Arthroplasty, Replacement, KneeNCT07058623
Nurse-Led Telehealth vs In-Person Follow-Up After Total Knee Replacement
A study testing Nurse-Led Telehealth Consultation and Traditional In-Person Nursing Consultation in people with Arthroplasty, Replacement, Knee and Osteoarthritis, Knee, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.
Trial summary
Brief Summary The goal of this clinical trial is to learn if nurse-led telehealth consultations can help detect complications and support recovery after total knee replacement surgery. The study will compare telehealth nursing consultations to traditional in-person nursing visits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Osteoarthritis, Knee
- What is being tested?
- Nurse-Led Telehealth Consultation and Traditional In-Person Nursing Consultation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Sep 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Undergoing their first total knee replacement surgery
- Within 4 weeks after surgery
- Medically stable for discharge and suitable for home-based follow-up care
- Have access to a smartphone and internet (for telehealth participants)
- Able to communicate effectively in Cantonese
- Provide informed consent to participate in the study
Who cannot join
- Undergoing bilateral or revision total knee replacement surgery
- Require immediate or intensive medical attention post-surgery (e.g., severe infection, hospitalization over 7 days)
- Have severe systemic disease (ASA physical status classification III or higher)
- Lack the technical ability or resources to participate in telehealth consultations
- Unable to communicate effectively in Cantonese
- Undergoing surgeries other than first-time total knee replacement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Tseung Kwan O Hospital
Hong Kong
King Sum Wong, ANC, RN, BSN, MScHSM, +852 6385 5831, wks008@ha.org.hk
King Sum Wong, ANC, RN, BSN, MScHSM
About this study
Official title: A Randomized Controlled Trial of Nurse-Led Telehealth Versus In-Person Consultations in Detecting Complications and Improving Recovery After Total Knee Replacement
Brief Summary
The goal of this clinical trial is to learn if nurse-led telehealth consultations can help detect complications and support recovery after total knee replacement surgery. The study will compare telehealth nursing consultations to traditional in-person nursing visits.
Read more
The main questions it aims to answer are:
- Can nurse-led telehealth detect post-surgery complications as well as or better than in-person consultations?
- Does telehealth nursing support better or equivalent recovery outcomes and patient satisfaction compared to in-person care?
Participants will:
- Be adults who had their first total knee replacement surgery.
- Receive follow-up care either through telehealth consultations using the HA Go mobile app or through traditional face-to-face nurse visits in the outpatient clinic.
- Attend scheduled consultations and provide information about their recovery and any complications they experience.
- Complete surveys about their satisfaction with the care they receive.
This study will help determine if telehealth nursing consultations can provide safe, effective, and convenient follow-up care for patients after knee replacement surgery, potentially improving access and reducing travel burdens.
Read the detailed description
Detailed Description This study is a randomized controlled trial designed to evaluate the clinical effectiveness and feasibility of nurse-led telehealth consultations compared to traditional in-person nursing consultations for post-operative care following total knee replacement (TKR) surgery.
Background and Rationale Total knee replacement is a common surgical intervention for end-stage knee osteoarthritis, offering significant pain relief and improved function. Post-operative follow-up is essential to monitor recovery, detect complications early, and support rehabilitation. However, traditional in-person consultations can pose logistical challenges for patients, including mobility limitations, travel burden, and time constraints. Telehealth has emerged as a promising alternative by enabling remote clinical assessments and patient monitoring, especially amplified by recent advances and adoption during the COVID-19 pandemic.
While telehealth models led by physicians have been studied extensively, there is a relative lack of evidence regarding nurse-led telehealth consultations in the orthopedic post-operative setting. Nurses play a crucial role in patient education, symptom monitoring, and care coordination, making nurse-led telehealth a potentially efficient and scalable solution. This study aims to fill this gap by rigorously evaluating whether nurse-led telehealth consultations can detect complications and support recovery as effectively as standard in-person visits.
Study Design
This is an open-label, parallel-group randomized controlled trial with two arms:
- Intervention arm: Nurse-led telehealth consultations delivered via a secure, hospital-approved mobile platform (the HA Go app).
- Control arm: Traditional in-person nursing consultations conducted at the Specialist Outpatient Department (SOPD).
Randomization will be performed using computer-generated block randomization with allocation concealment ensured through sealed opaque envelopes. Blinded outcome assessment and data analysis will be conducted to minimize bias.
