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

Status: Recruiting
Location: See location...
Intervention Type: Device, Diagnostic test, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To date, treatment options for knee osteoarthritis remain limited, and their clinical evaluation is complex due to the day-to-day fluctuations in symptoms. Hospital tests provide a point-in-time measurement that is influenced by various factors (fatigue, recent activity, weather, etc.), making reliable assessment difficult. The aim of the study is to assess the feasibility and acceptability of monitoring actual activity using the Syde® portable device in up to 30 subjects. Numerical variables derived from data collected by Syde® will be compared with conventional on-site clinical assessment criteria and with data from healthy participants, in order to identify a reliable and robust metric, thereby improving treatment evaluation and personalised patient management. MAIN OBJECTIVES * Evaluate the use of the device * Identify numerical variables and determine the optimal time window for evaluation Patients will have two visits: one at inclusion and a second two months later. They will wear Syde® magneto-inertial sensors, one on each ankle, for the month following the initial visit, then a Syde® sensor on the ankle and another on the wrist on the side of the non-dominant hand for the following month. The total duration of the recording period is two months.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 70
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Belgium
Centre de référence des maladies neuromusculaire (CRMN Liège), Hopital de la Citadelle
RECRUITING
Liège
Contact Information
Primary
Camila Gonzalez-Barral
camila.gonzalezbarral@citadelle.be
+3243218222
Backup
Nicolas Bovy
nicolas.bovy@citadelle.be
Time Frame
Start Date: 2025-05-14
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Treatments
Active_comparator: Patient with osteoarthritis of the knee
Patients will have two visits: one at inclusion and a second two months later. They will wear Syde® magneto-inertial sensors, one on each ankle, for the month following the initial visit, then a Syde® sensor on the ankle and another on the wrist on the side of the non-dominant hand for the following month. The total duration of the recording period is two months.
Active_comparator: Healthy Subjects
Healthy subjects with similar age and BMI to patients with osteoarthritisof the knee
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Liege
Collaborators: SYSNAV, Centre Hospitalier Régional de la Citadelle

This content was sourced from clinicaltrials.gov