Accepted Manuscript

Validity and Responsiveness of the 2-Minute Walk Test for Measuring Functional
Recovery after Total Knee Arthroplasty

Aasis Unnanuntana, MD, Pakpoom Ruangsomboon, MD, Worawut Keesukpunt, MD

PII: S0883-5403(18)30033-0
DOI: 10.1016/j.arth.2018.01.015
Reference: YARTH 56336

To appear in: The Journal of Arthroplasty

Received Date: 21 November 2017

Revised Date: 28 December 2017
Accepted Date: 8 January 2018

Please cite this article as: Unnanuntana A, Ruangsomboon P, Keesukpunt W, Validity and
Responsiveness of the 2-Minute Walk Test for Measuring Functional Recovery after Total Knee
Arthroplasty, The Journal of Arthroplasty (2018), doi: 10.1016/j.arth.2018.01.015.

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 ACCEPTED MANUSCRIPT

Validity and Responsiveness of the 2-Minute Walk Test for Measuring Functional

Recovery after Total Knee Arthroplasty

Aasis Unnanuntana, MD1; Pakpoom Ruangsomboon, MD1; Worawut Keesukpunt, MD2

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1
Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol

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University, Bangkok, Thailand

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Department of Orthopaedics, Rayong Hospital, Rayong, Thailand

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Conflict of interest statement: We have no conflicts.
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Corresponding author:

Aasis Unnanuntana, MD
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Associate Professor of Orthopedic Surgery

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Department of Orthopaedic Surgery

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Faculty of Medicine Siriraj Hospital, Mahidol University

2 Wang Lang Road, Bangkok Noi

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Bangkok 10700, Thailand

Tel: (+66) 2-419-7968; Fax: (+66) 2-412-8172

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E-mail: uaasis@gmail.com
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1 Validity and Responsiveness of the 2-Minute Walk Test for Measuring Functional

2 Recovery after Total Knee Arthroplasty

3 ABSTRACT

4 Background: The 2-minute walk test (2mwt) is a performance-based test that evaluates

5 functional recovery after total knee arthroplasty (TKA). This study evaluated its validity

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6 compared with the modified Western Ontario and McMaster Universities Osteoarthritis Index

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7 (WOMAC), Oxford Knee Score (OKS), modified Knee Score (modified KS), Numerical

8 Pain Rating Scale (NPRS) and Timed Up and Go test (TUG), and its responsiveness in

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9 assessing functional recovery in TKA patients.

10 Methods: This prospective cohort study included 162 patients undergoing primary TKA

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between 2013 and 2015. We used patient-reported outcome measures (modified WOMAC,
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12 OKS, modified KS, NPRS) and performance-based tests (2mwt and TUG) at baseline and 3,
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13 6 and 12 months postoperatively. The construct validity of 2mwt was determined between the

14 2mwt-distances walked and other outcome measurements. To assess responsiveness, effect

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15 size and standardized response mean were analyzed. Minimal clinically important difference
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16 (MCID) of 2mwt at 12 months after TKA was also calculated.

17 Results: All outcome measurements improved significantly from baseline to 3, 6 and 12

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18 months postoperatively. Bivariate analysis revealed mild to moderate associations between

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19 the 2mwt and modified WOMAC function subscales, and moderate to strong associations
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20 with OKS. Mild to moderate correlations were found for pain and stiffness between 2mwt

21 and other outcome measurements. The effect size and standardized response mean at 12

22 months were large, with an MCID of 12.7 meters.

23 Conclusion: 2mwt is a valid performance-based test with responsiveness properties. Being

24 simple and easy to perform, it can be used routinely in clinical practice to evaluate functional

25 recovery after TKA.

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26 Keywords: 2-minute walk test, Timed Up and Go test, validity, responsiveness, total knee

27 arthroplasty, functional recovery, osteoarthritis knee

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28 Introduction

29 As total knee arthroplasty (TKA) continues to evolve over time, an increasing number

30 of outcome measures targeting the functional status of patients with knee osteoarthritis (OA)

31 and those undergoing a TKA have been developed [1-3]. These measures include patient-

32 reported outcome measures (PROMs) and performance-based tests, with PROMs being

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33 endorsed and applied more often [4]. However, some studies have encouraged the use of

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34 performance-based tests as important tools for capturing the actual improvement in functional

35 status as PROMs often overestimate the ability of patients to ambulate after total hip

