Modular External Fixation for an Open Tibial Shaft Transverse Fracture

This module applies user-centered, reproducible, and accessible design choices to maximize adoption in resource-constrained settings.

Design for Extreme Accessibility in Low Resource Settings[edit | edit source]

This module applies user-centered, reproducible, and accessible design choices to maximize adoption in resource-constrained settings.

User-Centered Design[edit | edit source]

Medical officers are fully trained, non-specialist physicians who have not received any exposure to orthopedic surgery outside of their undergraduate medical education. Surgeons who are not orthopedic specialists have received formal advanced training in their surgical specialty but have not been trained to perform external fixation procedures for tibial fracture patients.

The placement of an external fixator is one of the 44 essential surgical procedures identified by the World Bank.[1] This module teaches modular external fixation because this procedure offers the greatest freedom in fracture management and maximum patient safety when performed by practitioners who are not orthopedic specialists in resource-constrained settings. The advantages of training non-orthopedic specialists to perform modular external fixation over uniplanar external fixation are that modular external fixationː

  • is the preferred method for the temporary stabilization of open tibial fractures
  • requires less experience and surgical skill
  • permits the practitioner to freely place pins at suitable sites to avoid nerves, vessels, and traumatized soft tissues
  • does not require intraoperative X-rays and,
  • allows for subsequent definitive fixation.[2]

Although medical officers will have training and clinical experience with performing abdominal surgery, they will not have had experience with making stab incisions to insert external fixation pins. The Tibial Shaft Transverse Fracture Simulator includes a simulated soft tissue-bone interface to give the learner confidence and competence with making stab incisions for placement of Schanz screws for modular external fixation of open tibial shaft fractures.

Medical officers in low-resource settings may not have access to direct fluoroscopy. Modular external fixation of an open tibial fracture is a procedure that can be quickly applied without image intensification and adjusted afterwards.[2]

Practitioners in resource-constrained settings may not have access to orthopedic surgical drills for training. This module recommends a cost-saving ISO 13485 compliant orthopedic surgical drill that is designed for LMICs and permits back-to-back surgeries with a single power drill.[3]

Learners require access to high quality, standardized simulators and training. This module gives surgical practitioners in LMICs access to open-source, affordable, high fidelity, locally reproducible 3D printed bone simulation models for both basic and advanced training that are comparable to state-of-the-art, quality-tested artificial bone products that are available in high income countries.[4][5]

Learners need access to safe simulation training. All of the 3D printed bone models have a vise attachment to allow the user to secure the model inside a standard vise clamp to maximize learner safety during simulation training. Learners will be obtaining vise clamps locally and these devices can vary in size. We increased the height of the vise attachment of the Tibial Shaft Simulator to 6.0 cm in order to maximize compatibility with different sizes of locally available vise clamps.

Based on our user testing, we removed the Far Cortex Breakthrough Detection entirely from the module and chose not to include the Plunge Depth Measurement for the Tibial Shaft Transverse Fracture Simulator. The rationale for these design choices is becauseː

  • the likelihood of perforating the far cortex and plunging is very low with the manual advancement of the Schanz screw into the far cortex
  • the transparent cellophane allows the learner to visually inspect and confirm that the self-drilling Schanz screws did not perforate the far cortex
  • plunge detection has not been shown to confer long-term learning benefits in reducing plunge
  • we want to avoid fostering dependence on augmented feedback ("anti-skills") since the learner will not have augmented feedback during the actual procedure, and
  • this increases simulator fidelity, reduces simulator costs, simplifies the simulator build, and minimizes simulator assembly time for the learner.[6][7]

Medical officers and surgeons who are not orthopedic specialists in LMICs have busy work schedules and typically do not have a technical background. We tailored the design of the surgical training module prototype to meet their training needs by:

  • Providing high fidelity 3D printed bone models for both basic and advanced simulation training that are designed to substantially simplify the simulator build, minimize the simulator assembly time, and accelerate the learning process for greater convenience for the learner
  • Adding detailed instructions on how to input the customized settings for the 3D printed bone models into a 3D slicing program in case the user was not familiar with using advanced 3D slicer settings, and
  • Designing the Tibial Shaft Simulator and Tibial Shaft Transverse Fracture Simulator to be easy and quick to assemble and 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.

