Abstract
Background: A recent development in valgus-producing knee braces has
been the adjustable "unloader" brace. The purpose of this study
was to compare the effectiveness of off-the-shelf and custom-made
patient-adjustable, valgus-producing knee unloader braces in relieving pain,
reducing stiffness, and improving function and in reducing varus angulation
and the peak adduction moments about the knee during gait and stair-stepping
in patients with painful varus gonarthrosis of the knee.
Methods: Ten adult patients served as their own controls for the
measurement of baseline values and then wore each of the two braces, one after
the other, for four to five weeks in a random order. Pain, stiffness, and
function were assessed with the Western Ontario and McMaster Universities
Osteoarthritis Index. Gait and stair-stepping were evaluated with a
three-dimensional motion analysis system and multicomponent force platform.
Full-length (hip, knee, and ankle) standing anteroposterior radiographs were
used to determine alignment of the knee.
Results: Both braces significantly reduced pain and stiffness (p
< 0.05), with the custom brace reducing stiffness significantly more than
the off-the-shelf brace (p = 0.030). The custom brace significantly improved
function (p = 0.010) and reduced the peak knee adduction moments during gait
(p = 0.033) and stair-stepping (p = 0.002) compared with baseline values and
compared with the off-the-shelf brace (p = 0.029 and p = 0.027, respectively).
The custom brace significantly reduced varus angulation of the knee by
1.5° compared with baseline (p = 0.001) and by 1.3° compared with the
off-the-shelf brace (p = 0.009). The off-the-shelf brace did not significantly
reduce the varus angle.
Conclusions: We investigated only the short-term effects of custom
and off-the-shelf patient-adjustable valgus-producing knee
"unloader" braces and found that patients with varus gonarthrosis
of the knee may benefit significantly with respect to pain relief and reduced
stiffness from use of either brace. However, such patients may experience
additional significant benefit in improved function and reduced stiffness,
varus angulation, and medial compartment loading of the knee from use of the
custom-made patient-adjustable brace.
Level of Evidence: Therapeutic Level II. See Instructions
to Authors for a complete description of levels of evidence.
Although gait is the most common of daily activities of mobility, gait
places relatively small demands on the muscles of the lower extremities and
results in maximum tibiofemoral compressive loads of just under four times
body weight1.
However, stair-stepping is one of the most demanding of daily activities on
the quadriceps muscles, producing tibiofemoral compressive loads of as much as
six times body
weight1. We could
find no report on the effects of valgus-producing braces on external adduction
moments during stair-stepping.
A relatively recent development in valgus-producing knee braces is the
adjustable "unloader" brace. In one such device, the adjustment to
valgus alignment is made by the health-care provider and is not available to
the patient2. In
other such devices, patients have the possibility of adjusting the amount of
valgus alignment and, hence, external valgus load applied during actual
wear3. In the latter
case, this allows each patient to achieve the brace configuration that
produces optimal pain relief.
The purpose of this study was to compare the effectiveness of an
off-the-shelf patient-adjustable valgus-producing brace with a custom
patient-adjustable valgus-producing brace in decreasing pain and stiffness,
improving function, and in reducing the peak varus moments about the knee
during gait and stair-stepping. We hypothesized that the custom and
off-the-shelf patient-adjustable braces would each be effective in decreasing
pain and stiffness, improving function, and in reducing the varus angle of
alignment and the peak external adduction moments about the knee during gait
and stair-stepping. We also hypothesized that the custom patient-adjustable
brace would be more effective than the off-the-shelf patient-adjustable brace
in decreasing pain and stiffness, improving function, and in reducing the
varus angle of alignment and the peak external adduction moments about the
knee during gait and stair-stepping.
This was a crossover study; each patient served as his or her own control
and wore each of two braces, one after the other, for four to five weeks. Ten
consecutive adult patients with painful varus gonarthrosis of the knee who
were seen at our institution, met the criteria for inclusion, and agreed to
participate in this study were evaluated. The mean age, height, and weight
(and standard deviation) of the patients were 50.8 ± 5.4 years (range,
forty-three to fifty-nine years), 1.74 ± 0.08 m (range, 1.60 to 1.83
m), and 102.6 ± 13.4 kg (range, 79.6 to 118.2 kg), respectively. The
body mass index of the patients ranged from 24.5 kg/m2 to 43.0
kg/m2 and averaged 34.1 ± 4.9 kg/m2. The
institutional review board of The University of Chicago approved the protocol
for the study. Informed consent for participation in this study was obtained
from all patients who participated. To be included, patients must have been
diagnosed as having osteoarthritis of the knee on the basis of the criteria of
Altman et al.4.
