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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Remote monitoring
Other interventionThe remote monitoring group will be more closely followed than the control group in order to detect any deterioration over time. This group will not be scheduled for a face-to-face consultation unless it is deemed necessary by a physiotherapist or if the patient contacts the hospital themselves.
Usual Care
Other interventionThe control group will follow usual care with face-to-face consultation with a physiotherapist at 2 and 12 months. They will also anwer questionnaires at 2, 6 and 12 months, but these will not be monitored.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Control groupActive comparator 1 intervention
Group B: Remote monitoringExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
OMERACT-OARSI responder criteria
The OMERACT-OARSI responder criteria is a composite index where participants are classifies as responders or non-responders (binary outcome) based on the following criteria: High improvement on pain or function * ≥50% improvement + absolute change of ≥2 points in pain, OR * ≥50% improvement + absolute change of ≥2 point on KOOS) OR Improvement in at least two of the three following * ≥20% improvement + absolute change of ≥1 point in pain * ≥20% improvement + absolute change of ≥1 point in function * ≥20% improvement + absolute change of ≥1 point in disease activity
Time frame
Baseline, 6 monthsSecondary outcomes
1
OMERACT-OARSI responder criteria
The OMERACT-OARSI responder criteria is a composite index where participants are classifies as responders or non-responders (binary outcome) based on the following criteria: High improvement on pain or function • ≥50% improvement + absolute change of ≥2 points in pain, OR • ≥50% improvement + absolute change of ≥2 point on KOOS) OR Improvement in at least two of the three following • ≥20% improvement + absolute change of ≥1 point in pain • ≥20% improvement + absolute change of ≥1 point in function • ≥20% improvement + absolute change of ≥1 point in disease activity
Time frame
Baseline, 12 months2
Healthcare costs
Direct (consultations in primary or specialist healthcare) and indirect costs (sick leave, medication, travel costs) collected from national registers (NAV, KUHR, NPR) or self-report. Summed up to cost per patient (euro).
Time frame
Baseline, 6 and 12 months3
Health-related quality of life (EQ5D-5L)
5 dimensions rated on a 5-point Likert scale, calculated utility score between 0 and 1 (best health)
Time frame
Baseline, 6 months, 12 months4
Safety measures
Any adverse events during the follow-up period. Any contact with hospital, emergency unit and general practitioned due to acute worsening. 1 and 3 months only for the remote monitoring group
Time frame
1 month, 2 months, 3 months, 6 months, 12 monthsOther outcomes
1
Fatigue
Measured on a numeric rating scale (0-10) with 10 indicating most fatigue
Time frame
Baseline, 2 months, 6 months, 12 months2
Change in problems related to daily activity
Measured on a numeric rating scale (0-10) with 10 indicating more problems (question no.6 in the WPAI questionnaire)
Time frame
Baseline, 2 months, 6 months, 12 months3
Pain self-efficacy Questionnaire (PSEQ-2)
Two questions on pain self-efficacy measured on a 6-point scale (not at all confident to completely confident)
Time frame
Baseline, 2 months, 6 months, 12 months4
OsteoArthritis Quality Indicator questionnaire
17 item quality indicator questionnaire with yes, no, don't know/not relevant response categories. Summarized to a pass rate (number of yes divided by number of yes+number of no responses)
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov