Actively Recruiting
Remote Monitoring After Total Knee Replacement
Led by Diakonhjemmet Hospital · Updated on 2025-08-13
140
Participants Needed
1
Research Sites
551 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Remote Monitoring After Total Knee Replacement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women, 50 years of age or older
- Referred to total knee replacement surgery due to knee osteoarthritis
You will not qualify if you...
- 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
- Cognitive 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 or cannot answer questionnaires digitally (lack BankID, do not possess a smartphone)
- Deemed inappropriate for remote monitoring by orthopedic surgeon
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Diakonhjemmet Hospital
Oslo, Please Select, Norway, 0370
Actively Recruiting
Research Team
A
Anne Therese Tveter, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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