Pilot Study to Identify and Validate Digital Biomarkers in Osteoarthritis of the Knee

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE LIEGE · Jun 19, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to monitor knee osteoarthritis, a condition that causes pain and stiffness in the knee. Traditional tests done in hospitals only show how the knee is doing at one moment, but symptoms can change a lot from day to day. This study uses a small portable device called Syde®, which patients will wear on their ankles and wrist for two months to track their real-life movement and activity. The goal is to see if this device can give doctors better and more consistent information about how knee osteoarthritis affects daily life, helping to improve treatment and care for each person.

People who have been diagnosed with knee osteoarthritis by a specialist and have had an X-ray or MRI to confirm it may be eligible. Participants should have mild to severe symptoms recently and a body mass index (BMI) below 35. They need to be able to walk on their own without help and not have had recent knee surgery or certain treatments like steroid injections. During the study, participants will visit the clinic twice—once at the start and once after two months—and wear the Syde® sensors at home to record their movements. This trial is currently recruiting, and it aims to find new ways to better understand and manage knee osteoarthritis through everyday activity monitoring.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with bi- or unilateral Knee Osteoarthritis as confirmed by a qualified rheumatologist/orthopaedist or rehabilitation doctor and having had at least one X-ray or MRI for diagnosis confirmation with Kellgren-Lawrence grade minimum 1
• • WOMAC 3.1 total score at screening indicating mild, moderate, or severe symptoms in the past 48 hours
• • BMI below 35.0 kg/m2
• Exclusion Criteria:
• • Patients with significant cognitive disorders, limiting the understanding of the exercises to be performed or the presence of apparent communication difficulties hindering the correct collection of data.
• • Unable to walk independently (10 meters without any type of external help)
• • History of any joint replacement surgery.
• • Currently undergoing or had corticosteroid injections within the past 3 weeks.
• • Underwent knee surgery in the past 6 months.
• • Expecting joint replacement surgery or arthroscopy within 3 months.
• • Pregnant women or women planning to become pregnant during the study
• • Presence of any other conditions than osteoarthritis (musculoskeletal or neurological) that may affect normal gait. OA in other joints is not considered as an exclusion criterion as long as OAK is the most significant cause of walking impairment.