NCT06650631

The Effectiveness of Heat Treatment on Knee Pain in Patients With Osteoarthritis - an International, Multicenter Clinical Investigation

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: All
• Age: 19 Years – 69 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pain Management
• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-10-21
• Primary completion: 2025-08-29
• Completion: 2025-08-29
• First posted: 2024-10-21
• Last updated: 2025-09-08

Locations

1 site across 1 country: Switzerland