Clinical Trial

Remote Monitoring After Knee Replacement Surgery

Study acronym: OA-AID TKR
Recruiting
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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. 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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-05-27; most recent amendment 2026-05-17.
Status change: Not Yet Recruiting → Recruiting 2025-08-08
Trial Details
NCT Number NCT07003932
Lead Sponsor Diakonhjemmet Hospital
Conditions Knee Arthroplasty, Total, Knee Replacement Arthroplasty
Enrollment 140 participants
Start Date 2025-06-04
Primary Completion 2027-05-15 (estimated)
Study Completion 2035-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-19