Participants The trial will enroll adult patients (≥18 years old) who undergo first-time unilateral total knee replacement surgery at Tseung Kwan O Hospital. Eligible participants must be medically stable for discharge, have access to the necessary technology for telehealth, and provide informed consent. Patients with revision surgery, bilateral TKR, severe systemic disease (ASA Class III or above), or insufficient technological capacity will be excluded.
Interventions
Nurse-Led Telehealth:
Participants randomized to the telehealth arm will receive scheduled virtual consultations through the HA Go app. Consultations will include remote symptom assessment, wound evaluation via video, patient education on recovery and rehabilitation exercises, and management of minor complications. An executive assistant will provide technical support to patients unfamiliar with the app.
In-Person Nursing Consultation:
Participants assigned to the control group will attend face-to-face follow-up visits at the SOPD, receiving standard nursing care including physical examinations, education, and complication management.
Outcome Assessments The primary outcome is the rate of timely detection and management of post-operative complications within four weeks post-surgery. Secondary outcomes include functional recovery (assessed by validated scales such as KOOS), patient satisfaction, healthcare utilization (unplanned readmissions and emergency visits), and cost-effectiveness analyses encompassing travel and consultation time savings.
Data Collection and Management Data will be collected prospectively via electronic medical records, patient questionnaires, and telehealth system logs. Missing data will be managed using multiple imputation techniques under the assumption of missing at random. Security and confidentiality will be maintained according to Hospital Authority policies, with data encrypted and access restricted to authorized study personnel.
Significance By rigorously comparing nurse-led telehealth to traditional care, this study will generate high-quality evidence to inform post-operative management in TKR patients. Positive findings could support wider implementation of nurse-led telehealth services, improving accessibility, reducing patient burden, and optimizing healthcare resources. This model may be generalizable to other orthopedic and chronic disease care pathways.
Trial Registration and Ethics The study will be registered prior to recruitment, with ethical approval obtained from the Hospital Authority Central Institutional Review Board. Participants will provide informed consent, and the trial will adhere to CONSORT and Good Clinical Practice guidelines.
- Being tested
- Nurse-Led Telehealth Consultation, Traditional In-Person Nursing Consultation
- Keywords
- Total knee replacement, Knee arthroplasty, Postoperative care, Nurse-led telehealth, Telemedicine nursing consultation, Telehealth follow-up, Orthopedic nursing, Surgical complication detection, Recovery after knee surgery, Patient satisfaction, Outpatient follow-up care, Digital health interventions, HA Go mobile application, Remote patient monitoring
- Medical subject headings
- Osteoarthritis, Knee, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Telehealth ConsultationProcedure or surgery
Also called Telehealth Nursing Consultation, Virtual Nurse Consultation, Remote Nursing Follow-Up, Telemedicine Nursing Care
Participants receive scheduled postoperative nursing consultations delivered remotely via the HA Go mobile application, a secure, hospital-approved telehealth platform. Consultations occur approximately two weeks after total knee replacement surgery, with additional sessions arranged as clinically needed within the first month post-surgery. Each telehealth session lasts about 20 to 30 minutes and includes assessment of recovery progress, monitoring for complications, patient education, and guidance on rehabilitation exercises. Patients receive technical support to facilitate effective use of the telehealth platform. This intervention leverages virtual care technology to provide convenient, accessible nursing follow-up without requiring in-person clinic visits.
