Tibial Fracture Fixation Team Logo.jpg

Caption underneath

This module provides data-driven, gender-specific, easy to print, labor-saving, environmentally friendly, hygienic, and cruelty-free bone simulation models that are not made with natural rubber latex, are designed with safety features to protect users, and can be locally reproduced to provide the highest fidelity, standardized orthopedic surgical simulation training at the lowest cost.

Innovative Design[edit | edit source]

This module provides data-driven, gender-specific, easy to print, labor-saving, environmentally friendly, hygienic, and cruelty-free bone simulation models that are not made with natural rubber latex, are designed with safety features to protect users, and can be locally reproduced to provide the highest fidelity orthopedic surgical simulation training at the lowest cost.

Safety By Design[edit | edit source]

Our team has prioritized safety in the design of our simulators.

All of the module's 3D printed bone models have a vise attachment to allow the user to secure the model inside a standard vise clamp to maximize safety during simulation training. Although using a vise clamp is more costly, it is standard training practice for bone models to be secured inside a vise clamp to maximize safety during bicortical drilling and fracture fixation simulation training.[1][2][3][4] Based on our clinical experience and user testing, we do not recommend having an assistant hold a bone model during drilling training because this exposes the assistant to potential injury. There is always a risk that the drill bit may slip when drilling through the bone simulation model during training.[5]

This training module instructs all learners to wear proper protective equipment (protective eyewear and gloves) during the simulation skills training in accordance with "The ten best practices for healthcare simulation safety" as listed on the Foundation for Healthcare Simulation Safety website.[6]

High Fidelity[edit | edit source]

To maximize learning efficiency and minimize simulator overall costs and assembly time, we provide high fidelity, standardized bone simulation models for basic and advanced simulation training instead of having the learner progress through a range of homemade (DIY) simulators of varying and increasing fidelity.

The 3D printed bone models accurately simulate bone length and diameter, external contour, cross-sectional shape, bicortical anatomy, cortical hardness, cancellous bone porosity, and microstructure, and far cortex thickness for both genders at tibial shaft fracture drilling sites for modular external fixation.[7][8][9][10][11][12][13][14][15][16]

Cortical thickness varies depending on gender, age, and regions in the tibia.[16] In LMICs, tibial fractures predominantly occur in young adults (< 40 years) with a male to female patient ratio of 3:1.[17] The 3D printed bone models are designed to accurately simulate far cortex thickness values for young (< 50 years), healthy (BMI < 30) adult males and females at tibial diaphysis drilling sites for modular external fixation.[16]

During bicortical drilling skills training, the learner adjusts the applied drilling force to minimize plunge depth.[18] Drilling forces are influenced by cortical thickness, bone site, patient age, and bone mineral density.[19] To minimize the risk of teaching anti-skills (excessive or inadequate drilling forces), the high fidelity 3D printed bone models are made of plastic with similar hardness to human cortical bone and are designed to accurately simulate the age, gender, and bone site-specific cortical thickness values and cancellous bone porosity for the target patient population.[10][11][12][16][17]

A simulator without augmented (extrinsic) feedback is a higher fidelity simulator than a simulator with augmented feedback because this more accurately reflects real clinical scenarios. Thus, we removed the augmented feedback feature for plunge detection from the Tibial Shaft Simulator and Tibial Shaft Transverse Fracture Simulator to provide higher fidelity bicortical drilling and modular external fixation skills training to learners.

Easy to Manufacture[edit | edit source]

3D printing technology empowers local, labor-saving, and automated reproduction of high fidelity bone simulation models to permit standardized, high quality, self-assessed simulation training in LMICs. Using our high fidelity 3D printed bone models substantially simplifies the simulator build, minimizes the simulator assembly time, and accelerates the learning process for greater convenience for the learner.

High fidelity 3D printed surgical simulation models are typically made on expensive ($300,000 USD), closed system printers that use costly, proprietary filaments ($302.50 - $432.26/kg USD) and software and require a team of highly trained professionals to operate and maintain.[20][21] These high priced 3D printed anatomic models generally require time-consuming, laborious, and multi-step digital file preparation and significant post-processing of the 3D printed model before use by the practitioner.[20][21][22][23]

All of the module's 3D printed bone simulation models are open source and can be locally reproduced on open-source, open filament, user friendly, single extruder desktop 3D printers that print polylactic acid (PLA), a low-cost and easy to print plastic.[24][25][26][27][28][29]

To minimize material, equipment and labor costs during production, all of the module's 3D printed bone models are designed to:

  1. print without support material, rafts or brims
  2. require no cleaning, sanding, gluing, priming, painting, dipping, coating, smoothing, polishing, or any post-processing
  3. not require any non-3D printed parts, and
  4. be ready for use right out of the 3D printer.[30]

The Tibial Shaft Simulator and Tibial Shaft Transverse Fracture Simulator are easy and quick to assemble and do not require any tools, specialized equipment, technical expertise, or time-consuming preparation to build, install, operate and maintain these simulators within the intended place of use.