There were additional inclusion criteria
(Table I) and exclusion
criteria (Table II). Diagnoses
were made on the basis of the history, physical examination, and full-length
anteroposterior weight-bearing radiographs. Two patients had osteoarthritis in
both knees and wore the braces on the more painful knee.
The braces were of two types: an off-the-shelf patient-adjustable brace
(OAdjuster; dj Orthopedics, Vista, California) and a custom patient-adjustable
brace (Adjustable OA Defiance; dj Orthopedics). Both braces were of similar
structural design, with thigh and leg straps used to secure the braces to the
patient, and had a double-upright, strap-and-frame style with rigid thigh and
calf support members that were connected by polycentric hinges located on the
medial and lateral sides (Figs. 1-A and
1-B). In addition, both braces were adjustable, allowing the
wearer to adjust the amount of valgus loading applied by the brace to the knee
with an adjustment key.
A representative of the brace manufacturer selected the off-the-shelf brace
that best fit the patient and also made anthropometric measurements of the
lower limb for use in the manufacture of the custom brace. The representative
was blinded to the order of brace wear, did not discuss with the patient any
aspect of the study, and met with each patient a single time to make
measurements of the lower limb and to demonstrate how to apply and adjust the
braces. Each patient was instructed to adjust each brace to the perceived
level of optimal pain relief, to wear each brace as much as possible, and to
keep a daily log of brace wear. The individuals who tested the gaits of the
patients were not blinded to the types of braces worn and did not discuss the
study with the patients. Patients were evaluated at three time-points: at
baseline and between days 28 and 35 of the period when each brace was worn.
After the first brace was worn, there was a two-week period when no brace was
worn. The order of brace wear was randomly assigned by drawing ten
identical-appearing tags in a sequence such that five patients wore the custom
brace first and five patients wore the off-the-shelf brace first.
Pain, stiffness, and function were assessed with the Western Ontario and
McMaster Universities Osteoarthritis Index
(WOMAC)5. Patients
responded to each of twenty-four questions (five related to pain, two related
to stiffness, and seventeen related to function) using separate visual analog
scales that ranged from 0 to 100 mm. The distances were summed for each
component (pain, stiffness, and function) and for each of the three
time-points. A greater sum reflected greater impairment, and a lower sum
reflected improvement.
Kinematic parameters were collected at a rate of 100 Hz with the Optotrak
three-dimensional digitizing system (Northern Digital, Waterloo, Ontario,
Canada). Ground reaction forces were measured with a multicomponent force
platform (Advanced Mechanical Technology, Watertown, Massachusetts) in the
center of the walkway. Patients wore their own low-heeled shoes. A
force-sensing resistor (Interlink Electronics, Camarillo, California) was
attached to the plantar surface of the heel of the diseased limb to detect
heel-strike. Clusters of six or eight infrared light-emitting diodes were
strapped to the foot, leg, and thigh of the diseased limb and the control,
contralateral limb. DAP software (Northern Digital) was used to determine the
spatial orientation of each rigid segment in the inertial coordinate system.
Euler angles were used to calculate the three-dimensional angles. The external
three-dimensional moments about the knee were calculated with use of inverse
dynamics. The joint moments were normalized to body weight and lower-limb
length. Gait was initiated at one end of the 9.5-m walkway. Two consecutive
heel-strikes, with the first occurring on the force platform, were used to
determine gait speed. This methodology for determining gait speed, kinematics,
and moments in our laboratory has been
reported6,7.
Custom-written software, developed in our laboratory, was used to identify and
extract the data of interest. These data were then confirmed by visual
inspection of the waveforms. This methodology for identifying and extracting
data in our laboratory has been
reported8.
Knee motions and moments were measured for two gait protocols and one
stair-stepping protocol. In the first gait protocol, patients walked in a
self-selected manner and speed. In the second gait protocol, patients walked
with a speed between 0.95 and 1.06 m/sec to remove the influence of speed on
the moments and motions generated. For stair-stepping, patients stood with the
feet at a distance of 20 cm from a 20-cm-high step (26 cm deep and 42.5 cm
wide) that rested on the force platform, stepped onto the step with the
affected limb, stepped over the step and onto the ground with the
contralateral limb, and then stepped onto the ground with the affected limb,
all in a continuous
fashion6,9.
The data from three trials for each protocol and for each time-point were
averaged.
Full-length (hip, knee, and ankle) standing anteroposterior radiographs
were used to determine the alignment (varus-valgus angle) of the knee,
measured as the hip-knee-ankle angle formed by the intersection of the femoral
and the tibial mechanical axes, for nine patients. The radiographs for one
patient were lost. With use of Adobe Illustrator (Adobe, San Jose,
California), digital images of the radiographs were displayed. Two evaluators
independently digitized the osseous landmarks, constructed the mechanical
axes, and calculated the knee angles. Neither evaluator was blinded. The
measurements made by the two evaluators were averaged for each subject and for
each experimental state. Measurements for one examiner were repeated and used
only to assess intrarater reliability.
Power and sample-size analysis was performed with PASS 2000 (Power Analysis
and Sample Size; NCSS Statistical Software, Kaysville, Utah). The covariance
matrix was generated with use of the standard deviation for a healthy
forty-four-year-old man tested three times in our laboratory. A one-sided
sample-size derivation indicated that ten patients would yield a power of 83%
for an a level of 0.05 in order to detect differences between normalized
adduction moments of 0.4%, reported for patients with and without a custom
brace10.
SPSS software (SPSS, Chicago, Illinois) was used for the statistical
analysis. Paired t tests were used to determine differences in the mean times
that the custom and off-the-shelf braces were worn. One-way analysis of
variance with repeated measures was used to determine the effects of brace
wear on pain, stiffness, function, varus-valgus knee angle, knee flexion
angles, and peak moments about the affected knee during gait and
stair-stepping. The Greenhouse-Geisser adjustment to the degree of freedom was
used in assessing significance levels. The Helmhert post hoc test was used to
determine significant differences among the means. P values of =0.05 were
considered significant. Pearson correlation coefficients were calculated for
assessment of interrater and intrarater reliability for the measures of
tibiofemoral angle and for assessment of the relationships between the
reductions in varus alignment and pain, function, and peak adduction
moment.
Patients wore the off-the-shelf brace an average (and standard deviation)
of 9.0 ± 3.3 hours per day and the custom brace for an average of 8.8
± 2.5 hours per day. The difference was not significant (p = 0.62).
The average baseline value for pain (the minimum possible score was 0 mm,
and the maximum possible score was 500 mm) was 197 mm. Pain was significantly
reduced to an average of 71 mm (p = 0.007) with the custom brace and to an
average of 120 mm (p = 0.040) with the off-the-shelf brace
(Fig. 2). Stiffness was
significantly reduced from an average baseline of 91 mm (maximum possible
score, 200 mm) to 36 mm (p = 0.008) with the custom brace and to an average of
63 mm (p = 0.038) with the off-the-shelf brace. The reduction in stiffness
provided by the custom brace was significantly (p = 0.030) greater than that
provided by the off-the-shelf brace. Function was significantly improved with
the custom brace, from an average baseline score of 664 mm (maximum possible
score, 1700 mm) to 248 mm (p = 0.010), whereas the off-the-shelf brace did not
significantly affect function.
The average speed of self-selected gait was 1.11 ± 0.10 m/sec with
the custom brace and 1.12 ± 0.14 m/sec with the off-the-shelf brace;
both speeds were less than the average baseline speed of 1.20 ± 0.15
m/sec. With the numbers available, no significant difference could be detected
among these speeds.
When walking speed was controlled, the average speed of gait was 1.00
± 0.02 m/sec with the custom brace, 1.01 ± 0.03 m/sec with the
off-the-shelf brace, and 1.02 ± 0.03 m/sec when no brace was worn. With
the numbers available, no significant difference could be detected among these
speeds.
On the average, the external moments tending to adduct the knee were
maximum at approximately 20% of the gait cycle
(Fig. 3). The average peak
adduction moment, calculated as the percentage of body weight times height,
was significantly reduced with the custom brace (5.9% ± 2.0%) compared
with the baseline value (6.9% ± 1.9%) (p = 0.033), but it was not
significantly reduced with the off-the-shelf brace (6.6% ± 2.2%).
Furthermore, the custom brace reduced the average peak adduction moment
compared with the off-the-shelf brace (p = 0.029). Pearson correlation
coefficients for the relationships between the reductions in peak adduction
moment and pain were 0.18 for the custom brace and 0.10 for the off-the-shelf
brace.
The average knee flexion angle at heel-strike was 1° ± 5° at
baseline, 3° ± 4° with the custom brace, and 0° ±
5° with the off-the-shelf brace. The average maximum knee flexion angle at
midstance was 9° ± 7° at baseline, 10°± 6° with
the custom brace, and 8° ± 7° with the off-the-shelf brace. The
average peak knee flexion angle during the gait cycle occurred during swing
phase and was 58° ± 5° at baseline, 59° ± 4°
with the custom brace, and 58° ± 5° with the off-the-shelf
brace. With the numbers available, no significant differences could be
detected.
On the average, the external moments tending to adduct the knee were
maximum at approximately 35% to 45% of the stance period during stair-stepping
(Fig. 4). The average peak
adduction moment, calculated as the percentage of body weight times height,
was significantly reduced from baseline (6.9% ± 2.3%) with the custom
brace (5.2% ± 2.5%) (p = 0.002), but it was not significantly reduced
with the off-the-shelf brace (6.3% ± 2.2%). Furthermore, the average
peak adduction moment was significantly reduced with the custom brace compared
with the off-the-shelf brace (p = 0.027). The Pearson correlation coefficients
for the relationships between the reductions in peak adduction moment and pain
were 0.20 for the custom brace and 0.05 for the off-the-shelf brace.
The minimum knee flexion angle occurred during mid-stance on the step and
was a mean of 25° ± 7° at baseline, 25° ± 10°
with the custom brace, and 25° ± 9° with the off-the-shelf
brace. The maximum knee flexion angle occurred when the foot was pushing off
of the step and was a mean of 88° ± 4° at baseline, 87°
± 7° with the custom brace, and 88° ± 6° with the
off-the-shelf brace. With the numbers available, no significant differences
could be detected.
All of the knees were in relative varus angulation both with and without
the braces. The mean varus angulation was 6.4° ± 3.0° at
baseline, 4.9° ± 2.8° with the custom brace, and 6.2°
± 3.5° with the off-the-shelf brace. For both evaluators, the
custom brace was found to reduce the varus angulation in eight of the nine
patients. The average reduction in varus angulation of 1.5° with the
custom brace was significant (p = 0.001). The off-the-shelf brace did not
significantly change the varus alignment. The custom brace significantly
reduced the varus angulation by 1.3° compared with the off-the-shelf brace
(p = 0.009).
The Pearson correlation coefficient for evaluating interrater reliability
of the measures of tibiofemoral angle was 0.89 and that for intrarater
reliability was 0.86. The Pearson correlation coefficients for the
relationships between the reductions in varus alignment and pain were 0.35 for
the custom brace and 0.42 for the off-the-shelf brace. The Pearson correlation
coefficients for the relationships between the reductions in varus alignment
and function were 0.60 for the custom brace and 0.04 for the off-the-shelf
brace. Also, the Pearson correlation coefficients for the relationships
between the reductions in varus alignment and peak adduction moment were 0.20
for the custom brace and 0.28 for the off-the-shelf brace.
The purpose of this study was to compare the effectiveness of an
off-the-shelf brace and a custom-made, patient-adjustable, valgus-producing
functional knee unloader brace on improving the results for patient-perceived
pain, stiffness, and function and in reducing the angle of varus alignment and
the peak adduction moments about the knee during gait and stair-stepping in
patients who had painful varus gonarthrosis of the knee. The custom brace was
more effective than the off-the-shelf brace in improving the results for pain,
stiffness, and function, and in reducing the varus angle of alignment of the
knee and the peak external adduction moments about the knee during gait and
stair-stepping. We presume that the custom brace was more effective than the
off-the-shelf brace because the custom brace fit the limb better, and this
then allowed the custom brace to maintain higher levels of valgus loading of
the knee in the patients during the activities of daily living. This is
evident by the results of the gait and stair-stepping activities in the
present study, which demonstrated that the reductions in the peak adduction
moments were three to four times greater for the custom brace than for the
off-the-shelf brace. Furthermore, since each patient made his or her own
adjustments in the amounts of valgus moments applied to both types of brace,
the results indicate that custom-fitting the valgus brace to the patients had
a greater effect on the outcomes than self-adjustments in the valgus
moments.
