Collaborative model of care between orthopaedics and allied healthcare professionals (CONNACT) in knee osteoarthritis: Effectiveness-implementation hybrid randomized controlled trial of a community-based, multidisciplinary, stratified intervention.

OBJECTIVE: To compare the clinical and cost effectiveness of the Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals (CONNACT), a community-based, stratified, multidisciplinary intervention consisting of exercise, education, psychological and nutrition delivered through a chronic care model to usual hospital care in adults with knee osteoarthritis (OA). METHODS: Pragmatic, parallel-arm, single-blinded superiority RCT trial. Community-dwelling, ambulant adults with knee OA (Kellgren-Lawrence grade > 1; Knee Injury and OA Outcome Score (KOOS4) ≤75) were enrolled. Primary outcome was KOOS4 at 12-months; secondary outcomes included: quality of life, physical performance measures, symptom satisfaction, psychological outcomes, dietary habits, and global perceived effect. Intention-to-treat analysis using generalized linear model (GLM) and regression modeling were conducted. Economic evaluation through a societal approach was embedded. RESULTS: 110 participants (55 control, 55 intervention) were randomized. No between-group difference found for the primary outcome (MD [95%CI]: -1.86 [-9.11. 5.38]), although both groups demonstrated within-group improvement over 12-months. Among the secondary outcomes, the CONNACT group demonstrated superior dietary change (12 months) and physical performance measures (3 months), and global perceived effect (6 months). While there was no between-group difference in total cost, significant productivity gains (reduced indirect cost) were seen in the CONNACT group. CONCLUSION: CONNACT was not superior to usual care at 1 year. Further efforts are needed to understand the underlying contextual and implementation factors in order to further improve and refine such community-based, stratified care models moving forward. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT03809975. Registered January 18, 2019. https://clinicaltrials.gov/ct2/show/NCT03809975.

Effectiveness, safety, and cost-utility of a knee brace in medial knee osteoarthritis: the ERGONOMIE randomized controlled trial.

OBJECTIVE: This pragmatic, multicenter, open-label, randomized controlled trial (RCT) aimed to compare the effectiveness, safety, and cost-utility of a custom-made knee brace versus usual care over 1 year in medial knee osteoarthritis (OA). DESIGN: 120 patients with medial knee OA (VAS pain at rest >40/100), classified as Kellgren-Lawrence grade II-IV, were randomized into two groups: ODRA plus usual care (ODRA group) and usual care alone (UCA group). The primary effectiveness outcome was the change in VAS pain between M0 and M12. Secondary outcomes included changes over 1 year in KOOS (function) and OAKHQOL (quality of life) scores. Drug consumption, compliance, safety of the knee brace, and cost-utility over 1 year were also assessed. RESULTS: The ODRA group was associated with a higher improvement in: VAS pain (adjusted mean difference of -11.8; 95% CI: -21.1 to -2.5); all KOOS subscales (pain: +8.8; 95% CI: 1.4-16.2); other symptoms (+10.4; 95% CI: 2.7-18); function in activities of daily living (+9.2; 95% CI: 1.1-17.2); function in sports and leisure (+12.3; 95% CI: 4.3-20.3); quality of life (+9.9; 95% CI: 0.9-15.9), OAKHQOL subscales (pain: +14.8; 95% CI: 5.0-24.6); and physical activities (+8.2; 95% CI: 0.6-15.8), and with a significant decrease in analgesics consumption at M12 compared with the UCA group. Despite localized side-effects, observance was good at M12 (median: 5.3 h/day). The ODRA group had a more than 85% chance of being cost-effective for a willingness-to-pay threshold of €45 000 per QALY. CONCLUSIONS: The ERGONOMIE RCT demonstrated significant clinical benefits of an unloader custom-made knee brace in terms of improvements in pain, function, and some aspects of quality of life over 1 year in medial knee OA, as well as its potential cost-utility from a societal perspective.

Are education, exercise and diet interventions a cost-effective treatment to manage hip and knee osteoarthritis? A systematic review.

