Prosthetics and Orthotics International

December 2010; 34(4): 461–471

The effect of orthotic treatment on midfoot osteoarthritis

assessed using specifically designed patient evaluation
questionnaires

AILEEN IBUKI1, ANDREI CORNOIU2, ANDREW CLARKE1,

REBECCA UNGLIK1, & ANDREW BEISCHER2
1
Melbourne Orthotics, Burwood, and 2Victoria Orthopaedic Foot and Ankle Clinic, The Epworth
Centre, Richmond, Victoria, Australia

Abstract
Midfoot osteoarthritis (OA) is a degenerative condition of the foot that can be treated non-
operatively by the use of orthotics. This prospective study was conducted to determine the effects
of custom-made semi-rigid foot orthoses (FOs) and rigid carbon fibre (CF) footplates for the
treatment of midfoot OA evaluated using specifically designed questionnaires. Fifty-seven subjects
diagnosed with midfoot OA were recruited through a private clinic for inclusion in the study.
Subjects were required to complete pre-treatment questionnaires prior to receiving orthotic
treatment. All subjects received a pair of custom-made full-length semi-rigid FOs and 36 subjects
also received CF footplates that were incorporated into the soles of the shoes worn on the
symptomatic feet. Subjects completed post-treatment questionnaires at six weeks, three months
and six months after receiving the orthotic treatment. The results demonstrated that there were no
significant differences between the results of the subjects who received CF footplates and those
who did not. The results of the questionnaires demonstrated that subjects experienced significant
improvements in pain, activity levels, walking ability and footwear comfort at all intervals following
the orthotic treatment (p 5 0.01). Subjects’ satisfaction with the appearance of their footwear did
not decrease with the orthotic treatment despite needing shoes to fit the FOs and CF footplates.
The questionnaires also demonstrated that subjects were generally satisfied with the orthotic
treatment for the management of their midfoot OA.

Keywords: Lower limb orthotics, midfoot osteoarthritis, questionnaire, semi-rigid foot orthoses, carbon
fibre footplate

Introduction
Midfoot osteoarthritis (OA) is a common foot condition encountered in orthopaedic practice1
involving degenerative changes in the tarsometatarsal joints.2 Midfoot OA causes
symptoms such as pain and discomfort in the early stages with the later stages occasionally
resulting in structural changes to the foot such as pes planus and abductus deformities, and
the development of prominent osteophytes.3 The pain caused by midfoot OA varies with the
degenerative changes and is commonly identified clinically by focal tenderness and
prominent osteophyte formation on the dorsum of the foot.2 Unfortunately, details regarding

Correspondence: Ms Aileen Ibuki , BPO (Hons) PhD, Melbourne Orthotics, 44 Highbury Road, Burwood, Victoria, 3125 Australia.
E-mail: admin@melborthotics.com

ISSN 0309-3646 print/ISSN 1746-1553 online Ó 2010 ISPO

DOI: 10.3109/03093646.2010.503672
462 A. Ibuki et al.

the exact course of the degeneration is not well characterized and in need of further study.4
Inevitably, increased disability caused by midfoot OA leads to decreased activity levels and
quality of life.3
The treatment of midfoot OA can be classified as non-operative and operative. While
often effective as a definitive measure, operative intervention in the form of joint arthrodesis
is associated with complications such as wound breakdown and infections5 which can
significantly increase the risk of non-union.6,7 Even after achieving successful union of the
symptomatic arthritic joints, increased stresses to surrounding joints can lead to the need for
progressively larger fields of surgery.8
Orthotic treatment is the preferred non-operative method of treatment for midfoot OA to
alleviate pain and to provide a form of immobilization to the irritable arthritic joints.2 The aim
of the orthotic treatment is to improve ambulation, activity levels and overall quality of life.9
Orthotic treatment has the advantage of minimal side effects and low levels of risk. The main
disadvantages for the patient are the financial costs (where funding would not be provided
by the healthcare system), as well as the necessary compromise on footwear. However,
these disadvantages could be overlooked if the orthotic treatment avoided the need for more
costly and risky surgery.
Orthotic treatment for midfoot OA usually involves the use of foot orthoses (FOs),
supportive accommodative footwear with or without rocker soles, and the addition of full-
length carbon fibre (CF) footplates to stiffen the soles of shoes (Figure 1).3 These
treatments work in combination to support and immobilize the arthritic midfoot joints,
decrease joint aggravation, decrease inflammation and therefore, decrease pain, ultimately
leading to an increase in activity.
There are numerous designs of FOs for the treatment of midfoot OA. The two main
designs are the three-quarter-length (Þ) rigid FO and the full-length semi-rigid FO (Figure 2).
There is no published literature to demonstrate the most effective design for the mid- to long-
term treatment of midfoot OA. There is also limited evidence regarding the use of CF
footplates for the treatment of midfoot OA; specifically addressing effects of the footplates
when used within the shoe compared to being imbedded into the sole of the shoe (Figure 3).
Rao et al.2 recently conducted a study on the effect of Þ rigid FOs compared with CF
footplates on midfoot OA and found improvements in pain and activity levels as well as
reduced magnitude and duration of loading under the midfoot region with the CF footplates.
This study provided evidence that orthotic treatment may be useful for midfoot OA over a
four-week period; however, long-term effects remain unknown.

