Study population
This study is a cross-sectional, observational cohort investigation into knee OA. All protocols were approved by the Beihang University Biological Science and Medical Engineering Review Board (No. : BM20200096) and written consent was obtained from all participants prior to participation after being given detailed instructions on the protocols.
The participants in this study were recruited from an outpatient community orthopedic clinic. As the purpose of this study is to evaluate whether flat feet may aggravate knee OA symptoms, invitation letters for participation were sent to all patients of the clinic who had been diagnosed as having knee osteoarthritis in the month of August 2019 according to the American College of Rheumatology Clinical Criteria[13] (n = 146). The inclusion criteria were knee pain, no history of knee surgery, no rheumatoid osteoarthritis, no inflammatory arthritis, no previous joint injury and being able to walk independently. Of the patients providing positive responses (n = 120), adequate foot posture data could not be located for 23 patients and knee radiographs could not be located for 2 patients. The remaining patients (n = 95) comprised the study population, of whom 84 participants exhibited bilateral knee OA and 11 participants exhibited unilateral knee OA. Characteristics of all participants are shown in Table 1.
Table 1
Demographic characteristics, knee-level characteristics, and foot posture of the research population. (n=95).
Subject characteristics
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|
Age (years)
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58.0±10.5
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Male, N (%) / Female, N (%)
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14 (14.7) / 81 (85.3)
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BMI (kg/m²), Median (IQR)
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25.76±3.35
|
Knee-level characteristics
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|
Severity of knee OA (K-L grade), N (%)
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|
K-L 2
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28 (29.5)
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K-L 3
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51 (53.7)
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K-L 4
|
16 (16.8)
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FTA (°)
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-7.23±3.33
|
Pain (WOMAC score), Median (IQR)
|
1.97±0.54
|
Physical function (WOMAC score), Median (IQR)
|
1.73 ±0.49
|
Foot posture (AI value)
|
0.68 ±0.37
|
Foot posture assessment |
Foot posture was assessed using the arch index (AI). To calculate the AI, static footprints were obtained from each subject when standing in a relaxed bipedal stance on a foot printer (Mingscan Footprinter MP-5, Vers Tech Science Co. Ltd., Taiwan) with toes pointed forward. The AI value was calculated as the ratio of the length from point c to point d (Line cd) and from point c to point e (Line ce)[14] (Fig. 1). The lengths of Line cd and Line ce were measured three times (accuracy: 0.1mm). The mean AI from the three calculations was used as the value for that foot. A participant was deemed as having flat feet when AI ≤ 0.84. Flat feet within the range of 0.84 ≥ AI > 0.42 were defined as mild flat feet, and those with a value 0.42 ≥ AI were deemed severe flat feet[14]. The intra-interclass correlation coefficient (ICC) was 0.993 for AI, suggesting good reliability across the measurements[15].
Assessment of OA-related knee symptoms
Weight bearing anteroposterior radiographs were obtained from each participant with the patella facing forward and the legs in full extension. All radiographs were taken in the same medical imaging department using the same machine (uDR 770i, United Imaging Healthcare Co., Ltd., China). The severity of knee OA was quantified using the Kellgren and Lawrence (K-L) grading system with a range of 0 - 4. Femorotibial alignment was quantified by the femoral-tibial angle (FTA) (α). The FTA measurement method recommended by Moyer et al.[16] was used in this study, as this method uses short knee films and has been proven to give comparable results to long hip-knee-ankle films for the prediction of femorotibial alignment. Using this method, the anatomical FTA range for males is -5°<α< -1° and for females is -7°<α< -3°[16]. More negative values indicated a larger varus angle (refer to Supplementary data). The FTA of each knee was measured on radiographs using the software PicPick (version 5.0.7, Korea) (accuracy: 0.01°). The angle was measured three times by a single investigator with an interval of one week between measurements. The average of the three measurements was used as the FTA for that knee. Knee pain and physical function were evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) interview technique[12]. Each of the 24 items assessed with this method was graded on a five-point Likert scale ranging from 0 to 4. The score for each parameter (pain, stiffness, and physical function) was calculated as the sum of all the constituent item scores divided by the number of items assessed. A high score reflected a high severity for that parameter. This study did not consider the stiffness scores because of the limited evaluation of knee stiffness in the WOMAC survey[17]. The intra-interclass correlation coefficient (ICC) was 0.913 for FTA, 0.920 for K-L grade, 0.991 for pain, and 0.993 for function, suggesting good reliability across all measurements[15].
Statistical analysis
To minimize any bias produced by similarities between the right and left knees of the same subject[18], only the affected side was selected for evaluation. To eliminate the confounding variable of bilateral involvement, the more painful side was selected in each patient[19].
This study assessed whether the presence or severity of flat feet was associated with the symptoms of knee OA. Categorical variables were summarized as a number (%) and continuous variables were summarized as a mean (standard deviation (± SD)) or median (interquartile range (IQR)), as appropriate.
The patients were divided into groups without flat feet, with mild flat feet and with severe flat feet, and differences in knee symptoms between the groups were compared.
The study used 4 variables to describe the condition of each knee, with an appropriate statistical analysis method chosen depending on the continuity and normality of the variables. K-L is a categorical variable, divided into four levels (I, II, III, IV). Therefore, the Chi-square test for dichotomous variables was used to compare the difference in K-L between groups. FTA, pain score, and physical function are continuous variables. The normality test for continuous variables showed that FTA and functional scores conformed to a normal distribution, but the pain scores did not. Therefore, a t test for continuous variable was used to compare differences in FTA and physical function between the different groups, and the Mann-Whitney U test for non-parametric continuous variable was used to compare differences in pain scores. The software PASS version 15 (NCSS, LLC, Kaysville, UT, USA) was used to calculate sample sizes. A priori power analysis with a significance level of 0.05 (type - I error), a desired power of 90%[20] and the effect size or odd ratio was used to evaluate the sample size. The required sample size was calculated for the three tests above, among which the maximum sample size required was 68 individuals.
Linear regression was used to assess the association between flat feet and symptoms of knee OA[18]. Binary linear regression was used to analyze the effects of the presence of flat feet (with or without flat feet) or severity of flat feet (mild and severe) on the FTA, pain score and physical function, because these parameters are continuous. Ordinal logistic regression was used to analyze the impact on the K-L grade, because K-L is considered an ordered discrete variable. In the regression analyses, the parameters for assessing knee OA symptoms (severity of knee OA, FTA, pain and physical function) were assigned as dependent variables and the presence of flat feet (with or without) or severity of flat feet (mild and severe) were assigned as independent variables. Age, sex, and BMI are known to be associated with both flat feet and knee OA[18], and so were used as covariates to adjust the regression models.
SPSS 22.0 (SPSS, IBM, USA) was used for all the statistical analyses. Significance was set as p<0.05.