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1 Arthritis Care & Research Vol. 67, No. 2, February 2015, pp DOI /acr , American College of Rheumatology ORIGINAL ARTICLE Early Rehabilitation After Total Knee Replacement Surgery: A Multicenter, Noninferiority, Randomized Clinical Trial Comparing a Home Exercise Program With Usual Outpatient Care ANNIE S. Y. HAN, 1 LILLIAS NAIRN, 1 ALISON R. HARMER, 1 JACK CROSBIE, 1 LYN MARCH, 1 DAVID PARKER, 2 ROSS CRAWFORD, 3 AND MARLENE FRANSEN 1 Objective. To determine, at 6 weeks postsurgery, if a monitored home exercise program (HEP) is not inferior to usual care rehabilitation for patients undergoing primary unilateral total knee replacement (TKR) surgery for osteoarthritis. Methods. We conducted a multicenter, randomized clinical trial. Patients ages years were allocated at the time of hospital discharge to usual care rehabilitation (n 196) or the HEP (n 194). Outcomes assessed 6 weeks after surgery included the Western Ontario and McMaster Universities Osteoarthritis Index pain and physical function subscales, knee range of motion, and the 50-foot walk time. The upper bound of the 95% confidence interval (95% CI) mean difference favoring usual care was used to determine noninferiority. Results. At 6 weeks after surgery there were no significant differences between usual care and HEP, respectively, for pain (7.4 and 7.2; 95% CI mean difference [MD] 0.7, 0.9), physical function (22.5 and 22.4; 95% CI MD 2.5, 2.6), knee flexion (96 and 97 ; 95% CI MD 4, 2 ), knee extension ( 7 and 6 ; 95% CI MD 2, 1 ), or the 50-foot walk time (12.9 and 12.9 seconds; 95% CI MD 0.8, 0.7 seconds). At 6 weeks, 18 patients (9%) allocated to usual care and 11 (6%) to the HEP did not achieve 80 knee flexion. There was no difference between the treatment allocations in the number of hospital readmissions. Conclusion. The HEP was not inferior to usual care as an early rehabilitation protocol after primary TKR. INTRODUCTION Total knee replacement (TKR) is a common surgical procedure worldwide. Osteoarthritis (OA) is one of the 10 ACTRN: The Maximum Recovery After Knee Replacement (MARKER) Study was funded by the Hospitals Contribution Fund of Australia (HCF) Health and Medical Research Foundation and the British United Provident Association (BUPA; formerly MBF) Foundation, Australia. 1 Annie S. Y. Han, BPhty(Hons), Lillias Nairn, MPH, Alison R. Harmer, PhD, Jack Crosbie, PhD, Lyn March, PhD, Marlene Fransen, PhD: University of Sydney, Lidcombe, New South Wales, Australia; 2 David Parker, MB, BS: Sydney Orthopaedic Research Institute, Chatswood, New South Wales, Australia; 3 Ross Crawford, PhD: Queensland University of Technology, Brisbane, Queensland, Australia. Address correspondence to Marlene Fransen, PhD, Faculty of Health Sciences, University of Sydney, 75 East Street, Lidcombe 2141, New South Wales, Australia. marlene.fransen@sydney.edu.au. Submitted for publication February 19, 2014; accepted in revised form August 26, most disabling diseases in developed countries, and it is the most common reason that people undergo TKR surgery (1 5). Moreover, the use of this procedure has been rising steadily in recent years. According to the Australian National Joint Replacement Registry, there was an 84% increase in TKR surgeries from 2003 to 2011 in Australia (3). In the US, the annual number of TKR surgeries increased 162% over the past 2 decades among the Medicare population (4). Similarly, in Europe there was a marked increase in the annual number of TKR surgeries in the past decade, with numbers tripling in Denmark and doubling in Spain (1). The increasing incidence and prevalence of TKR and knee OA in the developed world is likely to continue due to factors such as the ageing population and increasing prevalence of obesity, as well as a higher demand for surgery at a younger age to improve physical function (1,2,6 8). Rehabilitation practice variation after hospital discharge is evident between and within countries worldwide. However, some form of early rehabilitation (0 6 weeks) after hospital discharge appears to be usually recommended 196

2 Monitored Home Exercise Versus Usual Care in TKR Rehabilitation 197 Significance & Innovations A monitored home exercise program for 6 weeks after hospital discharge is not inferior to usual outpatient rehabilitation care after primary total knee replacement (TKR) surgery. Serious adverse events were similar between the treatment allocations, with approximately 5% of patients readmitted to hospital for knee-related issues. Many patients undergoing primary TKR surgery do not access available physiotherapy outpatient services during the first 6 weeks after hospital discharge. (9 12). There is currently limited evidence supporting any form of early rehabilitation after TKR. A systematic review of 6 small randomized trials compared various forms of physiotherapy exercise or delivery modes for patients after TKR and