Effectiveness of an online management platform (Joint Cloud) versus standard process for patients undergoing total knee arthroplasty: study protocol for a prospective randomised controlled trial

Abstract

Introduction

Osteoarthritis (OA) is one of the main causes of mobility impairment in the elderly worldwide. Therefore, total knee arthroplasty (TKA) is often performed and is one of the most successful surgery and has resulted in substantial quality-of-life gains for people with end-stage arthritis. There is still room for improvement in the standard treatment process in the preoperative, intraoperative and postoperative period of TKA. Telerehabilitation has the potential to become a positive alternative to face-to-face rehabilitation nowadays. But it remains unclear how well telemedicine interventions cover the entire surgical pathway (preoperation, intraoperation, postoperation). This study aims to explore the effectiveness of Joint Cloud (JC, an online management platform) compared with existing standard process in regulating functional recovery, pain management, muscle strength changes and other health-related outcomes in patients undergoing total knee arthroplasty preoperation, intraoperation and postoperation.

Methods and analysis

A randomised controlled trial was designed to compare the online management platform (JC) with standard process (SP) in patients undergoing TKA. A total of 186 TKA patients will be randomly assigned to the intervention (n=93) or control (n=93) group. Patients in the intervention group will receive access to the ‘JC’ mini-program. This mini-program provides popular science information (eg, information about OA and TKA), functional exercise information and communication channels. Patients evaluate their condition and functional level through standardised digital questionnaires. The control group of patients will not accept any functions of this mini-program. The primary outcome is knee functional recovery, and the secondary outcomes are pain management, isometric knee extensor muscle strength, patient satisfaction and cost-benefit analysis. Assessments will be performed 1 month and 3 days before surgery (T0) and 1 month and 3 months after surgery. Data analysis will be performed according to the intent-to-treat (ITT) principle. Repeated measures of linear mixed models and parametric and non-parametric testing will be used for statistical analysis.

Ethics and dissemination

The study was reviewed and approved by the Tianjin Hospital Medical Ethics Review Committee on 10 February 2023 (2022YLS155). Test data are considered highly sensitive but are available upon request. The findings will be disseminated in peer-reviewed publications.

Trial registration number

ChiCTR2300068486.

Strengths and limitations of this study.

• This study will conduct a non-inferiority, pragmatic randomised controlled trial (PRCT) using a two-arm pretest and post-test design.

• This RCT will be the first study in China to evaluate the effectiveness of a perioperative online management platform covering the entire patient journey (preoperation, intraoperation and postoperation) based on enhanced recovery after surgery for patients undergoing total knee arthroplasty.

• The lack of blinding of subjects and investigators is a limitation of this study design. But we try to apply the assessor blinding.

• Another limitation of this trial is its single-centre design.

Introduction

Background {#6a,6b}

Osteoarthritis (OA) is considered to be one of the leading causes of mobility impairment in the elderly worldwide.¹ Therefore, total knee arthroplasty (TKA) is often performed and is one of the most successful examples of innovative surgery and has resulted in substantial quality-of-life gains for people with end-stage arthritis.² It can relieve pain and improve knee function in patients with knee OA.² In an increasingly ageing society, the demand for TKA is likely to increase further.² According to the 2021 American Joint Replacement Registry (AJRR) Statistical Annual Report, from 2012 to 2020, the total number of TKA surgeries registered in the USA reached 12 232 993.³ In China, the number of TKA operations nationwide in 2019 was 374 833, with an average annual growth rate of 27. 4%.⁴

After more than 20 years of development, enhanced recovery after surgery (ERAS) has consistently been associated with superior recovery, decreased morbidity, reduced hospital length of stay and cost savings.⁵ In the past decade, the concept of ERAS has made significant progress in the application of hip and knee arthroplasty.⁶ The main components of TKA ERAS pathway include preoperative patient education, provision of adequate multimodal analgesia and early mobilisation after surgery.⁵ However, ERAS in TKA has a problem similar to other surgeries: low adherence (the overall rate of adherence to the ERAS protocol was 50.0% (IQR, 43.8%–62.5%)).⁷ The possible reason for this non-adherence is that with the substantial reduction in hospital stay and the average return to sports of TKA patients being 13 weeks to 24 weeks (the time for patients to rely on themselves is much longer than the time for them to receive treatment in the hospital),^{8 9} the actual effect of ERAS depends more on patients’ self-management. Therefore, patient self-management has become a crucial factor in optimising patient health outcomes.