Figure 1. A carbon fibre footplate.

 Orthotic treatment of midfoot osteoarthritis 463

Figure 2. A custom-made full-length semi-rigid foot orthosis.

Figure 3. Cross section of a shoe with a carbon fibre footplate (indicated with an arrow) incorporated into the sole.

Our clinical experience favours the use of custom-made full-length semi-rigid FOs
(Figure 2) used in conjunction with CF footplates imbedded into the soles of shoes (Figure
3). Anecdotally, patients tend to find semi-rigid FOs more tolerable and comfortable than
rigid FOs due to their increased cushioning and shock absorption capabilities.10 CF
footplates imbedded into the soles of shoes appear to be a more effective method of use, as
this does not decrease the amount of room within the shoe (especially if room is required to
accommodate the FO). This method also ensures that there is minimal movement between
the footplate, shoe and FO, which is important if the aim is to achieve immobilization.
Evidence to support the effects of orthotics for the treatment of midfoot OA is lacking.
Literature does not provide clear guidelines regarding orthotic prescription, and the duration
of improvement following orthotic treatment is unknown. There has been a considerable
amount of research conducted to demonstrate the effectiveness of orthotic treatment for
rheumatoid arthritis of the feet,11–14 but whether these results can be generalized to midfoot
OA is uncertain.
The aims of this study were:

(1) To assess the effects of orthotic treatment for midfoot OA through specifically designed
patient evaluation questionnaires;
(2) To assess subjects’ satisfaction with the orthotic treatment (including service provided
and cost to the patient);
(3) To determine if subjects who had previously received orthotic treatment would
experience greater relief of their symptoms and improvement with their function
following the new orthotic treatment; and
464 A. Ibuki et al.

(4) To determine if the radiographic severity of midfoot OA had an effect on the outcome of
the orthotic treatment.

Methods
Subjects
Subjects were recruited through a private orthopaedic foot and ankle clinic. All subjects were
assessed by a fellowship-trained foot and ankle orthopaedic surgeon. Subjects who were
diagnosed with midfoot OA based on clinical and radiographic findings and who satisfied the
inclusion criteria were invited to participate in the study. The inclusion criteria were as
follows:

. Diagnosis of midfoot OA (unilateral or bilateral) and confirmed with radiographic

evidence;
. Presence of pain in the midfoot region;
. A rating of one or greater than one on a midfoot severity scale (Table 1);
. Consented to orthotic treatment of the midfoot OA;
. Comprehension of English sufficient to understand and complete the evaluation
questionnaires; and
. Able to give informed consent.

Subjects were excluded if they had any other symptomatic conditions of their feet or ankles
unrelated to midfoot OA. Subjects were also excluded if they had previously received the
same orthotic treatment as that prescribed in this study - full-length semi-rigid FOs and CF
footplates modified into the soles of their footwear.

Evaluation questionnaire
To our knowledge, there is only one midfoot specific evaluation questionnaire detailed in
literature known as the AOFAS midfoot score.15 The AOFAS midfoot score was developed
by orthopaedic surgeons for the evaluation of surgical outcomes. As a result, it is not entirely
suitable for the evaluation of orthotic treatments as it has low sensitivity to detect change,
does not provide sufficient detail regarding variables such as pain and function, and it lacks
specificity. Due to these limitations, patient evaluation questionnaires were developed
based on the AOFAS midfoot score to provide a means for evaluating the success of
orthotic treatment for midfoot OA.
Two questionnaires were developed, one that was used prior to orthotic treatment
(Appendix 1, available online at www.informahealthcare.com/doi/suppl/10.3109/03093646.
2010.503672) and one that was used after commencing the orthotic treatment (Appendix 2,

Table 1. Four-point diagnostic midfoot severity score.