concluded that interventions including physiotherapy functional exercises after discharge result in shortterm benefit, compared with traditional exercises, home programs, or usual care (13). One of the studies (which provided all patients with an unmonitored home exercise program) in the review evaluated the addition of several outpatient physiotherapy visits in terms of knee range of motion (ROM) only and found no significant benefit 3 months after surgery (14). A randomized trial published subsequently to this review found no difference in patientreported pain or physical function at 3 months postsurgery when comparing inpatient physiotherapy and a homebased program for early rehabilitation (15). Despite the limited evidence for the utility of early clinic-based rehabilitation after hospital discharge, it remains common practice for most patients undergoing TKR to be referred for 6 to 8 weeks of clinic-based physiotherapy immediately after discharge from hospital. Interestingly, one randomized clinical trial included in the review evaluated the effects of delayed rehabilitation (commencing 2 months after TKR) compared with usual care on patient self-reported pain and function and the 6-minute walking distance (6MWD) (16). Patients allocated to the delayed rehabilitation program received more intensive rehabilitation and reported less pain and functional limitation than the usual care group at 12 months after surgery. The main aim of the MARKER (Maximum Recovery After Knee Replacement) Study is to determine if an intensive 12-week, class-based exercise program, commencing 6 to 8 weeks after TKR surgery, produces better longterm outcomes compared to the current usual practice of rehabilitation restricted to the first 1 or 2 months after hospital discharge (17). However, during the first 6 weeks after TKR, surgery patients allocated to the experimental MARKER delayed intensive exercise program received a monitored home exercise program (HEP). The aim of the current study is to determine whether the HEP is not inferior to usual care in terms of self-reported pain and physical function, knee ROM, walking ability, and safety at 6 weeks. PATIENTS AND METHODS Patients from 10 large public and private hospitals in 3 Australian states (New South Wales, Queensland, and Victoria) were recruited to the MARKER study from September 2009 to October The study was conducted in compliance with the Helsinki Declaration. Ethics approval was obtained from the University of Sydney Human Research Ethics Committee and through the National Ethics Application Form (Sydney South West Area Health Service as lead committee), and ethics governance approval was obtained from each participating hospital. Written informed consent was obtained from all patients. This study is registered with the Australia New Zealand Clinical Trials Registry (ACTRN: ). Inclusion and exclusion criteria. Inclusion criteria were 1) ages years, 2) planned unilateral or bilateral primary TKR, and 3) able to be discharged home from the orthopedic ward. Exclusion criteria were 1) previous unicompartmental replacement or tibial osteotomy on the same knee, 2) previous lower extremity joint replacement surgery within the last 6 months, 3) anticipation of other lower extremity joint replacement surgery in the next 12 months, 4) comorbidity that precluded exercise at 50 60% maximum heart rate (e.g., unstable angina, acute myocarditis, aneurysm, or uncontrolled symptomatic heart failure), 5) rheumatoid arthritis, 6) major neurologic conditions, and 7) inability to return to a participation site for the intensive exercise classes. Randomization. Eligible patients were recruited at the orthopedic preadmission clinic of each participating hospital. No changes were made to the usual orthopedic, medical, or physiotherapy care provided during the admission period. Randomization was conducted just prior to discharge from the orthopedic ward. The randomization schedule was generated at a central administrative site by an independent researcher using a computer-generated random number sequence. Randomization was conducted in varying blocks of 4 or 6, and stratified by hospital site and unilateral or bilateral TKR. Allocations were sealed in opaque and consecutively numbered envelopes with a clear audit trail. Interventions. The patients allocated to the HEP received 1 session of instruction from the local study project manager (a physiotherapist) prior to hospital discharge and received a written copy of the HEP and instructions regarding effective icing. The HEP was divided into 2 stages (see Supplementary Appendix A, available in the online version of this article at com/doi/ /acr.22457/abstract). Stage 1 (weeks 1 2) focused on 6 exercises to increase full active and passive knee ROM in sitting and supine positions, while stage 2 (weeks 3 6) focused on 6 functional and weight-bearing exercises to increase ROM and maintain muscle strength.