The main contents of self-management of TKA patients are pain management, physiotherapy exercises and daily self-care activities.¹⁰ Hospitals use oral and written forms of health education for patients in the hope of better recovery after patients are discharged. While physicians have been comprehensive or even oversaturated in teaching patients such knowledge, many patients quickly forget the critical information.¹¹ Unable to understand the knowledge and lack of confidence are common difficulties faced by patients due to the complexity, professionalism and non-intuitive educational forms of the information.^{12 13} Postoperation exercise provides short-term (~3 months) benefits, small to moderate effect sizes and no long-term (~12 months) benefits.¹⁴ Basically, in China, patients mainly go to postoperative clinical visit approximately 1 month after discharge, and at this time, physicians will evaluate patients’ recovery status and conduct health education again. Because of economical and other factors, most patients will not choose professional rehabilitation physicians for rehabilitation in China. This may result in poor recovery and reduced satisfaction, because outpatient physical therapy performed in a clinic under the supervision of a trained physical therapist may provide better outcomes after the surgery.¹⁵

In recent years, some research teams in Europe, USA and China have conducted research on the role of telerehabilitation of TKA, and most of them have concluded that telerehabilitation has better pain management than traditional face-to-face patient education.^{10 16–23} The benefits of telerehabilitation include improved quality of life, increased satisfaction and at worst a non-inferiority substitute for standard patient education.^{10 16–23} However, some studies also have these situations, such as the lack of consensus and guidelines,^{18 21–23} the sample size is not statistically significant^20–23 and the app downloading level is low.¹⁰ At present, orthopaedic surgeons in European and American countries mostly use mobile phone calls, online chats, web pages, mobile apps or smart devices for telerehabilitation, while Chinese orthopaedic surgeons mostly use mobile phone calls, WeChat messaging and mobile applications for telerehabilitation. However, there are problems with these methods, such as low app download rates, the high cost of smart devices and basically no relevant education on the use of these platforms for patients before admission. According to the 2022 WeChat Open Class Forum, WeChat app is almost one of the basic apps for every smartphone user in China, and the WeChat mini-program (built into WeChat app) is an app that can be used without downloading and installing. Users can open the mini-program after scanning or searching in WeChat. Therefore, this research innovatively uses the WeChat mini-program as a platform to build an online management platform (named Joint Cloud (JC)) that comprehensively assists patients in self-management preoperation, intraoperation and postoperation. Unlike previous studies that only used postoperative rehabilitation, this study adopts a perioperative ERAS pathway that includes teleprehabilitation and preoperative patient education. ERAS Society recommendations recommend preoperative education and exercise, pointing out that although current research has not yet proven that preoperative education and exercise can improve postoperative functional recovery, it can reduce preoperative anxiety.⁶ Meanwhile, qualitative studies detailing the patient perspective highlight the importance of patients getting the right information and support.⁶ A meta-analysis also pointed out that moderate-certainty evidence supported prehabilitation over usual care in improving preoperative function and strength in TKA.²⁴ JC can provide patients with easily accessible, low-cost, formal, scientific guidance of patient education and self-management without frequent returns between family and hospital, thus will hopefully help establish a standardised intervention for TKA patients that will improve compliance, enhance recovery and reduce the cost of travelling and save time for patients.

The study

Objectives {#7}

The purpose of this study is to develop a comprehensive research protocol for assessing the short-term efficacy of JC in patients undergoing unilateral TKA. The primary outcome is to evaluate the effectiveness of JC for functional recovery in the short term (3 months after surgery). Secondary outcomes are to assess its effectiveness in pain management, muscle strength and patient satisfaction. The study will also conduct a cost-benefit analysis from a hospital and patient perspective and evaluate user experience. On the one hand, this online management platform (JC) will hopefully help establish a standardised intervention for TKA patients that will maintain adherence, individual motivation, functional recovery and pain management. On the other hand, it is also hopeful to reduce doctors’ duplication of work and to reduce healthcare costs. The study aims to test the above hypothesis at a significance level of 0. 05 (p<0. 05).

