Shape accuracy of an acrylonitrile butadiene styrene canine tibia model fabricated using fused deposition modelling and the effects of hydrogen peroxide gas plasma sterilisation

doi:10.21203/rs.3.rs-35517/v1

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Research article

Shape accuracy of an acrylonitrile butadiene styrene canine tibia model fabricated using fused deposition modelling and the effects of hydrogen peroxide gas plasma sterilisation

https://doi.org/10.21203/rs.3.rs-35517/v1

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Background

Three-dimensional (3D) printing techniques have been used for anatomical models and surgical guiding instruments in orthopaedic surgery. The accuracy of these surgical guiding tools is important for obtaining good clinical outcomes. This study assessed the shape accuracy of an acrylonitrile butadiene styrene (ABS) canine tibia model printed using fused deposition modelling (FDM) and evaluated its morphological change after hydrogen peroxide (H₂O₂) gas plasma sterilisation. The tibias of six canine cadavers underwent computed tomography for 3D reconstruction. Tibia models were fabricated from ABS on a 3D printer through FDM. Reverse-engineering technology was used to compare morphological errors (root mean square; RMS) between the 3D-FDM models and virtual models segmented from original tibia images (3D-CT) and between the models sterilised with H₂O₂ gas plasma (3D-GAS) and 3D-FDM models on tibia surface and in cross-sections at: 5%, 15%, 25%, 50%, 75%, 85%, and 95% of the tibia length.

Results

The RMS mean ± standard deviation and average positive and negative deviation values for all specimens in G1 (3D-FDM vs. 3D-CT) were significantly higher than those in G2 (3D-GAS vs. 3D-FDM; P < 0.0001). Mean RMS values for G1 at 5% bone length (proximal tibia) were significantly higher than those at the other six cross-sections (P < 0.0001). Mean RMS differences for G2 at all seven cross-sections were nonsignificant.

Conclusions

Our tibia model fabricated on an FDM printer had high shape accuracy with a low RMS value. The surface deviation in G1 indicated that larger errors occurred during manufacturing than during sterilisation. Therefore, the model may be clinically acceptable for bone surgery and surgical rehearsal.

Large Animal Medicine

Small Animal Medicine

Fused deposition modelling

Long bone model

Sterilisation

Surgical guide

Three-dimensional printing

Three-dimensional (3D) printing techniques have been used extensively for anatomical models, presurgical planning, surgical guiding instruments, custom-made implants, and client communication in human medicine, particularly in orthopaedic, facial reconstructive, spinal, and dental surgery [1–3]. Presurgical planning using 3D-printing anatomical models has been adopted in veterinary medicine [4–6] and related research [7, 8], particularly in orthopaedic surgery, thus improving surgeon confidence and reducing surgical time, the occurrence of surgical complications, and surgeons’ exposure to radiation [4, 6, 8]. These studies have indicated that 3D-printed models are beneficial when used for managing complex cases and when used by inexperienced surgeons [4, 6, 9]. Additionally, 3D-printed bone models are suitable for presurgical rehearsals of plate contouring, osteotomy, and the design of surgical guides [4, 6, 7, 9]. The accuracy of anatomical models and surgical guides is crucial for achieving favourable clinical outcomes and model advantages. However, in veterinary orthopaedics, only three studies have evaluated the linear deviation of 3D-printed long-bone models [10–12]. Moreover, the shape accuracy of 3D-printed long bones, which is crucial for bone-plate contouring and the design of patient-specific surgical guides, has not been evaluated.

The majority of commercially available desktop printers for rapid prototyping, known as fused deposition modelling (FDM) printers, have the advantage of using a low-cost thermoplastic filament, such as acrylonitrile butadiene styrene (ABS). They are also easy to use and suitable for offices, and they provide prints with a similar accuracy to that of industrial printers [13, 14]. Consumer-grade FDM printers have been used in some studies to produce inexpensive maxillofacial and long-bone models in an office setting [11, 12]. Other studies have demonstrated that 3D-printing patient-specific guides is a safe, promising, and affordable method that achieves satisfactory clinical outcomes [15, 16]. Given the low melting point of plastic filament and its intraoperative usage, the sterilisation of plastic models using an autoclave has been suggested [3, 12]; however, other studies have demonstrated deformation of plastic models after steaming [17–19] or alteration to their mechanical strength after gas plasma sterilisation [20]. This evidence suggests such plastic filaments are problematic since they are sensitive to conventional thermal steam sterilisation. However, little is known regarding the accuracy and morphological changes of these plastic bone models after sterilisation. Because this is a new field, further research is warranted [1].

