Actively Recruiting
Study on the Safety and Effectiveness of the KeriFlex4 Silicone Joint Implant for Treating Arthritis in Finger Joints
Led by Keri Medical SA · Updated on 2025-09-11
86
Participants Needed
3
Research Sites
443 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the performance and safety of the KeriFlex4 silicone joint implant and its associated instruments in adults with rheumatoid arthritis, osteoarthritis, or post-traumatic osteoarthritis affecting the hand joints. The study aims to establish both short- and long-term safety and how well the implant improves hand function over time. Participants will undergo arthroplasty surgery using the KeriFlex4 implant to replace damaged metacarpophalangeal MCP or proximal interphalangeal PIP joints. The device is designed specifically for these finger joints and is used according to official instructions and labeling. This is an observational study with no placebo or comparison groups. During the study, researchers will assess the effectiveness of the implant in improving hand function six months after surgery. Safety and performance will be monitored throughout the implants life cycle. Participants will be followed up long term to observe the implants durability and any related health outcomes. The study may last several years, with the final completion estimated by 2035.
CONDITIONS
Brief Title
Post Market Clinical Follow-Up KeriFlex®
Research Team
C
CAUX
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