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36 arthroplasty [5,6]. For example, Parent et al. [7] demonstrated that although patients with

37 total knee arthroplasty showed dramatic improvements at 2 months, as assessed by the

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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function
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39 subscale, there were no significant changes when measured with performance-based tests
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40 assessing gait speed and stair ascent duration. Therefore, clinicians should be cautious when

41 interpreting findings from studies providing PROM scores only. Given that PROMs may
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42 overestimate the functional status after joint arthroplasty, some authors have advocated the
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43 use of performance-based tests as another outcome measure, recommending their use during

44 the preoperative period for baseline measurements, followed by subsequent comparison with
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45 postoperative measurements [2,8].

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46 The 6-minute walk test and the Timed Up and Go test (TUG) are among the most
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47 commonly reported performance-based tests used to assess the function of the lower

48 extremities [2,3,9]. Although the 6-minute walk test has been shown to be a valid and reliable

49 outcome measure [3], it may be difficult to perform routinely, especially during the

50 preoperative period with patients using walking aids. An alternative walking test is the 2-

51 minute walk test. This is a shorter, more clinically practical, walking test that is commonly

52 used in patients with cardiopulmonary diseases [10,11]. Both the 2-minute walk test and
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53 TUG are simple and quick, require minimal staff and equipment, and can be applied in a

54 short period of time as part of a routine follow-up after a TKA.

55 To utilize the 2-minute walk test in TKA patients routinely, it has to be reliable, valid,

56 and responsive in this particular population, since a measure that has been shown to be valid

57 in one clinical context may not be valid in a different context. Although the validity of the 2-

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58 minute walk test has previously been reported in patients undergoing total hip arthroplasty

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59 [6,12], no studies have validated and documented the longer-term outcomes and

60 responsiveness of this particular walking test in TKA patients. Responsiveness is defined by

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61 the ability to detect changes in a clinical condition. Measures of responsiveness have

62 commonly been reported as effect size, standardized response mean (SRM), and minimal

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clinically important difference (MCID). This provides a threshold that permits a judgement to
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64 be made of whether a difference between two outcome scores in a population of patients
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65 represents a true change in the outcome being assessed, or can be attributed to measurement

66 inaccuracies [13-15].
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67 The objective of this study was to characterize the utility of the 2-minute walk test in
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68 a TKA population. The specific study goals were: 1) describe the changes of a 2-minute walk

69 test at 3, 6, and 12 months postoperatively; 2) evaluate the validity of the 2-minute walk test
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70 by comparing this test with other validated measures that are commonly used to assess
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71 mobility in TKA patients; and 3) measure the responsiveness of the 2-minute walk test at 12
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72 months postoperatively by calculating the effect size, SRM and the minimal detectable

73 change of score.

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75 Materials and Methods

76 The protocol and consent forms used in this study were approved by the XXX

77 Institutional Review Board (SIRB), Faculty of Medicine, XXX Hospital, XXX University.
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78 This study was registered in the ClinicalTrials.gov database via the Protocol Registration and

79 Results System (NCT02156453). Patients treated by a single surgeon and scheduled for

80 primary knee arthroplasty between April 2013 and October 2015 were prospectively

81 included. Patients were eligible if they were between 40 and 100 years of age and were

82 medically stable. They were excluded if they had received unicompartmental knee

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83 arthroplasty; had postoperative complications such as an infection or fracture; had undergone

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84 a complex surgical procedure which required bone grafting, a metal augment, a sleeve or a

85 stem during the operation; or had been diagnosed with a neurological disorder that caused

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86 gait disturbances. Patients who did not return PROMs or were unable to understand verbal

87 and written instructions were also excluded. For those who had been diagnosed with bilateral

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OA knees and were scheduled for a staged bilateral procedure within a year, we collected
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89 data from the second TKA. The recruitments and enrollments were conducted when the
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90 patients visited the hospital during their hospital admission. At enrollment, patients

91 completed all PROMs and were asked to execute the performance-based tests.
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92 Operative procedure and postoperative care

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93 All surgeries were performed by a single surgeon (AU) using a medial parapatellar

94 approach. The prostheses used in this study were either the Press Fit Condylar Sigma (PFC
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95 Sigma) posterior stabilized design (DePuy Synthes, Warsaw, IN) or the Attune posterior
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96 stabilized design (DePuy Synthes, Warsaw, IN). The patella was selectively resurfaced, based
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97 on the intraoperative findings. If the cartilage on the patella was generally preserved with