Score Description

0 Plain X-ray normal, no associated symptoms

1 Plain X-ray normal, MRI or bone scan abnormal and associated symptoms
2 Plain X-ray abnormal with associated symptoms
3 Plain X-ray abnormal with significant bony deformity and associated symptoms
 Orthotic treatment of midfoot osteoarthritis 465

also available online at www.informahealthcare.com/doi/suppl/10.3109/03093646.2010.

503672). The questionnaires were separated into five sections and consisted of 0–10
rating scales, 5-point categorical scales and questions with tick box answers. The first
section evaluated pain levels, the second section evaluated activity levels, the third section
evaluated perception of footwear and the fourth section evaluated subjects’ expectations.
The final section detailed any previous orthotic treatment the subject may have received for
their midfoot OA apart from full-length semi-rigid FOs and/or CF footplates, which excluded
them from the study.
The pre- and post-treatment questionnaires were identical except for the fifth section.
The questions regarding previous orthotic treatment were eliminated from the post-
treatment questionnaire as it was unnecessary to repeat this information. The post-
treatment questionnaire included the addition of two questions regarding subject
satisfaction. The questionnaires were designed to be easily comprehensible so that
subjects could complete them with minimal assistance.

Procedures
Ethical approval by an ethics committee was not required for this study, however, all
subjects were required to give informed consent to be included in the study. Initial
consultation by the treating orthopaedic surgeon included both clinical and radiographic
assessments. Based on the imaging, a diagnostic midfoot severity score was developed to
grade the radiographic severity of the midfoot OA (Table 1). Subjects who were
subsequently diagnosed with midfoot OA with a grade greater than or equal to one were
presented with the option of managing their condition non-operatively. Subjects were then
referred to an orthotist who had a particular expertise in orthotic management of foot and
ankle conditions. All subjects were referred for a pair of custom-made full-length semi-rigid
FOs and CF footplates for the symptomatic foot/feet.
During the consultation, subjects were fully educated regarding the nature of midfoot OA
and the orthotic treatment. Subjects were also educated regarding the appropriate footwear
requirements for treatment, which involved extra depth supportive footwear to accom-
modate the FOs with soles thick enough to accommodate the CF footplates. Once subjects
had agreed to try orthotic treatment, they were invited to participate in the research project.
After consenting to participate in the study, subjects completed the pre-treatment
questionnaire.
Subjects then underwent an assessment of their feet and had impressions taken with
compressible foam impression boxes (Gotz Service, Goppingen, 73037, Germany). The
impressions were filled with plaster to produce positive moulds that were then modified. A pair
of FOs was produced by heat moulding two sheets of high density foam (EVA 220 kg/m3 first
layer and 270 kg/m3 second layer) over the casts which were then shaped. One week after the
consultation, subjects returned to have their FOs custom fitted into their own pre-existing
footwear (if appropriate) or footwear recommended by the orthotist.
Subjects who agreed to try the CF footplates had the shoe of their symptomatic foot/feet
modified. CF footplate modification involved splitting the sole of the shoe with a sharp knife
and grinding a cavity out of the sole that was the shape and depth of the CF footplate. The
CF footplate was then glued into the cavity and the base of the sole glued back onto the
shoe. This method ensured no movement between the CF footplate and the shoe. The
height of the shoe was not affected as a cavity was created within the sole to accommodate
the CF footplate. Subjects who did not agree to try the CF footplates were advised to wear
their FOs in supportive firm soled shoes.
466 A. Ibuki et al.

After receiving the orthotic treatment, subjects attended at least one review consultation
with the orthotist and a separate review consultation with the orthopaedic surgeon. Subjects
who required further adjustments to their orthotic devices were able to make review
consultations with the orthotist as required. Post-treatment evaluation questionnaires were
mailed out to subjects at six weeks, three months and six months following the treatment.
Subjects were requested to complete the questionnaires and mail them back to the orthotist
in reply paid envelopes.

