RecruitingNot ApplicableNCT07003932

Remote Monitoring After Total Knee Replacement


Sponsor

Diakonhjemmet Hospital

Enrollment

140 participants

Start Date

Jun 4, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 Years

Inclusion Criteria2

  • Men and women, 50 years of age or older
  • Reffered to total knee replacement surgery due to knee osteoarthritis

Exclusion Criteria7

  • 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)
  • Congitive 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/ cannot answer questionnaires digitally (lack BankID, do not possess a smartphone)
  • Deemed inappropriate for remote monitoring by orthopedic surgeon

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Interventions

OTHERRemote monitoring

The 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.

OTHERUsual Care

The 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.


Locations(1)

Diakonhjemmet Hospital

Oslo, Please Select, Norway

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NCT07003932


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