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Section 2: Upper Limb
Figure 3
distal-level donor hand that has been dissected, tagged, and preplated for transplantation.
(Copyright Jaimie T. Shores, M D, Baltimore, MD.)
Intraoperative photograph of a
Surgery commences with the arrival
and inspection of the donor limbs. One
surgical team per recipient and one surgical team per donor limb are used. Simultaneous dissection of the donor and
recipient limbs is performed with skin
flap elevation 90° opposite one another
(volar dorsal skin flaps on one limb, radial ulnar skin flaps on another limb),
with each tendon, muscle, nerve, vein,
and artery on each limb being tagged.
Hybrid forearm lengths are determined
based on the contralateral limb or a projected “normal,” which is symmetric in
the case of bilateral transplants. All dissection on the donor limbs is performed
on sterile ice with towels between the
tissue and ice to keep the limb cool
during the surgery right up until the
arterial clamps are removed to initiate
reperfusion.
34,35
Distal Forearm Level
Radial and ulnar skin flaps are elevated
on the donor limb using a carpal tunnel
incision with zigzag extension across
the wrist creases and midaxis incision
down the forearm. The dorsal incision
is midaxis as well. All veins are tagged
and preserved if possible. The radial and
ulnar arteries are not overdissected, and
their perforators are left intact within
the septae to the skin flaps. All structures are tagged (Figure 3). The radius
and the ulna are preplated in neutral
forearm rotation. The authors of this
chapter have used long, locking distal
radius plates as well as locking distal
ulna plates for fixation.
The recipient residual limb is dissected under sterile tourniquet with
volar and dorsal skin flaps using a radial-to-ulnar fish-mouth incision and
elevated skin flaps. Radial and ulnar
artery perforators are preserved where
possible. Tendons are identified based
on position and tagged, as are vessels and nerves. Bones are débrided
to healthy levels and then measured.
The total forearm length is determined,
and corresponding osteotomies for the
donor limb are marked. After this dissection is completed, the tourniquet is
removed.
34,35
The donor limb plates are removed,
and osteotomies are performed. An
oblique ulnar osteotomy may be used,
and the plates are replaced. The osteosynthesis and condensation of two
teams to one is then performed. Again,
the surgery continues with sterile ice
packed beneath the donor limb under
sterile towels. After the osteosynthesis
is complete, a Pulvertaft weave reconstruction of all extensors is typically
performed, first pulling the metacarpophalangeal joints into hyperextension with the wrist in neutral position.
Then the flexor tendons are reconstructed with Pulvertaft weaves, pulling the
digits into a standard flexed cascade.
After the tendons are completed, a
microscope is brought in, and either the
34-36
arteries or the nerves may be coapted
next. The benefit of the nerve-next
sequence is the benefit of performing
nerve coaptations in a bloodless field,
which can be more rapid and accurate. If
individual motor and sensory groups are
identified within the median and ulnar
nerves, these can be repaired individually. The superficial radial nerve also is
repaired. Depending on preference and
availability, the antebrachial cutaneous
nerves may or may not be repaired.
The arteries are then repaired, usually in end-to-end fashion. The anterior interosseous artery also may be
repaired if it appears especially large.
The vena comitantes may be repaired
at this time as well. The superficial
veins are left open. At this time, the ice
is removed, the clamps are left on all
repaired veins, the clamps are removed
from the repaired arteries, and reperfusion is initiated. The authors of this
chapter typically give a bolus of heparin
and steroids systemically for this step for
ischemia-reperfusion injury. Egress of
blood, which can be collected for washing/purification and autotransfusion, if
desired, is allowed into a basin. Allogeneic blood transfusion is usually required before and during this step, with
leukoreduced and irradiated packed red
blood cells. In addition, fresh frozen
plasma should be given in a 1:1 or 2:1
ratio of packed red blood cells to fresh
frozen plasma.33 After the egressing
blood becomes a more normal bright
red color, the clamps can be removed
from the repaired veins to allow normal
venous return with anesthesia on standby for metabolic derangements. The
remaining superficial and deep veins
are repaired. Any remaining tendons,
such as the flexor carpi radialis or flexor
carpi ulnaris that may have obscured
the vessels previously, are now repaired.