Data analysis
Research data were entered into MD Analyze, a medical outcome patient database
(Medtech, Global Ltd, South Melbourne, 3205, Australia) and analysed using SPSS (SPSS
Inc, Chicago, IL, USA). Differences across the four time intervals were analysed using a
one-way repeated measures analysis of variance (ANOVA). Mauchly’s test of sphericity was
used to determine whether distributions were normal, and if they were not, a Greenhouse-
Geiser adjustment was used. Where the ANOVA were found to be statistically significant,
post hoc tests with Bonferroni adjustments were conducted to determine which pair-wise
comparisons were different.
Two-way repeated measures ANOVA was used to determine if there were any significant
differences between subjects who received the CF footplates compared to those who did not.
Group effects were also analysed for subjects with a midfoot severity score of one compared to
those with a score of two or three. Data were further analysed to determine if subjects who had
previously received orthotic treatment for their midfoot OA differed in their expectation levels
and satisfaction levels from subjects who had not received prior treatment.
Differences between pre-treatment and 6 month post-treatment questionnaires for the
non-parametric data were analysed using McNemar’s test. Statistical significance for all
tests was set at a ¼ 0.01.

Results
Seventy-three subjects diagnosed with midfoot OA were recruited over a period of 24
months. Sixteen subjects were excluded from the study as 12 subjects failed to return post-
treatment questionnaires and four subjects requested to be withdrawn for personal reasons.
Therefore, the data for 57 subjects were included for analysis. The means and standard
deviations for the scores on the 0–10 rating scales between the four intervals were used to
calculate the power. The standard deviations were quite consistent around 2.2. It was
estimated that the sample size of 57 subjects would provide 100% power to be able to
detect a change from baseline of at least 2 units on the 0–10 rating scales. As this study was
exploratory in nature, no pilot trial was conducted to estimate effect sizes for the calculation
of power prior to the commencement of the study.
The subjects consisted of 16 men and 41 women aged between 37 and 81 years (mean
age 63.95 years). Fifteen subjects had midfoot OA diagnosed in both feet, 14 had only the
right foot affected and 28 had only the left foot affected. The mean midfoot OA severity score
was 1.63 (Table 2). All of the subjects were fitted with custom-made FOs and 36 subjects
(63%) also had CF footplates modified into their footwear.
Twenty-seven (47%) subjects had previously been managed with FOs for their midfoot
OA before attending the orthopaedic surgeon’s clinic. Twenty (74%) of those subjects had
received their FOs from a podiatrist, five (19%) from an orthotist and two (7%) from other
healthcare professionals. Sixteen (59%) of those subjects had been previously treated with
 Orthotic treatment of midfoot osteoarthritis 467

Þ rigid FOs of which six had the addition of full length soft covers. Fifteen of those Þ rigid
FOs had been custom-made and two had been prefabricated. Five subjects (19%) had
previously had Þ semi-rigid EVA FOs, another five (19%) with full-length semi-rigid EVA
FOs and one subject had a UCBL FO.
Of the 27 subjects who had previously tried orthotic treatment for their midfoot OA, 25
(93%) indicated that they achieved better results with the new orthotic treatment in their six-
month post-treatment questionnaires. Of the 16 subjects who had previously tried Þ rigid
FOs, 14 subjects (88%) stated that they received better results with the new orthotic
treatment.
The ANOVA revealed significant differences between the four questionnaires for worst
pain (F ¼ 44.474, df ¼ 3, p ¼ 0.000), average pain (F ¼ 22.491, df ¼ 3, p ¼ 0.000), walking on
uneven ground (F ¼ 29.895, df ¼ 2.2, p ¼ 0.000), walking up and down stairs (F ¼ 9.170
df ¼ 2.520, p ¼ 0.000) and footwear comfort (F ¼ 15.170, df ¼ 1.506, p ¼ 0.000) (Table 3).
Post hoc tests revealed that the six-week, three-month and six-month questionnaires were
all significantly different from the pre-treatment questionnaires (p 5 0.01). There were no
significant differences between the pre- and post-treatment questionnaires regarding
footwear appearance (F ¼ 1.015, df ¼ 1.955, p ¼ 0.364) (Table 3).
There were significant differences (p ¼ 0.001) between the pre-treatment questionnaires
and the six-month post-treatment questionnaires regarding whether subjects reported being
woken up by their pain at night (Table 4). There were also significant differences between
the pre-treatment questionnaires and the six-month post-treatment questionnaires for the
questions regarding how long subjects could walk before their pain began (p ¼ 0.000)
(Table 5), and how long subjects could walk before their pain was so severe that they
needed to stop walking (p ¼ 0.001) (Table 6).
The results of the two-way ANOVA demonstrated that there were no significant
differences in expectation levels, willingness to try orthotic treatment or satisfaction levels

Table 2. Distribution of midfoot severity scores.