Traditional In-Person Nursing ConsultationProcedure or surgery
Also called Face-to-Face Nursing Consultation, In-Clinic Nursing Follow-Up, Standard Nursing Consultation, Outpatient Nursing Visit
Participants receive scheduled postoperative nursing consultations in person at the Specialist Outpatient Department. Each consultation lasts approximately 20 to 30 minutes and includes physical assessment, monitoring for complications, patient education, and rehabilitation guidance. Follow-up visits are typically scheduled two weeks after total knee replacement surgery, with additional visits as clinically indicated. This intervention represents standard postoperative nursing care delivered face-to-face.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-Led Telehealth Consultation | Experimental | Participants receive postoperative nursing follow-up via virtual consultations using the HA Go mobile app, a secure, hospital-approved telehealth platform. Nurses monitor recovery, assess for complications, provide education, and manage minor issues remotely. Consultations are scheduled 2 weeks post-surgery, with additional sessions as clinically indicated, lasting approximately 20-30 minutes each. Support is provided to assist patients unfamiliar with the technology. This arm tests the effectiveness of remote nursing care compared to traditional in-person visits. Receives: Procedure: Nurse-Led Telehealth Consultation |
| Traditional In-Person Nursing Consultation | Active comparator | Participants attend face-to-face postoperative nursing consultations at the Specialist Outpatient Department. Nurses perform physical assessments, monitor recovery progress, detect complications, provide education, and manage minor issues in-person. Follow-up visits are scheduled 2 weeks after surgery, with additional visits as needed. Consultations typically last 20-30 minutes. This arm represents standard care and serves as the active comparator to the telehealth intervention. Receives: Procedure: Traditional In-Person Nursing Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Postoperative Complications Detected Within Four Weeks Following Total Knee Replacement
This outcome measures the total number of participants in whom any postoperative complications are identified and managed during the follow-up period. Complications include both major events (e.g., deep vein thrombosis, surgical site infections) and minor issues (e.g., swelling, delayed wound healing, pain requiring intervention). The detection is based on clinical assessment during nurse-led telehealth or traditional in-person consultations.
Measured: Within 4 weeks (28 days) post-surgery
Secondary outcomes (9)
Change in Functional Recovery as Measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS)
This outcome measures participants' functional recovery and pain levels using the KOOS questionnaire, which ranges from 0 (extreme symptoms) to 100 (no symptoms). Higher scores indicate better recovery and function.
Measured: Baseline (pre-surgery) and 3 months post-surgery
The Chinese version of the Mobile Health App Usability Questionnaire (I-C-MAUQ) (Telehealth group)
Patient-reported usability of the mobile-health platform will be assessed in participants randomised to the telehealth arm using the Chinese version of the Mobile Health App Usability Questionnaire (I-C-MAUQ). The 18 items are summed and rescaled to 0-100; higher scores denote better perceived usability and satisfaction with the nursing consultation.
Measured: Within 4 weeks after surgery - immediately after the first telehealth follow-up consultation
Patient Satisfaction with Nursing Consultation
A standardized Hospital Authority patient satisfaction survey for both groups. Higher scores indicate greater satisfaction with the nursing consultation.
Measured: Within 4 weeks post-surgery, following the first consultation
Unplanned Hospital Readmissions within 28 Days Post-Surgery
This outcome records the number of participants who have unplanned hospital readmissions within 28 days after total knee replacement surgery.
Measured: 28 days post-surgery
Number of Visits to Accident and Emergency (A&E) Department within 3 Months Post-Surgery
This outcome counts participant visits to the A\&E department related to postoperative complications or concerns within 3 months after surgery.
Measured: 3 months post-surgery
Direct out-of-pocket travel cost (HK $)
Total patient-paid transport expenditure, including fares, parking fees, and tolls, incurred for the index post-operative follow-up consultation. The amount is reported per participant in Hong Kong dollars.
Measured: Day of the first follow-up consultation (within 4 weeks after surgery)
Total travel time to clinic (minutes)
Round-trip door-to-door travel duration self-reported by each participant for the index post-operative follow-up consultation. One value in minutes is recorded for every participant.
Measured: Day of the first follow-up consultation (within 4 weeks after surgery)
Nursing preparation time before follow-up consultation (minutes)
Clock time a nurse spends on preparatory tasks for a single post-operative follow-up consultation. These tasks include initiating or joining the telehealth platform, verifying patient identity and coaching the patient on system login. Record one value per consultation, rounded to the nearest whole minute.
Measured: Day of the first follow-up consultation (within 4 weeks after surgery)
Nursing face-to-face consultation time (minutes)
Elapsed clock time from the nurse's first direct interaction with the patient, either in person or on telehealth video, until completion of chart documentation and termination of the encounter. One value in whole minutes is recorded for each consultation.
Measured: Day of the first follow-up consultation (within 4 weeks after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start10 Sep 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel-group design in which participants are randomly assigned to one of two groups: the nurse-led telehealth consultation group or the traditional in-person nursing consultation group. Both groups receive follow-up care after total knee replacement surgery, and their outcomes will be compared to evaluate the effectiveness of telehealth versus in-person consultations. Randomization is performed using block randomization with concealed allocation to ensure balance between groups and minimize selection bias.
