Tibial Fracture Fixation Team Logo.jpg

Modular External Fixation for an Open Tibial Shaft Transverse Fracture

This module allows medical officers and surgeons who are not orthopedic specialists to become confident and competent in irrigation and debridement, powered and manual drilling, positioning and correctly inserting Schanz screws, and constructing the rod-to-rod modular frame as part of external fixation procedures for open tibial shaft fractures performed in regions without specialist coverage.

Overview[edit | edit source]

Global Impact[edit | edit source]

A systematic review of 204 countries estimated there were 455 million prevalent cases of acute or long-term symptoms of a fracture in 2019.[1]. The 2019 global prevalence of fractures of the patella, tibia or fibula, or ankle was 300 million cases resulting in an estimated 15.5 million years lived with disability (YLD). In the United Kingdom, two-thirds of open fractures of these bones were found to be fractures of the tibia or fibula.[2] Open tibial shaft fractures are the most common open long-bone fractures, and absolute fracture counts have been increasing substantially over the past 30 years.[1][3]

In low to middle income countries (LMICs), tibial fractures most often result from motor vehicle accidents, predominantly occur in young male adults (< 40 years, male to female ratio of 3:1), and often lead to reduced quality-of-life, loss of employment, and financial hardship for patients and their young families.[4][5][6] A 2018 Ugandan study found that only 12% of tibial fracture patients had recovered physically and economically at 24 months post-injury.

Access to high-quality orthopedic care in LMICs is limited by a lack of providers, resources, and training programs.[7] The global standard is a ratio of 1 orthopedic surgeon to 200,000 people.[8] In 2008, Uganda reported a ratio of 1 orthopedic surgeon for every 1.3 million people.[9] In 2020, Nigeria had an estimated population of over 206 million people.[10] According to the Nigerian Orthopaedic Association, Nigeria's ratio is 1 orthopedic surgeon to approximately 500,000 people.[8] An estimated 75% of Nigerian orthopedic surgeons are located in 4 major cities which leaves other urban areas and rural regions without coverage.[11]

The national shortages of orthopedic surgeons in LIMCs leaves patients vulnerable to traditional bone setters whose unsafe practices result in worse outcomes compared to no treatment and commonly lead to malunion, limb shortening, gangrene, limb loss, and death.[12][13][14][15][16] A 2007 study of Nigerian healthcare institutions found unacceptably high rates of amputation (57% to 77.8%) and mortality (11.1% to 26.7%) secondary to bone setter's gangrene.[12] A 2004 study on 82 Nigerian patients (median age of 27 years) found that the leading cause for limb amputation (32%) was gangrene resulting from treatment of extremity injuries by traditional bone setters.[13] Since medical officers do not receive adequate exposure to orthopedic surgery during their undergraduate medical education, they often refer fracture patients to traditional bone setters in regions without orthopedic specialist coverage.

In 2022, over 274 million people require humanitarian aid due to emergencies caused by conflict or natural disasters.[17] Nearly 45 million people in conflict zones lack basic access to healthcare.[18] Long bone fractures resulting from penetrating gunshot wounds account for over 25% of injuries sustained in conflict settings.[19] Conflict depletes an already overstretched surgical workforce, as doctors may become internally displaced or are forced to flee.[20] There is a lack of access to high quality surgical education in many conflict zones, as residency training programs either never existed or are closed down due to security risks, economic factors, and a lack of surgical mentors to oversee trainees. Surgeons operating in conflict-affected regions face targeted attacks, often with devastating consequences, which further reduces their numbers.[20][21] The security risks to healthcare workers in conflict zones pose a barrier to recruitment of local and international surgical staff.[20]

A 2017 review paper determined that 87% of injuries requiring treatment after earthquakes were orthopedic injuries, 65% of these injuries were fractures, 22% were open fractures, and the tibia/fibula was the most common fracture location (27%).[22] External fixator frames have been successfully used for orthopedic damage control for mass casualty events.[23][24] Over a 10 day period after the 2010 Haiti earthquake, orthopedists used external fixator frames to stabilize 72 lower extremity fractures (48 femoral fractures, 24 tibial/fibular fractures, and 1 humeral fracture) in a field-style operating room where limb alignment was evaluated via manual palpation, intraoperative imaging was not available, and soft tissue care was provided after bone stabilization.

