Clinical Research Directory

Sola2 AMF Knee System Added to Surgery and Antibiotics in Adults With Knee Implant Infection

The goal of this clinical trial is to learn whether the Sola2 AMF Knee System, when added to surgery and antibiotic treatment, can safely improve outcomes, knee function, and quality of life in adults with knee implant infection. The main questions this study aims to answer are: 1. Whether adding the Sola2 AMF Knee System improves knee function and quality of life at 6 months. 2. Whether adding the Sola2 AMF Knee System to surgery and antibiotic treatment affects the need for additional infection-related surgery. 3. Whether the Sola2 AMF Knee System can be used safely, based on device-related adverse events through 12 months. This study has two stages. In Stage 1, participants will be enrolled into sequential sentinel groups at increasing AMF temperature levels. All sentinel participants will receive active Sola2 AMF treatment. A safety review will occur after each sentinel group before proceeding to the next group. In Stage 2, researchers will compare participants who receive active Sola2 AMF treatment to participants who receive sham AMF treatment. All participants will receive surgery called debridement, antibiotics, and implant retention (DAIR), and antibiotic treatment for knee implant infection. Participants will: * Have DAIR surgery for knee implant infection; * Receive pathogen-appropriate antibiotic treatment from the study doctor; * If enrolled in Stage 1, receive active Sola2 AMF treatment at the designated sentinel temperature level; * If enrolled in Stage 2, receive either active Sola2 AMF treatment or sham AMF treatment, depending on randomization assignment; and * Complete follow-up visits and assessments for safety, infection status, pain, knee function, x-rays, laboratory tests, and other study-related outcomes.