Lower Cost[edit | edit source]

The 3D Printed Adult Tibial Bone Models can be locally reproduced to provide the highest fidelity simulators at the lowest cost for orthopedic surgical simulation training. The costs of the 3D Printed Adult Tibial Bone Models will vary depending on the region's 3D printing organizations, and locally available brands of filament.

In Canada, a 1.0 kg roll of white PLA costs $17.95 CAD which is equal to about 1.4¢ USD per gram.[31] The Tibial Shaft Simulator (3D Printed Adult Female Tibial Bone Model #1) weighs 138.57 grams and the total filament cost in Canada is $1.95 USD. The Tibial Shaft Transverse Fracture Simulator (3D Printed Adult Female Tibial Bone Models # 2 and # 3) weighs 332.86 grams and the total filament cost in Canada is $4.69 USD.

In Nigeria, one 750 gram roll of Ultimaker White PLA filament (Shore Hardness 83D) costs €33 Euros which is equal to about 5¢ USD per gram.[10][32] The total filament cost of the Tibial Shaft Simulator (3D Printed Adult Female Tibial Bone Model #1) in Nigeria can be $6.88 USD or less. The total filament cost of the Tibial Shaft Transverse Fracture Simulator (3D Printed Adult Female Tibial Bone Models # 2 and # 3) in Nigeria can be $16.53 USD or less.

The benefits of 3D printing the Tibial Shaft Transverse Fracture Simulator locally in Nigeria for modular external fixation skills training are that the 3D printer filament costs are over 3 times cheaper and the production time is over 33 times faster than purchasing a comparable artificial bone product that is imported from abroad, and the 3D printer filament costs are over 9 times cheaper than acquiring a human cadaveric tibia prepared by a local university anatomy lab.[32][33][34] By obtaining locally made 3D printed bone models for modular external fixation skills training, the learner also supports the local economy while saving on customs dues, processing fees, and international shipping costs that would be incurred when using artificial bone products that are not made locally.

Comparison of Tibial Shaft Transverse Fracture Simulator Locally Made in Nigeria to Commercially Available Artificial Bone and Human Cadaveric Bone
Tibial Shaft Transverse Fracture Simulator

(3D Printed Adult Female Tibial Bone Models #2 and #3)

Sawbones Tibia, Plastic Cortical Shell, Left

(SKU:1104-9)[33]

Human Cadaveric Tibia

(Prepared by an University Anatomy Lab in Nigeria)[34]

Bone Simulator Features 3D printed, biorenewable plastic anatomic bone models are made with a rigid plastic shell and inner cancellous material. Plastic cortical shell models are made of a rigid plastic shell with inner cancellous material.
  • Human cadaveric tibial bone specimen prepared by an anatomy lab.
  • Age of donor may not be known.
  • Requires wet storage (which incurs additional fees)
Fracture Simulation Simulates a transverse mid-shaft fracture of the tibia for modular external fixation training. Requires additional preparation by user to simulate a fracture. Requires additional preparation to simulate a fracture.
Fracture Encapsulation Encapsulates transverse fracture with cellophane. Does not encapsulate or re-attach fracture. No. This would incur additional preparation and storage fees.
Vise Attachment Contains a vise attachment to safely secure the model inside a standard vise clamp. Does not contain a vise attachment. Does not contain a vise attachment.
Bone Simulator Dimensions Tibia with an overall length of 41 cm. Tibia with an overall length of 42 cm. Varies.
Unit Cost $16.53 USD[32] $53.50 USD $150.00 USD
Production Time 15 hours 8 minutes (when Adult Female Tibial Bone Models #2 and #3 are printed consecutively). Ready to ship in 21 days or more. Depends on local availability of cadaver specimens which is difficult to predict.

Noteː A product comparison was not made with the:

  • Sawbones Tibia, Solid Foam, Large ($16.00 USD) because this model simulates the intramedullary canal but not cancellous bone, and the foam material does not simulate the hardness of cortical bone and thus, could foster anti-skills, and
  • Sawbones Cylinder with Encapsulated Oblique Fracture ($37.50 USD) because the hollow short fiber reinforced epoxy cylinder does not have anatomic features that make it suitable for modular external fixation training and does not appear to have adequate length to properly simulate an adult tibial midshaft fracture for modular external fixation training which requires the placement of widely spaced pins in each fracture fragment.[35][36][37]

The benefits of 3D printing the Tibial Shaft Simulator locally in Nigeria for bicortical drilling skills training are that the 3D printer filament costs are 12 times cheaper and the production time is 84 times faster than purchasing a comparable artificial bone cylinder product that is imported from abroad.[32][38] By obtaining locally made 3D printed bone models for bicortical drilling skills training, the learner also supports the local economy while saving on customs dues, processing fees, and international shipping costs that would be incurred when using artificial bone products that are not made locally.

Comparison of Tibial Shaft Simulator Locally Made in Nigeria to Commercially Available Composite Cylinder
Tibial Shaft Simulator

(3D Printed Adult Female Tibial Bone Model #1)

Sawbones Composite Cylinder

(SKU:3403-7)[38]

Bone Simulator Features Anatomic model that simulates mid-diaphyseal tibial bone for bicortical drilling skills training in preparation for modular external fixation training of an open tibial shaft transverse fracture. Cylinder that simulates mid-diaphyseal bone for fracture fixation testing.
Bone Simulator Materials 3D printed, biorenewable plastic anatomic bone models are made with a rigid plastic shell and inner cancellous material. Hollow short fiber reinforced epoxy cylinder. Customized cellular rigid polyurethane foam filling available upon request.
Vise Attachment Contains a vise attachment to safely secure the model inside a standard vise clamp. Does not contain a vise attachment.
Bone Simulator Dimensions Variable outer diameter (including 40 mm) x 6.2 mm wall thickness x 203.05 mm length. 40 mm outer diameter x 6 mm wall thickness x 500 mm length.
Unit Cost $6.88 USD per model[32] $78.78 USD (original $194.00 USD pricing adjusted for model length of 203.05 mm)[38][39]
Production Time 6 hours and 2 minutes Ready to ship in 21 days or more[38]

Not Made With Natural Rubber Latex[edit | edit source]

Instead of using conventional rubber latex bands glued to re-attach artificial bone fracture fragments, the Tibial Shaft Transverse Fracture Simulator uses inexpensive, locally available, and easy to apply clear cellophane to encapsulate displaced fracture fragments in a simulated soft-tissue envelope.[40] Using cellophane, a material that is not made with natural rubber latex, reduces the risk of triggering latex sensitivities and potentially life-threatening allergic reactions in healthcare workers.[41]

Eco-Friendly[edit | edit source]

All of the module's 3D printed bone simulation models are made from polylactic acid (PLA), a biorenewable, biodegradable, and minimally off-gassing thermoplastic.[42][43][44][45][46][47]

Cruelty-Free[edit | edit source]

Our 3D printed bone models provide a higher fidelity, hygienic, and humane training alternative to using live animal models or mammal cadaveric bones which makes them suitable for the 1.2 billion followers of Hinduism, over 520 million followers of Buddhism, 4.5 million followers of Jainism, and ethical vegans who refrain from using any animal products.[48][49][50][51]

No animal should be harmed from using this training module in accordance with the principles of ahimsa (non-violence or non-injury to all living beings), no killing of any living being under the Right Action Factor of The Eightfold Path of Buddhism, and the recognition of consciousness of all mammals outlined in The Cambridge Declaration on Consciousness.[49][50][52][53]

Equity[edit | edit source]

To make global surgical care equitable, then surgical training (including simulation models) for the Global South must be equivalent in quality to the Global North. This module gives surgical practitioners in LMICs access to open-source, affordable, high fidelity, locally reproducible 3D printed bone simulation models that are comparable to state-of-the-art, quality-tested artificial bone products that are available in high income countries.[33][38]

To advance surgical education and care in LMICs, surgical simulation training must be standardized to monitor performance and clinical outcomes. Providing standardized surgical simulation training requires using reproducible simulators. This module provides high fidelity, 3D printed bone models that can be locally reproduced in any country with an inexpensive, single extruder, fused deposition modeling desktop 3D printer with a minimum build volume Z height of 210 mm, such as the open-source Original Prusa i3 MK3S+ that costs $999 USD.[24] This Appropedia module and our open-source, high fidelity, locally reproducible 3D printed bone simulators can empower unrestricted access to standardized, self-assessed orthopedic surgical simulation training around the world.

Targeted Feedback[edit | edit source]

The Tibial Shaft Simulator has a simulated Soft Tissue Layer for Plunge Depth Measurement to permit the measurement of plunge depth for the self-assessment framework.

