Does socket liner material affect clinical outcomes in lower limb prosthesis users? Insights from a randomized...

Area of Science:

• Biomedical Engineering
• Prosthetics and Orthotics
• Materials Science

Background:

• Flexible prosthesis liners can cause increased perspiration, leading to discomfort, suspension problems, and tissue damage.
• Phase change materials (PCMs) integrated into prosthesis liners offer potential for improved temperature regulation and reduced sweating.
• Previous research confirmed PCM liners slow temperature rise at the limb-socket interface, but clinical outcome data were lacking.

Purpose of the Study:

• To compare conventional liners with phase change material (PCM) liners.
• To evaluate differences in prosthesis utilization, physical performance, and patient-reported outcomes.

Main Methods:

• A randomized, double-blind, cross-over study design was employed.
• Participants experienced 6-month intervention periods with both conventional and PCM liners.
• Participant completion was impacted by the COVID-19 pandemic, leading to a reduced sample size.

Main Results:

• Temperature control liners showed a trend towards improved prosthesis utilization.
• The observed effects did not achieve statistical significance.
• Reduced sample size due to high attrition is a likely reason for non-significant findings.

Conclusions:

• PCM liners show potential for enhancing prosthesis utilization through better temperature management.
• Further research with adequate sample size is needed to confirm the clinical efficacy of PCM liners.
• The study highlights the challenges in conducting clinical trials during global health crises.