Trial design {#8,13}

This study will conduct a single-centre, non-inferiority, pragmatic randomised controlled trial (PRCT) using a two-arm pretest-post-test design (figure 1), and the study protocol will be prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement.²⁵

Figure 1.

Study design

Sample size calculation {#14}

The calculation of the sample size of this study is based on the recommendations of Consolidated Standards of Reporting Trials (CONSORT)²⁶ and PASS15.0 is used for non-inferiority tests for the ratio of two proportions. The parameters used include the following: a non-inferiority ratio of 9%, which was fixed at 20% less (as recommended by previous work¹⁶) than the minimal clinically important difference for the WOMAC^{16 26}; type I error was set 5% (α=0.05); power (1-β) 90%; and the required sample size of each group was 74 cases. According to a dropout rate of 20%, it was estimated that a sample size of 93 per group would be necessary to test our research hypothesis on the primary outcome.

Research ethics approval {#24}

The study was reviewed and approved by the Tianjin Hospital Medical Ethics Committee on 10 February 2023 (2022YLS155). The study will adhere to ethical standards based on informed and voluntary consent. Written informed consent of the subjects will be obtained before inclusion in the study (Declaration of Helsinki, 2013). Participation is voluntary, and any subject withdrawal from the study will be respected and will not have any adverse impacts on the subject. Randomisation of subjects will ensure that all subjects have a fair chance of being assigned to the intervention or control group.

Recruitment {#9, 15}

This study will be conducted at Tianjin Joint Centre (Department of Joint, Tianjin Hospital, China). In 2021, the annual number of TKAs completed by the whole department was approximately 3000. Patients with indications of TKA in the outpatient department of the hospital will be screened according to the inclusion and exclusion criteria if they are willing to receive TKA treatment. Screening is usually carried out by the physician in charge, who carries out recruitment and surgery in the study. During the outpatient visit (usually 2 months before surgery), the physician orally informed the eligible patients about the content of the study and provided written informed consent with the details of the study. After this outpatient service, the patient will have time to consider and then decide whether to perform surgery and participate in the study at the outpatient visit 1 month before surgery. Signed written informed consent will be returned if the patient agreed to participate in the study. At the same time, patients who decide to participate will be assigned to standard process (SP) group or JC group by randomly selecting anonymous letters. At this time, the measurement of baseline data will be completed by an evaluator who is blinded.

Inclusion criteria {#10}

1. Aged 50 years and onwards.

2. Patients with clinical symptoms of knee OA confirmed by X-ray.

3. A primary and unilateral TKA is confirmed to be required after evaluation by the orthopaedic physician.

4. Visual Analogue Scale (VAS) of pain (100 mm) before operation ≥30 mm.

5. The ability to understand the test requirements and a willingness to actively cooperate with the test. The patient or his/her family member has a smart device (smartphone, tablet computer or desktop computer) and a WeChat account.

Exclusion criteria {#10}

1. Patients with TKA contraindications (such as those with local or systemic infection).

2. Patients with psychiatric diseases.

3. The opposite TKA is required within 3 months.

4. VAS score (100 mm) <30 mm before the operation.

5. JC cannot be used because of subjective and objective reasons (eg, patient and his/her coliving family member(s) do not have a smart device, or patient is illiterate).

Allocation {#16a, 16b, 16c}

The randomisation will be generated using the random number function in Excel (Microsoft, USA). The randomisation process will be carried out without any blocking or hierarchical restrictions. A research assistant, independent of other researchers, will perform the randomisation. The research assistant will assign each assignment according to the generated random sequence and assign a unique identification number to each assignment and then put identification numbers into separate anonymous envelopes (same appearance).

The random sequence, corresponding identification numbers and the respective research groups will be recorded in a spreadsheet. This spreadsheet will be saved by the research assistant on an encrypted hard disk within the department, accessible only to the primary investigator and research assistant. Importantly, this spreadsheet will not contain any patient’s personal information. During the baseline, all envelopes will be handed over to the physician in charge at the clinic. Once a patient confirms participation in the study, the physician will provide all the anonymous envelopes to the patient for selection. The patient will then randomly choose one envelope, which will determine their assignment to either the SP group or JC group.