Hemostasis is achieved, and the inter
digitating skin flaps are assessed for
perfusion and inset over closed suction
drains. The wrist is splinted in neutral
position with the digits left free to begin
Atlas of Amputations and Limb Deciencies, Fourth Edition © 2016 American Academy of Orthopaedic Surgeons
412
Chapter 33: Hand Transplantation
immediate active and passive motion
therapy, if this can be tolerated based
on the quality of the tendon repair.
34,35
Midforearm Level
The same skin incisions and procedures
described for transplantation at the distal forearm level are performed for the
midforearm level (Figure 4). The key
differences are the lack of tendon for
Pulvertaft-type tendon repairs or reconstructions, more proximal neurorrhaphies, and more proximal bone fixation.
Osteosynthesis is performed with 3.5mm forearm plates on the radius and
2.4- to 3.5-mm plates on the ulna, as
indicated. A technique using an oblique
osteotomy of the ulna and an ulnar
shortening plate for osteosynthesis has
been described.37 Muscle-tendon unit
repairs are typically within the muscle
substance and fascia and are performed
with multiple woven synthetic sutures.
These may be reinforced with overlaid
or woven tendon or fascial grafts as
desired or necessary. Vascular reconstructions and nerve reconstructions are
performed as described previously. The
skin flaps are trimmed and inset, as allowed by their postreperfusion patterns,
over closed suction drains. The forearm
and wrist are splinted in neutral flexion and extension. The digits may be
left free or splinted in the intrinsic-plus
position as desired.
Proximal Forearm Level
For transplantation at the proximal
forearm level, the recipient limb skin
flaps are made volar/dorsal, and the donor skin flaps are made radial/ulnar.
The donor flexor/pronator origin and
extensor origins are dissected off the
medial and lateral epicondyles and the
radiocapitellar joint after a longitudinal
incision down the subcutaneous border
of the ulna. The volar muscle mass does
not require much dissection, which is
left for later and performed only as
much as necessary for brachial artery
and median nerve reconstruction. This
“sleeve” of muscle is elevated off the
supracondylar humerus procurement
level donor arm and elevated distally
on the dorsal side past the point of
desired osteotomy to allow for adequate plate placement. Both plates are
placed through this dorsal approach.
The volar muscle attachments to the
forearm bones distal to the osteotomy
are undisturbed. Great care is taken to
prevent injury to the posterior interosseous nerve or its branches during the
dissection. Individual branches of the
radial nerve into the superficial radial
nerve, posterior interosseous nerve, and
extensor carpi radialis brevis branch
may be identified and tagged. After the
position of osteotomy has been decided
(and if helpful), the forearm bones may
be temporarily locked into the desired
position of rotation with Kirschner
wires on both the donor and recipient
to aid in osteosynthesis. The authors of
this chapter use the ulnar shortening
osteotomy plate technique for osteosynthesis of the ulna along the subcutaneous border and a 3.5-mm metaphyseal
locking compression plate for the radius
dorsally, again taking care to not damage the posterior interosseous nerve
on either the donor or recipient sides.37
The residual volar/dorsal muscle masses
of the recipient proximal forearm are
left in place. The donor flexor/pronator
and extensor muscle masses are draped
over the recipient muscle masses and
anchored into the medial and lateral
epicondyles with suture anchors and
reinforced with fascia-to-fascia suture
repairs.
38
Nerve transfers are then performed
by denervating the recipient native
forearm muscles and transferring the
divided nerves into the donor nerves
with direct coaptations. The posterior
interosseous nerve, the superficial radial
nerve, and the extensor carpi radialis
brevis branch of the radial nerve are
repaired individually. The superficial
head of the pronator teres may require
division for the median nerve repair at
Figure 4
a recipient’s limb that has been dissected and
tagged and is ready to receive a midforearm
level transplant. (Copyright Jaimie T. Shores,
MD, Baltimore, MD.)
Intraoperative photograph of
the level of the first motor branch to the
pronator teres. The ulnar nerve is transposed anteriorly before muscle mass
anchoring, and a hybrid level of subcutaneous versus intramuscular transposition is achieved. The nerve is repaired
at the level of its first motor branch. The
brachial artery may be repaired either
end to end or end to side. The benefit
of end-to-side anastomosis is that some
direct perfusion to the now denervated
recipient muscle mass and the proximal
radius and ulna can be maintained. All
available veins (superficial and deep) are
anastomosed. Hemostasis is achieved,
and interdigitating skin flaps are closed
over drains. The elbow is splinted in 90°
of flexion with neutral forearm rotation
and neutral wrist flexion and extension.
