NCT05057559

Observational Clinical Investigation of Arthrosamid in Knee Osteoarthritis

Prospective, Observational, Open-label, Clinical Investigation of Intra-articular Arthrosamid® Injection in Subjects With Knee Osteoarthritis

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 201 (actual)
• Sponsor: Contura · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee osteoarthritis who is eligible for treatment with Arthrosamid® according to the Instruction for Use.

Detailed description

This is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee OA who is eligible for treatment with Arthrosamid® according to the Instruction for Use (IFU). All subjects will be followed over an observational period of five years with yearly follow-up check points. The first follow-up visit should be six months after the treatment. All follow up visits can be performed as telephone visits.

Conditions

• Knee Osteoarthritis

Timeline

• Start date: 2021-04-21
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2021-09-27
• Last updated: 2024-01-05

Locations

9 sites across 5 countries: Denmark, France, Germany, Italy, United Kingdom