Designing patient-specific surgical tools for canine tibial plateau levelling osteotomy (TPLO), including 3D-printed tibias and bone-cutting instruments, is our field of interest in veterinary medicine. Tibial bone–surface curvature is critical for plate implantation and design of bone-cutting instruments. To the best of our knowledge, no data are currently available regarding the effects of low-temperature sterilisation on the surface accuracy of 3D-printed ABS canine tibias manufactured using FDM. Therefore, an accurate 3D plastic model is crucial for preoperative planning and intraoperative applications, and the extent of plastic model deformation after sterilisation should be evaluated. We focused on hydrogen peroxide (H₂O₂) low-temperature sterilisation, which is suitable for surgical instruments that are sensitive to heat and moisture [21].

The objectives of this study were (1) to compare the shape accuracy of an ABS tibia model 3D printed using FDM with that of a 3D tibia model derived using computed tomography (CT) and (2) to evaluate the possible shape change of the 3D ABS tibia model after sterilisation with H₂O₂ gas plasma.

Shape deviation of the whole-tibia model

Tables 1 and 2 provide the superimposition results of the RMS values for 12 tibias in the two comparison groups: G1 (3D-FDM vs. 3D-CT) and G2 (3D-GAS vs. 3D-FDM). The RMS mean ± standard deviation and average positive and negative deviation values for all specimens in G1 (0.1214 ± 0.0185 mm, 0.0973 ± 0.0182 mm, and − 0.0737 ± 0.0170 mm, respectively) were significantly higher than those in G2 (0.0431 ± 0.0248 mm, 0.0234 ± 0.0162 mm, and − 0.0258 ± 0.0196 mm, P < 0.0001, respectively; Table 3, Fig. 2). These results indicate that the difference that occurred during 3D printing was significantly larger than the deviation that occurred after H₂O₂ plasma sterilisation. Therefore, the change due to H₂O₂ plasma sterilisation was sufficiently small to disregard.

Cross-sectional profile deviation of the tibia model

Figure 1 is a graph of the G1 and G2 cross-sectional profiles at 5% of the total tibia length. Additionally, the mean RMS values of G1 at 5% of the total bone length (0.3025 ± 0.2159 mm) were significantly higher than those at the other six cross-sections (15%: 0.0863 ± 0.0227 mm; 25%: 0.0645 ± 0.0186 mm; 50%: 0.1313 ± 0 .0449 mm; 75%: 0.1307 ± 0.0385 mm; 85%: 0.1020 ± 0.0353 mm; and 95%: 0.1288 ± 0.0674 mm; P < 0.0001). The differences in mean RMS values of G2 at all seven cross-sections were nonsignificant (Table 3, Figs. 3 and 4). The deviation at the proximal tibia (5%) with high curvature increased noticeably during 3D printing. Moreover, no regional deviation was observed in the tibia model after H₂O₂ plasma sterilisation.

Some surgical studies have reported the application of 3D plastic models as surgical guides for intraoperative use [5, 6, 9, 16]. Moreover, the shape accuracy of surgical guides is critical during surgery. Our tibia model had high bone-surface accuracy, which is beneficial for bone-plate contouring and presurgical rehearsal. Additionally, the surface curvature of the ABS 3D-printed tibia model was preserved without significant changes after gas plasma sterilisation, indicating the possible clinical use of our model as a guide during surgery.

Our tibia model fabricated using an FDM printer and measured using a 3D point cloud had high shape accuracy with a lower mean RMS value (G1: 0.1214 mm) than those of previous studies performing linear RMS measurements on the basis of two-dimensional CT images obtained from 3D plastic long-bone models; these studies have reported RMS values of 0.40 mm [11] and < 1 mm [12]. Another study reported that a human mandible model had an absolute mean surface deviation of 0.159 mm [13], which is consistent with our observations. Furthermore, two studies that evaluated human long-bone models revealed that the largest deviation errors occurred in the bone epiphyses with high curvatures [22, 23]. This was observed in our G1 group; the curvature difference of the cross-section at the proximal tibia (5%) was significantly larger than that of the other cross-sections. Similarly, the curvature variations at 15% (0.0863 mm) and 25% (0.0645 mm) of the total tibia length in G1 were smaller than those in the other sections (Table 3). These variations may have occurred because the tibia shape at the proximal-medial site was relatively flat. Additionally, the small RMS error may be related to the 3D-printing build orientation with a 90° build angle and thick support structure [24, 25]. Our tibia models were printed with the long-bone axis parallel to the printer surface and the proximal-medial side facing up with a substantial support structure underneath. These results indicate that the data acquisition method, bone size and shape, manufacturing process, and material could have influenced the accuracy of the final model.

