Remote Monitoring After Total Knee Replacement

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Men and women, 50 years of age or older

• Reffered to total knee replacement surgery due to knee osteoarthritis

Locations
Other Locations
Norway
Diakonhjemmet Hospital
RECRUITING
Oslo
Contact Information
Primary
Anne Therese Tveter, PhD
a.t.tveter@medisin.uio.no
+47 91115550
Time Frame
Start Date: 2025-06-04
Estimated Completion Date: 2035-12-31
Participants
Target number of participants: 140
Treatments
Active_comparator: Control group
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.
Experimental: Remote monitoring
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.
Related Therapeutic Areas
Sponsors
Leads: Diakonhjemmet Hospital

This content was sourced from clinicaltrials.gov