The digits are left free.
Transhumeral Level
Most transhumeral transplants have
used the recipient’s own elbow flexors
and extensors to power the elbow, and
procurement is performed at the middle
to upper humerus level. Anterior and
posterior skin flaps are elevated on the
recipient, and medial-lateral skin flaps
are elevated on the donor without extending the incisions down to the olecranon. The recipient brachialis, biceps,
© 2016 American Academy of Orthopaedic Surgeons Atlas of Amputations and Limb Deciencies, Fourth Edition
413
Section 2: Upper Limb
and triceps muscles are dissected.
Keeping some amount of scar on the
distal muscle and all possible tendon
is helpful.39 The donor muscles are dissected, and if adequate muscle length is
present on the recipient side, the muscle
tissue can be removed from the donor
leaving only the biceps tendon, the brachialis fascia, and the triceps tendon
and fascia. However, if adequate muscle
length is not present, some amount of
muscle may be left on the donor. The
recipient humerus is shortened back
to fresh, healthy bone, and the donor humerus osteotomy is planned to
re-create symmetric upper arm length.
A single 4.5- or 3.5-mm metaphyseal
locking compression plate may be used
for osteosynthesis, with an anterolateral
approach through the brachialis/brachioradialis interval. The donor limb
may be preplated. Plate removal and
osteotomy are then performed. The
plate is replaced so that osteosynthesis
can commence. Muscle repair or reconstruction is then performed. Muscle/
scar to muscle or muscle/scar to tendon/
fascia repairs are performed, depending
on the level. Fascial or tendon autografts
or allografts may be used for weaves or
onlay reinforcement if desired. The triceps should be repaired first, followed
by the elbow flexors, the radial nerve,
the median nerve, and the ulnar nerve
after anterior transposition. All tendons
and nerves should be coapted as distally as possible. The brachial artery and
veins are then repaired. It is important
to make sure that there is no substantial
redundancy in the brachial artery to
prevent kinking of the artery during
elbow flexion.36 All superficial and deep
veins available are anastomosed. Hemostasis is then obtained, and skin flap
closure is performed over drains. The
elbow is splinted in 90° of flexion with
neutral forearm rotation and the wrist
in neutral flexion and extension. Elbow
motion is prevented for 6 weeks. Wrist
and digit passive motion may begin
immediately.
Postoperative Care
The surgical or transplant intensive
care unit is used for initial postoperative management. Various monitoring
devices may be used to assess perfusion,
including, for example, clinical assessment of color and capillary refill, pulse
oximetry probes placed on both the radial and ulnar digits compared between
hands or another reference point on the
body to assess both waveform and saturation, handheld Doppler monitors, and
implanted venous or arterial Doppler
devices. Dressings are typically changed
on postoperative day 2 or 3, and therapy
commences at this time. The indwelling
peripheral nerve catheters are bolused
with local anesthetic in the operating
room after the microvascular surgery is
completed and are used for postoperative pain control combined with multimodal analgesia that is managed by
the acute pain management team. Specialists in transplant infectious diseases
help manage necessary postoperative
antibiotics. No casts or circumferential
rigid binding is placed because swelling can be substantial in the first week.
After the surgical team is confident that
intensive-level monitoring is no longer
necessary, the patient can be moved to a
standard transplant floor for continued
recuperation.
Immunotherapy
Currently, there is no agreement at
transplant centers on a standard immunotherapy protocol, but patients
should expect to be placed on lifelong
immunosuppression of some sort.40
Most immunotherapy protocols are
adapted from solid organ transplantation, with, at least initially, a polyclonal
or monoclonal antibody induction therapy followed by traditional triple drug
combinations of corticosteroids, tacrolimus, and mycophenolate mofetil for
maintenance therapy. Some centers, on
a patient-by-patient basis, have weaned
patients from steroids and may later attempt a slow conversion from tacrolimus
to sirolimus to mitigate long-term re
nal toxicity. In addition, a cell-based
immunotherapy protocol using donor
bone marrow combined with monoclonal antibody induction and tacrolimus
monotherapy has been successfully used
and reported.36 Rejection is typically
first identified in the skin and is a very
dynamic process, usually presenting as
an erythematous maculopapular rash,
with or without swelling. It can progress
to coalescent patches of erythema and
even blisters and ulceration. Skin biopsy
is the standard diagnostic tool for acute
rejection using the classification criteria
created in Banff, Canada.
41-4 3
Transplant
vasculopathy also has been described;
however, it is not apparent if this is
chronic rejection that is cell mediated or
antibody mediated against alloantigens
or stimulated by mechanical trauma
during vessel dissection, which is more
nonspecific. High-resolution ultrasonography can be used for noninvasive
monitoring of vessel wall thickening and
narrowing of the luminal diameter.
44,45
All transplant patients will experience
rejection episodes that can be treated
topically at the skin level (with topical
tacrolimus and steroid creams) and/or
systemically.
Complications
Complications can be related to (1)
the transplant itself, including surgical
complications (for example, bleeding,
hematoma, tissue necrosis, or immediate limb loss caused by vascular complications), subacute complications
in the limbs (wound healing complications, nonunions, or chronic pain),
chronic complications (for example,
poor functional outcomes, poor motor
or sensory recovery, rejection, or limb
loss); (2) the overall procedure of transplantation (for example, heart attack,
stroke, death, blood clots, thromboembolism, pneumonia); or (3) the effects
of the immunomodulatory medications
(for example, renal injury, malignancy,
opportunistic or higher susceptibility to
Atlas of Amputations and Limb Deciencies, Fourth Edition © 2016 American Academy of Orthopaedic Surgeons
414
Chapter 33: Hand Transplantation
serious and life-threatening infections,
rejection, hypertension, diabetes mellitus, leukopenia, osteonecrosis, Cushing
syndrome, or serum sickness).
36,4 0,46,47
All patients should be monitored closely
by experienced transplant physicians
for the rest of their lives for both surveillance and management. For these
reasons, many centers worldwide are
developing or have already implemented novel immunotherapy protocols to
mitigate these risks. It should be noted
that all of these complications have been
reported in hand transplant patients.
Outcomes
Outcomes are difficult to assess because of a lack of standardization in
the measurement of outcomes, the nature of differing functionality expected
by differing levels of amputation, the
unique anatomic features of each limb
loss and the subsequent transplant, and
the overall low numbers of transplants
performed. In the worldwide experience, at least 107 hand or upper limb
transplants have been performed on 72
patients (with at least 3 patients and 4
limbs transplanted that are known to
this chapter’s authors but not yet reported).40 In patients with reported outcomes for isolated hand or upper limb
transplantation in China, Europe, and
North America, one patient has died,
resulting in a 99% patient survival rate.
However, at least four cases of combined face plus hand or hand plus leg
transplantation have been performed in
France, the United States, and Turkey.
Three of the four patients died, resulting in a 75% mortality rate for multisite
(unilateral or bilateral upper limb plus
another body region) VCAs.
one patient who survived ultimately
lost both transplanted hands but had
survival of the face transplant after
an immediate postoperative episode
of septic shock. Although at least 7 of
12 patients in the Chinese experience
had transplanted hand loss because of
a lack of access to immunosuppressive
48,4 9
The
medications and/or compliance, the
Western European, Australian, and US
experiences have shown more encouraging results.40 In the United States, 21
patients have undergone isolated unilateral or bilateral hand or upper limb
transplantation, with more patients
known to the authors of this chapter
but not yet reported. Of those reported,
8 were bilateral, and 13 were unilateral, with 2 transhumeral transplants. Of
these 21 patients, only 1 patient sustained an immediate transplant loss
(during the initial hospitalization). A
second patient experienced partial graft
losses with some fingertip necrosis but
overall survival of the transplanted
hands. Long-term follow-up of the remaining 20 patients has demonstrated
delayed graft loss in 3 patients (at 9
months after the transplant resulting
from aggressive vasculopathy of unknown origin, at 2 years resulting from
noncompliance and advanced rejection,
and at 4 years resulting from noncompliance and advanced rejection). In the
Western European and Australian experiences, 30 patients have been reported
to receive 47 hand or upper limb (17 bilateral, 13 unilateral) transplants in isolation. There has been one immediate
postoperative loss and one long-term
loss resulting from noncompliance and
uncontrolled rejection.
With regard to functional outcomes,
it may take several years before maximal improvement is observed in motor
recovery for more proximal transplants;
sensation continues to improve year by
year in the transplant. Therefore, reported data may be only a snapshot
of a dynamic functional recovery that
patients experience. In addition, no single validated instrument for functional
measurement for hand transplants exists; thus, the Hand Transplant Scor
ing System was developed. In addition,
most centers report Disabilities of the
Arm, Shoulder and Hand scores and
other functional tests in an individual,
center-by-center manner.
