Short description
The 3D footplate is a non-commercially viable tool to assist medical imaging of complex hindfoot pathologies. This 'Class I Medical Device' helps to position and fixate the foot to the lower leg, allowing clinical stress tests to be simulated during CT scans. The medicla image acquired can provide quantitative displacements of bones.
What is the 3D Footplate and how can it help in clinical practice?
Currently, laxity and instability of the hindfoot is diagnosed through manual stress tests by a clinician. However, for complex hindfoot problems they cannot distinguish instability on joint level, nor provide quantitative data for preoperative planning. Therefore, a 3D CT-stress test has been developed to obtain quantitative data of the relative positions of the bones (https://doi.org/10.1016/j.jbiomech.2008.02.020). This test mimics the manual stress test as follows: the 3D Footplate allows positioning of the foot relative to the lower leg and holds this position while performing a CT scan (https://doi.org/10.1016/j.ergon.2011.10.006). The foot can be readjusted to a new position to acquire additional imaging. The 3D Footplate has been evaluated for usability (https://doi.org/10.1016/j.ergon.2011.10.006) and is meant to be cleaned and disinfected, but does not have to be sterilised for use. See also https://www.utwente.nl/en/et/be/news-events/2025/6/197708/open-source-accelerates-tools-for-small-patient-groups#the-3d-footplate
Why do we provide the material for the 3D Footplate open source?
The development and market introduction of medical devices often require a lot of time and cost. In addition to compliance with strict Medical Device Regulation, financing and drawing up a business case are also major challenges. Especially for devices aimed at small patient groups or rare diseases, it is difficult to set up a profitable revenue model. As a result, many innovative tools never reach the users who could benefit from them. The 3D Footplate is such an example.
How to use this repository?
This repository does not only provide all material to fabricate the 3D Footplate but also offers a substantial set of documentation to speed up the Medical Device Regulation compliance process.
Best way to start is as follows:
-Order the parts using 3.03.3D Footplate Bill of Materials v1.2
-Laser cut the parts indicated in 3.03.3D Footplate Bill of Materials v1.2, using folder 0302_Technical Drawings and laser settings indicated in 3.04.3D Footplate Lasercutter Settings v1.1
-3D print the parts indicated in 3.03.3D Footplate Bill of Materials v1.2, using folder 0301_3D Models
-Assembly all components using 3.04.3D Footplate Assembly manual v1.1
-Execute tests according to 6.3D Footplate preclinical validation
-Do additional tests to verify, validate or mitigate all risks indicated in 5.3D Footplate Hazard Traceability Matrix v1.1, and all criteria indicated in 3.00.3D Footplate DesDev v1.4 and in 4.01.3D Footplate GSPR checklist v1.3
-Complete documentation to comply with the Medical Device Regulation using remaining document 1.3D Footplate Device Classification v1.1
-To do this process properly consult a MDR expert and study the background material offered in the form of MSc theses, vanElst_MScThesis_UTwente, Masih_MScThesis_UTwente and Norg_MScThesis_TU Eindhoven; and scientific publications as indicated in 1.3D Footplate Device Classification v1.1
-Once all steps are in place, use 2.02.3D Footplate User manual v3.0 for proper use of the 3D Footplate and 2.02.3D Footplate Maintenance manual v1.0 to replace or tweak components
Limitation of liability for documents provide in repository 3D Footplate The authors of this document hereby make no guarantees as to the accuracy, thoroughness or quality of the information in this document, which is provided only on an "AS-IS" and "AS AVAILABLE" basis at the user's sole risk. To the fullest extend the authors disclaim being appointed as the legal manufacturer, that the information provided is sufficient to demonstrate that this medical device is compliant with the Medical Device Regulation, and all warranties regarding the use of the documentation. Always consult with a qualified and trained technical and healthcare professional(s) to manufacture this medical device and perform the necessary additional verification, validation, and documentation to fully comply with the Medical Device Regulation.
License Copyright (c) 2025 Gabrielle Tuijthof This repository describes Open Hardware All material is published under a Creative Commons Attribution-ShareAlike 4.0 license (CC BY-SA 4.0) .