Score Number of patients

0 0
1 24
2 30
3 3

Table 3. Average scores for questions with responses rated on a 0–10 rating scales (Mean + SD).

6-wks 3-mths 6-mths

Questions Pre-treatment post-treatment post-treatment post-treatment

Indicate your worst level of pain 7.81 + 1.65 5.70 + 2.23* 5.55 + 2.15* 4.54 + 2.33*
Indicate your average level of pain 4.70 + 1.63 3.41 + 1.83* 3.09 + 1.85* 2.55 + 2.02*
Indicate the difficulty you have 7.81 + 2.69 4.53 + 2.80* 4.12 + 2.54* 4.07 + 2.73*
walking outdoors
Indicate the difficulty you have walking 4.70 + 3.00 2.86 + 2.16* 3.11 + 2.49* 3.00 + 2.77*
up and down stairs
Are you satisifed with the appearance 6.84 + 2.88 7.40 + 2.31 7.26 + 2.36 7.39 + 2.37
of your footwear?
Are you satisfied with the comfort 6.04 + 2.91 7.91 + 2.07* 7.88 + 1.99* 8.19 + 2.07*
of your footwear?

*Significantly different from baseline (p 5 0.01).

468 A. Ibuki et al.
Table 4. 2 6 2 cross table for the responses to the question: ‘Does the pain wake you at night?’.

6 months post-treatment

Yes No Total

Pre-treatment
Yes 8 17 25
No 2 30 32
Total 10 47 57

Table 5. 5 6 5 contingency table for the responses to the question: ‘How long can you walk before the pain
begins?’.

6 months post-treatment

0–10mins 10–20mins 20–30mins 30–60mins 60minsþ Total

Pre-treatment
0–10mins 8 7 4 5 4 28
10–20mins 1 0 3 6 4 14
20–30mins 1 0 1 4 5 11
30–60mins 0 0 0 0 1 1
60minsþ 0 0 0 1 2 3
Total 10 7 8 16 16 57

Table 6. 5 6 5 contingency table for the responses to the question: ‘How long can you walk before the pain is so
severe that you need to stop walking?’.

6 months post-treatment

0–20mins 20–40mins 40–60mins 1–2hrs 2hrsþ Total

Pre-treatment
0–20mins 2 4 2 0 2 10
20–40mins 2 1 2 2 5 12
40–60mins 2 0 0 2 9 13
1–2hrs 0 0 1 3 7 11
2hrsþ 0 0 1 0 10 11
Total 6 5 6 7 33 57

with the orthotic treatment between subjects who had previously received orthotic treatment
and those who had not. There were also no significant group effects for subjects who were
treated with FOs alone and subjects who received the addition of CF footplates. Likewise,
there were no significant differences between subjects with a midfoot severity score of one
compared with those with scores of two or three.
At six-months post-treatment, the mean score for subjects’ satisfaction of the overall
treatment process was 8.4 + 2.0 on the 0–10 rating scale, with 0 being not satisfied and
10 being very satisfied. The mean score for subjects’ satisfaction with quality of service
received and amount paid was 7.9 + 2.2 on the same scale. When subjects were asked
if they would recommend the treatment to others with their condition, their mean score
was 8.5 + 2.3, with 0 being would not recommend and 10 being would highly
recommend.
 Orthotic treatment of midfoot osteoarthritis 469

