Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT07003932

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

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women, 50 years of age or older
  • Referred to total knee replacement surgery due to knee osteoarthritis
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Diakonhjemmet Hospital

Oslo, Please Select, Norway, 0370

Actively Recruiting

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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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