Blinding {#17a}

Due to the special nature of the study intervention, the blind method cannot be used by the subject or the medical team. However, until the baseline data are measured, the subjects and outpatient physicians will be hidden in the recruitment process (identification number is hidden). At the same time, the evaluators and the statistical analyst will be blinded. Each patient in the JC group will have an independent account and password to log in to JC, so the risk of contamination in this study is very small. Furthermore, the JC and SP group will provide participants with essentially the same information (different in form), so we do not believe that the outcomes of the study will be biased.

The intervention {#11a}

A total of 186 TKA patients will be randomly assigned to the intervention or control groups. The same orthopaedic surgeon with rich surgical experience will perform TKA in both groups. Both groups will use regional anaesthesia, and if the anaesthesia method is changed to general anaesthesia, the participant will withdraw from this study (regional anaesthesia offers advantages over general anaesthesia, including decreased incidence of postoperative cognitive dysfunction and reduced postoperative opioid requirements^{27 28}). At the beginning of the operation, sedative drugs (such as propofol or midazolam) will be administered to patients. Anaesthesiologists will adjust the dosage of sedative drugs based on the level of sedation required during the operation. Both groups will adopt the same type of prosthesis, posterior stabilised (PS), and the same surgical method, anteromedial approach. For those with more severe patellar articular surface invasion, it will be repaired, and all prostheses will be fixed with bone cement. All subjects will use the same set of ERAS pathway, including preoperative exercise, preoperative patient education, provision of adequate multimodal analgesia and early mobilisation after surgery. The difference is that the intervention group will use the telemedicine (JC) for preoperative exercise, preoperative patient education and early mobilisation after surgery, while the control group will use the standard approach. The evaluation will be conducted 1 month before surgery (T0), 3 days before surgery (T1), 1 month after surgery (T2) and 3 months after surgery (T3).

Intervention group {#11a}

The mini-program (Tencent, China) named JC will be used to intervene with the subjects randomly assigned to the intervention group. The JC includes a patient dashboard and a doctor dashboard. Physicians can view the patient’s exercise situation, questions and step statistics through the doctor’s side. WeChat can display the daily steps recorded by the smartphone (rough data), and JC can extract step data from WeChat with the patient’s consent for statistical purposes. Physicians can answer patients’ questions and encourage patients to exercise (physicians check the dashboard every 3 days. If there are adverse events, patients can directly contact doctors through WeChat). The mini-program is attached to the WeChat app, and patients can use it regardless of whether they have an Android or IOS system; they just need a WeChat. WeChat has a large user amount (approximately 1.2 billion) and is widely used as a daily communication tool in China and highly accepted by patients.

The JC mini-program and the multimedia contents are designed and developed by orthopaedic surgeons, research assistants, nurses and rehabilitation physicians based on the concept of ERAS^{6 29} and fundamental exercises recommended by the American Academy of Orthopaedic Surgeons (AAOS) Clinical Practice Guidelines as well as the American Association of Hip and Knee Surgeons (AAHKS) guidelines.^{30 31} The implementation of the WeChat mini-program framework and functions will be completed by the technology provider. After recording the baseline data, the research assistant will share the JC with the patients who are randomly assigned to the JC group and teach patients how to use JC. The system will unlock the corresponding functions according to the different periods of the patient (the contents of prehabilitation and patient education will be unlocked 1 month before operation, the contents related to admission will be unlocked 1 week before operation and the contents of rehabilitation will be unlocked on the day of operation, so as to avoid the patient from contacting too many complicated contents and only focus on the contents that should be paid attention to at the stage). All participants in the intervention group will receive the same information from the JC. Patients can log in to the JC through their own account. JC can provide patients with preoperative education information at baseline, including patient education of osteoarthritis and TKA and how to carry out preoperative exercise (quadriceps sets, straight leg raises, ankle pumps, assisted knee bends, knee straightening, sitting supported knee bends). Patients can view the relevant content of patient education on surgery preparation and detailed guidance on admission process 1 week before surgery. Patients can view the relevant contents of the use of painkillers; how to prevent thrombosis; and how to carry out wound care on the day of the surgery. The patient can also use the counting and timing plug-in at the bottom of the video to assist with exercise, complete the sign-in after exercise and complete the questionnaire (T1, T2, T3) sent by the physician. And face-to-face follow-up will also be conducted at T1, T2 and T3. Patients can check the countdown of admission in the schedule, the countdown of follow-up and completion status of daily exercises; in the feedback interface, they can send their questions to the physician through photos, videos and messages and then obtain answers.