OBJECTIVE: To identify research gaps and inform implementation we systematically reviewed the literature evaluating cost-effectiveness of recommended treatments (education, exercise and diet) for the management of hip and/or knee OA. METHODS: We searched Medline, Embase, Cochrane Central Register of Controlled Trials, National Health Services Economic Evaluation Database, and EconLit from inception to November 2019 for trial-based economic evaluations investigating hip and/or knee OA core treatments. Two investigators screened relevant publications, extracted data and synthesized results. Risk of bias was assessed using the Consensus on Health Economic Criteria list. RESULTS: Two cost-minimization, five cost-effectiveness and 16 cost-utility analyses evaluated core treatments in six health systems. Exercise therapy with and without education or diet was cost-effective or cost-saving compared to education or physician-delivered usual care at conventional willingness to pay (WTP) thresholds in 15 out of 16 publications. Exercise interventions were cost-effective compared to physiotherapist-delivered usual care in three studies at conventional WTP thresholds. Education interventions were not cost-effective compared to usual care or placebo at conventional WTP thresholds in three out of four publications. CONCLUSIONS: Structured core treatment programs were clinically effective and cost-effective, compared to physician-delivered usual care, in five health care systems. Providing education about core treatments was not consistently cost-effective. Implementing structured core treatment programs into funded clinical pathways would likely be an efficient use of health system resources and enhance physician-delivered usual primary care.

Cost-effectiveness of 12 weeks of supervised treatment compared to written advice in patients with knee osteoarthritis: a secondary analysis of the 2-year outcome from a randomized trial.

OBJECTIVE: To assess the 24-month cost-effectiveness of supervised treatment compared to written advice in knee osteoarthritis (OA). DESIGN: 100 adults with moderate-severe OA not eligible for total knee replacement (TKR) randomized to a 12-week individualized, supervised treatment (exercise, education, diet, insoles and pain medication) or written advice. Effectiveness was measured as change in quality-adjusted life years (QALYs) from baseline to 24 months, including data from baseline, 3, 6, 12 and 24 months, while healthcare costs and transfer payments were derived from national registries after final follow-up. Incremental costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated. A sensitivity analysis resampling existing data was conducted and the probability of cost-effectiveness was estimated using a 22,665 Euros/QALY threshold. In a sensitivity analysis, cost-effectiveness was calculated for different costs of the supervised treatment (actual cost in study; cost in private practice; and in-between cost). RESULTS: Average costs were similar between groups (6,758 Euros vs 6,880 Euros), while the supervised treatment were close to being more effective (incremental effect (95% CI) of 0.075 (-0.005 to 0.156). In the primary analysis excluding deaths, this led the supervised treatment to be cost-effective, compared to written advice. The sensitivity analysis demonstrated that the results were sensitive to changes in the cost of treatment, but in all scenarios the supervised treatment was cost-effective (ICERs of 6,229 to 20,688 Euros/QALY). CONCLUSIONS: From a 24-month perspective, a 12-week individualized, supervised treatment program is cost-effective compared to written advice in patients with moderate-severe knee OA not eligible for TKR. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT01535001.

Rehabilitation needs in individuals with knee OA in rural Western Cape, South Africa: an exploratory qualitative study.

BACKGROUND: Current clinical practice guidelines have suggested that each individual with knee osteoarthritis (OA) should receive three core treatments from their health care provider. These core treatments comprise of exercise, education and weight loss. Identification of the health care and rehabilitation needs of individuals with knee OA in rural areas are imperative for focusing service delivery in a specific context in order to empower the individual. The aim of this study was to explore the rehabilitation needs of individuals with knee OA living in rural Western Cape in order to identify the gaps in services offered and inform rehabilitation programmes in these settings. METHODS: Semi-structured in-depth individual interviews were performed on 16 individuals with knee OA living in rural settings of the Western Cape, South Africa. A deductive data analysis approach was used and the needs of the individuals were identified and categorised for interpretation and comparison with the reported services received. FINDINGS: The three major themes identified were 'I would like to know more', 'There's not much support from the clinic' and 'I don't feel myself anymore'. These themes relate to the lack of disease-specific education, barriers in the health systems and service delivery resulting in individuals lack of self-worth and poor mental wellbeing. The results revealed the integral relationship between health care systems, service delivery and the effect on patient wellbeing. CONCLUSION: The rehabilitation needs of individuals with knee OA in rural areas advocates for addressing barriers in rural primary health care system such as adequate human resources, referral systems and continuity of care. This will allow for a comprehensive, person-centred and context-specific multidisciplinary approach focused on empowering individuals with knee OA through disease-specific education, improving functional participation and symptom management strategies. This could improve the social inclusion and mental wellbeing of individuals living with knee OA.

Effects of Virtual Exercise Rehabilitation In-Home Therapy Compared with Traditional Care After Total Knee Arthroplasty: VERITAS, a Randomized Controlled Trial.