98 adequate patellofemoral congruency and there was no history of crystalline and inflammatory

99 synovitis, the patellar was not resurfaced [16]. All components were cemented. Following the

100 TKA, all participants underwent a standardized 4- to 5-day in-hospital care protocol.

101 Generally, all patients were mobilized out of bed and started walking, as tolerated, on the first

102 postoperative day. The postoperative pain was controlled with a combination of oral
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103 analgesics, including a nonsteroidal analgesic drug, tramadol, tylenol and oral opioids, as

104 needed. Intravenous morphine was given when the patient’s pain score was > 5. The goal was

105 to keep pain at 2 to 3 out of 10, as measured by the Numerical Pain Rating Scale (NPRS).

106 The intravenous fluid and foley catheter were typically removed on the second postoperative

107 day. All patients were discharged to their home. Patients were instructed to do simple knee

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108 exercises and to walk using a walker a few times a day for 2–3 weeks after discharge. One

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109 month after surgery, they were instructed to continue doing a range of motion exercises and

110 quadriceps exercises, and practice walking with or without an assistive walking device for

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111 approximately 20–30 minutes each time, twice a day.

112 Testing procedures

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All patients underwent testing at 4 different periods in this prospective cohort
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114 investigation: 1 day before surgery (to establish the baseline data), and 3, 6 and 12 months
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115 postoperatively. Patients were asked to complete all PROMs before performing the 2-minute

116 walk test and TUG.

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117 Patient-reported outcome measures

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118 Modified WOMAC

119 WOMAC is a disease-specific questionnaire, which is valid, reliable, and sensitive to

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120 change in the health status of patients with hip and knee OA [1,17]. The original WOMAC is
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121 composed of 24 items grouped into 3 dimensions: pain (5 items), stiffness (2 items), and
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122 physical function (17 items). However, in this study, we used the 22-item, modified Thai

123 WOMAC index. Because of some cross-cultural differences, a Thai index had been modified

124 from the original index (the 17-item functional subscale was decreased to 15 items) and had

125 been validated by previous investigators for OA knees [18]. The test-retest reliability of this

126 modified WOMAC had correlation coefficients ranging from 0.65–0.71, with its internal
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127 consistency ranging from 0.85–0.97 [18]. Similar to the original WOMAC, higher scores

128 indicate a worsened function of the knee, while lower scores indicate an improved function.

129 Oxford Knee Score (OKS)

130 OKS is a 12-item, patient-reported questionnaire specifically designed and developed

131 to assess pain and function after a TKA [19]. Each question is based on one modality, which

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132 can be classified into 5 grades of severity, ranging from 0 (the worst) to 4 (the best). The final

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133 score therefore ranges from the worst (0) to the best (48) patient outcome. This tool has been

134 proved to be valid, clinically meaningful, and easy to perform [20]. In addition, OKS has

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135 been shown to have a good correlation with patients’ postoperative satisfaction levels [21].

136 Modified Knee Score

137
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This scoring system was modified from the original Knee Society Clinical Rating
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138 system by Insall in 1993 [22]. The system is based on 3 categories: pain, range of motion and
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139 stability. The total of the individual scores given for each category is then reduced by the

140 total of the scores given for extension lag, flexion contracture, malalignment and pain at rest,
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141 resulting in an overall modified knee score. The modified knee score is based on a total of
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142 100 points, with higher scores indicating an improved function of the knee, and lower scores

143 indicating a worsened function.

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144 Numeric Pain Rating Scale (NPRS)

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145 The knee pain experienced by the patients was recorded using the NPRS. Subjects
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146 quantified their pain intensity on a scale ranging from 0 (no pain) to 10 (extreme pain, or pain

147 as bad as it can be). NPRS is efficient for use in clinical practice and has been demonstrated

148 to have a good test-retest reliability in different population [23,24].

149 Performance-Based Tests

150 Functional evaluation was conducted using 2 performance-based tests: the 2-minute

151 walk test and TUG test. The results of these tests were recorded preoperatively (to establish
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152 the baseline data) and postoperatively (at the 3-, 6- and 12-month follow-ups) by a research

153 assistant.

154 Two-Minute Walk Test

155 Patients were instructed to walk for 2 minutes at their normal pace up and down a

156 designated corridor, turning around at each end of the corridor without stopping [25]. They

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157 were permitted to use walking aids if they wished. The results were recorded as total distance

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158 walked in meters.

159 Timed Up and Go Test

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160 Patients were instructed to rise from a high-seated chair, walk at a safe and

161 comfortable pace to a mark 3 meters away, and return to a sitting position with their backs

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against the chair [2]. Patients were permitted to use their arms when rising from and returning
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163 to a seated position. A stopwatch was used to measure the time to complete this activity to
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164 the nearest one-tenth of a second. Patients were asked to perform this task 3 times, and the

165 average time was used for analysis.

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166 Demographic data and clinical information were collected at enrollment. Specifically,
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167 the patients’ physical status was measured with the American Society of Anesthesiologists’

168 (ASA) classification, a widely-used grading system to assess the preoperative health of
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169 surgical patients. The ASA score, a subjective rating of a patient’s overall health, is presented
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170 as five classes (I to V) [26]. In class I, the patients are completely healthy and fit. Class II
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171 defines patients with mild systemic disease, whereas Class III is for patients with a severe

172 systemic disease that is not incapacitating. Class IV patients have an incapacitating disease

173 which is a constant threat to life, while Class V is reserved for moribund patients who are not

174 expected to live longer than 24 hours, with or without surgery [27]. Active back pain and the

175 number of painful joints of the lower extremities were also recorded; the results were

176 reported as the total number of additional painful joints in each patient. We also recorded the
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177 use of walking aids, categorized as none (walking without any assistive device) or requiring a

178 cane, walker or wheelchair.

179 Sample size calculation

180 A power analysis was conducted using nQuery Advisor 6.0. The results of a previous

181 investigation [28] found that the effect size of the 6-minute walk test was approximately 0.66.

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182 A power analysis conducted a priori determined that a minimum of 128 subjects were

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183 required to establish a minimum effect size of difference of 0.25, with a 2-sided alpha level

184 of 0.05 and 80% power. Since recruitment was increased by 20% to compensate for loss to

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185 follow-up, a total of 154 subjects were required for this study.

186 Data analysis

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Data analyses were performed using SPSS Statistics for Windows, version 18.0
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188 (SPSS Inc., Chicago, Ill., USA). Data are presented as number and percentage, mean ±
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189 standard deviation, or median [IQR] and range. Outcome scores for all instruments were

190 calculated at each follow-up visit. A p-value less than 0.05 was regarded as being statistically
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191 significant for all tests.

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192 Validity

193 We determined the construct validity of the 2-minute walk test by calculating
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194 Pearson’s correlation coefficient between the scores of the 2-minute walk test and the scores
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195 of the other outcome measurements (WOMAC, OKS, modified knee score, NPRS and TUG).
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196 Construct validity refers to the extent to which the scores on a particular measure relate to

197 other measures in a manner that is consistent with theoretically derived hypotheses

198 concerning the concepts being measured [29]. We evaluated the correlation between the data

199 of the 2-minute walk test and the scores from other outcome measures at all 4 time points

200 (baseline, and 3, 6 and 12 months after surgery). Correlation coefficients of 0.1 to 0.3 were

201 considered weak; 0.3 to 0.6, moderate; and > 0.6, strong [30].
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202 Responsiveness and minimal clinically important difference (MCID)

203 Responsiveness is the ability of a questionnaire to detect clinically important changes

204 over time. Changes in the scores of all instruments were calculated from baseline-data to data

205 recorded at the 12-month follow-up. To assess responsiveness, effect size and standardized

206 response mean were used. Effect size was defined as the mean change in the patient scores

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207 divided by the standard deviation (SD) of the baseline scores. Effect estimates were

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208 interpreted according to Cohen, as follows: a standardized response mean of 0.2 to 0.4 was

209 considered a small effect; 0.5 to 0.7, a moderate effect; and, ≥ 0.8, a large effect [31,32]. The

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210 standardized response mean was defined as the mean change in the patient scores divided by

211 the SD of the changed scores.