46,47
A single repository exists at some
participating centers, which is managed
by the International Registry on Hand
and Composite Tissue Transplanta-
46,47,50,51
tion.
This registry has published
summative functional outcome results
of early transplant patients in the years
2005, 2007, 2008, 2010, and 2011. Most
of the data is for transplants at the distal
and middle forearm levels; few proximal
level transplants are included. The registry summarized 39 patients with 57
upper limb transplants with follow-ups
ranging from 6 months to 3 years in
the most recent publication.46 The registry demonstrated that, at the least,
protective sensation developed in all of
the patients within the first year after
transplantation, and tactile or discriminative sensibility developed in 90% of
the patients as time progressed.47 The
Hand Transplant Scoring System result,
which is a measure of function after a
hand transplant, demonstrated substantial improvement within the first 2 years
and continued improvement over time
in those with bilateral transplants, with
a more gradual improvement in those
with a unilateral transplant. The Disabilities of the Arm, Shoulder and Hand
score demonstrated the most substantial
improvement in patients with bilateral
transplants, with the most significant
decrease in disability within the first 2
years. Greater than 75% of the patients
also reported improvement in their
quality of life after transplantation.
Evolving Issues and
the Future of VCA
Hand transplantation has seen success,
and the future holds remarkable promise for this restorative treatment option.
Orthopaedic surgeons must, however,
reevaluate what has and has not worked
-
and continuously reevaluate the current
public and medical field acceptance of
allotransplantation. Many obstacles remain, including funding, immunology,
candidate selection, and the long-term
assessment of outcomes. The future of
47
© 2016 American Academy of Orthopaedic Surgeons Atlas of Amputations and Limb Deciencies, Fourth Edition
415
Section 2: Upper Limb
VCA must be approached with cautious
optimism, and physicians must continue to evaluate all they do with bench
science, the peer review of clinical outcomes (both good and bad), and the
ethical treatment of their patients.
13
Recently, the United Network for Organ Sharing and the Organ Procurement
and Transplantation Network became
involved in VCA. Currently, a United
Network for Organ Sharing VCA committee has established criteria for VCA
centers, including institutional capability, surgeon and team preparation,
and specific guidelines for allocation
and distribution of hands and faces to
VCA centers. This oversight and regulation has been welcomed by the VCA
community and has served as recognition that VCA is indeed a part of the
transplantation community. Although
hands and arms have been transplanted successfully, the future of VCA will
likely—eventually—expand to include
partial hand transplants, digital transplantation, vascularized joint transfers
(such as at the elbow or the wrist),
and pediatric hand transplantation if
immunosuppressive side effects can be
minimized. In select cases, VCA is an
alternative to prosthesis use and must
be considered as a restorative option for
some patients with upper limb loss.
Summary
Although successful transplantations
have been performed at the hand and
other upper limb levels, the future of
VCA is unclear. This modality holds
incredible promise, but functional
outcomes need to be more adequately
defined in the literature to allow comparison with more traditional treatments of upper limb loss. Screening
protocols for VCA require optimization
based on collective reporting of experiences throughout the world. With
minimization of immunosuppressive
regimens, VCA will potentially expand
to include partial hand transplants, digit
transplants, vascularized joint transfers
(such as the elbow or wrist), and pediatric hand transplants. In select patients,
VCA is an alternative to prosthesis use
and should be considered as a restorative option for some patients with upper limb loss.
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Atlas of Amputations and Limb Deciencies, Fourth Edition © 2016 American Academy of Orthopaedic Surgeons
418
Chapter 34
Outcome Measures in Upper Limb Prosthetics
Laura Miller, PhD, CP
Abstract
Appropriate upper limb prosthetic outcome measures have been identied for pediatric and
adult patients in settings ranging from research and development to patient care. Although
there is no single benchmark, a toolbox of measures has evolved for use in answering questions of interest to prosthetists, therapists, and researchers.
Keywords: outcome measures; pediatrics; upper limb prosthetics
Introduction
An outcome measure is a means of
systematically collecting patient data
through a testing procedure that has
emerged through a formal development
process. The development process often
includes validation of the measure and
an evaluation of psychometric properties such as reliability and responsiveness.
validated outcome measure include the
ability to reliably compare results over
time and between or within test groups.