Steam heat, dry heat, H₂O₂ gas plasma, and ethylene oxide gas sterilisation are used to sterilise plastic surgical models at clinics [1, 5]. Shape deviation of sterilised FDM products made of ABS was mentioned in only one study [19]. Uniform rectangular samples sterilised in an autoclave that used steam heat deformed significantly (> 10 mm), and deformations could be observed by the naked eye. However, the average shape deviation of samples after H₂O₂ gas plasma sterilisation was 0.036 mm [19], which is similar to our observation in G2 (0.043 mm). Our G2 results indicate acceptable mean surface deviations with no significant differences between any cross-sections, but plasma sterilisation may have a greater effect on shape accuracy for more complex anatomical models [19].

The shape accuracy of 3D-printed models designed for surgical use should be considered because overall errors are influenced by model geometry, printing materials, manufacturing processes, and sterilisation processes [1]. In our ABS canine tibia model, the surface deviation in G1 indicated that errors occurred during the manufacturing process. These errors were significantly larger than the G2 deviations in shape change after plasma sterilisation. The mean total error was 0.1645 mm (G1 + G2 = 0.1214 + 0.0431). These results indicate that our ABS canine tibia model was fabricated with high accuracy [13] and successfully sterilised using H₂O₂ plasma without significant effects on its surface shape. Therefore, the model may be suitable for clinical use in bone surgery [3, 26].

A limitation of our study was its focus on medium-sized canine tibias (length:15–18 cm) because linear RMS errors become larger with bone model size [11]. The TPLO procedure requires extensive experience and is technically challenging in small and medium-sized dogs [27]. Therefore, our tibia model may serve as a patient-specific surgical model for TPLO in medium-sized dog breeds before and during surgery. However, shape accuracy may vary for different tibia sizes.

The CT-derived data were not compared with bone gross anatomy in this study. One study reported that the articular surface derived from CT images in small bones (e.g. feline radius) had dimensional errors and lacked precision when used to plan limb corrective osteotomy [28]. However, CT imaging can still be used to accurately evaluate and represent musculoskeletal anatomy [29–32] because the average deviation of CT-based human femur models from a bone-surface scan is negligible and clinically acceptable [22]. Therefore, further canine tibia cadaver reverse 3D scanning would be beneficial for ensuring shape accuracy with respect to gross anatomy.

In veterinary medicine, the increasing demand for improved visualisation and surgical outcomes have made 3D-printed anatomical models and patient-specific guides popular, and they are becoming common for implant contouring, surgery rehearsal, client communication, and education. Our study demonstrated the high shape accuracy of an FDM-printed ABS tibia model when compared with CT data. Furthermore, surface curvature deviation of the model after H₂O₂ plasma sterilisation was minimal. Therefore, preoperative plate contouring and surgical planning using our tibia model may reduce surgical time and achieve adequate bone reduction. Additionally, our model may be used during operations because it has nearly the same surface curvature as that of real bone. Additional studies evaluating the shape accuracy of patient-specific 3D-printed cutting guides for intraoperative use may provide an improved method for future clinical applications.

Sample collection

All experimental protocols complied with the guidelines for the care and use of animals and were approved by the Institutional Animal Care and Use Committee of National Taiwan University (NTU108–EL-00015). Six mixed-breed sexually matured canine cadavers (Mean body weight: 12 kg (10–15); 3 female and 3 male) were used and the informed consent was obtained from the animal shelter. The dogs’ deaths were unrelated to this study, and the dogs had no known histories of orthopaedic surgery. Coxofemoral amputation was performed on all 6 cadavers, and the 12 pelvic limbs were covered with saline-rinsed gauze and stored at − 20 °C. All experiments were performed 24 hours after the pelvic limbs were thawed at room temperature.