Over 4 billion people do not have access to the Internet.[8] The penetration of high-speed Internet connectivity (broadband, 3G, or better mobile connections) is less than 30% in rural regions.[9] In 2020, only 46% of the population in sub Saharan Africa owned a mobile phone and smartphones made up only 48% of total mobile connections in sub Saharan Africa.[10][11] In 2021, nearly 711 million people were in extreme poverty, which is defined as living on less than $1.90 per day.[12] To promote adoption of this surgical training module in low resource settings, we:

  • Designed the non-3D printed simulator components to be made using low cost, locally available materials and supplies
  • Switched to using cost-saving modelling clay for the backstop instead of single-use foam material for plunge depth measurement on the Tibial Shaft Simulator because clay is reusable and can be locally obtained in LMICs
  • Developed an Appropedia module which does not require the downloading of a mobile app, creation of an account, inputting of a username and password, or paying journal or other subscription fees to access the training content
  • Provided step-by-step instructions and labelled images (instead of only videos) and published our self-assessment frameworks directly in Appropedia so the module content can be available in multiple languages and exported for offline access
  • Created self-assessment frameworks that only require taking photos and not videos which allows learners to use any cellphone with a camera and not only smartphones.

Reproducible Design[edit | edit source]

3D printing technology empowers the local, reliable, and automated manufacturing of high fidelity bone simulation models to permit high quality, standardized simulation training around the world. All of the module's bone simulation model files and print settings are open-source and available on Appropedia, can be locally reproduced on open-source, open filament desktop 3D printers using low-cost, biorenewable plastic, and are designed to be ready for use right out of the 3D printer.[13][14][15][16][17][18][19][20] These high fidelity 3D printed bone models are designed to substantially simplify the simulator build, minimize the simulator assembly time, and accelerate the learning process for greater convenience for the learner.

On-site access to a 3D printer is not required for the learner. Only one 3D printer is required within a country. The open-source 3D files can be emailed to any 3D printing organization anywhere.[21] The 3D printed simulation models can be picked up by the learner or delivered anywhere across the country by motorcycles, all-terrain vehicles, trucks, or airplanes within 1-2 days.[22]

This module does not require access to teachers, animal bones, artificial bones or human cadaveric bones, and uses locally available hardware and materials, and locally made, high fidelity bone simulation models for bicortical drilling skills and modular external fixation procedure skills training.

When possible, the surgical hardware and equipment are reusable to minimize the use of consumables and maximize their lifespan in the place of use.

The primary risk to reproducibility of this surgical training module is access to affordable orthopedic surgical hardware for training. We have developed local and international partnerships to deliver modular external fixation kits, and surgical drills with autoclavable covers on demand and at minimal cost for up to 39,600 medical officers and surgeons across Nigeria who are not orthopedic specialists.[23][3][22][24]

The total cost of Tibial Shaft Simulator consumables per learner is $9.73 USD. The total cost of purchasing reusable supplies in Nigeria for the Tibial Shaft Simulator for Bicortical Drilling Skills Training is $81.60 USD with the Far Cortex Breakthrough Detector and $60.00 USD without the Far Cortex Breakthrough Detector. This Tibial Shaft Simulator cost calculation does not cover shipping, delivery or orthopedic surgical hardware, supplies, and equipment costs.

2021 Learner Costs for Supplies Locally Purchased in Nigeria for the Tibial Shaft Simulator for Bicortical Drilling Skills Training
Item Quantity Purchase Cost in USD Consumable or Resuable
3D Printed Adult Male Tibial Bone Model #1 (manufactured locally by a 3D printing company in Nigeria[21]) 1 $8.90 (includes filament, 3D printing, and staffing costs) Consumable
Vise Clamp 1 G-clamp and 1 vise clamp $54.00 Reusable
Shallow Container 1 Readily available in place of use Reusable
Aluminum Foil 17.0 cm by 3.0 cm strip $0.03 (one 30.0 cm x 10.0 m roll of aluminum foil costs $19.20) Consumable
Ruler 1 Readily available in place of use Reusable
Marker 1 Readily available in place of use Reusable
Scissors 1 Readily available in place of use Reusable
Tape Multiple strips Readily available in place of use Consumable
Optionalː Wire Stripper 1 Not used; estimated cost is $10.67 Reusable
Alligator Clips 4 $21.60 Reusable
Buzzer 1 Covered above Reusable
9 V Battery 1 Covered above Reusable
Small Gauge, Non-Insulated Wire Short length (~12.0 cm or less) Covered above Reusable
Cellophane Two 20.0 cm by 100.0 cm strips $0.80 (one 30.0 cm x 20.0 m roll costs $12.00) Consumable
Modelling Clay 1 block $6.00 Reusable