BACKGROUND: Financial burden for patients, providers, and payers can reduce access to physical therapy (PT) after total knee arthroplasty (TKA). The purpose of the present study was to examine the effect of a virtual PT program on health-care costs and clinical outcomes as compared with traditional care after TKA. METHODS: At least 10 days before unilateral TKA, patients from 4 clinical sites were enrolled and randomized 1:1 to the virtual PT program (involving an avatar [digitally simulated] coach, in-home 3-dimensional biometrics, and telerehabilitation with remote clinician oversight by a physical therapist) or to traditional PT care in the home or outpatient clinic. The primary outcome was total health-care costs for the 12-week post-hospital period. Secondary (noninferiority) outcomes included 6 and 12-week Knee injury and Osteoarthritis Outcome Score (KOOS); 6-week knee extension, knee flexion, and gait speed; and 12-week safety measures (patient-reported falls, pain, and hospital readmissions). All outcomes were analyzed on a modified intent-to-treat basis. RESULTS: Of 306 patients (mean age, 65 years; 62.5% women) who were randomized from November 2016 to November 2017, 290 had TKA and 287 (including 143 in the virtual PT group and 144 in the usual care group) completed the trial. Virtual PT had lower costs at 12 weeks after discharge than usual care (median, $1,050 compared with $2,805; p < 0.001). Mean costs were $2,745 lower for virtual PT patients. Virtual PT patients had fewer rehospitalizations than the usual care group (12 compared with 30; p = 0.007). Virtual PT was noninferior to usual PT in terms of the KOOS at 6 weeks (difference, 0.77; 90% confidence interval [CI], -1.68 to 3.23) and 12 weeks (difference, -2.33; 90% CI, -4.98 to 0.31). Virtual PT was also noninferior to usual care at 6 weeks in terms of knee extension, knee flexion, and gait speed and at 12 weeks in terms of pain and hospital readmissions. Falls were reported by 19.4% of virtual PT patients and 14.6% of usual care patients (difference, 4.83%; 90% CI, -2.60 to 12.25). CONCLUSIONS: Relative to traditional home or clinic PT, virtual PT with telerehabilitation for skilled clinical oversight significantly lowered 3-month health-care costs after TKA while providing similar effectiveness. These findings have important implications for patients, health systems, and payers. Virtual PT with clinical oversight should be considered for patients managed with TKA. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Does telephone-delivered exercise advice and support by physiotherapists improve pain and/or function in people with knee osteoarthritis? Telecare randomised controlled trial.

OBJECTIVE: Evaluate a physiotherapist-led telephone-delivered exercise advice and support intervention for people with knee osteoarthritis. METHODS: Participant-blinded, assessor-blinded randomised controlled trial. 175 people were randomly allocated to (1) existing telephone service (≥1 nurse consultation for self-management advice) or (2) exercise advice and support (5-10 consultations with a physiotherapist trained in behaviour change for a personalised strengthening and physical activity programme) plus the existing service. Primary outcomes were overall knee pain (Numerical Rating Scale, range 0-10) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, range 0-68) at 6 months. Secondary outcomes, cost-effectiveness and 12-month follow-up were included. RESULTS: 165 (94%) and 158 (90%) participants were retained at 6 and 12 months, respectively. At 6 months, exercise advice and support resulted in greater improvement in function (mean difference 4.7 (95% CI 1.0 to 8.4)), but not overall pain (0.7, 0.0 to 1.4). Eight of 14 secondary outcomes favoured exercise advice and support at 6 months, including pain on daily activities, walking pain, pain self-efficacy, global improvements across multiple domains (overall improvement, improved pain, improved function and improved physical activity) and satisfaction. By 12 months, most outcomes were similar between groups. Exercise advice and support cost $A514/participant and did not save other health service resources. CONCLUSION: Telephone-delivered physiotherapist-led exercise advice and support modestly improved physical function but not the co-primary outcome of knee pain at 6 months. Functional benefits were not sustained at 12 months. The clinical significance of this effect is uncertain. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (#12616000054415).

Development and evaluation of a tailored e-self-management intervention (dr. Bart app) for knee and/or hip osteoarthritis: study protocol.

