient-specific implants in three different AM companies. The research goal was to develop an integrated quality control procedure based on the synthesis and the adaptation of the best quality control practices with the three examined companies and/or reported in literature. The study resulted in the development of an integrated quality control procedure consisting of 18 distinct gates based on the best identified industry practices and reported literature such as the Food and Drug Administration (FDA) guideline for AM medical devices and American Society for Testing and Materials (ASTM) standards, to name a few. This integrated quality control procedure for patient-specific implants seeks to prepare the AM industry for the inevitable future tightening in related medical regulations. Moreover, this study revealed some critical success factors for companies developing additively manufactured patient-specific implants, including ongoing research and development (R&D) investment, investment in advanced technologies for controlling quality, and fostering a quality improvement organizational culture.

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From ideas to long-term studies: 3D printing clinical trials review

Cited by 48 publications

References 20 publications

Investigating accuracy of 3D printed liver models with computed tomography

Investigating accuracy of 3D printed liver models with computed tomography

Accessing 3D Printed Vascular Phantoms for Procedural Simulation

Development of 18 Quality Control Gates for Additive Manufacturing of Error Free Patient-Specific Implants

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