NCT07003932 Remote Monitoring After Knee Replacement Surgery
| NCT ID | NCT07003932 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Diakonhjemmet Hospital |
| Condition | Knee Arthroplasty, Total |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-06-04 |
| Primary Completion | 2027-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2025-06-04 with a primary completion date of 2027-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * Men and women, 50 years of age or older * Referred to total or unicondylar knee replacement surgery due to knee osteoarthritis Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07003932 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Knee Arthroplasty, Total. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07003932 currently recruiting?
Yes, NCT07003932 is actively recruiting participants. Contact the research team at a.t.tveter@medisin.uio.no for enrollment information.
Where is the NCT07003932 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT07003932 clinical trial?
NCT07003932 is sponsored by Diakonhjemmet Hospital. The trial plans to enroll 140 participants.