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The minimal clinically important difference (MCID) of the 2-minute walk test was
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213 calculated using the distribution-based approach [33], which can be estimated using the
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214 following formula: SD baseline [√(1-r)], where SD baseline is the standard deviation of the

215 baseline data of the 2-minute walk test, and r is the intraclass correlation coefficient of the 2-
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216 minute walk test between the baseline and the 1-year follow-up.
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217

218 Results
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219 Of the total of 209 patients screened for this study, 162 were enrolled. The reasons for
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220 exclusion were: patients who had received unicondylar knee arthroplasty (n=17); those who
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221 had undergone complex total knee arthroplasty (n=24); those with immediate postoperative

222 complications (n=5); and those who unable to follow verbal or written instructions (n=1).

223 With 5 patients also lost to follow-up during the 12-month study period, 157 subjects

224 remained in the study (Figure 1). The descriptive statistics on patient demographics and

225 clinical characteristics are at Table 1. The mean age of the included patients was 69.6 years,

226 with most being female (87.2%). Twenty-four patients (15.3%) had bilateral simultaneous
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227 TKAs. The majority of patients were ASA class II (79.0%). In the preoperative period, 78

228 patients (49.7%) walked without a gait aid. A majority of subjects did not have active back

229 pain or other joint pain of the lower extremities before the procedure (Table 1).

230 All outcome measurements had a symmetrical distribution. The baseline scores of

231 each preoperative outcome are at Table 2. The mean modified WOMAC pain, stiffness and

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232 function scores at baseline were 29.9, 11.2 and 93.3, respectively. The baseline OKS,

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233 modified knee score and NPRS were 16.6, 58.0 and 7.4, respectively. These scores improved

234 significantly from baseline to 3, 6 and 12 months, postoperatively (Figure 2). The mean

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235 distance walked in 2 minutes was 46.2 meters at baseline. The mean distance walked in 2

236 minutes improved significantly to 55.6, 62.5 and 66.1 meters at 3, 6 and 12 months after

237
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surgery, respectively (p < 0.001; Figure 3A). The mean baseline TUG was 23.9 seconds,
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238 which subsequently decreased to 19.7, 17.1 and 15.6 seconds at 3, 6 and 12 months after
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239 surgery, respectively. Like the 2-minute walk test results, the scores of the TUG improved

240 significantly at all time points (Figure 3B).

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241 The correlation between the 2-minute walk test results and the scores of the other
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242 outcome measurements at each time point are at Table 3. A bivariate analysis revealed mild

243 to moderate associations between the 2-minute walk test and the modified WOMAC function
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244 subscale, and a moderate to strong association with the OKS. Conversely, there were no
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245 associations between the 2-minute walk test and the modified knee score at 3 and 12 months,
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246 postoperatively (p-value > 0.05). The association between the 2-minute walk test and the

247 modified knee score at baseline and 6 months postoperatively was found to be weak, with an

248 r-value of 0.165 and 0.178, respectively. In the case of the correlation between the 2-minute

249 walk test and the outcome measurements for pain, a mild to moderate association was

250 observed between the 2-minute walk test and the modified WOMAC pain subscale at 3, 6

251 and 12 months postoperatively and the NPRS at all time points. In addition, there were mild
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252 associations between the 2-minute walk test and the modified WOMAC stiffness subscale at

253 6 and 12 months postoperatively. As for the correlation between the 2 performance-based

254 tests, the correlations between the 2-minute walk test and TUG were strong at all time points,

255 with r-values ranging from 0.781–0.831.

256 The responsiveness of each outcome measurement is at Table 4. The effect size and

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257 standardized response mean of the 2-minute walk test at 12 months after surgery were 1.01

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258 and 1.12, respectively. Based on the standardized response mean at 12 months after surgery,

259 all outcome measurements except the TUG had large effect estimates. The effect size and

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260 standardized response mean of the TUG at 12 months after surgery were 0.58 and 0.68,

261 respectively. Since the intraclass correlation coefficient of the 2-minute walk test between

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baseline and the 1-year follow-up was 0.584 (based on the distribution-based approach), the
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263 MCID of the 2-minute walk test at 12 months after surgery was 12.7 meters. By using the
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264 same equation, the MCID of the TUG at 12 months after surgery was approximately 9.5

265 seconds.
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266
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267 Discussion

268 The level of impairment in patients with knee OA can be measured using validated
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269 PROM, which can be categorized into disease-specific questionnaires (such as WOMAC,
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270 OKS and the modified knee score) and generic, quality-of-life questionnaires (such as the SF-
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271 36). Although PROM provides information on how individuals perceive their physical

272 function in their own environment, it does not describe their ability to perform a specific task

273 or action [34]. In addition, some investigators have demonstrated that the scores from

274 PROMs taken before and after arthroplasty can overestimate patients’ actual functional

275 capacity [5,7,35]. Therefore, evaluations that include both PROM and performance-based
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276 tests are important to provide a more comprehensive perspective of functional recovery after

277 a TKA.

