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).
Signed written informed consent before inclusion in the investigation.
Any gender, any ethnic origin, 19-69 years old inclusive.
Body Mass Index 18.5-40 kg/m2 inclusive.
Full comprehension: ability to comprehend the full nature and purpose of the clinical investigation.
Clinically significant abnormal physical findings which could interfere with the objectives of the investigation
History of anaphylaxis to drugs or allergic reactions in general, which could affect the outcome of the clinical investigation.
Significant history of diseases that may interfere with the aim of the clinical investigation.
History of (in the last 6 months) or ongoing intra-articular injection involving the selected knee. History of ongoing physical therapy involving the selected knee.
Aziende Chimiche Riunite Angelini Francesco S.p.A
Lead sponsor
Cross Research S.A.
Collaborator