3 198 Han et al Patients were asked to complete 10 repetitions of each exercise, 3 times daily. The study project manager arranged 1 clinic-based appointment in the first week after hospital discharge to monitor adherence and ability to complete the HEP and to assess knee symptoms and walking ability. Brief weekly telephone calls were made thereafter to monitor adherence and evaluate readiness to commence the intensive exercise classes (surgical wound healed, walking independently outdoors 50 meters, full weight bearing tolerated, not requiring opioid-based analgesics). Based upon information gained from the patient during the telephone calls, further face-to-face physiotherapy appointments were arranged if deemed necessary. The usual care group was offered the postoperative rehabilitation recommended by their hospital or orthopedic surgeon. Usual care mostly involved access to clinic-based outpatient physiotherapy for the 6 weeks after discharge from the orthopedic ward. Outcome measures. At each respective hospital site the 6-week assessment was conducted by a study-employed physiotherapist who was blinded to treatment allocation. Main outcomes: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC is a self-report questionnaire specifically designed to evaluate pain, stiffness, and physical function among people with knee and hip OA (18,19). The WOMAC has been validated among patients undergoing TKR (20) and includes 2 subscales: pain (5 items, 0 20 score range) and physical function (17 items, 0 68 score range). Higher scores indicate more pain or disability. Patients completed the WOMAC separately for the left and right lower extremities. Secondary outcome: knee ROM. Knee ROM was measured using a long-arm goniometer that provides acceptable reliability for group data (21). The goniometer axis was centered at the lateral knee joint line and the arms were aligned with the greater trochanter and lateral malleolus. Active knee flexion was measured in sitting. Active knee extension was measured in long sitting or supine. Secondary outcome: 50-foot walk time. Maximal walking speed is a more reliable and predictive measure of walking ability compared with walking at a comfortable pace (22,23). Patients were asked to walk as fast as they safely could with or without a walking aid. The patients were timed from a standing start until the point at which they walked through the 50 feet (15.24 meters) marker. Each patient attempted the test once only. Secondary outcome: physiotherapy attendance and adverse medical events. Patients were asked to complete a study-specific diary during this 6-week, postdischarge period. Information collected included employment status, time off work, physiotherapy attendance, medical appointments, and hospital readmissions. Statistical analysis. The aim of the current analysis was to demonstrate noninferiority of the HEP program compared with usual care in the first 6 weeks after unilateral knee replacement. Independent t-tests were conducted to compare outcomes between the 2 treatment allocations at 6 weeks. An established criterion of a minimum clinically important difference (MCID) of 15% difference with the usual care group was used to ensure noninferiority (20). The HEP program would be considered noninferior to usual care if the upper bound of the 95% confidence interval (95% CI) favoring usual care WOMAC subscales (main outcomes) did not exceed this criterion (24). Our study had 88% and 82% power to detect this difference for pain and physical function, respectively, at the 0.05 significance level. The data were de-identified, so statistical analysis was completed with the researcher blinded to allocation. Statistical analysis was conducted per intentto-treat for the WOMAC subscale scores, using the last observation carried forward (from the baseline scores) if 6-week scores were missing. The physical performance outcome measures of knee ROM and 50-foot walk time were only conducted at the 6-week assessment. The number of patients who did not achieve 80 knee flexion in each allocation group was compared. All data were analyzed using IBM SPSS Statistics, version 19. RESULTS A total of 1,935 patients were screened for eligibility, with 422 patients proceeding to randomization. For the present study, those who underwent bilateral knee replacement (n 32) were excluded; hence, the 390 patients with unilateral replacement comprised the usual care (n 196) or HEP (n 194) groups (Figure 1). At the 6-week assessment, 13 patients (7%) had withdrawn from the usual care group and 15 (8%) had withdrawn from the HEP. In addition, a total of 7 patients from the usual care group were unable to attend the clinic-based assessment to undertake the physical performance tests at 6 weeks (4 of whom did return a completed WOMAC questionnaire). One patient in the HEP group did not complete the