Control group {#11a}

During the study period, the information preoperation and postoperation of the SP group is provided in oral and written form (the content is the same as that of the JC group). The patient will receive information registration in the outpatient clinic, and the physician will call the patient 1 week before admission, and the patient will be discharged 2–3 days after operation. The patient will receive rehabilitation guidance (oral, written, on-site guidance) at the baseline (1 month before surgery) and 1 day after surgery. Digital questionnaire and face-to-face follow-up will be conducted at T1, T2 and T3. Patients will communicate with the physician in charge and the research assistant using phone calls, network chats and outpatient services. The content selection of the standard process in the control group was also designed and developed based on the concept of ERAS^{6 29} and fundamental exercises recommended by the AAOS Clinical Practice Guidelines as well as the AAHKS guidelines.^{30 31}

Criteria for discontinuing or modifying allocated interventions for a given trial participant {#11b}

At present, no suspension or modification of assigned interventions is foreseen. The programming code of the WeChat mini-program will not be changed during the study. The knee replacement itself has no impact on the use of the app.

Strategies to improve adherence to intervention {#11c}

Electronic questionnaire collection can reduce the time and cost of gathering data and comply with quality standards by automatically completing checks. The JC and research assistant will remind the patient to complete the questionnaire.

Relevant concomitant care and interventions that are permitted or prohibited during the trial {#11d}

This study is designed within the scope of health service research to assess the situation of JC in the actual environment. Therefore, the patient is allowed to perform all other interventions, such as physical rehabilitation therapy and additional painkillers.

Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial or future use {#33}

Not applicable. No biological specimens will be obtained during this study.

Outcomes {#12}

Demographical information (baseline data)

Age, sex, marital and work status, education level, height and weight (Body Mass Index (BMI)), smoking history, drinking history, complications (hypertension, diabetes and other medical history), knee joint injury and surgery and food and drug allergy history data will be collected. In addition, the smartphone step count tool will be used to count the patients’ daily activities.

Primary outcome

The primary outcome measure is the Western Ontario and McMaster Universities Osteoarthritis Index (LK3. 1 V.5, WOMAC) and its gain of overall score from baseline (T0) to the last follow-up (T3). It consists of 24 questions each answered using a five-point Likert scale (none, mild, moderate, severe and extreme). The score can be reported as a total or for three separate subscales assessing pain, physical function and stiffness and each score from 0 to 4. The questionnaire is widely used to evaluate the effect of intervention after total knee replacement, and its metrological characteristics are widely recognised.^{32 33} Furthermore, research shows that the electronic WOMAC scoring form completed on smartphones is closely consistent with the paper version, with no significant difference.³⁴ The culturally and linguistically validated Chinese version of the WOMAC is psychometrically robust in its validity, reliability and sensitivity to change for patients with knee OA.³⁵ The minimum clinically important difference (MCID) is determined to be 10.³⁶

Secondary outcomes

The knee function will be also evaluated by American Knee Society Score (AKSS) and its gain of overall score from baseline (T0) to the last follow-up (T3). The AKSS score adopts a variable weighting method and consists of ‘joint score’ and ‘functional score’. The joint score is used to evaluate the pain, stability and range of motion of the knee joint. The highest score is 100 points, and the full score standard is no pain. The knee joint is firmly combined and can perform more than 125 activities, and there is no sense of instability in front of and behind. Contracture, active extension insufficiency and poor force line were deducted from the total score. Functional scoring will be used to assess walking distance and stair climbing. The highest score is also 100 points, and individuals who can walk freely and go up and down stairs normally receive full marks. The use of crutches or other walking aids should be deducted from the total score. The AKSS scale is useful and reliable for evaluating individuals with OA or receiving TKA.³⁷

