Remote Monitoring After Total Knee Replacement

NCT07003932 | Recruiting

• 1 other identifier: 855137
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthroplasty, Total

Keywords

knee arthroplasty; remote follow-up; non-inferiority

Outcome Measures

Primary Outcomes (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

  Baseline, 6 months

Secondary Outcomes (11)

• OMERACT-OARSI responder criteria

  Baseline, 12 months

• Healthcare costs

  Baseline, 6 and 12 months

• Health-related quality of life (EQ5D-5L)

  Baseline, 6 months, 12 months

• Safety measures

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

• Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Baseline, 6 months, 12 months

Other Outcomes (21)

• Fatigue

  Baseline, 2 months, 6 months, 12 months

• Change in problems related to daily activity

  Baseline, 2 months, 6 months, 12 months

• Pain self-efficacy Questionnaire (PSEQ-2)

  Baseline, 2 months, 6 months, 12 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Remote monitoring

EXPERIMENTAL

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.

Other: Remote monitoring

Interventions

Remote monitoring 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.

Remote monitoring

Usual Care 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.

Control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead

Study Sites (1)

Diakonhjemmet Hospital

Oslo, Please Select, 0370, Norway

RECRUITING

MeSH Terms

Interventions

Remote Patient Monitoring

Intervention Hierarchy (Ancestors)

Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Central Study Contacts

Anne Therese Tveter, PhD

CONTACT

+47 91115550; a.t.tveter@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The statistician conducting the primary analysis will be blinded to group allocation
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, open-labeled, parallel group, non-inferiority, single-site clinical trial

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 4, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): December 31, 2035
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)