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The Effectiveness of Heat Treatment on Knee Pain in Patients With Osteoarthritis - an International, Multicenter Clinical Investigation
Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
Summary
This post-market clinical follow-up, open-label, multicenter clinical investigation is designed to investigate the effectiveness, safety and tolerability of ThermaCare® Knee Heatwraps in the painful knee joint due to osteoarthritis. Approximately 80 patients, 19-69 years old inclusive, with moderate knee osteoarthritis (without acute flares or inflammation) will be enrolled. The overall duration of the investigation is expected to be 11 days, including screening days. The maximum treatment duration for each patient is 7 days (8h/d).
Official title: The Effectiveness of Heat Treatment on Knee Pain in Patients With Osteoarthritis - an International, Multicenter Clinical Investigation. Prospective, Open-label, One-arm, Post-market, Effectiveness Clinical Investigation
Key Details
Gender
All
Age Range
19 Years - 69 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-10-21
Completion Date
2025-08-29
Last Updated
2025-09-08
Healthy Volunteers
No
Conditions
Interventions
Knee Heatwraps
To treat the painful knee joint in patients with osteoarthritis without acute flares or inflammation. The investigational device will be used in accordance with the Instructions for Use.
Locations (1)
Ars Medica Clinic
Gravesano, Switzerland, Switzerland