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wong King Sum, Hospital Authority, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058623
- Sponsor's protocol ID
- TKR-TEL-2025-TKOH
- Status last verified
- Sep 2025
- First submitted
- 10 Jun 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographics and Baseline Data: Including age, sex, and pre-operative ASA status. Primary Outcome: Data on the detection of post-operative complications within four weeks. Secondary Outcomes: Knee Injury and Osteoarthritis Outcome Score (KOOS) results , Mobile Health App Usability Questionnaire (I-C-MAUQ) scores , patient satisfaction surveys , healthcare utilization (unplanned readmissions, A\&E visits) , and cost-effectiveness data (travel/consultation time). Adherence Data: Participant attendance and completion rates for scheduled consultations.
Publications
Zhao R, Cheng L, Zheng Q, Lv Y, Wang YM, Ni M, Ren P, Feng Z, Ji Q, Zhang G. A Smartphone Application-Based Remote Rehabilitation System for Post-Total Knee Arthroplasty Rehabilitation: A Randomized Controlled Trial. J Arthroplasty. 2024 Mar;39(3):575-581.e8. doi: 10.1016/j.arth.2023.08.019. Epub 2023 Aug 11.
PubMed 37572720Windsor EN, Sharma AK, Gkiatas I, Elbuluk AM, Sculco PK, Vigdorchik JM. An Overview of Telehealth in Total Joint Arthroplasty. HSS J. 2021 Feb;17(1):51-58. doi: 10.1177/1556331620972629. Epub 2021 Feb 21.
PubMed 33967642Visperas AT, Greene KA, Krebs VE, Klika AK, Piuzzi NS, Higuera-Rueda CA. A Web-Based Interactive Patient-Provider Software Platform Does Not Increase Patient Satisfaction or Decrease Hospital Resource Utilization in Total Knee and Hip Arthroplasty Patients in a Single Large Hospital System. J Arthroplasty. 2021 Jul;36(7):2290-2296.e1. doi: 10.1016/j.arth.2021.01.037. Epub 2021 Jan 21.
PubMed 33581971Shan Y, Ji M, Xie W, Li R, Qian X, Zhang X, Hao T. Chinese Version of the Mobile Health App Usability Questionnaire: Translation, Adaptation, and Validation Study. JMIR Form Res. 2022 Jul 6;6(7):e37933. doi: 10.2196/37933.
PubMed 35793132Pitaro NL, Barbera JP, Ranson WA, Zubizarreta N, Poeran J, Chen DD, Moucha CS, Hayden BL. Evaluating Resource Utilization for In-Person and Virtual Joint Classes in Total Joint Arthroplasty: An Analysis of Attendance Patterns at a Large Metropolitan Health System. J Arthroplasty. 2022 Sep;37(9):1708-1714. doi: 10.1016/j.arth.2022.03.079. Epub 2022 Apr 1.
PubMed 35378234McKeon JF, Alvarez PM, Vajapey AS, Sarac N, Spitzer AI, Vajapey SP. Expanding Role of Technology in Rehabilitation After Lower-Extremity Joint Replacement: A Systematic Review. JBJS Rev. 2021 Sep 13;9(9). doi: 10.2106/JBJS.RVW.21.00016.
PubMed 34516463Hofmann UK, Hildebrand F, Mederake M, Migliorini F. Telemedicine in orthopaedics and trauma surgery during the first year of COVID pandemic: a systematic review. BMC Musculoskelet Disord. 2023 Feb 7;24(1):101. doi: 10.1186/s12891-023-06194-3.
PubMed 36750962Fahey E, Elsheikh MFH, Davey MS, Rowan F, Cassidy JT, Cleary MS. Telemedicine in Orthopedic Surgery: A Systematic Review of Current Evidence. Telemed J E Health. 2022 May;28(5):613-635. doi: 10.1089/tmj.2021.0221. Epub 2021 Aug 10.
PubMed 34375150Fabres Martin C, Ventura Parellada C, Herrero Anton de Vez H, Ordonez Urgiles CE, Alonso-Rodriguez Piedra J, Mora Guix JM. Telemedicine approach for patient follow-up after total knee and reverse total shoulder arthroplasty: a pilot study. Int J Comput Assist Radiol Surg. 2023 Mar;18(3):595-602. doi: 10.1007/s11548-022-02784-z. Epub 2022 Nov 23.
