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Knee Arthroplasty, TotalOA-AID TKRNCT07003932

Remote Monitoring After Knee Replacement Surgery

A study testing Remote monitoring in people with Knee Arthroplasty, Total and Knee Replacement Arthroplasty, run by Diakonhjemmet Hospital at 1 site in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 knee replacement surgery due to knee osteoarthritis. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Remote monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteNorway
Study dates
4 Jun 2025to 31 Dec 2035
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women, 50 years of age or older
  • Referred to total or unicondylar knee replacement surgery due to knee osteoarthritis

Who cannot join

  • Revision of previous knee replacement surgery
  • Serious comorbidities (such as severe malignancies, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease, severe respiratory disease)
  • Congitive dysfunction
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anne Therese Tveter, PhD contact

+47 91115550

a.t.tveter@medisin.uio.no

Norway1 site, 1 recruiting
  • Diakonhjemmet Hospital

    Oslo, Please Select, 0370

    Anne Therese Tveter, PhD, +47 91115550, a.t.tveter@medisin.uio.no

    Anne Therese Tveter, PhD

    Recruiting

Other trials in Norway

About this study

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.

Read more

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.

Read the 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 or unicondylar (medial) knee replacement surgery due to knee osteoarthritis

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

  • revision of previous knee replacement surgery
  • serious comorbidities (such as severe malignancues, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease, severe respiratory disease)
  • congnitive dysfunction
  • 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/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:

  • 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/Dignio 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
Being tested
Remote monitoring, Usual Care
Keywords
knee arthroplasty, remote follow-up, non-inferiority

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote monitoringOther

    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.

  • Usual CareOther

    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.

Study groups in NCT07003932
Study groupRoleWhat they receive
Control groupActive comparatorPatients 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.
Receives: Other: Usual Care
Remote monitoringExperimentalPatients 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.
Receives: Other: Remote monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline, 6 months

Secondary outcomes (11)
  1. 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

    Measured: Baseline, 12 months

  2. 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).

    Measured: Baseline, 6 and 12 months

  3. 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)

    Measured: Baseline, 6 months, 12 months

  4. 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

    Measured: 1 month, 2 months, 3 months, 6 months, 12 months

  5. 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.

    Measured: Baseline, 6 months, 12 months

  6. Change in pain

    Measured on numeric rating scales (0-10) with higher score indicating more pain

    Measured: Baseline, 2 months, 6 months, 12 months

  7. Change in disease activity

    Measured on a numeric rating scale (0-10) with 10 indicating worst disease activity.

    Measured: Baseline, 2 months, 6 months, 12 months

  8. Satisfaction with care

    Measured on a numeric rating scale (0-10) with higher score indicating higher satisfaction with care.

    Measured: 2 months, 6 months, 12 months

  9. 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")

    Measured: 2 months, 6 months, 12 months

  10. 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.

    Measured: Baseline, 1, 2, 3, 6, 12 months

  11. Number of extra visits

    Number of extra visits in both groups

    Measured: Baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2025
  2. Study start4 Jun 2025
  3. Primary completion15 May 2027 (estimated)
  4. Study completion31 Dec 2035 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, open-labeled, parallel group, non-inferiority, single-site clinical trial
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07003932
Sponsor's protocol ID
855137
Acronym
OA-AID TKR
Status last verified
May 2026
First submitted
27 May 2025
Last updated
19 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to GDPR regulations, IPD cannot be shared

Questions about this trial

What is this clinical trial studying?

A study testing Remote monitoring in people with Knee Arthroplasty, Total and Knee Replacement Arthroplasty, run by Diakonhjemmet Hospital at 1 site in Norway.

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 2 inclusion and 7 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 19 May 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 Norway. 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 Anne Therese Tveter, PhD (+47 91115550, a.t.tveter@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OMERACT-OARSI responder criteria (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 19 May 2026.

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