The total cost of Tibial Shaft Transverse Fracture Simulator consumables per learner is $19.45 USD. The total cost of purchasing the additional reusable supplies in Nigeria for the Tibial Shaft Transverse Fracture Simulator for Modular External Fixation for an Open Tibial Shaft Transverse Fracture Training is $56.40 USD. This Tibial Shaft Transverse Fracture Simulator cost calculation does not cover shipping, delivery or orthopedic surgical hardware, supplies, and equipment costs.

2021 Learner Costs for Supplies Locally Purchased in Nigeria for the Tibial Shaft Transverse Fracture Simulator for Modular External Fixation for an Open Tibial Shaft Transverse Fracture Training
Item Quantity Purchase Cost in USD Consumable or Resuable
3D Printed Adult Male Tibial Bone Model #2 (manufactured locally by a 3D printing company in Nigeria[21]) 1 $9.35 (includes filament, 3D printing, and staffing costs) Consumable but can be reused indefinitely after hardware removal for a planned module on the Management of Non-Displaced Fractures
3D Printed Adult Male Tibial Bone Model #3 (manufactured locally by a 3D printing company in Nigeria[21]) 1 $9.30 (includes filament, 3D printing, and staffing costs) Consumable but can be reused indefinitely after hardware removal for a planned module on the Management of Non-Displaced Fractures
Additional Vise Clamp 1 G-clamp and 1 vise clamp $54.00 Reusable
Cellophane One 40.0 cm by 100.0 cm strip $0.80 Consumable
Protractor 1 $2.40 Reusable
Cellphone Camera 1 Readily available in place of use Reusable

No tools, specialized equipment, technical expertise, or time-consuming preparation is required to build, install, operate and maintain the Tibial Shaft Simulator and Tibial Shaft Transverse Fracture Simulator within the intended place of use.

Our high fidelity simulators offer significant value for money in comparison to existing approaches such as artificial bones and human cadaveric bones.

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.[25] 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, the 3D printer filament costs for the Tibial Shaft Simulator is $6.88 USD or less and the estimated print time is 6 hours and 2 minutes.[26] The benefits of 3D printing the Tibial Shaft Simulator (3D Printed Adult Female Tibial Bone Models #1) 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.[4] 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.

In Nigeria, the 3D printer filament costs for the Tibial Shaft Transverse Fracture Simulator is $16.53 USD or less and the estimated print time is 15 hours 8 minutes (when the 3D Printed Adult Female Tibial Bone Models #2 and #3 are printed consecutively).[26] 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 comparable artificial bone products that are imported from abroad, and the 3D printing filament costs are over 9 times cheaper than acquiring a human cadaveric tibia prepared by a local university anatomy lab.[5][27] 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.

Accessible Design[edit | edit source]

This Appropedia-based module is available in the 6 official languages of the United Nations, Kiswahili, the lingua franca of the East African Community, and other languages to help ensure that surgical practitioners from anywhere in the world will be able to engage with the content without barriers or gatekeeping.

Each 3D printed bone simulation model displays the model number translated in the 6 official languages of the United Nations, and the model gender using internationally recognized ISO 7001 graphical symbols for males and females to assist with model identification.

We provided step-by-step instructions and labelled images (instead of only videos) so the module content can be available in multiple languages and exported for offline access.

We published our self-assessment frameworks directly in the Appropedia module (instead of a downloadable pdf) to provide automatic translations of the Training Logbooks in multiple languages to learners around the world.

We created self-assessment frameworks that only require taking photos and not videos which allows learners to use any cellphone with a camera and not only smartphones.

