Clinical Outcome of Transfemoral Direct Socket Interface (Part 2)

Area of Science:

• Prosthetics and Orthotics
• Rehabilitation Engineering
• Biomedical Engineering

Background:

• Transfemoral (TF) amputation presents challenges in prosthetic fitting, functional outcomes, and quality of life (QoL).
• Socket discomfort is a primary complaint among TF prosthesis users.
• The Direct Socket TF is a novel, single-visit interface fabrication process.

Purpose of the Study:

• To evaluate the quality of life (QoL), comfort, and mobility of transfemoral (TF) prosthesis users with the Direct Socket interface.
• To compare user experience with the Direct Socket TF interface against their previous prostheses.

Main Methods:

• A prospective cohort study with a pre/post design involving 47 subjects.
• 36 subjects completed a 6-month follow-up, with outcome measures assessed at baseline, 6 weeks, and 6 months.
• Standardized outcome measures included EQ-5D-5L, PLUS-M, CLASS, ABC, AMPPRO, and TUG.

Main Results:

• Significant improvements were observed in all outcome measures for subjects completing the study.
• The Direct Socket TF interface demonstrated enhanced stability, suspension, comfort, and appearance (CLASS).
• Improved mobility, performance (K-Level), and increased QoL (QALY) were noted.

Conclusions:

• The Direct Socket TF system provides a viable alternative to traditional prosthetic interface delivery methods.
• This novel approach shows potential for improving outcomes for transfemoral amputees.