Page 100 - REV T-I JOURNAL INTERIOR ISSUU 18 2-3

176 KAHLE ET AL.

INTRODUCTION fluctuations require an iterative process involving
In the U.S., approximately two million people numerous trips to the prosthetist for socket adjust-
live with limb loss (1). It is estimated that by 2050, ments. Poor fit can lead to prosthetic abandonment
nearly 3.6 million Americans will be living with (9). RL volume management is a common issue for
lower extremity (LE) limb loss (1). Of the two mil- prosthetic users, especially during the intermedi-
lion American amputees, approximately 86% are ate recovery stage of amputee rehabilitation when
individuals living with lower limb loss and 18.5% the most rapid volume fluctuation occurs (7). It has
have transfemoral amputation (TFA) (2). In spite of been shown that limb volume decreases 17% to 35%
this increasing amputee population, there is limited over the first 160 d post amputation, 7% to 10% in
prosthetic research, resulting in healthcare service the 12-month post-operative period and approxi-
gaps, excess hospital utilization, and increased cost mately 2% on a daily basis thereafter, thus requiring
to patients and payors (3). Addressing these issues is patient-provider coordination (7,10). In addition,
of critical importance since rehabilitation care, fitting chronic volume change may continue for up to 12
of prostheses, and adjustment of devices alone were to 18 months post amputation due to tissue atrophy
the fifteenth most expensive condition treated in U.S. and indefinite diurnal volume fluctuations. Poor vol-
hospitals in 2011, with a total cost of more than $5.4 ume management can result in a variety of secondary
billion (4). adverse effects of prosthetic use, including ulcers,
The socket-limb interface is vital for functionality verrucous hyperplasia, and osteomyelitis (7). These
and provides stability and mobility for the ampu- effects may lead to further amputation and re-hospi-
tee. An inadequate fit may lead to skin breakdown, talization, which contributes to the annual $8 billion
thereby limiting mobility and requiring additional expenditure on amputee hospital care (11).
clinician time, replacement components, and a pos- Traditional rigid sockets do not accommodate vol-
sible remaking of the prosthesis altogether (5). As a ume fluctuations. Poor fit can cause skin ulcerations
result, Medicare data shows that 45% of the overall and infection and may lead to revision amputation
$750 million in Medicare expenditures on prosthetic (12). Furthermore, socket discomfort is common
among LE amputees and may delay prosthetic use,
technology each year were for socket-related codes.
Successful socket fitting reduces this economic prevent return to normal function, compromise
burden and increases prosthetic usage. Amputees patient outcomes, and increase healthcare costs. The
encounter multiple challenges during their recovery, primary cause for failure of amputee prostheses is
user dissatisfaction associated with poor socket fit
rehabilitation, and reintegration into their homes and and comfort (9,12-14). In addition to the unmet
communities. Learning and adopting new strategies need in addressing comfort, there is a considerable
for basic mobility, personal hygiene, and activities of technology gap in the area of socket fabrication and
daily living with a prosthesis is difficult (6). Compli- access. Therefore, the objective of this prospective
cating this process, the residual limb (RL) naturally experimental clinical case study is to compare the
goes through a period of volume fluctuation post effectiveness of the standard of care (SOC) ischial
amputation that impacts fit (7). Newly amputated ramus containment (IRC) to an adjustable transfemo-
limbs commonly undergo reduction in size, shape, ral prosthetic interface socket in the accommodation
and volume (7,8). This progression occurs in two of volume fluctuation by observing both functional
phases: 1) rapid, acute shrinkage immediately fol- and subjective outcomes.
lowing amputation and 2) progressive stabilization of
volume one year post amputation. These changes are METHODS
dependent on individual lifestyle, activity level, and Methods were in accordance with the Declaration
weight. Moreover, amputees experience daily volume of Helsinki, and the subjects provided informed con-
fluctuations influenced by multiple factors, including sent.
diet, environment, and weather conditions. These