In 2021, nearly 711 million people were in extreme poverty, which is defined as living on less than $1.90 per day.[25] This module's innovative, open-source, locally reproducible, low-cost, high fidelity, data-driven, gender-specific, labor-saving, eco-friendly, hygienic, and cruelty-free 3D printed bone simulators could empower local 3D printing entrepreneurs in low­ and middle ­income countries to build sustainable livelihoods.[26][27][28][29][30]

This self-assessed training module uses open source, locally reproducible, high fidelity 3D printed bone simulation models to educate and empower physicians who are not orthopedic specialists to perform external fixation procedures as part of the surgical management of open tibial shaft fractures to save limbs and lives. This module teaches essential irrigation and debridement, powered and manual drilling, and modular external fixation skills that are transferable to the performance of other limb-saving and life-saving surgeries that require hardware stabilization and fixation.[31] These skills can be used to prevent needless suffering, disability, and deaths for the estimated 133 million patients who sustain extremity and pelvic fractures globally every year.[1]

Open-Source 3D Printing Technologies for High Fidelity Orthopedic Surgery Simulation Training[edit | edit source]

Open-source 3D printing technology supports the local and automated reproduction of the highest fidelity bone simulation models at the lowest cost for medical officers and surgeons who are not orthopedic specialists in LMICs.

Open-source, open filament and user-friendly desktop 3D printers are currently in use at small to medium enterprises, Makerspaces (including but not limited to approximately 2,000 Fab Labs in over 149 countries), start-up incubators, universities, and hospitals worldwide.[26][27][28][29][30][32][33][34][35][36][37][38][39][40] Our 3D printed bone simulation models are designed to reduce simulator costs, simplify the simulator build, and minimize simulator assembly time for the learner.

This module provides an open source library of downloadable, 3D printed bone simulation models which accurately represent bone length and diameter, external contour and cross-sectional shape, bicortical anatomy, cortical hardness, cancellous bone porosity, and microstructure, and far cortex thickness for both genders at drilling sites for tibial shaft fractures.[41][42][43][44][45][46][47][48][49][50][51][52]

All of the module's 3D printed models can be locally reproduced on open source, open filament, user-friendly, fused deposition modelling, single extruder desktop 3D printers that print polylactic acid (PLA), a low-cost, biorenewable, and biodegradable plastic.[53][54][55][56][57] According to two filament manufacturers, 3D printed PLA at 100% infill has a Shore Hardness D value of 81D, 83D and 84D while independently measured Shore Hardness D values of 3D printed PLA samples range from 80D to 88D (n=12).[44][45][46][47] These Shore Hardness D values of 3D printed PLA are within the 3-sigma range for the Shore Hardness D measurements of 86.7D + 1.91D (ave. ± s.d., n=1815) for human cortical bone.[48]

To maximize the likelihood that these 3D printed models provide similar tactile feedback as human bone and do not foster the development of anti-skills, the bone simulation models are made from PLA, a plastic filament with a hardness level similar to cortical bone, which exhibits force and displacement ratios similar to artificial bone, and whose haptic feedback was rated as similar to bone during drilling by experienced maxillofacial surgeons and surgical residents.[44][45][46][47][48][53][58][59] These bone simulation models are digitally manufactured using customized settings to match age, gender, and bone site-specific cortical thickness values, and cancellous bone porosity values for the target patient population.[4][5][49][50][51][52]

We addressed the shortcomings of 3D printed bone simulation models which lack overlying soft tissue and skin simulation layers in teaching the performance of modular external fixation of an open tibial shaft transverse fracture by highlighting the steps that cannot be performed during simulation training but must be performed during the actual clinical procedure in the training objectives, knowledge objectives, and procedure steps of the skills training module page and the checklist of the training logbook module page. The user's learnings on high fidelity 3D printed bone simulation models will translate into the clinical performance of Modular External Fixation for an Open Tibial Shaft Transverse Fracture which is described in 48 learning objectives on the skills training module page.

Pre-Learning Clinical Confidence Assessment[edit | edit source]

Before the learner starts this module:

  1. Go to this link.
  2. Download, print out, and complete the pre-learning clinical confidence assessment for this training module.
  3. Photograph the completed assessment on your cellphone as a backup and file the assessment in your training records.

Phase 1: Knowledge Review[edit | edit source]

It is highly recommended that the learner be familiar with this content before proceeding to the skill pages.