As a result, the information gained is
known to be relevant to the question under investigation. Developing and refining a psychometrically strong outcome
measure can be a 10- to 15-year process,
and it is generally recognized that all
parts of an outcome measure should be
considered as a unit, as intended by its
developers.3 However, some measures
are designed so that subscales can be
used independently (for example, the
Self-Care and Mobility subscales of
the Pediatric Evaluation of Disability
Inventory).
or clinical question to be answered is
the first step in selecting an appropriate
outcome measure. Historically, it has
Dr. Miller or an immediate family member serves as a board member, owner, ocer, or committee
member of the US Chapter of the International Society for Prosthetics and Orthotics.
1,2
The advantages of using a
4
Identifying the study question and/
been common for groups of prosthetists
to create their own test for patient evaluation, adapt an existing measure, and/
or use selected parts of a measure in an
attempt to tailor it to a specific question or clientele. In 2009, the American
Academy of Orthotists and Prosthetists
recommended the development of a
toolbox of outcome measures to guide
clinicians and researchers in selecting
measures appropriate for answering
their identified questions. This recommendation was in line with the argument that, despite the shortcomings of
existing measures and the quest to develop new measures, prosthetists need
to adopt and consistently use a standard
set of measures.
5
Categorization of Upper
Limb Outcomes Measures
The need to evaluate the increasing complexity of advanced prosthetic componentry has led to renewed interest in the
area of outcome measures for upper limb
prostheses. Two meetings encouraged
discussion among individuals working
in this area: a preconference workshop
held at the 2005 Myoelectric Controls
Symposium in Fredericton, Canada, and
a 2007 workshop held in Trondheim,
Norway, which was jointly organized by
the Norwegian University of Science and
Technology and the University of New
Brunswick Institute of Biomechanical
Engineering. Both meetings included
engineers, prosthetists, therapists, and
prosthesis users. One major finding of
the 2007 meeting was that each group
of stakeholders was interested in using outcome measures to answer different questions, in settings ranging
from early research and development
through clinical fitting and evaluation
to home use and long-term acceptance.
The World Health Organization International Classification of Functioning,
Disability and Health (WHO-ICF)
model was used to relate how various
outcome measures might correspond
to the phases of research and clinical
practice (the Function, Activity, and
Participation components of the WHOICF model
a researcher who is developing a new
hand prosthesis might be interested in
learning whether the hand operates or
how easy it is for a user to open and close
the device. A simple test, such as the
Box and Block test of manual dexterity,
might be appropriate (as related to the
WHO-ICF Function component).8 As
the prosthetic hand is further developed
and refined for clinical use, the researcher might become interested in how the
device can be used in daily tasks (the
Activity component). A measure that
evaluates use in a simulated clinical environment, such as the Southampton
Hand Assessment Procedure, might be
appropriate.9 After the prosthetic hand
becomes clinically available, a clinician
or researcher might want to know how
well users are able to operate the device
6,7
(Figure 1). For example,
© 2016 American Academy of Orthopaedic Surgeons Atlas of Amputations and Limb Deciencies, Fourth Edition
419
Section 2: Upper Limb
Figure 1
search to daily use, as related to the Function, Activity, and Participation assessment domains of
the World Health Organization International Classication of Functioning, Disability and Health.
(Reproduced with permission from Hill W, Stavdahl O, Hermansson L, et al: Functional outcomes
in the WHO-ICF model: Establishment of the Upper Limb Prosthetic Outcome Measures Group.
J Prosthet Orthot 2 00 9; 21:115-119. )
in the home and community (the Participation component). An evaluation of
quality of movement during activities of
daily living (such as the Assessment of
Capacity for Myoelectric Control) or a
home survey of use (such as the Orthotics and Prosthetics Users’ Survey Upper
Extremity Functional Status module)
can be used.
After the 2005 and 2007 meetings,
the Upper Limb Prosthetic Outcome
Measures (ULPOM) group of volunteers critically evaluated 34 outcome
measures that are routinely used
during upper limb prosthesis fittings.
The purpose, clinical utility, and psychometric properties of each measure
were documented.
sponsored by the American Academy
of Orthotists and Prosthetists as part
of its State of the Science Conference.