3D-printed tibia model

To obtain a 3D reconstruction, all the limbs underwent CT [1] imaging on a 128-slice CT scanner (Ingenuity Core 128, Philips Medical Systems, Cleveland, OH, USA). All limbs were placed in a caudal extension position and scanned at 120 kV and 105–115 mA [10]. Transverse collimated images were obtained in 1.0-mm–thick slices. Image preprocessing, such as thresholding, segmentation, and exporting of the 3D tibia volume information, were performed on commercial software (Mimics 22.0, Materialise NV, Belgium). Volume information was then reconstructed into triangular meshes using a high-frequency algorithm (Marching Cubes) at increments of 0.3 mm and exported as standard tessellation language (STL)-format files. The segmentation was visually inspected to confirm its accuracy, and the tibia was isolated using a digital scissor tool.

Both tibias of each dog were printed to be the same size as the cadavers’ tibias. The tibia models were printed on a 3D printer (Up Box+, Milpitas, CA, USA). The printing material was ABS with a layer height of 200 microns. The additive manufacturing error was 0.1 mm. All tibia models were printed with an analogous orientation of the longer axis parallel to the printing surface and were fixed to a plastic ABS-printed base. After printing, the plastic base and supports were gently removed manually from the tibia bone model.

Tibia morphological analysis before and after sterilisation

After careful harvesting of the 12 tibia models, reverse-engineering technology was used to analyse their errors [33]. The tibias were first scanned using an optical scanner (Breuckmann smartSCAN 3D, AICON 3D Systems, Braunschweig, Germany) with an accuracy of 0.02 mm, and 3D virtual (point cloud) models (3D-FDM) were obtained from the images of the scanned 3D-printed tibia models. The scanned images were stacked and decomposed into multiple points to form the test model. The virtual model (3D-CT) was obtained from the original tibia CT images and decomposed into multiple points to form the reference model. Subsequently, the differences between the 3D-FDM and 3D-CT models were compared on a point-by-point basis by superimposing the two virtual models, and calculations were performed using the closest projection point algorithm and Newton’s method [34, 35]. Additionally, root mean square (RMS) errors were calculated; RMS errors are generally used to assess the mean value of errors and are typically used as a criterion for assessing the similarity of two N-dimensional vector sets after optimal superimposition [36]. A higher RMS value indicates a larger error. The superimposition results were also illustrated by a colour difference map (Tables 1 and 2). The maximum and minimum values of the colour difference map were + 500 and − 500 µm, respectively.

A low-temperature H₂O₂ STERRAD NX steriliser (50 minutes/cycle, temperature < 55 °C, Johnson & Johnson Company) was used to sterilise the printed tibia models. The sterilised tibias were scanned a second time, and 3D virtual models (3D-GAS) were reconstructed. The difference between the 3D-GAS and 3D-FDM was also evaluated using the closest projection point algorithm and Newton’s method [34, 35]. Consequently, two comparisons were made: G1 (3D-FDM vs. 3D-CT) and G2 (3D-GAS vs. 3D-FDM). The reverse-engineering software program RevCAD (PouYuen Tech Corp., Taoyuan, Taiwan) was employed for error analysis among all models.

Morphological analysis at the tibia cross-sectional profile

Tibia length was defined as the longest distance from the proximal to distal end in the craniocaudal view of the 3D virtual model. The cross-sectional plane was simulated on the 3D virtual model at: 5%, 15%, 25%, 50%, 75%, 85%, and 95% of the previously recorded tibia length, and the contour points where the tangential plane intersected the model were extracted as point cloud data. A total of seven cross-sectional datasets were obtained for each tibia model (Fig. 1). The RMS value was evaluated through comparison of G1 and G2 using calculations obtained by superimposing two points of cloud data at the same cross-section.

Statistical analysis

A paired t test was conducted to evaluate the RMS mean differences between G1 and G2. A one-way analysis of variance was used to test the RMS mean differences among the seven cross-sectional datasets in each group. All statistical analyses were performed using GraphPad Prism 8.0 (GraphPad Software, Inc., San Diego, CA, USA). The significance level was set at P < 0.05.

3D: Three-dimensional; ABS:Acrylonitrile butadiene styrene; FDM:Fused deposition modelling; H₂O₂:Hydrogen peroxide; RMS:Root mean square; TPLO:Tibial plateau levelling osteotomy; CT:Computed tomography; STL:Standard tessellation language;

Ethics approval and consent to participate

The study was approved by the Institutional Animal Care and Use Committee of National Taiwan University (NTU108–EL-00015) and conducted by trained professionals. The informed consent for the study was obtained from the animal shelter. No additional permissions were required for sample collection from canines.