Phase 2: Simulator Build[edit | edit source]

3D Printed Adult Male Tibial Bone Models[edit | edit source]

The advantage of using 3D Printed Adult Male Tibial Bone Models is that these models are representative of the patient population that the surgical practitioner is most likely to encounter in real clinical scenarios because tibial fractures predominantly occur in young male adults (male to female ratio of 3:1).[4][5] The drawback is the relatively higher cost of the 3D Printed Adult Male Tibial Bone Models due to the greater amount of 3D printed filament required for the thicker far cortex of male adults.[52]

Instructions for 3D Printing Organizations[edit | edit source]

OOjs UI icon notice-destructive.svg

Please pay attention to and follow all the instructions closely to ensure the bone models are printed properly and display the required visual, tactile, and acoustic fidelity for orthopedic surgical simulation training.

  1. Confirm 3D Printing and Delivery Capabilities
  2. Download 3D Print Files
  3. Prepare 3D Print Files
  4. Check Print Settings
  5. 3D Print Sample Models
  6. Calculate Price Quote
  7. Inspect Models Before Delivery

Simulator Assembly[edit | edit source]

Surgical Hardware[edit | edit source]

Any locally available 4.5 or 5.0 mm diameter self-drilling Schanz Screws and compatible modular external fixator hardware, instruments, and surgical drill can be used for this skills training module.

Phase 3: Skills Practice[edit | edit source]

Phase 4: Self-Assessment[edit | edit source]

The Tibial Shaft Transverse Fracture Simulator is designed to include mechanisms for targeted feedback which enables the user to: ensure they are practicing the appropriate skills; modify their performance to improve competence; and determine when they have practiced to a sufficient level of mastery to perform the procedure in a patient.

The transparent cellophane that is wrapped around the 3D printed bone models and simulates the overlying periosteum will permit the learner to visually inspect and confirm post-fixation fracture alignment, the Schanz screws did not perforate the far cortex of the Tibial Shaft Transverse Fracture Simulator, and the Schanz screws are properly positioned medial to the tibial crest 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.[60]

The Training Logbook and Self-Assessment Framework include:

  • Step-by-step procedural checklist to confirm following of the proper modular external fixation technique for open tibial shaft fractures
  • Visual inspection and taking cellphone photos ("digital X-rays") to verify post-fixation fracture alignment, no pin penetration of the far cortex, proper pin positioning in each fracture fragment, and drill trajectory angles are within the acceptable ranges for the safe zones of the tibia

Based on our user testing, we opted not to use Far Cortex Breakthrough Detection or 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 learner dependence on augmented feedback ("anti-skills") since the learner will not have augmented feedback during the real procedure, and
  • this increases simulator fidelity, reduces simulator costs, simplifies the simulator build, and minimizes simulator assembly time for the learner.[61][62]

Training Module Certificate of Completion[edit | edit source]

Once the self-assessment framework has been completed:

  1. Go to this link.
  2. Click on "Get your certificate" button under the "Menu" section in the upper right corner of the module page.
  3. Type in your name, download and print out a certificate of completion for this training module.
  4. Photograph your certificate on your cellphone as a backup and file the printed certificate in your training records.

Post-Learning Clinical Confidence Assessment[edit | edit source]

After the learner completes this module:

  1. Go to this link.
  2. Download, print out, and complete the post-learning clinical confidence assessment for this training module.
  3. Photograph the completed assessment on your cellphone as a backup and file the assessment in your training records.

If the learner does not feel confident in performing this procedure in real clinical scenarios, the learner can repeat this module and practice the skills training as many times as they feel necessary to gain the confidence to perform this procedure on patients.

Supplemental Learning Topics[edit | edit source]

(Optional) After completion of the module, the learner may wish to learn more about 3D printing technology:

Additional Module Information[edit | edit source]

(Optional) After completion of the module, the learner may wish to learn more about this module:

Follow-on[edit | edit source]

(Optional) After completion and practice to competency, the learner may wish to continue study with these courses:

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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FA info icon.svg Angle down icon.svg Page data
Part of Tibial Fracture Fixation
Keywords orthopedic surgery, surgical training, tibial fracture, bicortical drilling, modular external fixation, open tibial shaft fracture, 3d printing, artificial bones
SDG SDG03 Good health and well-being
Authors Medical Makers
License CC-BY-SA-4.0
Organizations Medical Makers
Language English (en)
Translations French, French
Related 19 subpages, 76 pages link here
Impact 9,191 page views
Created June 17, 2021 by Medical Makers
Modified February 28, 2024 by Felipe Schenone
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