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. 2021 Jun 8;4(1):36065.
doi: 10.33137/cpoj.v4i1.36065. eCollection 2021.

Clinical Outcome of Transfemoral Direct Socket Interface (Part 2)

J Walker  1 , W R Marable  2   3 , C Smith  3 , B Þ Sigurjónsson  3 , I F Atlason  3 , G A Johannesson  1
Affiliations

Clinical Outcome of Transfemoral Direct Socket Interface (Part 2)

J Walker et al. Can Prosthet Orthot J. .

Abstract

Background: Amputation at the transfemoral (TF) level reduces the rate of successful prosthetic fitting, functional outcome, and quality of life (QoL) compared with transtibial amputation. The TF socket interface is considered the most critical part of the prosthesis, but socket discomfort is still the most common user complaint. Direct Socket for transfemoral prosthesis users is a novel interface fabrication process where the socket is shaped and laminated directly on the residual limb and delivered in a single visit.

Objectives: The aim of this study was to investigate if prosthetic users' quality of life (QoL), comfort, and mobility with a Direct Socket TF interface were comparable to their experience with their previous prostheses.

Methodology: The pre/post design prospective cohort study included 47 subjects. From this cohort, 36 subjects completed the 6-months follow-up (mean age 58 years, 27 males). Outcomes at baseline included EQ-5D-5L®, PLUS-M™, CLASS, ABC, AMPPRO, and TUG. At 6-weeks and 6-months, subjects repeated all measures. Seven Certified Prosthetist (CP) investigators performed observations and data collection at six different sites (from July 2018 to April 2020).

Findings: Results showed significant improvement in all outcome measures for the 36 subjects that completed both 6-weeks and 6-months follow-ups. CLASS sub-scales showed significantly improved stability, suspension, comfort, and socket appearance. Improvement in K-Level and less use of assistive devices were observed with the AMPPRO instrument, indicating improved user mobility and performance. QoL was also increased, as measured in Quality-Adjusted-Life-Years (QALY) from the EQ-5D-5L.

Conclusions: Evidence from the findings demonstrate that the Direct Socket TF system and procedure can be a good alternative to the traditional method of prosthetic interface delivery.

Keywords: Amputee; Comfort; Direct Casting; Health; Interface; Outcome Measure; Prosthesis; Satisfaction; Socket; Transfemoral Amputation.

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Conflict of interest statement

All authors are employees of össur HF except I. F. Atlason. Study principle investigators received no compensation from össur HF.

Figures

Figure 1:
Figure 1:
Flow chart of the trial.
Figure 2:
Figure 2:
Age groups at 6MFU divided into “clinical need” (N=26) and “no clinical need” (N=10).
Figure 3:
Figure 3:
CLASS score at baseline (with existing socket) and at delivery of the new socket, including follow-up at 6 weeks and 6 months.
Figure 4:
Figure 4:
Changes from Baseline to 6MFU in K Levels using the AMPPRO Score, and assistive device use.
Figure 5:
Figure 5:
A: Illustrating changes (index value from 0-100%) in outcomes for all participants that completed the study from Baseline (Orange) to 6MFU (Blue) for all measures except TUG. B and C: Illustrating changes (measured on a scale from 0-100%) in outcomes for the “clinical need” sub-group and the “no clinical need” sub-group (5C), from Baseline (Orange) to 6MFU (Blue) for all measures except TUG.
See this image and copyright information in PMC

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