BACKGROUND: This paper describes (the development of) an eHealth tool (dr. Bart app) to enhance self-management and to optimize non-surgical health care utilization in patients with knee and/or hip osteoarthritis (OA) and presents a study aiming 1) to study the effectiveness of the dr. Bart app on health care use 2) to explore differences in use, usability and the clinical outcomes of the dr. Bart app between the Netherlands and Germany. METHODS: The dr. Bart app is a fully automated eHealth application and is based on the Fogg model for behavioural change, augmented with reminders, rewards and self-monitoring to reinforce app engagement and health behaviour. The dr. Bart app propose goals to a healthier lifestyle based on machine learning techniques fed by data collected in a personal profile and choosing behaviour of the app user. Patients ≥50 years with self-reported knee and/or hip OA will be eligible to participate. Participants will be recruited in the community through advertisements in local newspapers and campaigns on social media. This protocol presents a study with three arms, aiming to include 161 patients in each arm. In the Netherlands, patients are randomly allocated to usual care or dr. Bart app and in Germany all patients receive the dr. Bart app. The primary outcome of the first research question is the number of self-reported consultations in secondary health care. The primary outcome of the second research question (comparison between the Netherlands and Germany) is self-management behaviour assessed by the patient activation measure (PAM-13) questionnaire. Secondary outcomes are costs, health-related quality of life, physical functioning and activity, pain, use and usability of the dr. Bart app. Data will be collected through three online questionnaires (at baseline and after 3 and 6 months after inclusion). DISCUSSION: This study will gain insight into the effectiveness of the dr. Bart app in the (conservative) treatment of patients with knee and/or hip OA and differences in the use and usability of the dr. Bart app between the Netherlands and Germany. TRIAL REGISTRATION: Dutch Trial Register (Trial Number NTR6693 / NL6505 ). Registration date: 4 September 2017.

Variation in rehabilitation setting after uncomplicated total knee or hip arthroplasty: a call for evidence-based guidelines.

BACKGROUND: High-level evidence consistently indicates that resource-intensive facility-based rehabilitation does not provide better recovery compared to home programs for uncomplicated knee or hip arthroplasty patients and, therefore, could be reserved for those most impaired. This study aimed to determine if rehabilitation setting aligns with evidence regardless of insurance status. METHODS: Sub-study within a national, prospective study involving 19 Australian high-volume public and private arthroplasty centres. Individuals undergoing primary arthroplasty for osteoarthritis participated. The main outcome was the proportion participating in each rehabilitation setting, obtained via chart review and participant telephone follow-up at 35 and 90 days post-surgery, categorised as 'facility-based' (inpatient rehabilitation and/or ≥ four outpatient-based sessions, including day-hospital) or 'home-based' (domiciliary, monitored or unmonitored home program only). We compared characteristics of the study cohort and rehabilitation setting by insurance status (public or private) using parametric and non-parametric tests, analysing the knee and hip cohorts separately. RESULTS: After excluding ineligible participants (bilateral surgeries, self-funded insurance, participation in a concurrent rehabilitation trial, experience of a major acute complication potentially affecting their rehabilitation pathway), 1334 eligible participants remained. Complete data were available for 1302 (97%) [Knee: n = 610, mean age 68.7 (8.5) yr., 51.1% female; Hip: n = 692, mean age 65.5 (10.4) yr., 48.9% female]; 26% (158/610) of knee and 61% (423/692) of hip participants participated predominantly in home-based programs. A greater proportion of public recipients were obese and had greater pre-operative joint impairment, but participated more commonly in home programs [(Knee: 32.9% (79/240) vs 21.4% (79/370) (P = 0.001); Hip: 71.0% (176/248) vs 55.6% (247/444) (P <  0.001)], less commonly in inpatient rehabilitation [Knee: 7.5% (18/240) vs 56.0% (207/370) P (< 0.001); Hip: 4.4% (11/248) vs 33.1% (147/444) (P <  0.001], and had fewer outpatient treatments [Knee: median (IQR) 6 (3) vs 8 (6) (P < 0.001); Hip: 6 (4) vs 8 (6) (P < 0.001)]. CONCLUSIONS: Facility-based programs remain the norm for most knee and many hip arthroplasty recipients with insurance status being a major determinant of care. Development and implementation of evidence-based guidelines may help resolve the evidence-practice gap, addressing unwarranted practice variation across the insurance sectors.

Assessment of Outcomes of Inpatient or Clinic-Based vs Home-Based Rehabilitation After Total Knee Arthroplasty: A Systematic Review and Meta-analysis.