278 To interpret data from any outcome measurement tool, it is a prerequisite that each

279 outcome measurement must be valid, reliable and responsive to changes in a patient’s

280 condition. To our knowledge, this is the first study to investigate the validity and

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281 responsiveness of the 2-minute walk test in patients who had undergone a TKA. We had

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282 hypothesized that the 2-minute walk test measures a different, but related, construct than that

283 measured by the currently available PROMs, and this hypothesis was supported by the

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284 findings that there were mild to moderate correlations between the 2-minute walk test and the

285 modified WOMAC, and a moderate to strong correlation between the 2-minute walk test and

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OKS. This confirms that they do not measure exactly the same construct, but are merely
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287 related as they assess knee function in different ways. In contrast, there were strong
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288 correlations between the 2-minute walk test and TUG (the r values ranged from 0.781–

289 0.831), yielding convergence validity between these 2 performance-based tests. Although
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290 both the 2-minute walk test and TUG measure the function of the lower extremity, the 2-
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291 minute walk test assesses patients’ walking ability and cardiovascular fitness while walking

292 on a level surface, whereas TUG evaluates the ability of patients to adjust their body position
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293 with a voluntary movement, and assesses their strength for vertical and horizontal transitions
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294 in their body’s position [25,36]. Thus, these 2 tests may be appropriate in different clinical
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295 settings, and a combination of these 2 performance-based tests is likely to provide a more

296 comprehensive assessment of function in TKA patients.

297 Unlike previous investigations which showed a moderate association between the

298 knee society score and some performance based tests [37], our study showed that there were

299 no associations between the 2-minute walk test and the modified knee score at 3 and 12

300 months postoperatively, whereas there were mild correlations between the 2-minute walk test
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301 and the modified knee score at baseline and 6 months post-TKA. This can be explained by

302 the fact that the modified knee score that was used in this study measured only pain, the

303 range of motion, and stability. There was no functional domain in this modified knee score.

304 Similar to the modified knee score, the correlations between the 2-minute walk test and the

305 modified WOMAC pain and stiffness subscales and NPRS were mild to moderate (the r

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306 values ranged from 0.042–0.366). This finding has significant clinical importance as it

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307 implies that the 2-minute walk test cannot capture some dimensions, such as pain, stiffness,

308 range of motion, and stability, which are all important dimensions of knee function.

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309 Therefore, performance-based tests and PROM are not interchangeable and provide distinct

310 information about different aspects of physical function after a TKA.

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Moreover, we speculated that with longer-term follow-up, the scores from the
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312 performance-based tests might reduce due to patients getting older and tending to have more
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313 musculoskeletal disorders or co-morbidities. In contrast, the scores from PROMs might be

314 maintained because their knees still performed well. Thus, performance-based tests and
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315 PROM cannot replace one another, and they must therefore both be used to comprehensively
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316 assess the knee function of patients after TKA.

317 Our study provides new information regarding the responsiveness properties of the 2-
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318 minute walk test and TUG. The MCID of the 2-minute walk test and TUG 12 months after
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319 surgery were 12.7 and 9.5, respectively. Our MCID can be used as a guide to follow each
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320 TKA patient routinely. If a patient tends to have a slower progression than expected from the

321 MCID, consideration should be given to interventions such as an intensive session of

322 physical therapy and more frequent follow-up and monitoring. Yuksel E et al. [38] reported a

323 minimal detectable change (MDC) score of approximately 15 meters for the 2-minute walk

324 test, which is similar to our findings. However, the data for their MDC calculations were

325 obtained on the same postoperative follow-up day after the TKA. Therefore, we believe that
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326 our MCID represents the true responsiveness property of the 2-minute walk test at 1 year

327 after surgery.

328 We recommend using the 2-minute walk test instead of a longer walk test, such as the

329 6-minute walk test, after a TKA. Although the 6-minute walk test has been used more often

330 in previous literature and clinical research [39-41], it might overburden patients with knee

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331 OA during the preoperative and early postoperative visits, and may be more difficult to

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332 perform routinely in clinical practice. Thus, a shorter walk test is both more clinically

333 practical and more appropriate for TKA patients. In addition, we found that the 2-minute

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334 walk test was well received by patients, who were most willing and able to complete the test

335 during the preoperative visit and the postoperative follow-ups. In other words, the 2-minute

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walk test can be easily used to assess and monitor physical function in a clinical setting.
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337 Our study has several limitations. Firstly, our follow-up time of approximately 12
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338 months might be considered short. Nevertheless, previous investigators have established that

339 TKA patients reach their plateau phase of recovery within 12 months postoperatively [28].
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340 We therefore do not believe that a longer follow-up period would significantly change the
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341 results or the conclusions of our study. Secondly, this study investigated the association

342 between scores from PROMs and performance-based tests in patients who had undergone
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343 primary TKA. Hence, it cannot be inferred that the results would be the same for a different
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344 population, such as patients with fractures or complex deformities. Thirdly, we chose the 2-
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345 minute walk test and TUG because they are simple and easy to use in routine clinical

346 practice. Nonetheless, other performance-based tests are available, and we are not able to

347 recommend which ones are best to evaluate functional recovery in patients undergoing a

348 TKA.

349 In conclusion, the association between the scores from most PROMs and the 2-minute

350 walk test is mild to moderate. Consequently, the 2-minute walk test provides distinct
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351 information regarding aspects of the knee function that are not captured from PROM; the 2-

352 minute walk test and PROM are therefore not interchangeable. This means that a

353 comprehensive evaluation should include a combination of PROM and performance-based

354 tests to better assess functional recovery in patients after a TKA. Performance-based tests are

355 necessary to fully characterize the change in the physical function of patients after the TKA.

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356 Our study showed that the 2-minute walk test is a valid performance-based test that has a

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357 responsiveness property with an MCID of 12.7 at 12 months after surgery. Given that the 2-

358 minute walk test is a simple and easy-to-conduct performance-based test, it can be used

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359 routinely in clinical practice for evaluating functional recovery after a TKA.

360

361 Conflicts of interest

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362 The authors hereby declare that there are no personal or professional conflicts of
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363 interest regarding any aspect of this study.

364
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365 Funding disclosure

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366 This research project was supported by XXX Research Fund, Grant number

367 R015732004, Faculty of Medicine, XXX Hospital, XXX University.

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368
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369 References
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Acknowledgements

The authors acknowledge the assistance given by Wachirapan Narktang, MSc, and Krit

Boontanapibul, MD, with data collection. The authors also acknowledge Suthipol

Udompunthurak, MSc (Applied Statistics), for his assistance with the statistical analyses.

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Figure Legend

Figure 1. Flow chart showing the patient inclusion process

Figure 2. Mean values of each patient-reported outcome measure (PROM), and within

group p-values to compare data at baseline, 3, 6 and 12 months postoperatively. (A)

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modified WOMAC pain; (B) modified WOMAC stiffness; (C) modified WOMAC

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function; (D) Oxford Knee Score; (E) modified Knee Score (KS) and; (F) Numerical Pain

Rating Scale (NPRS). The error bars indicate standard deviation.

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Figure 3. Mean values of the performance-based tests and within group p-values to

compare data at baseline, 3, 6 and 12 months postoperatively. (A) Two-minute walk test

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and; (B) Timed Up and Go test. The error bars indicate standard deviation.
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Table 1. Patient demographic and clinical characteristics

Clinical variables Total (N=157)

Age (years), mean±SD 69.6 ± 8.1

Female gender, n (%) 137 (87.2)

Side, n (%)

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- Right 59 (37.6)
- Left 74 (47.1)

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- Bilateral 24 (15.3)

Body mass index (kg/m2), mean±SD 26.6 ± 4.4

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Procedure, n (%)
- Unilateral TKA 133 (84.7)
- Bilateral TKAs
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Prosthesis type, n (%)
- PFC sigma 92 (58.6)
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- Attune 65 (41.4)
ASA classification, n (%)
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- I 6 (3.8)
- II 124 (79.0)
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- III 27 (17.2)
- IV 0 (0)
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- V 0 (0)
Use of gait aid preoperatively, n (%)
- None 78 (49.7)
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- Cane 49 (31.2)
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- Walker 29 (18.5)
- Wheel chair 1 (0.6)
Active back pain, n (%)
- Yes 19 (12.1)
- No 138 (87.9)
Number of lower extremities pain, n (%)
- Yes 35 (22.2)
- No 122 (77.8)
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Abbreviations: N, total population; SD, standard deviation; n, number; TKA, total knee
arthroplasty; PFC Sigma, Press Fit Condylar Sigma; ASA, American Society of
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Table 2. Baseline scores of each outcome measurement