This module does not require the downloading of a mobile app, creation of an account, inputting of a username and password, or paying journal or other subscription fees to access the training content.

Offline and Off Grid Access[edit | edit source]

Self-directed training is typically only available online or via mobile apps. These traditional approaches have accessibility barriers in low resource settings because:

  • Over 4 billion people do not have access to the Internet
  • The penetration of high-speed Internet connectivity (broadband, 3G, or better mobile connections) is less than 30% in rural regions
  • Only 46% of the population in sub Saharan Africa owns a mobile phone
  • Smartphones make up only 48% of total mobile connections in sub Saharan Africa, and
  • An estimated 770 million people worldwide lack access to electricity and 600 million of these individuals reside in sub Saharan Africa.[8][9][10][11][28]

The demand for this module will be greatest in regions with little or no access to the Internet, smartphones, or grid electricity. Our self-assessment frameworks only require taking photos and not videos. This allows learners to use any cellphone with a camera and not only smartphones. When possible, we have provided images (instead of only videos) so the module content can be available in pdf format using Appropedia's export function for offline access.

Over 235 million people require humanitarian assistance and 44.7 million people in conflict zones lack access to basic medical care.[29][30] Every day, hospitals, patients, healthcare staff, ambulances, and aid workers come under attack in regions affected by conflict and other emergencies.[31][32] Online platforms and mobile phones are vulnerable to security breaches which can be used to target bombing attacks on hospitals in conflict zones.[33] It is critical that this training module be available offline to remain isolated from any surveillance from an external Internet connection to prevent hackers from targeting healthcare workers and facilities in conflict zones.

Paper-based versions of surgical training modules are sub-optimal because they cannot provide video and multimedia content which is essential for self-assessed surgical skills training. We can use Linux open-source software and an offline (air gapped), energy-efficient, ultraportable Raspberry Pi with integrated 7-inch touchscreen display to make this module safely available to the surgical practitioners serving the 4 billion people who do not have access to the Internet and the millions of the most vulnerable civilians in conflict zones.[34][35]

A 2015 study shows that a Raspberry Pi ($35 USD) with a 10 inch display consumes almost the same amount of energy (21.24 kJ/h) as a smartphone ($400 USD) with 4.7 inch display (18 kJ/h), 4.2 times less energy than a $320 USD tablet (90 kJ/h), and 8.5 times less energy than a $728 USD laptop (180 kJ/h).[36] The advantages of using a Raspberry Pi with an integrated 7-inch display screen over a smartphone or tablet are reduced costs, energy efficiency and a larger screen area to optimize learning.

To minimize the use of offline storage capacity and maximize the number of validated, open-source GSTC Appropedia modules that can be stored and made available offline on a Raspberry Pi, we designed this module to minimize the number of secondary or tertiary links, when possible. Our team will be recruiting volunteer Medical Makers to help make GSTC Appropedia modules available offline to maximize the global impact of the GSTC.

Last Mile Implementation[edit | edit source]

We will be evaluating the concept of setting up a Medical Makerspace in a government hospital in a LMIC to serve as a training, manufacturing, and distribution center that educates local Makers to make high fidelity, 3D printed bone models and offline simulation training modules at the lowest cost for any practitioner across the country.

Over half of Nigeria's population of 206 million people live in rural areas but only 15% of the road networks are paved.[37] We are continuing to develop local and international partnerships to deliver locally made 3D printed bone models, modular external fixation kits for simulation training and clinical use, surgical drills with autoclavable covers, and offline training modules on demand and at minimal cost for up to 39,600 medical officers and surgeons across Nigeria who are not orthopedic specialists.[23][21][3][22][24][38]

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.

References[edit | edit source]

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Page data
Part of Tibial Fracture Fixation
Type Medical course
Keywords orthopedic surgery, surgical training, tibial fracture, bicortical drilling, modular external fixation, open tibial shaft fracture, 3D printing, artificial bones
SDG Sustainable Development Goals SDG03 Good health and well-being
Authors Medical Makers
Published 2022
License CC-BY-SA-4.0
Affiliations Medical Makers
Impact Number of views to this page. Updated once a month. Views by admins and bots are not counted. Multiple views during the same session are counted as one. 32