Consent for publication

Not applicable. The manuscript does not contain any human data.

Availability of data and materials

All data generated or analysed during this study are included in this published article and available from the corresponding author on reasonable request.

Competing interests

The author declare that they have no competing interests.

Funding

This study was funded by a grant from National Taiwan University- Yonglin Humane Project (grant numbers FB004-6, 2018). The funding body had no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript

Authors' contributions

ILL conceived the research grant. ILL and CPH designed the study. ILL, CPH, and CHF performed the experiments. ILL, CPH, CSL, CHF, NYC, CWT, and CMC contributed in analyzing the results, writing, and reviewing the manuscript. All authors read and approved the manuscript.

Acknowledgements

The authors thank the staffs in the National Applied Research Laboratories, Taiwan Instrument Research Institute for help in CT scan and optical scan.

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Table 1

Superposition of 3D-FDM and 3D-CT tibia models.

3D Comparison of G1 (3D-FDM vs. 3D-CT)
Case	RMS value (µm)	Representative image
No.1	130.0
No.2	156.4
No.3	146.3
No.4	115.1
No.5	129.2
No.6	132.3
No.7	91.0
No.7	91.0		(mm)
No.8	107.4
No.9	102.4
No.10	117.8
No.11	109.9
No.12	119.4

The colour difference map represents the difference between the 3D-FDM and 3D-CT models (3D-FDM: images obtained from reverse-scanned 3D-printed tibia models before sterilisation; 3D-CT: original tibia images obtained from CT; RMS: root mean square).

Table 2

Superposition of 3D-GAS and 3D-FDM tibia models.

3D Comparison of G2 (3D-GAS vs. 3D-FDM)
Case	RMS value (µm)	Representative image
No.1	37.3
No.2	56.8
No.3	28.4
No.4	112.3
No.5	30.1
No.6	32.0
No.7	22.3
No.7	22.3		(mm)
No.8	25.8
No.9	61.4
No.10	40.2
No.11	39.8
No.12	31.1

The colour difference map represents the difference between 3D-GAS and 3D-FDM (3D-GAS: images obtained from reverse-scanned 3D-printed tibia models after sterilisation; 3D-FDM: images from reverse-scanned 3D printed tibia models before sterilisation; RMS: root mean square).

Table 3

Mean ± standard deviation values for comparisons of measurements obtained from 3D-CT, 3D-FDM, and 3D-GAS images of the tibial bone surfaces (n = 12) of six canine cadavers.

Variable	G1 (3D-FDM vs. 3D-CT)	G2 (3D-GAS vs. 3D-FDM)
Surface deviation	0.1214^a	0.0431
Root mean square (mm)	0.1214^a	0.0431
Average deviation positive (mm)	0.0973^a	0.0234
Average deviation negative (mm)	-0.0737^a	-0.0258
Curvature difference of cross-sectional measurements of bone surface at:
(a) 5% length of the tibia (mm)	0.3025^b	0.0491
(b) 15% length of the tibia (mm)	0.0863	0.0273
(c) 25% length of the tibia (mm)	0.0645	0.0247
(d) 50% length of the tibia (mm)	0.1313	0.0376
(e) 75% length of the tibia (mm)	0.1307	0.0263
(f) 85% length of the tibia (mm)	0.1020	0.0239
(g) 95% length of the tibia (mm)	0.1288	0.0351

^a paired t test, P < 0.0001.^b one-way analysis of variance, P < 0.0001.

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Editorial decision: Major revision
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Shape accuracy of an acrylonitrile butadiene styrene canine tibia model fabricated using fused deposition modelling and the effects of hydrogen peroxide gas plasma sterilisation

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Abstract

Background

Results

Conclusions

Figures

Background

Results

Shape deviation of the whole-tibia model

Cross-sectional profile deviation of the tibia model

Discussion

Conclusion

Methods

Sample collection

3D-printed tibia model

Tibia morphological analysis before and after sterilisation

Morphological analysis at the tibia cross-sectional profile

Statistical analysis

Abbreviations

Declarations

References

Tables

Supplementary Files

Status:

Journal Publication

Version 1