WOMAC questionnaire, but attended the physical performance assessment. The 2 allocation groups did not differ at baseline for demographic variables and WOMAC subscale scores (Table 1). The mean age was 65 years and most patients were overweight or obese. Approximately 55% of patients reported hypertension, 51% reported back pain, and 18% had diabetes (Table 1). Six weeks after TKR surgery, there were no significant differences between the treatment groups for the WOMAC pain and physical function scores (Table 2). The upper bound of the 95% CI favoring usual care for WOMAC pain could not exclude a possible 0.7 out of 20 points difference with HEP and for WOMAC physical function a 2.5 out of 68 points difference with HEP. These scores are well within the 15% margin of the usual care WOMAC outcomes at 6 weeks of 1.1 (15% of 7.4) and 3.4 (15% of 22.5) for pain and physical function, respectively. At 6 weeks, there were also no significant differences between the treatment groups for the secondary outcomes of knee ROM or 50-foot walk time (Table 2). Six weeks after surgery, 18 patients (9%) allocated to usual care and 11 patients (6%) allocated to HEP did not achieve 80 of active knee flexion. A total of 88 patients (23%) did not return a completed patient diary, 28 of these patients had withdrawn from the

4 Monitored Home Exercise Versus Usual Care in TKR Rehabilitation 199 Enrollment Allocation study (Table 3). Approximately 14% (15% usual care, 11% HEP) of the 302 patients who returned a completed diary reported not accessing physiotherapy during the first 6 weeks after hospital discharge. A larger proportion of patients in usual care received 7 or more physiotherapy sessions during the first 6 weeks, compared to patients allocated to the HEP (26% and 12%, respectively). The treatment groups were similar with respect to the number of hospital readmissions for knee-related issues (Table 4). Of all the patients who had hospital admissions, all but 1 reported a single hospital admission only. One patient allocated to usual care had 2 hospital admissions due to a leg blister that developed below the TKR site. Two patients allocated to usual care and 1 allocated to the HEP received manipulation under anesthesia for poor knee ROM within the first 6 weeks. There were various hospital admissions not related to the TKR, such as prostate check and cataract surgery. DISCUSSION Usual Care (n=196) Withdrawn, n=13 (7%) dissatisfied allocation (n=2) lost interest or busy (n=7) medical reasons (n=1) unknown (n=3) Lost to followup, n=3 Six-week assessment WOMAC n=180 (92%) Physical Performance* n=176 (90%) Analyzed WOMAC n=196 (100%) Physical Performance n=176 (90%) Screened for eligibility n=1935 Randomized (n=422) Randomized (n=390) Excluded n=1513 Classes inconvenient (n=561) Want usual care (n=315) Multiple comorbidity (n=202) Recent knee surgery (n=122) Poor English (n=106) Not interested (n=207) Bilateral surgery n=32 Home Exercise Program (n=194) Withdrawn, n=15 (8%) dissatisfied allocation (n=1) lost interest or busy (n=5) medical reasons (n=5) unknown (n=4) Lost to followup, n=1 WOMAC n=178 (92%) Physical Performance* n=179 (92%) WOMAC n=194 (100%) Physical Performance n=179 (92%) Figure 1. Study flow chart. WOMAC Western Ontario and McMaster Universities Osteoarthritis Index; physical performance (knee range of motion, 50-foot walk time) only collected at 6 weeks. The results of this study reveal the noninferiority of a monitored HEP compared with usual care physiotherapy, in terms of WOMAC self-reported pain and physical function, 6 weeks after primary TKR. Additionally, neither the secondary physical performance outcomes (knee ROM, 50-foot walk time) nor the adverse events differed between groups 6 weeks after surgery. A prospective observational study that evaluated the responsiveness of the WOMAC questionnaire among 516 patients after TKR concluded the MCID was 15% (20). Our results demonstrate that even at the upper boundary of the 95% CI mean difference favoring usual care, usual care would not result in clinically meaningful lower WOMAC pain and physical function scores compared with the HEP. Serious adverse events, indicated by hospital admissions in the first 6 weeks after TKR surgery, were recorded by 14 patients (7%) from usual care and 18 patients (9%) from the HEP group (Table 4). These comparable results suggest that allocation to the HEP did not increase the risk of hospital readmissions for knee-related issues during this period. Orthopedic surgeons typically use knee flexion ROM as a measure to determine the success of TKR surgery. A target knee flexion ROM of 90 after TKR is commonly specified in hospital clinical pathways, as this range allows for functional movement (25,26). At 6 weeks, 18 patients (9%) in the usual care group and 11 patients (6%) in the HEP group failed to achieve even a