The transparent cellophane that is wrapped around the Tibial Shaft Transverse Fracture Simulator and simulates the overlying periosteum will permit the learner to visually inspect and confirm that the self-drilling Schanz Screws did not perforate the far cortex for the self-assessment framework.

Unlike conventional artificial bone fracture models, the base of the 3D printed models of the Tibial Shaft Transverse Fracture Simulator allows the proximal and distal fracture fragments to be positioned on a flat surface to permit easy, convenient, and precise measurement of the drill trajectory angles of the Schanz Screws using a low-cost (20¢ USD) protractor for the self-assessment framework.[54][40]

Drawbacks of Traditional Approaches[edit | edit source]

According to the Global Surgical Training Challenge Discovery Awards: Mentoring Programme Handbook - March 2021, "anti-skills are clinically irrelevant skills that the simulator teaches that need to be unlearned when the clinician attempts to transfer what they have learned over to a real clinical scenario," and "[a]t its most fundamental level, anti-skills means incorrect or irrelevant technique, approach and methodology developed or reinforced as a result of using simulation."

During bicortical drilling, the surgeon adjusts drilling direction, speed and applied force to minimize plunge depth.[18] Drilling forces are influenced by cortical thickness, bone site, patient age, and bone mineral density.[19] Low fidelity simulators that do not accurately replicate human cortical bone hardness, and age- and gender-specific cortical thicknesses of tibial diaphyseal sites could foster anti-skills for bicortical drilling in learners. 100% of the orthopedic surgeons (n = 5) we surveyed agreed or strongly agreed that training on high fidelity simulators that accurately replicate human cortical bone hardness will translate into improved plunge depths when performing bicortical drilling on patients compared to low fidelity simulators.

Alternative approaches to orthopedic surgery simulation training include (in order of increasing fidelity): virtual reality simulators, DIY bone simulators, like the Fundamentals of Orthopedic Surgery (FORS) simulator, animal models, synthetic bones, and cadaver laboratories.[55][56]

Virtual reality simulators can be expensive and do not provide haptic or acoustic feedback for bicortical drilling skills training.

Low-cost DIY bone simulation models can be time-consuming to prepare and can vary widely in fidelity. This makes it impossible to provide standardized simulation training and to obtain objective, generalizable evaluation data to verify that the user's learnings will directly translate into the safe, clinical performance of bicortical drilling and external modular fixation procedures and will not foster the development of anti-skills.

The FORS simulator can be built from supplies purchased at a local hardware store.[56] However, the FORS Simulator uses low-fidelity polyvinyl chloride (PVC) hollow pipes which:

  1. do not recreate bone contours so the learner is unable to identify anatomic landmarks for proper positioning of external fixation pins into safe zones of the tibia, avoiding having the pins enter a joint cavity, or verifying post-fixation fracture alignment
  2. do not simulate cancellous bone
  3. are not available in accurate cortical thicknesses or cross-sectional shapes which could foster the development of anti-skills for bicortical drilling
  4. are made from vinyl chloride, an industrial carcinogen, and contain small amounts of phthalates, which are endocrine disrupting chemicals, and
  5. do not readily biodegrade and thus, contribute to the rising global levels of plastic waste in landfills, microplastics in oceans and atmosphere, and nanoplastics in the environment.[57][58][59][60][61][62][63][64][65][66][67]

Animal bones do not accurately simulate the length of human bones which would prevent learners from using the correctly sized orthopedic surgical hardware during simulation training.[68] Animal bones also do not have realistic human cortical thicknesses or cross-sectional shapes and this could foster the development of anti-skills for bicortical drilling.[69][70] Studies have shown significantly different drilling temperature values (which correlate with drilling energy and drilling force) in animal versus human bones.[19][69][70]  Animal bones also require the use of specialized, costly vise clamps ($730.50 USD per pair) for securing the models for safe simulation-based training and the slaughtering of sentient beings and additional time-consuming preparation for use in simulation training and cannot reliably reproduce different fracture patterns to permit standardized orthopedic surgical skills training.[53][71][72]

Artificial bones are inaccessible in low to middle income countries due to long delivery times and high import costs from customs dues and processing fees because they are not produced locally.[33][38]

There is limited or no practitioner access to costly cadaver labs outside of training centers.

Acknowledgements[edit | edit source]

This work is funded by a grant from the Intuitive Foundation. Any research, findings, conclusions, or recommendations expressed in this work are those of the author(s), and not of the Intuitive Foundation.

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