Clinical trial NCT07003932: Remote Monitoring After Total Knee Replacement
Official title: Remote Monitoring After Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Arthroplasty, Total
Keywords: knee arthroplasty
remote follow-up
non-inferiority
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, open-labeled, parallel group, non-inferiority, single-site clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this clinical trial is to evaluate the effect, cost-effectiveness, safety and satisfaction with replacing standardized, pre-scheduled face-to-face visits with remote monitoring and video consultations or face-to-face consultations only when needed after total knee replacement surgery due to knee osteoarthritis.

The primary outcome is the probability of being a OMERACT-OARSI responder at 6 months post-surgery. This is a composite index where participants are classified as a responder or non-responder based on improvement in pain, function and/or disease activity. Health-related quality of life and healthcare costs will be used to determine cost-effectiveness. Patient-reported adverse events and statisfaction will be used to determine safety and satisfaction.

Patients will be recruited from Diakonhjemmet Hospital. Patients undergoing total knee replacement surgery will be randomly allocated to a control group who are summoned for a face-to-face consultation at Diakonhjemmet Hospital at 2 and 12 months, or a remote monitoring group who will not be scheduled for hospital visits but will answer patient-reported outcomes throught a web-application at 1, 2, 3, 6 and 12 months post-surgery and only be scheduled for hospital visits when needed.

An additional study with follow-up after 5 and 10 years will be conducted.

Detailed description: Participants are eligible for inclusion in the study if the following criteria apply:

* men and women, 50 years of age or older
* referred to total knee replacement surgery due to knee osteoarthritis

Participants are excluded from the study of any of the following criteria apply:

* revision of previous total knee replacement surgery
* serious comorbidities (such as severe malignancues, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease, severe respiratory disease)
* congnitive dysfunction
* total knee replacement surgery due to trauma or inflammatory joint disease (such as psoriatic arthritis or rheumatoid arthritis)
* unable to understand Norwegian
* Cannot answer questionnaires digitally (lack BankID, do not possess a smartphone
* deemed inappropriate for remote monitoring by orthopedic surgeon

Patients included in both treatment arms will receive medical treatment according to current treatment recommendations as applied by the treating orthopedic surgeon after total knee replacement. All partients are recommended to seek physiotherapy treatment in primary care after surgery

Patients randomly allocated to the control group will be summoned for a hospital visit with a physiotherapist at 2 and 12 months. The physiotherapist will conduct assessment in line with regular clinical practice. If the patient is experiencing lack of improvement or adverse events, an orthopedic surgeon may be consulted. The patients will also answer patient-reported outcomes at 8 weeks and 6- and 12 months post-surgery, however, these answers will not be monitored.

Patients randomly allocated to the remote monitoring group will answer patient-reported outcome at 1, 2, 3, 6 and 12 months. They will be provided with a brief introduction from the study personnel on how to answer questions remotely through the Youwell platform. Patients will get an SMS notification on their mobile phone with a link to the questionnaire. They will have to log in with BankID to access the questionnaire. A physiotherapist will monitor the answers and will contact the patient if an unexpected deterioration or adverse events are detected.

Data will be collected through Nettskjema or the Youwell software program and will be stored in Services for Sensitive Data (TSD) and a a secure server at Diakonhjemmet Hospital.

The following data will be recorded through self-report in the baseline questionnaire:

* Demography: mobile number, education, work status, living arrangement, socioeconomic status, social support, expectations about treatment, fear of movement, catastrophizing, self-efficacy
* Disease variables: KOOS, other joints with osteoarthritis, duration of complaint, previous treatment, fatigue, disease activity, pain, function, pain medication, osteoarthritis quality indicators, knee flexion/extension, use of walking aids
* Lifestyle variables: physical activity, motivation for exercise, motivation for surgery
* Health competency, digital self-efficacy
* Patient satisfaction
* Health-related quality of life The following information will be collected from medical records
* Demographic variables: Age, gender, height, weight, comorbidity, referred knee, smoking,
* General medical history: description of radiographs, type of scheduled arthroplasty, joint status prior to surgery

Patients allocated to the remote monitoring group will receive an SMS with link to questionnaires in the Youwell platform at 1, 2, 3, 6 and 12 months. The following data will be collected for the remote monitoring group:

* Global rating of change
* Pain/Pain medication
* Fear of movement
* Expectations about treatment
* Disease activity
* Signs inflammation/swelling
* Function/activity
* Knee flexion/extension
* Use of walking aids
* Exercise
* Contact with physiotherapist/ rehabilitation stay
* Adverse events
* Patient satisfaction with care

A highly experienced physiotherapist will review the answers and based on these make a clinical judgement whether there is a need to call the patient or summon the patient for a physical examination, or if the patient seems to manage well at home.

Patients in the control group will also answer the remote monitoring questionnaire at 2 months, however, their answers will not be monitored (just for research purposes).

At follow-up, the following variables will be collected:

* Global rating of change
* Disease variables: KOOS, fatigue, disease activity, pain, function, pain medication,
* Fear of movement
* Self-efficacy
* Knee flexion/extension
* Lifestyle variables: physical activity,
* Patient satisfaction with care
* Health-related quality of life
* Health care costs: hospital stay, rehabilitation stay, travel distance to hospital, transportation, health care use
* Adverse events

Eligibility criteria: Inclusion Criteria:

* Men and women, 50 years of age or older
* Reffered to total knee replacement surgery due to knee osteoarthritis

Exclusion Criteria:

* Revision of previous total knee replacement surgery
* Serious comorbidities (such as severe malignancies, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease, severe respiratory disease)
* Congitive dysfunction
* Total knee replacement surgery due to trauma or inflammatory joint disease (such as psoriatic arthritis or rheumatoid arthritis)
* Unable to understand Norwegian
* Low digital competency/ cannot answer questionnaires digitally (lack BankID, do not possess a smartphone)
* Deemed inappropriate for remote monitoring by orthopedic surgeon

Primary outcomes:
measure: OMERACT-OARSI responder criteria
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: OMERACT-OARSI responder criteria
timeFrame: Baseline, 12 months
measure: Healthcare costs
timeFrame: Baseline, 6 and 12 months
measure: Health-related quality of life (EQ5D-5L)
timeFrame: Baseline, 6 months, 12 months
measure: Safety measures
timeFrame: 1 month, 2 months, 3 months, 6 months, 12 months
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline, 6 months, 12 months
measure: Change in pain
timeFrame: Baseline, 2 months, 6 months, 12 months
measure: Change in disease activity
timeFrame: Baseline, 2 months, 6 months, 12 months
measure: Satisfaction with care
timeFrame: 2 months, 6 months, 12 months
measure: Satisfaction with total knee replacement surgery
timeFrame: 2 months, 6 months, 12 months
measure: Change in range of motion
timeFrame: Baseline, 1, 2, 3, 6, 12 months
measure: Number of extra visits
timeFrame: Baseline to 12 months
Other outcomes:
measure: Fatigue
timeFrame: Baseline, 2 months, 6 months, 12 months
measure: Change in problems related to daily activity
timeFrame: Baseline, 2 months, 6 months, 12 months
measure: Pain self-efficacy Questionnaire (PSEQ-2)
timeFrame: Baseline, 2 months, 6 months, 12 months
measure: OsteoArthritis Quality Indicator questionnaire
timeFrame: Baseline
measure: Motivation for knee exercises
timeFrame: Baseline
measure: Motivation for knee surgery
timeFrame: Baseline
measure: Self-reported exercise
timeFrame: Baseline, 2 months, 6 months, 12 months
measure: Global rating of change in the knee
timeFrame: 2 months, 6 months, 12 months
measure: Digital self-efficacy
timeFrame: Baseline
measure: Demographics
timeFrame: Baseline
measure: Joint-spesific measures
timeFrame: Baseline
measure: Current treatment
timeFrame: Baseline, 1, 2, 3, 6 and 12 months
measure: Satisfaction with follow-up
timeFrame: 6 and 12 months
measure: Usability of remote follow-up
timeFrame: 6 and 12 months
measure: Adherence to answering remote monitoring questionnaire
timeFrame: 1, 2, 3, 6 and 12 months
measure: Previous treatment
timeFrame: Baseline
measure: Socioeconomic status
timeFrame: Baseline
measure: Change in use of medication
timeFrame: 1, 2, 3 and 6 months
measure: Fear of movement
timeFrame: Baseline, 1, 2, 3 months
measure: Health competency
timeFrame: Baseline
measure: Expectations about treatment
timeFrame: Baseline
Locations:
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
state: Please Select
Study officials:
References: