Remote Monitoring After Total Knee Replacement

NCT ID: NCT07003932

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-04
• Study Completion Date: 2035-12-31

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

Conditions

Knee Arthroplasty, Total

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control group

Patients randomly allocated to standard follow-up will be summoned for a hospital visit with a physiotherapist at 8 weeks and 12 months post-surgery. The physiotherapist will conduct an 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.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

The control group will follow usual care with face-to-face consultation with a physiotherapist at 2 and 12 months. They will also anwer questionnaires at 2, 6 and 12 months, but these will not be monitored.

Remote monitoring

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.

Group Type: EXPERIMENTAL

Remote monitoring

Intervention Type: OTHER

The remote monitoring group will be more closely followed than the control group in order to detect any deterioration over time. This group will not be scheduled for a face-to-face consultation unless it is deemed necessary by a physiotherapist or if the patient contacts the hospital themselves.

Interventions

Remote monitoring

The remote monitoring group will be more closely followed than the control group in order to detect any deterioration over time. This group will not be scheduled for a face-to-face consultation unless it is deemed necessary by a physiotherapist or if the patient contacts the hospital themselves.

Intervention Type: OTHER

Usual Care

The control group will follow usual care with face-to-face consultation with a physiotherapist at 2 and 12 months. They will also anwer questionnaires at 2, 6 and 12 months, but these will not be monitored.

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diakonhjemmet Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anne Therese Tveter

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Diakonhjemmet Hospital

Oslo, Please Select, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Anne Therese Tveter, PhD

Role: CONTACT

a.t.tveter@medisin.uio.no

+47 91115550

Facility Contacts

Anne Therese Tveter, PhD

Role: primary

a.t.tveter@medisin.uio.no

+47 91115550

Other Identifiers

855137

Identifier Type: -

Identifier Source: org_study_id