2.26 Improving the safety of direct skeletal fixation: Essential information to develop failsafe devices
- 27/04/2023 | 1:00 PM - 2:15 PM
Guadalajara 2, Ground floor
Lower limb amputees with Direct Skeletal Fixation (DSF) prostheses require a failsafe device to protect the bone and implant from mechanical overload. Although several failsafe devices have been developed, they are each based on different design criteria particularly related to the type of load (direct forces, bending moments, or torsional moments) they protect against and the magnitudes of loads at which the devices are triggered. Consequently, the extent of protection against overload varies between devices and makes comparisons between devices problematic. To address some of the challenges associated with testing failsafe devices, the ARC Training Centre for Medical Implant Technologies (cmit.arc.edu.au) hosted a virtual workshop with major DSF implant manufacturers in August 2020. Critical questions raised at the event included: Are standards required for the failsafe device? What are the safety concerns relating to the failure of a failsafe device? Is it to prevent bone fracture? Is it to avoid implant failure? What type of prosthetic loading profile data is currently used by engineers to inform the design of the failsafe device? The proposed symposium aims to address some of these questions by presenting:
1. Limitations of using the current ISO10328 to test failsafe devices.
2. The state-of-the-art in-vivo measurement techniques and data of loadings in patients with DSF.
3. Experimental and computational modelling technique to develop a safety envelope for designing failsafe devices.
The overarching goal is to establish a test standard for DSF failsafe devices to protect against mechanical overload and to ensure patient safety.
Statement of the objective / learning objectives
Identify the critical relationship between safety, efficacy and daily loading profile applied on Direct Skeletal Fixation.