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
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.
• Patient with diagnosis of mono or bilateral moderate knee osteoarthritis with knee pain intensity \> 40 mm on a 0-100 mm VAS, able to independently ambulate without walking aid.
• Availability of a radiography of the selected knee not older than 6 months.
• Patient is either not of childbearing potential or must agree not to start a pregnancy from the signature of the informed consent up to the final visit