Remote Monitoring After Knee Replacement Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorDiakonhjemmet Hospital

About this trial

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

Qualifiers

Men and women, 50 years of age or older

Referred to total or unicondylar knee replacement surgery due to knee osteoarthritis

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Remote monitoring
  • Usual Care

Treatment groups

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators