An interventional study of Remote monitoring and Usual Care in Knee Arthroplasty, Total and Knee Replacement Arthroplasty, sponsored by Diakonhjemmet Hospital. Recruiting at 1 site in Norway. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Diakonhjemmet Hospital · Not applicable, Interventional, and Health services research
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 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 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.
Participants are eligible for inclusion in the study if the following criteria apply:
Participants are excluded from the study of any of the following criteria apply:
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/Dignio 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:
Patients allocated to the remote monitoring group will receive an SMS with link to questionnaires in the Youwell/Dignio platform at 1, 2, 3, 6 and 12 months. The following data will be collected for the remote monitoring group:
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:
Diakonhjemmet Hospital is the lead sponsor of 62 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Usual Care
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/Dignio 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.
Other: 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.
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.
OMERACT-OARSI responder criteria
The OMERACT-OARSI responder criteria is a composite index where participants are classifies as responders or non-responders (binary outcome) based on the following criteria: High improvement on pain or function * ≥50% improvement + absolute change of ≥2 points in pain, OR * ≥50% improvement + absolute change of ≥2 point on KOOS) OR Improvement in at least two of the three following * ≥20% improvement + absolute change of ≥1 point in pain * ≥20% improvement + absolute change of ≥1 point in function * ≥20% improvement + absolute change of ≥1 point in disease activity
Time frame: Baseline, 6 months
OMERACT-OARSI responder criteria
The OMERACT-OARSI responder criteria is a composite index where participants are classifies as responders or non-responders (binary outcome) based on the following criteria: High improvement on pain or function • ≥50% improvement + absolute change of ≥2 points in pain, OR • ≥50% improvement + absolute change of ≥2 point on KOOS) OR Improvement in at least two of the three following • ≥20% improvement + absolute change of ≥1 point in pain • ≥20% improvement + absolute change of ≥1 point in function • ≥20% improvement + absolute change of ≥1 point in disease activity
Time frame: Baseline, 12 months
Healthcare costs
Direct (consultations in primary or specialist healthcare) and indirect costs (sick leave, medication, travel costs) collected from national registers (NAV, KUHR, NPR) or self-report. Summed up to cost per patient (euro).
Time frame: Baseline, 6 and 12 months
Health-related quality of life (EQ5D-5L)
5 dimensions rated on a 5-point Likert scale, calculated utility score between 0 and 1 (best health)
Time frame: Baseline, 6 months, 12 months
Safety measures
Any adverse events during the follow-up period. Any contact with hospital, emergency unit and general practitioned due to acute worsening. 1 and 3 months only for the remote monitoring group
Time frame: 1 month, 2 months, 3 months, 6 months, 12 months
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Assessment of three dimentions of the KOOS (pain, activity in daily living and health-related quality of life) summed up to 0-100 scales where 100 is best score.
Time frame: Baseline, 6 months, 12 months
Change in pain
Measured on numeric rating scales (0-10) with higher score indicating more pain
Time frame: Baseline, 2 months, 6 months, 12 months
Change in disease activity
Measured on a numeric rating scale (0-10) with 10 indicating worst disease activity.
Time frame: Baseline, 2 months, 6 months, 12 months
Satisfaction with care
Measured on a numeric rating scale (0-10) with higher score indicating higher satisfaction with care.
Time frame: 2 months, 6 months, 12 months
Satisfaction with total knee replacement surgery
Assessed using 4 primary questions, each rated on a 5-point Likert scale (from "very satisfied" to "very dissatisfied"), and a question about change in health-related quality of life rated on a 6-point scale (from "more improvement than I ever dreamed about" to "the quality of my life is worse")
Time frame: 2 months, 6 months, 12 months
Change in range of motion
Knee flexion and extension is self-reported based on pictures of different degrees of range of motion. Measurement at 1 and 3 months only for the remote monitoring group.
Time frame: Baseline, 1, 2, 3, 6, 12 months
Number of extra visits
Number of extra visits in both groups
Time frame: Baseline to 12 months
Fatigue
Measured on a numeric rating scale (0-10) with 10 indicating most fatigue
Time frame: Baseline, 2 months, 6 months, 12 months
Change in problems related to daily activity
Measured on a numeric rating scale (0-10) with 10 indicating more problems (question no.6 in the WPAI questionnaire)
Time frame: Baseline, 2 months, 6 months, 12 months
Pain self-efficacy Questionnaire (PSEQ-2)
Two questions on pain self-efficacy measured on a 6-point scale (not at all confident to completely confident)
Time frame: Baseline, 2 months, 6 months, 12 months
OsteoArthritis Quality Indicator questionnaire
17 item quality indicator questionnaire with yes, no, don't know/not relevant response categories. Summarized to a pass rate (number of yes divided by number of yes+number of no responses)
Time frame: Baseline
Motivation for knee exercises
Measured on a numeric rating scale from 0 to 10, with 10 indicating highly motivated for exercising.
Time frame: Baseline
Motivation for knee surgery
Measured on a numeric rating scale from 0 to 10, with 10 indicating highly motivated for undergoing knee surgery
Time frame: Baseline
Self-reported exercise
Measured with a question on how often the individual exercise with increased breathing and heart rate for at least 30 minutes. With five response categories (3 times or more per week; 1-2 times per week; 1-2 times per month; do not exercise regularily; cannot exercise)
Time frame: Baseline, 2 months, 6 months, 12 months
Global rating of change in the knee
One question with five response categories asking about experience of change in the knee. Responses from "a very small degree" to "a very large degree"
Time frame: 2 months, 6 months, 12 months
Digital self-efficacy
Six questions measuring how well the patients manage smartphones, padlets, pc, apps, and login with BankID and Helsenorge.no. Answered on a 5-point scale fron very poorly to very good, with an additional option of "never tried"
Time frame: Baseline
Demographics
Questions about age, gender, hight, weight, education level, working status, living arrangements, smoking, comorbidities.
Time frame: Baseline
Joint-spesific measures
Questions related to referred joint, other joints with pain/problems
Time frame: Baseline
Current treatment
Questions about if and how often they have been visiting a physiotherapist (1 and 3 months only for the remote monitoring group)
Time frame: Baseline, 1, 2, 3, 6 and 12 months
Satisfaction with follow-up
Measured on a five-point Likert scale, from "very satisfied" to "very dissatisfied"
Time frame: 6 and 12 months
Usability of remote follow-up
Measured with two questions from the system usability scale, modified to this study. The questions focus on the ease of answering the questionnaires and if help was needed. Measured on a 5-point likert scale from "totally disagree" to "totally agree"
Time frame: 6 and 12 months
Adherence to answering remote monitoring questionnaire
Number of remote monitoring questionnaires answered (1, 2, 3, 6 and 12 months)
Time frame: 1, 2, 3, 6 and 12 months
Previous treatment
Reporting of previous treatment (physiotherapy, osteoarthritis seminars, previous surgery in referred knee, previous arthroplasty in opposite knee)
Time frame: Baseline
Socioeconomic status
Reporting of sosioeconomic status and if they have someone to help if needed
Time frame: Baseline
Change in use of medication
Self-reported change in medication use (1 and 3 months only for remote monitoring group)
Time frame: 1, 2, 3 and 6 months
Fear of movement
Measured on a 7-point likert scale, measurement at 1 and 3 months only for the remote monitoring group. Response categories from "totally disagree" to "totally agree"
Time frame: Baseline, 1, 2, 3 months
Health competency
Measured on a 5-point likert scale, related to the understanding of their osteoarthritis disease and the treatment of their disease. Response categories from "completely" to "not at all"
Time frame: Baseline
Expectations about treatment
Measured with two questions from the Standford Expectations of Treatment Scale, focusing on expectations about the result of surgery. In addition, one question about expectancy of improvement with exercise. All measured on 7-point likert scales, from "totally disagree" to "totally agree".
Time frame: Baseline
Plan to share: No — Due to GDPR regulations, IPD cannot be shared
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for May 2027, 23 months after the start.
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Diakonhjemmet Hospital