Principal structural testing of trans-tibial prosthetic assemblies: specimen preparation

Area of Science:

• Biomedical Engineering
• Prosthetics and Orthotics
• Materials Science

Background:

• Standardized structural testing of prosthetic devices is crucial for ensuring patient safety and device longevity.
• Accurate alignment of prosthetic components is essential for reliable and reproducible mechanical testing.
• Existing methods may lack the precision required for comprehensive structural analysis according to international standards like ISO 10328.

Purpose of the Study:

• To introduce a simple alignment apparatus for precise load transfer in prosthetic structural testing.
• To validate the efficacy of the apparatus in preparing test specimens for ISO 10328 compliance.
• To assess the structural integrity of prosthetic components under maximum load specifications.

Main Methods:

• Development and utilization of a novel alignment apparatus featuring an aligned mandrel.
• Preparation of test specimens including laminated prosthetic sockets, adaptors, shanks, and foot blocks.
• Execution of static failure tests and cyclic tests according to ISO 10328 standards.

Main Results:

• The alignment apparatus facilitated accurate orientation and positioning of prosthetic components.
• All tested components, including sockets, met maximum load specifications during static failure tests.
• No component failures were observed during cyclic testing, indicating high durability.

Conclusions:

• The presented alignment apparatus is effective for ensuring proper component alignment in prosthetic structural testing.
• The validated prosthetic components demonstrate robust performance and durability under rigorous testing conditions.
• This method supports the development of reliable and safe prosthetic devices compliant with international standards.