PubMed 36422767El Ashmawy AH, Dowson K, El-Bakoury A, Hosny HAH, Yarlagadda R, Keenan J. Effectiveness, Patient Satisfaction, and Cost Reduction of Virtual Joint Replacement Clinic Follow-Up of Hip and Knee Arthroplasty. J Arthroplasty. 2021 Mar;36(3):816-822.e1. doi: 10.1016/j.arth.2020.08.019. Epub 2020 Aug 15.
PubMed 32893060Bovonratwet P, Song J, LaValva SM, Chen AZ, Ondeck NT, Blevins JL, Su EP. Telemedicine in Arthroplasty Patients: Which Factors Are Associated With High Satisfaction? Arthroplast Today. 2024 Jan 2;25:101285. doi: 10.1016/j.artd.2023.101285. eCollection 2024 Feb.
PubMed 38261888American Academy of Orthopaedic Surgeons. (2024). Total knee replacement. OrthoInfo. Retrieved January 8, 2025, from https://orthoinfo.aaos.org/en/treatment/total-knee-replacement
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Nurse-Led Telehealth Versus In-Person Consultations in Detecting Complications and Improving Recovery After Total Knee Replacement
- ClinicalTrials.gov ID
- NCT07058623
- Acronym / sponsor ID
- TKR-TEL-2025-TKOH
- Keywords
- Total knee replacement, Knee arthroplasty, Postoperative care, Nurse-led telehealth, Telemedicine nursing consultation, Telehealth follow-up, Orthopedic nursing, Surgical complication detection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brief Summary
The goal of this clinical trial is to learn if nurse-led telehealth consultations can help detect complications and support recovery after total knee replacement surgery. The study will compare telehealth nursing consultations to traditional in-person nursing visits.
The main questions it aims to answer are:
- Can nurse-led telehealth detect post-surgery complications as well as or better than in-person consultations?
- Does telehealth nursing support better or equivalent recovery outcomes and patient satisfaction compared to in-person care?
Participants will:
- Be adults who had their first total knee replacement surgery.
- Receive follow-up care either through telehealth consultations using the HA Go mobile app or through traditional face-to-face nurse visits in the outpatient clinic.
- Attend scheduled consultations and provide information about their recovery and any complications they experience.
- Complete surveys about their satisfaction with the care they receive.
This study will help determine if telehealth nursing consultations can provide safe, effective, and convenient follow-up care for patients after knee replacement surgery, potentially improving access and reducing travel burdens.
Detailed description
Detailed Description This study is a randomized controlled trial designed to evaluate the clinical effectiveness and feasibility of nurse-led telehealth consultations compared to traditional in-person nursing consultations for post-operative care following total knee replacement (TKR) surgery.
Background and Rationale Total knee replacement is a common surgical intervention for end-stage knee osteoarthritis, offering significant pain relief and improved function. Post-operative follow-up is essential to monitor recovery, detect complications early, and support rehabilitation. However, traditional in-person consultations can pose logistical challenges for patients, including mobility limitations, travel burden, and time constraints. Telehealth has emerged as a promising alternative by enabling remote clinical assessments and patient monitoring, especially amplified by recent advances and adoption during the COVID-19 pandemic.
While telehealth models led by physicians have been studied extensively, there is a relative lack of evidence regarding nurse-led telehealth consultations in the orthopedic post-operative setting. Nurses play a crucial role in patient education, symptom monitoring, and care coordination, making nurse-led telehealth a potentially efficient and scalable solution. This study aims to fill this gap by rigorously evaluating whether nurse-led telehealth consultations can detect complications and support recovery as effectively as standard in-person visits.
Study Design
This is an open-label, parallel-group randomized controlled trial with two arms:
- Intervention arm: Nurse-led telehealth consultations delivered via a secure, hospital-approved mobile platform (the HA Go app).
- Control arm: Traditional in-person nursing consultations conducted at the Specialist Outpatient Department (SOPD).
Randomization will be performed using computer-generated block randomization with allocation concealment ensured through sealed opaque envelopes. Blinded outcome assessment and data analysis will be conducted to minimize bias.