Pain intensity will be measured mainly by VAS from baseline (T0) to the last follow-up (T3). This is a widely used and effective method to measure the pain intensity of patients.³⁸ The VAS score ranges from 0 to 100, and higher scores indicate that the patient has experienced more pain. There are emoticon prompts above the scale line. These emoticon prompts usually represent different degrees of pain, from no pain to the most severe pain, and they usually include a series of expressions, such as smiling face, neutral face and crying face, so that patients can choose the expression that best reflects their pain. Patients are asked to mark a dot on a line representing the degree of pain they felt. The distance between the left end of the line and the point marked by the patient represents the intensity of the pain they experienced.

The measurement of isometric knee extensor muscle strength will be conducted through hand-held dynamometre (HHD). TKA patients often face challenges related to quadriceps weakness and other functional limitations.^39–41 Therefore, it is imperative to monitor quadriceps strength in patients undergoing TKA so that clinicians can promptly implement interventions to address muscle weakness and mitigate the risk of falls.⁴² Since the late twentieth century, various methods have been used to measure muscle strength.⁴³ HHD, one of these methods, has emerged as a promising instrument for clinical muscle strength assessment due to its great reliability, validity, portability and lower costs.^44–46

The psychological status of the patient will mainly be assessed by the PHQ-9 Depression Screening Scale (Patient Health Questionnaire) from baseline (T0) to the last follow-up (T3). The PHQ-9 has high sensitivity and specificity.⁴⁷

The questionnaire of satisfaction was designed based on the five-point Likert scale and will be used to evaluate the patients’ satisfaction with the medical process. There are five options: very dissatisfied, partially dissatisfied, average, basically satisfied and very satisfied.

Cost-benefit analysis will be performed using clinical data retrieved from medical records and patient-reported outcome measures (PROMs). These include time-based costs (such as average length of stay, nursing intensity, preoperative and postoperative patient contact frequency, readmission and adverse events), other resource consumption costs (such as additional drugs, additional physical rehabilitation therapy interventions, etc) and patient time-based costs (such as time and cost for transportation, telephone charges, etc).

Data collection {#18a}

The trial data will be collected by an independent research assistant who will be blinded during recruitment and baseline measurement. The data will include (a) online questionnaires, (b) data collected online by the JC (photos, videos), (c) data from medical records and (d) baseline data measured before randomisation. Some of these data will be measured repeatedly presurgery and postsurgery (table 1). Patients receiving TKA will be followed up for 12 weeks, and patients in the JC group will be required to complete relevant self-assessments (T1, T2, T3) through online questionnaires; at the same time, patients in the TP group will be asked to complete the same self-assessment using the same online questionnaires. All groups will undergo face-to-face follow-up at T1, T2 and T3 (in order to measure isometric knee extensor muscle strength). The data will be collected on day ±2 of the time point, during which JC will send a reminder every day, and the research assistant will remind both groups again in the last 2 days. The cost-benefit analysis will be conducted through clinical data retrieved from medical records and PROMs.

Table 1.

The measures and measurement points per study group

Target criteria	Assessment instruments	Measurement time points
		Baseline 1 month before surgery (T0)	3 days before surgery	Randomisation	1 month after surgery (T2)	3 months after surgery (T3)
Demographics	Medical record data and PROMs	√
Primary outcome
Knee functioning	WOMAC	√	√		√	√
Secondary outcomes
Knee functioning	AKSS	√	√		√	√
Pain	VAS	√	√		√	√
Isometric knee extensor muscle strength	HHD	√	√		√	√
Self-assessment of pain improvement	VAS		√		√	√
Self-assessment of quality of life improvement	VAS		√		√	√
Patient satisfaction	Patient Satisfaction Questionnaire					√
Use of painkillers	Self-made questionnaire	√	√		√	√
Wound complications	Photos				√	√
Mini-program user experience	Self-made questionnaire		√			√

AKSS, American Knee Society Score; HHD, Hand-held dynamometre; PROMs, Patient-reported outcome measures; VAS, Visual Analogue Scale; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index version 5, LK3.1.

Data management and confidentiality {#19,27}

JC can collect patient information only after obtaining the authorisation of the patient. Each patient has his/her own independent account to log in to JC and takes the pseudonymous research number as his/her own name. There is no clear name or personal characteristics data stored on the server at any time. Only the person authorised by the principal investigator can log in and view the data on the doctor dashboard, and only the principal investigator and research assistant can view the complete JC data. Online data is stored in a highly secure cloud database in China (Tencent Cloud, Shenzhen, China) and encrypted during transmission and storage. After the data collected through paper is pseudonymised by the research assistant, it is uniformly input into the department’s secure computer. Only the principal investigator and the research assistant can view the complete data. Once the research is completed, the research data will be transferred from the secure cloud database and secure computer to the offline storage device (external encrypted hard disk), and it will be provided to the data analysts who have implemented the blind method for statistical analysis. This external encrypted hard disk will be stored in the security cabinet of the research centre of the hospital for 5 years. Digital data collected through JC can be automatically checked for completeness and reasonableness (limited text input). Because of the research design, input errors can be basically eliminated. The paper-based data will be entered by two persons, and the range of values will be checked by a third person.

Plans to promote participant retention and complete follow-up {#18b}

Electronic questionnaire collection can reduce time and cost and comply with quality standards by automatically completing checks. The JC mini-program will remind the patients to complete the questionnaire.

Statistical methods {#20a}

Data analysis will be conducted according to the intent-to-treat (ITT) principle. All statistical analyses will be performed using SPSS version 26. 0 (IBM, Armonk, USA). We will compare baseline data between two groups using appropriate parametric and non-parametric statistical tests. The change in WOMAC, AKSS, VAS and isometric strength will be evaluated using a repeated measures linear mixed models with group, time and group by time as independent variables. The primary hypothesis will verify that the average WOMAC score gain of the JC group from baseline (T0) to the last follow-up (T3) will not be lower than that of the SP group. The MCID of the WOMAC is 10.³⁶ Compliance with the trial intervention will be analysed separately and used for efficacy analysis. Two compliance measures will be used to measure preoperative and postoperative compliance and include the interaction between patients and JC before and after surgery, which is measured by the percentage of completed tasks related to surgical preparation. In addition to the above compliance measures, the use of JC will also be investigated through log files, which will provide timestamp information about interactions with JC. For example, additional information will be provided by the user (such as step count and walking distance). The purpose of the use analysis is descriptive and aims to increase the understanding of the effective use mode of the test scheme. In the preliminary analysis, only the subjects who participated in all evaluations and at least 75% of the intervention processes will be considered in the per protocol set. An ITT analysis will also be conducted for all subjects who participated in at least one postoperative follow-up evaluation (T2 or T3).

Additional analyses {#20b}

Group differences based on sex, age, BMI and secondary diseases will also be analysed. If noticeable differences are found, risk adjustment will be made through logical regression analysis.

Definition of analysis population relating to protocol non-adherence and any statistical methods to handle missing data {#20c}

Because this trial will mainly use an online follow-up strategy, there will be basically no loss of questionnaire data. The paper data will be classified and saved in the special safe of the department by the research assistant. If the follow-up is not completed at the original measurement point, the existing data will be used for statistical analysis. However, there will still be cases where subjects quit the test due to subjective and objective reasons, so we set a 20% dropout rate when calculating the sample size. Generally, we will conduct ITT analysis and per protocol (PP) analysis. However, PP analysis is only used to validate ITT analysis. To solve our research problems, ITT is mainly used for analysis. ITT analysis is a widely respected analysis strategy in clinical trials.^{48 49} It can avoid selection bias and loss of follow-up bias.^{50 51}

Data monitoring {#21a}

There will be no external data security monitoring committee. The research team leader will be responsible for data and security monitoring. Any adverse events that may be reported will be recorded and followed up by the corresponding author and reported to the Medical Ethics Committee of Tianjin Hospital.

Harms {#22}

JC is consistent in content as a formal change in the standard treatment process, and it does not involve studying drug products or medical devices. Participation in this trial does not entail additional risks associated with standard treatment. However, we will also report any (serious) adverse events that occur in patients throughout the entire study process.

Protocol amendments {#25}

The study itself has no specific risks. In the case of important accidental plan modification, all members of the research team will be notified, recruitment will be suspended and the hospital ethics committee will be notified. At the same time, the patients involved will be informed of the changes in writing.

Data access {#29,31a}

This mini-program will be available in WeChat. The research results will be used to optimise the functions of mini-program and will be published in peer-reviewed journals. Detailed statistical codes are not available to the public and can only be viewed and retrieved by the primary researcher and research assistant of the study.

Patient and public involvement

Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

Discussion

Population ageing is an important trend of world population change. The data of China’s seventh national population census in 2020 show that the proportion of the elderly aged 60 and above has reached 18. 73%,⁵² and China will still be in an accelerated ageing stage in the next 30 years.⁵³ This fact means that more patients with osteoarthritis will suffer from pain. Even under the prevention-oriented treatment strategy, the number of joint replacement operations for patients with severe osteoarthritis will also increase. Improving the perioperative management of joint replacement patients is the goal of many orthopaedic surgeons. The standard process refers to that patients in our hospital usually receive advanced rehabilitation education and patient education on disease-related knowledge before surgery, receive rehabilitation guidance from professional rehabilitation physicians during hospitalisation after surgery and obtain patient education manuals for postoperative exercise and self-care at discharge. Even under such an intensive education system provided by physicians, the overall knowledge level of patients about disease, surgery and rehabilitation is very low.⁵⁴ At the same time, due to the influence of patients’ ideas and their own economical factors, they usually do not choose to go to community health centres or hospitals for professional treatment by rehabilitation physicians. After leaving the physician’s supervision, the patient’s compliance will decline and may even stop exercising, leading to dissatisfaction with the final recovery.⁵⁵ Lack of cognition, pain during exercise, lack of motivation and lack of supervision may be the reasons for the decline of compliance.⁵⁵ Although the ‘compliance’ of patients was not low during our follow-up, their lack of understanding and forgetting of knowledge led to unsatisfactory results of this ‘incorrect’ rehabilitation that seemed to be ‘compliance’.

The application of telemedicine may be an important measure to solve these issues above.⁵⁶ Social media, as an indispensable and important platform in this era, deepens the connection between users and shortens their sense of distance. Therefore, WeChat and its mini-program can serve as carriers to promote patient health. This RCT will be the first study in China to evaluate the effectiveness of the perioperative online management platform (JC), which covers the whole patient journey (preoperation, intraoperation, postoperation) of TKA based on ERAS. In JC, patients can receive professional, effective and timely guidance, and doctors can conduct health monitoring on patients to timely intervene, reduce time costs, reduce costs of travelling and improve the quality of medical care and patient satisfaction. JC may lead to further improvement in the prognosis of patients in clinical practice. A telemedicine platform similar to JC will be the most effective choice for improving communication and treatment efficiency at present and in the future. In future research, JC can be combined with high-tech technologies such as intelligent wearable devices and artificial intelligence to form a better patient management system.

Limitations

This study has some limitations. First, this will be a single-centre study with obvious regional and ethnic restrictions. Therefore, this research will adopt the concept of pragmatic trials to enhance the universality of the research results.⁵⁷ At the same time, the standard treatment process in the study was implemented by Tianjin Hospital in combination with the guidelines and clinical experience, which may be different from other medical centres. Therefore, we referred to the Chinese and American guidelines for perioperative TKA based on ERAS to carry out the trial design.

Due to the study design and the lack of blinding in the trial process (a common defect of relevant studies), the risk of observation bias increases. We adopted the evaluator blinding method to minimise bias. In addition, we set inclusion and exclusion criteria more widely and used random sequences generated by random functions and opaque anonymous envelopes to conduct hidden allocation after baseline data collection of eligible subjects to minimise selection bias. Finally, due to the particularity of the trial design, we often use the patient report type scale as the indicator of the research outcome, which may lead to deviation of the trial data due to the subjective factors of the subjects.

Conclusion

All in all, the purpose of this study is to evaluate the effectiveness of a perioperative online management platform (JC) covering the entire patient journey (preoperation, intraoperation and postoperation) based on ERAS for patients undergoing TKA. This will have a positive impact on the treatment and health economy.

Ethics statements

Patient consent for publication

Consent obtained directly from patient(s).