Importance: Recent publication of the largest trials to date investigating rehabilitation after total knee arthroplasty (TKA) necessitate an updated evidence review. Objective: To determine whether inpatient or clinic-based rehabilitation is associated with superior function and pain outcomes after TKA compared with any home-based program. Data Sources: MEDLINE, Embase, CINAHL, and PubMed were searched from inception to November 5, 2018. Search terms included knee arthroplasty, randomized controlled trial, physiotherapy, and rehabilitation. Study Selection: Published randomized clinical trials of adults who underwent primary unilateral TKA and commenced rehabilitation within 6 postoperative weeks in which those receiving postacute inpatient or clinic-based rehabilitation were compared with those receiving a home-based program. Data Extraction and Synthesis: Two reviewers extracted data independently and assessed data quality and validity according to the PRISMA guidelines. Data were pooled using a random-effects model. Data were analyzed from June 1, 2015, through June 4, 2018. Main Outcomes and Measures: Primary outcomes were mobility (6-minute walk test [6MWT]) and patient-reported pain and function (Oxford knee score [OKS] or Western Ontario and McMaster Universities Osteoarthritis Index) reported at 10 to 12 postoperative weeks. The GRADE assessment (Grading of Recommendations, Assessment, Development, and Evaluation) was applied to the primary outcomes. Results: Five unique studies involving 752 unique participants (451 [60%] female; mean [SD] age, 68.3 [8.5] years) compared clinic- and home-based rehabilitation, and 1 study involving 165 participants (112 [68%] female; mean [SD] age, 66.9 [8.0] years) compared inpatient and home-based rehabilitation. Low-quality evidence showed no clinically important difference between clinic- and home-based programs for mobility at 10 weeks (6MWT favoring home program; mean difference [MD], -11.89 m [95% CI, -35.94 to 12.16 m]) and 52 weeks (6MWT favoring home program; MD, -25.37 m [95% CI, -47.41 to -3.32 m]). Moderate-quality evidence showed no clinically important difference between clinic- and home-based programs for patient-reported pain and function at 10 weeks (OKS MD, -0.15 [95% CI, -0.35 to 0.05]) and 52 weeks (OKS MD, 0.10 [95% CI, -0.14 to 0.34]). Conclusions and Relevance: Based on low- to moderate-quality evidence, no superiority of clinic-based or inpatient programs compared with home-based programs was found in the early subacute period after TKA. This evidence suggests that home-based rehabilitation is an appropriate first line of therapy after uncomplicated TKA for patients with adequate social supports.

An assessment of early functional rehabilitation and hospital discharge in conventional versus robotic-arm assisted unicompartmental knee arthroplasty: a prospective cohort study.

AIMS: The objectives of this study were to compare postoperative pain, analgesia requirements, inpatient functional rehabilitation, time to hospital discharge, and complications in patients undergoing conventional jig-based unicompartmental knee arthroplasty (UKA) versus robotic-arm assisted UKA. PATIENTS AND METHODS: This prospective cohort study included 146 patients with symptomatic medial compartment knee osteoarthritis undergoing primary UKA performed by a single surgeon. This included 73 consecutive patients undergoing conventional jig-based mobile bearing UKA, followed by 73 consecutive patients receiving robotic-arm assisted fixed bearing UKA. All surgical procedures were performed using the standard medial parapatellar approach for UKA, and all patients underwent the same postoperative rehabilitation programme. Postoperative pain scores on the numerical rating scale and opiate analgesia consumption were recorded until discharge. Time to attainment of predefined functional rehabilitation outcomes, hospital discharge, and postoperative complications were recorded by independent observers. RESULTS: Robotic-arm assisted UKA was associated with reduced postoperative pain (p < 0.001), decreased opiate analgesia requirements (p < 0.001), shorter time to straight leg raise (p < 0.001), decreased number of physiotherapy sessions (p < 0.001), and increased maximum knee flexion at discharge (p < 0.001) compared with conventional jig-based UKA. Mean time to hospital discharge was reduced in robotic UKA compared with conventional UKA (42.5 hours (sd 5.9) vs 71.1 hours (sd 14.6), respectively; p < 0.001). There was no difference in postoperative complications between the two groups within 90 days' follow-up. CONCLUSION: Robotic-arm assisted UKA was associated with decreased postoperative pain, reduced opiate analgesia requirements, improved early functional rehabilitation, and shorter time to hospital discharge compared with conventional jig-based UKA.

Perceptions about participation in a 12-week walking program for people with severe knee osteoarthritis: a qualitative analysis.

PURPOSE: To explore the perceptions of people with severe knee osteoarthritis and increased cardiovascular risk about participating in a walking program. METHODS: Qualitative study using semistructured interviews for people with severe knee osteoarthritis and increased cardiovascular risk who participated in a 12-week walking program. Interviews were audiotaped, transcribed verbatim, member-checked, coded and themes developed using thematic analysis. Findings were triangulated with quantitative data including pain, function and cardiovascular risk factors from previously reported data. RESULTS: Twenty-one participants were interviewed after the completion of the walking program. The main theme identified was the preoccupation with the knee including pain, damage and the view that surgery was required. Three subthemes to emerge were (i) the perception of functional, cardiovascular and psychosocial benefits with the walking program; (ii) that supervision, monitoring and commitment were important enablers; and (iii) external factors such as ill-health, weather and the environment were key barriers. The perceived functional and cardiovascular benefits converged with results from quantitative data. CONCLUSIONS: Even when patients with severe osteoarthritis of the knee report other benefits from participating in a walking program, the core theme to emerge was their preoccupation with knee pain, knee damage and the view that they needed a knee replacement. Implications for Rehabilitation Patients with severe osteoarthritis of the knee and moderate cardiovascular risk reported functional, cardiovascular and psychosocial benefits from participating in a walking program. Despite patients reporting functional, cardiovascular and psychosocial benefits, the core theme to emerge was their preoccupation with knee pain, knee damage and the view that they needed a knee replacement. The core theme highlights the challenges in promoting physical activity for patients with severe knee osteoarthritis.