Participants The trial will enroll adult patients (≥18 years old) who undergo first-time unilateral total knee replacement surgery at Tseung Kwan O Hospital. Eligible participants must be medically stable for discharge, have access to the necessary technology for telehealth, and provide informed consent. Patients with revision surgery, bilateral TKR, severe systemic disease (ASA Class III or above), or insufficient technological capacity will be excluded.
Interventions
Nurse-Led Telehealth:
Participants randomized to the telehealth arm will receive scheduled virtual consultations through the HA Go app. Consultations will include remote symptom assessment, wound evaluation via video, patient education on recovery and rehabilitation exercises, and management of minor complications. An executive assistant will provide technical support to patients unfamiliar with the app.
In-Person Nursing Consultation:
Participants assigned to the control group will attend face-to-face follow-up visits at the SOPD, receiving standard nursing care including physical examinations, education, and complication management.
Outcome Assessments The primary outcome is the rate of timely detection and management of post-operative complications within four weeks post-surgery. Secondary outcomes include functional recovery (assessed by validated scales such as KOOS), patient satisfaction, healthcare utilization (unplanned readmissions and emergency visits), and cost-effectiveness analyses encompassing travel and consultation time savings.
Data Collection and Management Data will be collected prospectively via electronic medical records, patient questionnaires, and telehealth system logs. Missing data will be managed using multiple imputation techniques under the assumption of missing at random. Security and confidentiality will be maintained according to Hospital Authority policies, with data encrypted and access restricted to authorized study personnel.
Significance By rigorously comparing nurse-led telehealth to traditional care, this study will generate high-quality evidence to inform post-operative management in TKR patients. Positive findings could support wider implementation of nurse-led telehealth services, improving accessibility, reducing patient burden, and optimizing healthcare resources. This model may be generalizable to other orthopedic and chronic disease care pathways.
Trial Registration and Ethics The study will be registered prior to recruitment, with ethical approval obtained from the Hospital Authority Central Institutional Review Board. Participants will provide informed consent, and the trial will adhere to CONSORT and Good Clinical Practice guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a parallel-group design in which participants are randomly assigned to one of two groups: the nurse-led telehealth consultation group or the traditional in-person nursing consultation group. Both groups receive follow-up care after total knee replacement surgery, and their outcomes will be compared to evaluate the effectiveness of telehealth versus in-person consultations. Randomization is performed using block randomization with concealed allocation to ensure balance between groups and minimize selection bias.
| Arm | Type | Receives |
|---|---|---|
| Nurse-Led Telehealth Consultation | Experimental | Procedure: Nurse-Led Telehealth ConsultationParticipants receive postoperative nursing follow-up via virtual consultations using the HA Go mobile app, a secure, hospital-approved telehealth platform. Nurses monitor recovery, assess for complications, provide education, and manage minor issues remotely. Consultations are scheduled 2 weeks post-surgery, with additional sessions as clinically indicated, lasting approximately 20-30 minutes each. Support is provided to assist patients unfamiliar with the technology. This arm tests the effectiveness of remote nursing care compared to traditional in-person visits. |
| Traditional In-Person Nursing Consultation | Active comparator | Procedure: Traditional In-Person Nursing ConsultationParticipants attend face-to-face postoperative nursing consultations at the Specialist Outpatient Department. Nurses perform physical assessments, monitor recovery progress, detect complications, provide education, and manage minor issues in-person. Follow-up visits are scheduled 2 weeks after surgery, with additional visits as needed. Consultations typically last 20-30 minutes. This arm represents standard care and serves as the active comparator to the telehealth intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 years or older
- Undergoing their first total knee replacement surgery
- Within 4 weeks after surgery
- Medically stable for discharge and suitable for home-based follow-up care
- Have access to a smartphone and internet (for telehealth participants)
Key exclusion criteria (6 listed)
- Undergoing bilateral or revision total knee replacement surgery