conservative 80 of knee flexion. Patients not achieving 80 knee flexion may also be considered likely candidates for knee manipulation under anesthesia, a procedure used to restore flexion ROM when the knee flexion is less than (27 29). Whether more intensive physiotherapy input during this early phase of rehabilitation would markedly reduce the number of patients with inadequate knee flexion is unknown. The mean 50-foot walk time among our patients was 12 seconds, equivalent to a fastest gait speed of 1.3 meters/ second. An observational study, conducted among 29 older people undergoing inpatient orthopedic rehabilitation after TKR in Quebec, recorded the patients fastest gait speed over 10 meters at discharge from 8 weeks inpatient rehabilitation as 15.4 seconds (30), which is much slower than the 12 seconds over 50 feet (15 meters) found in our study. The noninferiority results of our study are comparable to 2 previous randomized clinical trials that recruited smaller cohorts. One study conducted among 160 patients compared a telephone-monitored HEP, which consisted of ROM and strengthening exercises, with an outpatient physiotherapy program (31). Three months after surgery, both treatment groups performed similarly for WOMAC scores, knee flexion ROM, and 6MWD. Another trial with 120 patients compared the addition of several outpatient physiotherapy visits to receipt of an unmonitored home program only (14). There were no significant differences between the groups in knee ROM at baseline, 3 months, 6 months, or 1 year after surgery. However, since these 2 studies recruited smaller samples, they may not have been able to detect smaller, but clinically meaningful, differences between the treatment allocations. A recent superiority study compared Oxford Knee Scores, WOMAC pain scores, and 6MWD scores between 249 patients allocated to individual physiotherapy, classbased physiotherapy, or a monitored HEP after TKR surgery (32). Treatment interventions commenced 2 weeks

5 200 Han et al Table 1. Baseline demographics* Variable Usual care (n 196) HEP (n 194) P Age, mean SD years Male sex 92 (47) 86 (44) 0.61 BMI, mean SD kg/m Employment Full time or part time 52 (27) 69 (36) 0.06 Retired/unemployed/carer/home duties 144 (73) 124 (64) 0.06 Surgery conducted in private hospital 78 (40) 76 (39) 0.84 Previous knee surgery 36 (18) 28 (14) 0.76 WOMAC scores, mean SD Unoperated knee Pain (0 20) Physical function (0 68) Operated knee Pain (0 20) Physical function (0 68) Comorbidity score 0 25 (13) 31 (16) (33) 57 (29) (37) 66 (34) (17) 40 (21) 0.32 Type of comorbidity Hypertension 101 (52) 114 (59) 0.15 Heart disease 27 (14) 37 (19) 0.16 Lung disease 22 (11) 13 (7) 0.12 Diabetes mellitus 34 (17) 35 (18) 0.86 Depression 27 (14) 40 (21) 0.07 Back pain 104 (53) 95 (49) 0.42 * Values are the number (percentage) unless indicated otherwise. HEP home exercise program; BMI body mass index; WOMAC Western Ontario and McMaster Universities Osteoarthritis Index. Comorbidity was reported using the self-administered comorbidity questionnaire, which records the presence of 12 current medical conditions; additional scores are given if the participant reports receiving treatment and if this condition limits activities. The scores range from 0 36 points, where a higher score indicates more comorbidity (34). after TKR surgery and continued for 6 weeks. The study concluded that individual physiotherapy was not superior to the other forms of rehabilitation either for short-term (10 weeks) or long-term (52 weeks) outcomes (32). These findings are similar to our results, i.e., the outcomes are comparable for usual outpatient care and a monitored HEP. The patient diary revealed some surprising findings. Although a survey of Australian hospitals indicated that usual care comprised outpatient physiotherapy during the first 6 to 8 weeks after hospital discharge (9), among our patients allocated to usual care, 15% did not access any physiotherapy and a further 30% only attended 1 3 sessions during the first 6 weeks after discharge. Similarly, 11% of patients allocated to the HEP did not utilize the monitoring visit offered during week 1. Pain may have been a barrier to attending a clinic during this early period after surgery. A questionnaire-based survey, conducted among a subgroup of 174 patients participating in the Table 2. Self-reported pain and physical function (WOMAC scores), knee ROM, and fastest walking speed (50-foot walk times) at 6 weeks* Outcome measure Usual care, mean SD HEP, mean SD Mean difference (95% CI) WOMAC score Pain (0 20) ( 0.7, 0.9) Physical function (0 68) ( 2.5, 2.6) Knee ROM (degrees) Flexion ( 4.1, 1.9) Extension ( 1.6, 1.2) 50-foot walk time (seconds) ( 0.8, 0.7) * WOMAC Western Ontario and McMaster Universities Osteoarthritis Index; ROM range of motion; HEP home exercise program; 95% CI 95% confidence interval.

6 Monitored Home Exercise Versus Usual Care in TKR Rehabilitation 201 Table 3. Visits, no. Number of face-to-face physiotherapy visits during first 6 weeks for usual care (UC; n 155) and home exercise program (HEP; n 147)* Hospital, Private practice, Home visits, Total visits, UC HEP UC HEP UC HEP UC HEP 0 89 (57) 50 (34) 97 (63) 115 (78) 120 (77) 96 (65) 24 (15) 16 (11) (17) 81 (55) 20 (13) 19 (13) 26 (17) 42 (29) 46 (30) 76 (52) (14) 13 (9) 22 (14) 6 (4) 5 (3) 9 (6) 45 (29) 38 (26) 7 17 (11) 3 (2) 16 (10) 7 (5) 4 (3) 0 (0) 40 (26) 17 (12) * 41 (21%) patient diaries missing from UC, and 47 (24%) patient diaries missing from HEP. MARKER Study, evaluated postoperative pain perceptions, experience, and management during the first 2 weeks after discharge from the hospital (33). The survey revealed that 23% of patients reported severe pain during this period, which possibly limited their desire or ability to travel to outpatient physiotherapy (33). Furthermore, driving restrictions are usually in place for 6 weeks after surgery, resulting in reliance on family or friends, or expensive taxis, for transport. This issue was also reflected during study recruitment. Only approximately 20% of potential participants actually proceeded to randomization, potentially restricting generalizability, with the major reason given being the limited number of locations for the intensive exercise classes we were able to offer. Usual care early rehabilitation services after TKR varied between hospital sites in our study. Several public hospitals participating in our study offered patients a weekly exercise class at the outpatients physiotherapy department for several weeks after discharge from the hospital. Patients who lived further away from the hospital could access home visits or receive 5 physiotherapy sessions funded by Medicare. Patients from private hospitals participating in our study were either required to contribute a small gap payment for nonhospital-based private physiotherapy or had free access to a hospital-based rehabilitation program. However, the strength of recommendation for physiotherapy from the orthopedic surgeons was variable between hospitals (private or public). The lack of inferiority of the HEP may be due to the unexpectedly low access to the available clinic-based rehabilitation by the usual care group. Table 4. Reason Hospital readmissions during first 6 weeks after discharge* Usual care, n 14 Patients, no. LOS, range Patients, no. HEP, n 18 LOS, range TKR-related Knee MUA Other, unrelated * HEP home exercise program; LOS length of stay (days); TKR total knee replacement; MUA manipulation under anesthesia. Operated knee swelling and/or extreme knee pain; excess wound leakage or bleeding. Our patients diaries revealed that many patients allocated to the HEP sought further physiotherapy, either on advice from the monitoring project manager or their orthopedic surgeon due to concerns regarding slow recovery, or at their own initiative. For ethical reasons we could not prohibit patients allocated to the HEP from seeking physiotherapy services if advised to do so by their treating surgeon or other health professionals. The survey also revealed that many patients did not anticipate the high levels of pain experienced after discharge from the hospital (33). It is probable that some patients felt the need for more reassurance (that they were progressing satisfactorily) than was provided to the HEP group. The strengths of our study are that it was a multicenter, randomized trial that included a large number of patients drawn from both the private and public health care systems; there was 10% loss to followup, and the assessors were blinded to treatment allocation. Uniquely, we also evaluated hospital readmissions and actual physiotherapy utilization during this first 6 weeks after discharge from the orthopedic ward. This study revealed that delivery of a monitored HEP is not inferior in terms of WOMAC pain and physical function to access to clinic-based usual care physiotherapy during the first 6 weeks after hospital discharge among patients who had undergone a TKR. The secondary outcomes of knee ROM, fastest walking speed, and hospital readmissions were also similar between groups. AUTHOR CONTRIBUTIONS All authors were involved in drafting the article or revising it critically for important intellectual content, and all authors approved the final version to be submitted for publication. Dr. Fransen had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study conception and design. Nairn, Harmer, Crosbie, March, Parker, Crawford, Fransen. Acquisition of data. 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