Influence of a periodized circuit training protocol on intermuscular adipose tissue of patients with knee osteoarthritis: protocol for a randomized controlled trial.

BACKGROUND: The objective of this study is to analyze the influence of a 14-week periodized circuit training protocol on patients with knee osteoarthritis (OA), in randomized intervention groups, on thigh intermuscular adipose tissue (interMAT), body composition, systemic inflammation, cartilage degradation, and its repercussion on pain, functional performance and quality of life. METHODS: This study presents a protocol for a randomized controlled trial. Sixty selected participants diagnosed with knee OA grades II and III, 40-65 years old and BMI < 30 kg/m2, will be randomly divided into three groups:periodized circuit training, strength training, and educational protocol. The circuit training and strength training protocols consist of 14-week training protocols conducted 3 times a week. The circuit training group will perform selected exercises previously stratified as light, moderate, and intense, arranged progressively in a circuit model, the strength group will perform regular strength exercises, and the educational protocol group will participate in a 14-week protocol with lectures twice a month about healthy lifestyles. Baseline and follow-up evaluations will be conducted for thigh interMAT (computed tomography), body composition (DXA), inflammation (IL-1ß, IL-6, IL-10, TNF-α, leptin, and adiponectin), and joint degradation biomarkers (uCTX-II and sCOMP), performance-based tests (30s Chair Stand Test, 40 m Fast-paced Walk Test and Stair Climb Test), quadriceps and hamstring maximal isometric voluntary contraction (MIVC), and questionnaires (WOMAC and pain catastrophizing scale). Repeated measures ANOVA will be used to compare differences between groups (circuit training X strength training X educational protocol) at the different times of assessment (baseline x follow-up or baseline x during protocol x follow-up) for each of the dependent variables. When significant main effects were found, the pots hoc Bonferroni test will be used to identify statistical differences. A significance level of 5% (p < 0.05) will be adopted. DISCUSSION: This will be the first randomized controlled trial to assess the effects of a circuit training protocol on patients with knee OA on thigh intermuscular adipose tissue (interMAT). Given the prevalence and impact of OA and the widespread availability of this intervention, assessing the efficacy of a low-cost, non-pharmacological, and non-invasive treatment for knee OA patients has the potential for immediate and high clinical impact. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02761590 , registered in May 4, 2016.

Evaluation of a digital platform for osteoarthritis treatment: study protocol for a randomised clinical study.

INTRODUCTION: Despite favourable results from structured face-to-face treatment of osteoarthritis (OA) in Sweden through the Better management of patients with OsteoArthritis (BOA) initiative, only around 20% of people with knee or hip OA receive the primary treatment recommended by international guidelines (ie, information, exercise, weight management). In 2014, a digital treatment programme named Joint Academy was introduced in Sweden, based on the same concept as the face-to-face BOA programme. In line with BOA, Joint Academy follows national and international guidelines and best practice for OA treatment. Results from observational studies suggest that this digital treatment is a valuable alternative to the traditional treatment approach and can positively impact patients' function and pain. However, conclusions from such studies commonly suggest that more rigorous testing is necessary to ascertain the benefits of digital treatment delivery for people with OA. METHODS AND ANALYSIS: A randomised clinical trial will be performed, comparing regular face-to-face care according to BOA with the digital version, Joint Academy. A total of 270 participants with clinically diagnosed knee OA will be recruited at primary care centres and randomised to either standard treatment (BOA) for 3 months, or the experimental group (digital intervention programme). Both groups will receive educational sessions and exercises yet with a difference in programme deliverance. The objective of the trial is to evaluate the effectiveness of the online treatment programme, in comparison with BOA. The two treatment groups will be compared with respect to the number of repetitions of the 30 s chair stand test at 3, 6 and 12 months, using a mixed model repeated measures analysis of variance. ETHICS AND DISSEMINATION: Ethical approval has been attained from the Regional Board of Ethics in Lund, Sweden (Dnr 2017/719). Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03328741.

COmmunity-based Rehabilitation after Knee Arthroplasty (CORKA): statistical analysis plan for a randomised controlled trial.

BACKGROUND: About 15% of patients fail to achieve a satisfactory clinical outcome following knee replacement, which may indicate the existing model of rehabilitation after surgery is possibly not the most efficacious. The COmmunity-based Rehabilitation after Knee Arthroplasty (CORKA) trial evaluates the effects of a new multi-component community-based rehabilitation programme following knee replacement compared with usual care. METHODS/DESIGN: The CORKA trial is a multi-centre, single-blind, two-arm randomised controlled trial. The primary outcome is the Late Life Function and Disability Instrument (LLFDI) overall function score measured at 12 months post-randomisation which will be analysed using a linear mixed effects model. Secondary outcomes are measured at 6 and 12 months post-randomisation and include the LLFDI frequency and limitation total dimension scores, the Oxford Knee Score, the Knee injury and Osteoarthritis Outcome Score quality of life subscale, the Physical Activity Scale for the Elderly, the EuroQol EQ-5D-5L, and several measurements of physical function. Full details of the planned analysis approaches for the primary and secondary outcomes are described here, as are the descriptive statistics which will be reported. This is an update to the CORKA protocol which has already been published in this journal. DISCUSSION: This paper provides details of the planned statistical analyses for this trial and will reduce the risks of outcome reporting bias and data-driven results. TRIAL REGISTRATION: ISRCTN registry, 13517704 . Registered on 12 February 2015. FUNDING/SPONSOR: The trial is funded by the National Institute for Health Research Health Technology Assessment programme under its commissioned research programme (HTA 12/196/08). The trial sponsor is the University of Oxford.

Cost-effectiveness of a blended physiotherapy intervention compared to usual physiotherapy in patients with hip and/or knee osteoarthritis: a cluster randomized controlled trial.

BACKGROUND: Blended physiotherapy, in which physiotherapy sessions and an online application are integrated, might support patients in taking an active role in the management of their chronic condition and may reduce disease related costs. The aim of this study was to evaluate the cost-effectiveness of a blended physiotherapy intervention (e-Exercise) compared to usual physiotherapy in patients with osteoarthritis of hip and/or knee, from the societal as well as the healthcare perspective. METHODS: This economic evaluation was conducted alongside a 12-month cluster randomized controlled trial, in which 108 patients received e-Exercise, consisting of physiotherapy sessions and a web-application, and 99 patients received usual physiotherapy. Clinical outcome measures were quality-adjusted life years (QALYs) according to the EuroQol (EQ-5D-3 L), physical functioning (HOOS/KOOS) and physical activity (Actigraph Accelerometer). Costs were measured using self-reported questionnaires. Missing data were multiply imputed and bootstrapping was used to estimate statistical uncertainty. RESULTS: Intervention costs and medication costs were significantly lower in e-Exercise compared to usual physiotherapy. Total societal costs and total healthcare costs did not significantly differ between groups. No significant differences in effectiveness were found between groups. For physical functioning and physical activity, the maximum probability of e-Exercise being cost-effective compared to usual physiotherapy was moderate (< 0.82) from both perspectives. For QALYs, the probability of e-Exercise being cost-effective compared to usual physiotherapy was 0.68/0.84 at a willingness to pay of 10,000 Euro and 0.70/0.80 at a willingness to pay of 80,000 Euro per gained QALY, from respectively the societal and the healthcare perspective. CONCLUSIONS: E-Exercise itself was significantly cheaper compared to usual physiotherapy in patients with hip and/or knee osteoarthritis, but not cost-effective from the societal- as well as healthcare perspective. The decision between both interventions can be based on the preferences of the patient and the physiotherapist. TRIAL REGISTRATION: NTR4224 (25 October 2013).

Using home sensing technology to assess outcome and recovery after hip and knee replacement in the UK: the HEmiSPHERE study protocol.