- Require immediate or intensive medical attention post-surgery (e.g., severe infection, hospitalization over 7 days)
- Have severe systemic disease (ASA physical status classification III or higher)
- Lack the technical ability or resources to participate in telehealth consultations
- Unable to communicate effectively in Cantonese
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-Led Telehealth ConsultationAlso: Telehealth Nursing Consultation, Virtual Nurse Consultation, Remote Nursing Follow-Up, Telemedicine Nursing CareParticipants receive scheduled postoperative nursing consultations delivered remotely via the HA Go mobile application, a secure, hospital-approved telehealth platform. Consultations occur approximately two weeks after total knee replacement surgery, with additional sessions arranged as clinically needed within the first month post-surgery. Each telehealth session lasts about 20 to 30 minutes and includes assessment of recovery progress, monitoring for complications, patient education, and guidance on rehabilitation exercises. Patients receive technical support to facilitate effective use of the telehealth platform. This intervention leverages virtual care technology to provide convenient, accessible nursing follow-up without requiring in-person clinic visits. | Procedure or surgery | Nurse-Led Telehealth Consultation |
| Traditional In-Person Nursing ConsultationAlso: Face-to-Face Nursing Consultation, In-Clinic Nursing Follow-Up, Standard Nursing Consultation, Outpatient Nursing VisitParticipants receive scheduled postoperative nursing consultations in person at the Specialist Outpatient Department. Each consultation lasts approximately 20 to 30 minutes and includes physical assessment, monitoring for complications, patient education, and rehabilitation guidance. Follow-up visits are typically scheduled two weeks after total knee replacement surgery, with additional visits as clinically indicated. This intervention represents standard postoperative nursing care delivered face-to-face. | Procedure or surgery | Traditional In-Person Nursing Consultation |
Primary outcome
Number of Participants with Postoperative Complications Detected Within Four Weeks Following Total Knee Replacement
Time frame: Within 4 weeks (28 days) post-surgery
This outcome measures the total number of participants in whom any postoperative complications are identified and managed during the follow-up period. Complications include both major events (e.g., deep vein thrombosis, surgical site infections) and minor issues (e.g., swelling, delayed wound healing, pain requiring intervention). The detection is based on clinical assessment during nurse-led telehealth or traditional in-person consultations.
9 secondary outcomes
Change in Functional Recovery as Measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline (pre-surgery) and 3 months post-surgery
The Chinese version of the Mobile Health App Usability Questionnaire (I-C-MAUQ) (Telehealth group)
Time frame: Within 4 weeks after surgery - immediately after the first telehealth follow-up consultation
Patient Satisfaction with Nursing Consultation
Time frame: Within 4 weeks post-surgery, following the first consultation
Unplanned Hospital Readmissions within 28 Days Post-Surgery
Time frame: 28 days post-surgery
Number of Visits to Accident and Emergency (A&E) Department within 3 Months Post-Surgery
Time frame: 3 months post-surgery
Direct out-of-pocket travel cost (HK $)
Time frame: Day of the first follow-up consultation (within 4 weeks after surgery)
Total travel time to clinic (minutes)
Time frame: Day of the first follow-up consultation (within 4 weeks after surgery)
Nursing preparation time before follow-up consultation (minutes)
Time frame: Day of the first follow-up consultation (within 4 weeks after surgery)
Nursing face-to-face consultation time (minutes)
Time frame: Day of the first follow-up consultation (within 4 weeks after surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Results publication: PubMed 37572720Zhao R, Cheng L, Zheng Q, Lv Y, Wang YM, Ni M, Ren P, Feng Z, Ji Q, Zhang G. A Smartphone Application-Based Remote Rehabilitation System for Post-Total Knee Arthroplasty Rehabilitation: A Randomized Controlled Trial. J Arthroplasty. 2024 Mar;39(3):575-581.e8. doi: 10.1016/j.arth.2023.08.019. Epub 2023 Aug 11.
- Results publication: PubMed 33967642Windsor EN, Sharma AK, Gkiatas I, Elbuluk AM, Sculco PK, Vigdorchik JM. An Overview of Telehealth in Total Joint Arthroplasty. HSS J. 2021 Feb;17(1):51-58. doi: 10.1177/1556331620972629. Epub 2021 Feb 21.
- Results publication: PubMed 33581971Visperas AT, Greene KA, Krebs VE, Klika AK, Piuzzi NS, Higuera-Rueda CA. A Web-Based Interactive Patient-Provider Software Platform Does Not Increase Patient Satisfaction or Decrease Hospital Resource Utilization in Total Knee and Hip Arthroplasty Patients in a Single Large Hospital System. J Arthroplasty. 2021 Jul;36(7):2290-2296.e1. doi: 10.1016/j.arth.2021.01.037. Epub 2021 Jan 21.