Outcome measures Mean ± standard Median Range

deviation (interquartile

ranges)

Two-minute walk test 46.2 ± 19.6 48.0 (30.0, 60.0) 2.0 – 94.5

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(meters) (n=157)

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Modified WOMAC (n=157)

- Pain 29.9 ± 9.8 30.0 (22.0, 37.0) 6.0 – 50.0

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- Stiffness 11.2 ± 4.9 12.0 (8.0, 15.0) 0.0 – 20.0

- Function 93.3 ± 27.6 97.0 (73.0, 113.0) 27.0 – 148.0

Oxford Knee Score (n=107)

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16.6 ± 5.8 15.0 (13.0, 20.5) 5.0 – 34.0
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Modified Knee Score 58.0 ± 6.1 58.0 (56.0, 62.0) 25.0 – 89.0
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(n=157)

Numeric Pain Rating Scale 7.4 ± 1.69 8.0 (6.0, 8.0) 2.0 – 10.0
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(n=157)
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Timed Up and Go test 23.9 ± 14.3 18.9 (14.9, 29.4) 9.3 – 95.0

(seconds) (n=157)
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Abbreviations: WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index

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Table 3. Construct validity of the 2-minute walk test and the modified WOMAC, Oxford Knee

Score, modified Knee Score, Numeric Pain Rating Scale and the Timed Up and Go test at

baseline, 3, 6 and 12 months after surgery

Outcome measures Two-minute walk test (meters)

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Baseline 3 months after 6 months after 12 months after

surgery surgery surgery

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Modified WOMAC

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Pain (n=157)

r value -0.042 -0.205 -0.366 -0.279

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95% CI -0.197 to 0.115 -0.350 to -0.049 -0.494 to -0.222 -0.417 to -0.127
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p-value 0.602 0.010 <0.001 <0.001

Stiffness (n=157)
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r value -0.090 -0.148 -0.258 -0.209

95% CI -0.243 to 0.068 -0.297 to 0.009 -0.399 to -0.106 -0.354 to -0.053

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p-value 0.263 0.065 0.001 0.009

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Function (n=157)

r value -0.167 -0.280 -0.366 -0.312

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95% CI -0.315 to -0.010 -0.419 to -0.129 -0.494 to -0.222 -0.448 to -0.163

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p-value 0.037 <0.00 <0.001 <0.001

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Oxford Knee Score (n=107)

r value 0.309 0.523 0.542 0.622

95% CI 0.125 to 0.472 0.370 to 0.649 0.392 to 0.663 0.489 to 0.726

p-value 0.001 <0.001 <0.001 <0.001

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Outcome measures Two-minute walk test (meters)

Baseline 3 months after 6 months after 12 months after

surgery surgery surgery

Modified Knee Score

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(n=157)

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r value 0.165 0.079 0.178 0.069

95% CI 0.008 to 0.314 -0.079 to 0.233 0.022 to 0.326 -0.089 to 0.224

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p-value 0.039 0.326 0.026 0.391

Numeric Pain Rating Scale

(n=157)
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r value -0.180 -0.167 -0.224 -0.193
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95% CI -0.328 to -0.024 -0.315 to -0.010 -0.368 to -0.069 -0.339 to -0.037

p-value 0.024 0.037 0.005 0.016

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Timed Up and Go test

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(seconds) (n=157)

r value -0.792 -0.825 -0.831 -0.781

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95% CI -0.844 to -0.725 -0.869 to -0.768 -0.874 to -0.775 -0.836 to -0.712

p-value <0.001 <0.001 <0.001 <0.001

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Table 4. Responsiveness of each outcome measurement at 12 months after TKA

Outcome measures Twelve months after surgery

Effect size Standardized response mean

Two-minute walk test 1.01 1.12

Modified WOMAC

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- Stiffness 1.96 1.95

- Function 2.94 2.65

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Oxford Knee Score 3.76 3.25

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Modified Knee Score AN 5.19 3.61

Numeric Pain Rating Scale 3.78 3.07

Timed Up and Go test 0.58 0.68

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