Wright
review of the literature on outcome measures related to upper limb prosthetics,
which expanded on her previously published work in this area. In 2009, the results of the two projects were combined
at the State of the Science Conference,
and the use of a toolbox of 23 specific
outcome measures was recommended.13
Schematic diagram showing the process of developing a prosthesis, from initial re-
The 2009 Conference Proceedings included Wright’s evidence-based review
and the review of the ULPOM group,
with detailed information about the
outcome measures initially considered.
Each of the measures was designated as recommended (9 measures) or
to be considered (14 measures). The
10-12
recommended measures were found to
have sufficient psychometric merit to
be useful in the evaluation of patients
with an upper limb amputation. Because
the recommended measures were not
adequate to answer all possible questions, the measures in the second group
(the to-be-considered category) were
suggested for further evaluation after
6,7
A similar effort was
modification and/or validity and reliability testing. Outcome measures were
categorized by stakeholder questions,
the WHO-ICF domain, and the field of
3,4
generated an evidence-based
application (development, clinical research, or patient care).13 The results of
this meeting’s discussion are presented
in Table 1.
The number of available validated
outcome measures continues to expand.
Since the 2009 State of the Science Conference, validation has been published
for measures originally assigned to the
consider category. The University of New
Brunswick Test of Prosthetic Function,
the Trinity Amputation and Prosthesis
Experiences Scale, the Jebsen-Taylor
Test of Hand Function, and the Box and
Block Test have begun to fill in some of
the assessment gaps for outcome measures pertaining to development.
13-1 5
A
new outcome measure for upper limb
prosthetics, the Activities Measure for
Upper Limb Amputees, also has been
developed and validated.16 The outcome
measures currently recommended or
being considered are listed in Table 2.
New outcome measures continue
to be developed for use in research or
clinical settings. In addition, work is being done to allow a measure’s minimal
detectable change to be calculated and
reported.15 Minimal detectable change is
a statistical estimate of the change that
must be observed before the difference
can be assumed to be greater than measurement error. A recent review of upper
limb outcome measures specific to adult
uses of upper limb prostheses was published by the US Department of Veterans
Affairs.17 In addition to evaluating ease
of use and reliability evidence, the report summarizes the minimal detectable
change for those measures in which it
was reported.
Highlights of Several
Recommended and
Considered Measures
Many of the outcome measures related
to upper limb prosthesis use were developed by occupational therapists working with pediatric patients.5 Therefore,
many of the outcome measures with the
most rigorous validation work are for
this population. However, the ULPOM
group and the State of Science Conference attendees found several other
outcome measures to be appropriate for
use with patients of any age. Although
many measures have been developed
and are most appropriately administered
by occupational therapists, they also
are of interest to prosthetists. A team
Atlas of Amputations and Limb Deciencies, Fourth Edition © 2016 American Academy of Orthopaedic Surgeons
420
Chapter 34: Outcome Measures in Upper Limb Prosthetics
Tab le 1
Examples of Research Questions and the Recommended Applicable Measures
Question To Be Addressed ICF-Related
Component
What is the client’s capacity to operate the upper limb
prosthesis? (competency)
a
ACMC
(myo only) Function and activity P, A P, A P, A
How well does the individual use their upper limb
prosthesis in ADLs? (performance)
a
PUFI
COPM
b
Activity P P
Activity and
participation
GAS
b
Activity and
participation
Is the upper limb prosthesis useful to the individual for
specic tasks?
b
COPM
(satisfaction with performance scale) N/A (related to QoL) P, A P, A
a
PUFI
Activity P P
How can we measure the functional eectiveness of
prosthetic treatment/occupational therapy?
Abilhand Kids
a
Activity and
participation
ACMC
AHA
COPM
a
c
b
Function and activity P, A P, A P, A
Function and activity P
Activity and
participation
GAS
b
Activity and
participation
PODCI
b
Activity and
participation
PUFI
a
Activity P P
Does the tool address individuals of higher-level
complexity?
c
AHA
COPM
b
Function and activity P
Activity and
participation
GAS
b
Activity and
participation
Does the tool address individuals with bilateral upper
limb involvement?
b
COPM
Activity and
participation
GAS
b
Activity and
participation
Field of Application Research
Development Clinical Patient
Care
P, A P, A
P, A P, A
P P
P, A P, A
P, A P, A
P P
P, A P, A
P, A P, A
P, A P, A
P, A P, A
© 2016 American Academy of Orthopaedic Surgeons Atlas of Amputations and Limb Deciencies, Fourth Edition
421
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