- Results publication: PubMed 35793132Shan Y, Ji M, Xie W, Li R, Qian X, Zhang X, Hao T. Chinese Version of the Mobile Health App Usability Questionnaire: Translation, Adaptation, and Validation Study. JMIR Form Res. 2022 Jul 6;6(7):e37933. doi: 10.2196/37933.
- Results publication: PubMed 35378234Pitaro NL, Barbera JP, Ranson WA, Zubizarreta N, Poeran J, Chen DD, Moucha CS, Hayden BL. Evaluating Resource Utilization for In-Person and Virtual Joint Classes in Total Joint Arthroplasty: An Analysis of Attendance Patterns at a Large Metropolitan Health System. J Arthroplasty. 2022 Sep;37(9):1708-1714. doi: 10.1016/j.arth.2022.03.079. Epub 2022 Apr 1.
- Results publication: PubMed 34516463McKeon JF, Alvarez PM, Vajapey AS, Sarac N, Spitzer AI, Vajapey SP. Expanding Role of Technology in Rehabilitation After Lower-Extremity Joint Replacement: A Systematic Review. JBJS Rev. 2021 Sep 13;9(9). doi: 10.2106/JBJS.RVW.21.00016.
- Results publication: PubMed 36750962Hofmann UK, Hildebrand F, Mederake M, Migliorini F. Telemedicine in orthopaedics and trauma surgery during the first year of COVID pandemic: a systematic review. BMC Musculoskelet Disord. 2023 Feb 7;24(1):101. doi: 10.1186/s12891-023-06194-3.
- Results publication: PubMed 34375150Fahey E, Elsheikh MFH, Davey MS, Rowan F, Cassidy JT, Cleary MS. Telemedicine in Orthopedic Surgery: A Systematic Review of Current Evidence. Telemed J E Health. 2022 May;28(5):613-635. doi: 10.1089/tmj.2021.0221. Epub 2021 Aug 10.
- Results publication: PubMed 36422767Fabres Martin C, Ventura Parellada C, Herrero Anton de Vez H, Ordonez Urgiles CE, Alonso-Rodriguez Piedra J, Mora Guix JM. Telemedicine approach for patient follow-up after total knee and reverse total shoulder arthroplasty: a pilot study. Int J Comput Assist Radiol Surg. 2023 Mar;18(3):595-602. doi: 10.1007/s11548-022-02784-z. Epub 2022 Nov 23.
- Results publication: PubMed 32893060El Ashmawy AH, Dowson K, El-Bakoury A, Hosny HAH, Yarlagadda R, Keenan J. Effectiveness, Patient Satisfaction, and Cost Reduction of Virtual Joint Replacement Clinic Follow-Up of Hip and Knee Arthroplasty. J Arthroplasty. 2021 Mar;36(3):816-822.e1. doi: 10.1016/j.arth.2020.08.019. Epub 2020 Aug 15.
- Results publication: PubMed 38261888Bovonratwet P, Song J, LaValva SM, Chen AZ, Ondeck NT, Blevins JL, Su EP. Telemedicine in Arthroplasty Patients: Which Factors Are Associated With High Satisfaction? Arthroplast Today. 2024 Jan 2;25:101285. doi: 10.1016/j.artd.2023.101285. eCollection 2024 Feb.
- Results publicationAmerican Academy of Orthopaedic Surgeons. (2024). Total knee replacement. OrthoInfo. Retrieved January 8, 2025, from https://orthoinfo.aaos.org/en/treatment/total-knee-replacement
- Individual participant dataSharing planned: Yes. Demographics and Baseline Data: Including age, sex, and pre-operative ASA status. Primary Outcome: Data on the detection of post-operative complications within four weeks. Secondary Outcomes: Knee Injury and Osteoarthritis Outcome Score (KOOS) results , Mobile Health App Usability Questionnaire (I-C-MAUQ) scores , patient satisfaction surveys , healthcare utilization (unplanned readmissions, A\&E visits) , and cost-effectiveness data (travel/consultation time). Adherence Data: Participant attendance and completion rates for scheduled consultations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Telehealth Consultation and Traditional In-Person Nursing Consultation in people with Arthroplasty, Replacement, Knee and Osteoarthritis, Knee, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact King Sum Wong, ANC, RN, BSN, MScHSM (+852 6385 5831, wks008@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Postoperative Complications Detected Within Four Weeks Following Total Knee Replacement (time frame: Within 4 weeks (28 days) post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07058623, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.