INTRODUCTION: Over 160 000 people with severe hip or knee pain caused by osteoarthritis undergo total hip (THR) or knee replacement (TKR) surgery each year in the UK within the National Health Service (NHS), and this number is expected to increase. Innovative approaches to evaluating surgical outcomes will be needed to respond to the increasing burden of joint replacement surgery. The Sensor Platform for Healthcare in a Residential Environment, Interdisciplinary Research Collaboration (SPHERE-IRC) have developed a system of sensors that can monitor the health-related behaviours of people living at home. The system includes sensors for the home environment (measuring temperature, humidity, room occupancy, water and electricity usage), a wristband body-worn activity monitor and silhouette (body outline) sensors. The aim of HEmiSPHERE (Hip and knEe study of a Sensor Platform of HEalthcare in a Residential Environment) is to (1) determine the accuracy and feasibility of the sensory data as it compares with conventional assessment of health outcomes after surgery using patient self-reported questionnaires, and (2) to explore how the SPHERE system is useful for everyday clinical decision-making. METHODS AND ANALYSIS: A feasibility study recruiting and installing the SPHERE system in the homes of up to 30 NHS adult patients as they undergo a THR or TKR. Through a mixed-methods design, the SPHERE system will monitor and record continuous measurements of daily behaviour. Main outcomes will assess the relationships between environmental, behavioural and movement data and the parameters of interest from the standard clinical assessments measuring patient outcomes over time. Patient interviews and focus groups with consultant orthopaedic surgeons will provide in-depth understanding of the acceptability, feasibility and accuracy of the data. ETHICS AND DISSEMINATION: We aim to disseminate the findings through regional talks and seminars, international conferences and peer-reviewed journals and social media.

Assessment of the content reporting for therapeutic exercise interventions among existing randomized controlled trials on knee osteoarthritis.

Purpose/Rationale: Physical exercise interventions for the management of knee osteoarthritis are well known to be effective and accessible forms of rehabilitation and symptom management. However, without adequate reporting of these interventions, accurate replication and clinical use is negatively impacted. OBJECTIVES: The main objective of this article was to assess content reporting using The Consensus on Exercise Reporting Template list and 2016 American College of Sports Medicine guidelines among moderate- to high-quality exercise interventions randomized controlled trials (total score of ≥6/10 on the PEDro scale) involving individuals with knee osteoarthritis. RESULTS: The Consensus on Exercise Reporting Template mean total score for all 47 included randomized controlled trials was 4.42 out of 19, demonstrating generally low quality of reporting. The Consensus on Exercise Reporting Template list and the 2016 American College of Sports Medicine guidelines scores were moderately correlated (based on 95% confidence interval, intraclass correlation coefficient = 0.508) for aerobic interventions only. CONCLUSION: The content analysis of exercise interventions in knee osteoarthritis demonstrated low scores for moderate- to high-quality trials. Improved standardized reporting is recommended to ensure knowledge transfer and replication of effective exercise programs for individuals with knee osteoarthritis.

Objective assessment of physical activity and sedentary behaviour in knee osteoarthritis patients - beyond daily steps and total sedentary time.

BACKGROUND: Knee osteoarthritis patients may become physically inactive due to pain and functional limitations. Whether physical activity exerts a protective or harmful effect depends on the frequency, intensity, time and type (F.I.T.T.). The F.I.T.T. dimensions should therefore be assessed during daily life, which so far has hardly been feasible. Furthermore, physical activity should be assessed within subgroups of patients, as they might experience different activity limitations. Therefore, this study aimed to objectively describe physical activity, by assessing the F.I.T.T. dimensions, and sedentary behaviour of knee osteoarthritis patients during daily life. An additional goal was to determine whether activity events, based on different types and durations of physical activity, were able to discriminate between subgroups of KOA patients based on risk factors. METHODS: Clinically diagnosed knee osteoarthritis patients (according to American College of Rheumatology criteria) were monitored for 1 week with a tri-axial accelerometer. Furthermore, they performed three functional tests and completed the Knee Osteoarthritis Outcome Score. Physical activity levels were described for knee osteoarthritis patients and compared between subgroups. RESULTS: Sixty-one patients performed 7303 mean level steps, 319 ascending and 312 descending steps and 601 bicycle crank revolutions per day. Most waking hours were spent sedentary (61%), with 4.6 bouts of long duration (> 30 min). Specific events, particularly ascending and descending stairs/slopes, brief walking and sedentary bouts and prolonged walking bouts, varied between subgroups. CONCLUSIONS: From this sample of KOA patients, the most common form of activity was level walking, although cycling and stair climbing activities occurred frequently, highlighting the relevance of distinguishing between these types of PA. The total active time encompassed a small portion of their waking hours, as they spent most of their time sedentary, which was exacerbated by frequently occurring prolonged bouts. In this study, event-based parameters, such as stair climbing or short bouts of walking or sedentary time, were found more capable of discriminating between subgroups of KOA patients compared to overall levels of PA and sedentary time. Thereby, subtle limitations in physical behaviour of KOA-subgroups were revealed, which might ultimately be targeted in rehabilitation programs. TRIAL REGISTRATION: German Clinical Trials Registry under ' DRKS00008735 ' at 02.12.2015.