Lower limb direct skeletal attachment. A Yucatan micropig pilot study.

Area of Science:

• Biomedical Engineering
• Orthopedic Research
• Prosthetics and Orthotics

Background:

• Successful prosthetic lower limb ambulation relies heavily on secure prosthetic attachment.
• Conventional prosthetic sockets present challenges, driving the need for alternative attachment methods.
• Direct skeletal attachment (DSA) offers a potential solution to improve prosthetic integration.

Purpose of the Study:

• To evaluate the feasibility of lower limb direct skeletal attachment (DSA) in a micropig model.
• To develop a systematic approach for the design and analysis of DSA systems.
• To assess the stability and infection control of a novel DSA device.

Main Methods:

• Designed a two-stage DSA device incorporating a load-carrying bone-embedded stage and a skin-interfacing stage.
• Utilized bone remodeling theory and finite element analysis for the load-carrying stage design.
• Surgically implanted the DSA device in Yucatan micropigs for a 10-week trial.

Main Results:

• The animal trial successfully progressed for 10 weeks, with no signs of infection observed.
• Potential surgical protocol flaws related to thermal necrosis were identified.
• Implant retrieval confirmed the absence of infection, supporting the barrier function of the skin-interfacing stage.

Conclusions:

• Results from this pilot study indicate the feasibility of direct skeletal attachment for prosthetic limb applications.
• The DSA approach shows potential for stable prosthetic integration and infection prevention.
• Further animal trials are required to validate the long-term viability and refine surgical protocols for DSA systems.