Valgus-producing braces have been found to reduce the external adduction
moments about the knee during gait in the present investigation and in other
studies2,10,11.
Also, it has been demonstrated that custom valgus-producing braces were
effective in reducing the actual load on the medial compartment of the knee
during gait by 11%2.
Furthermore, valgus-producing braces have been found to improve pain relief
and function in this and previous
studies3,10,12-16.
However, it is likely that proprioception also plays a role in this pathway as
suggested by researchers who have found that body sway is reduced by
valgus-producing
braces16. Several
studies have demonstrated that proprioception in osteoarthritis of the knee is
reduced17-21
and that proprioception can be improved with elastic bandages or neoprene
sleeves19,22,23.
Thus, in agreement with other
investigators15, we
believe that it is likely that the combination of compartment unloading and
improvement in proprioception led to the decreases in pain reported in this
and previous studies.
We calculated the Pearson correlation coefficients to investigate the
strengths of the relationships between the reductions in varus angle,
adduction moments, and pain. However, the values of the coefficients ranged
from those that were indicative of no association to only weak association. It
is possible that after a certain amount of load decrease occurred in the
medial compartment of the knee to reduce pain, additional decreases in load
did not have similar additional effects on pain reduction. Also, there were
likely interactions between the amount of compartment unloading, gait
adaptations, and the effects of bracing on proprioception that affected the
relationships between knee varus angle, adduction moments, and pain.
In a previous study, an adjustable custom brace was found to reduce the
peak adduction moment during gait by 17% when valgus alignment of the brace
was 8° greater than that of the subject's
knee2. This decrease
is very similar to the reduction in peak adduction moments found for the
adjustable custom brace in this study. However, the valgus adjustments to the
braces used in the
study2 were not
available to the patients. In contrast, the valgus adjustments made to the
braces used in the current study were performed by the patients. This suggests
that the patients in this study were able to make adjustments to the valgus
moments applied to the custom brace that were effective in reducing the
adduction moments about the knee. Theoretically, this allowed each patient to
achieve the brace configuration that produced optimal pain relief.
The results of this study strongly suggest that the closeness of fit of the
brace on the limb is important to improve results for pain, stiffness, and
function and to reduce the varus alignment of the knee and the peak external
adduction moments about the knee during gait and stair-stepping. One should
not extrapolate the results of the custom and off-the-shelf braces in this
study to those of other manufacturers. This is because different brace designs
may affect not only the closeness of fit but also the level of comfort and
proprioception.
There were two limitations in this study. First, the gait examiners were
not blinded to the type of brace worn. However, this should not have affected
the gait results, which are all based on quantified, objectively measured
data. Second, no attempts were made to measure proprioception, so no specific
conclusion can be made as to the role proprioception might have played in the
observed improvements.
The randomization of brace wear, the length of time that each brace was
worn, and the two-week washout period that were implemented in this study were
all carefully considered. Valgus-producing unloader braces exert their effects
through mechanical and not chemical means, and this study was primarily
designed to measure the effects of the braces on mechanical measures (such as
peak adduction moments) of gait. Although any mechanical effects would be
expected to occur immediately upon proper application of the brace, four to
five weeks was selected to allow the patient time to become well accustomed to
wearing a brace before testing. Since the mechanics of the brace-limb
construct were not expected to change over time, a longer period of brace wear
was considered to be unnecessary. Furthermore, upon removal of the brace, the
mechanics of the patient's limb were expected to immediately return to the
pre-brace state of wear, and there were no chemicals to wash out. However, we
wanted the patients to become well accustomed to not wearing a brace before
wearing the other one. Thus, a two-week period when no brace was worn was
considered adequate. The choice of which brace was worn first was randomized
such that half of the patients wore the off-the-shelf brace first and half of
the patients wore the custom brace first, and the custom brace consistently
performed better than the off-the-shelf brace regardless of whether it was
worn first or second. This is evidence that the two-week washout period was
indeed sufficient. ?
Note: The authors are grateful to Dr. Sherwin Ho for his
assistance in recruiting patients into this study.
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