Discussion
The results of this study demonstrated that orthotic treatment for midfoot OA significantly
decreased pain levels, increased activity levels and increased footwear comfort as
evaluated with specifically designed questionnaires. Subjects were able to walk longer
and with less pain with the use of FOs and for some the addition of CF footplates. Often,
there is a compromise in footwear appearance with the use of orthotic treatment; however,
subjects’ satisfaction with their footwear appearance was not significantly affected after
receiving the treatment.
The results also demonstrated that prior orthotic treatment for midfoot OA did not deter
subjects from trying another orthotic approach after all subjects received a thorough
explanation of the rationale behind the treatment strategy. Furthermore, previous treatment
did not have a significant effect on satisfaction outcomes, suggesting that subjects who had
previously tried orthotic treatment were not more critical of the treatment process than those
who had not received prior treatment.
The results also demonstrated that the majority of subjects who had previously received
orthotic treatment for their midfoot OA experienced greater relief with the treatment used in
the present study. The type of orthosis subjects had previously received was documented.
However, the fit and function of any previous orthoses were not assessed. No subject had
previously tried CF footplates.
The subjects who received CF footplates in addition to the FOs did not experience greater
relief than those who only received the FOs. This suggests one of two things. Firstly, that the
addition of CF footplates was unnecessary and simply wearing appropriate footwear with
firm soles was sufficient to experience relief of symptoms, or secondly, that those subjects
who received CF footplates were clinically worse and required the added support and
immobilization of the CF footplates. However, this is unlikely as the results of the two-way
ANOVA revealed no significant differences in outcome between subjects who received CF
footplates and those who did not. A randomized controlled trial would be necessary
to determine if the use of CF footplates has any additional benefits to firm soled shoes
alone.
To our knowledge, Rao et al.2 are the only other researchers who have assessed the
effects of FOs and CF footplates for the treatment of midfoot OA. They reported
improvements in the Foot Function Index- Revised scores and reductions in the magnitude
and duration of medial midfoot loading with CF footplates compared to Þ FOs in subjects
with midfoot OA. The authors suggested that CF footplates may be more effective in the
treatment of midfoot OA than Þ FOs. However, their results seemed biased as the authors
noted that subjects reported persistent midfoot complaints with their Þ FOs. The subjects
were tested using their existing Þ FOs that were apparently ineffective and no mention was
made of assessing the fit and function of the FOs. The results of the present study
demonstrated that the majority of subjects who had previously been provided with Þ rigid
FOs achieved greater relief with full-length semi-rigid EVA FOs, and it is believed that this
was due to the increased cushioning and comfort of the semi-rigid FOs.
Although all subjects were referred for CF footplates, 37% chose not to have them. The
main reason for this was that subjects did not want to have the soles of their shoes modified,
and fitting the CF footplates inside the shoes was not an option given to subjects for the
purposes of this study. Another reason for subjects not wanting the CF footplates was the
associated footwear limitation which was a significant factor since the majority of subjects
were female. All subjects who did not receive CF footplates were advised to wear their FOs
in supportive firm soled shoes.
470 A. Ibuki et al.

The additional cost of the CF footplates was also a factor for some subjects deciding
not to have them. All subjects were required to fund the full cost of the orthotic treatment
themselves. Some subjects were able to claim a reimbursement for a percentage of their
costs through external sources such as private health insurance. It was possible that the
out-of-pocket cost of the orthotic treatment influenced the results of how satisfied
subjects were with the orthotic treatment. It is also possible that subjects’ perception of a
successful outcome may have been different if the treatments had been provided free of
charge.
The primary limitation of this study was that the reliability and validity of the questionnaires
was not assessed and this warrants further investigation. The lack of a control group was
also a limitation of this study; however, as all subjects had been referred for management by
an orthopaedic surgeon in a private clinic, it was deemed unethical to withhold treatment or
to use a placebo treatment for any of the subjects. Further investigations into the effects of
orthotic treatment for midfoot OA should involve randomized controlled trials to produce
higher levels of evidence.

Conclusion
This study has demonstrated that custom-made semi-rigid FOs with and without the
addition of CF footplates were effective in decreasing pain and improving activity levels in
subjects with midfoot OA over a period of six months. It was also demonstrated that subjects
were satisfied with the orthotic treatment of their midfoot OA and would recommend the
same treatment to others with their condition. Subjects’ satisfaction with the appearance of
their footwear did not change significantly following implementation of the treatment
indicating that the appearance of shoes required to accommodate orthotic treatment was
not a concern for subjects.

Acknowledgements
We would like to acknowledge the Medical Research Foundation for Women and Babies
(East Melbourne, Victoria, Australia) for their financial support of this study.

Declaration of interest: The authors report no conflicts of interest. The authors alone are
responsible for the content and writing of the paper.

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Supplementary material available online

Appendix 1: Pre-treatment patient evaluation questionnaire
Appendix 2: Post-treatment patient evaluation questionnaire