Dataset Information

Clinical Outcome of Transfemoral Direct Socket Interface (Part 2).

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.

SUBMITTER: Walker J

PROVIDER: S-EPMC10443471 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Publications

Clinical Outcome of Transfemoral Direct Socket Interface (Part 2).

Walker J J Marable W R WR Smith C C Sigurjónsson B Þ BÞ Atlason I F IF Johannesson G A GA

Canadian prosthetics & orthotics journal 20210608 1

<h4>Background</h4>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 a ...[more]

PMID: 37614937

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Project description:BackgroundDirect Socket for transfemoral (DS-TF) prosthetic user is a novel method of fabricating a laminated interface on to the residual limb but requires different training, production method and service model than what most prosthetists are familiar with. This method and model may improve patient satisfaction by enabling interface fabrication and delivery in one visit.ObjectivesDocument patient satisfaction regarding DS-TF interface versus the prosthetic users' previous socket in terms of interface function and the clinic service model.MethodologyIn this longitudinal study (from July 2018 to April 2020), the DS-TF was implemented in six prosthetic clinics across the United States. Certified prosthetists (CP) and assistants were trained using a standard protocol. 47 prosthetic users participated, both those in need of a new socket and those without need. Two modules from the Orthotics and Prosthetics Users' Survey (OPUS), involving questions related to satisfaction with the Device and Services, was used to evaluate each DS-TF user outcome vs. baseline. The only part of the prosthesis that was replaced was the interface, except in 2 cases.FindingsEach DS-TF interface was fabricated, fit and delivered in a single clinic visit. At 6-months follow-up, 38 users reported an average of 29.8% increase in satisfaction with their new interface compared with original, and a 14.8% increase in satisfaction with the services they received from the clinic in providing of the new prosthesis vs. their original prosthesis. The main outcome increases were between baseline (initial fitting) and 6-week follow-up and remained consistent after 6 months. This improvement was consistent irrespective if the user needed a new socket for clinical reasons or not.ConclusionsThis study shows that after a standardized training and implementation, the DS-TF fabrication process including a new interface, improves the user's satisfaction with their prosthetic device and services.

Project description:BackgroundAmong the different factors affecting socket comfort, the pressure applied on residual limb tissues is a crucial parameter for the success or failure of any prosthetic device. However, only a few incomplete data are available on people with transfemoral amputation, in this regard. This work aims at filling this gap in the literature.MethodsTen people with transfemoral amputation wearing 3 different socket designs were recruited in this study: 2 ischial containment sockets featured by proximal trim lines that contain the ischial tuberosity and ramus and greater trochanter, 2 subischial sockets with proximal trim lines under the ischium level, and 6 quadrilateral sockets with proximal trim lines that contain the greater trochanter and create a horizontal seat for the ischial tuberosity. The pressure values at the anterior, lateral, posterior, and medial areas of the socket interface were recorded during 5 locomotion tasks (ie, horizontal, ascent, and descent walking, upstairs and downstairs) by using an F-Socket System (Tekscan Inc., Boston, MA). Gait segmentation was performed by exploiting plantar pressure, which was acquired by an additional sensor under the foot. Mean and standard deviation of minimum and maximum values were calculated for each interface area, locomotion task, and socket design. The mean pressure patterns during different locomotion tasks were reported, as well.ResultsConsidering all subjects irrespective of socket design, the mean pressure range resulted 45.3 (posterior)-106.7 (posterior) kPa in horizontal walking; 48.3 (posterior)-113.8 (posterior) kPa in ascent walking; 50.8 (posterior)-105.7 (posterior) kPa in descent walking; 47.9 (posterior)-102.9 (lateral) kPa during upstairs; and 41.8 (posterior)-84.5 (anterior) kPa during downstairs. Qualitative differences in socket designs have been found.ConclusionsThese data allow for a comprehensive analysis of pressures acting at the tissue-socket interface in people with transfemoral amputation, thus offering essential information for the design of novel solutions or to improve existing ones, in this field.

Dataset Information

Clinical Outcome of Transfemoral Direct Socket Interface (Part 2).

Background

Objectives

Methodology

Findings

Conclusions

Publications

Clinical Outcome of Transfemoral Direct Socket Interface (Part 2).

Similar Datasets

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