A Multicenter Study to Test the Safety and Performance of the HYALEX Knee Cartilage Implant in Adults with Cartilage Injury

What this Trial Is About

Researchers are evaluating the safety and technical performance of the HYALEX Knee Cartilage System in patients with cartilage injury of the knee femoral condyles who need surgical treatment. This first-in-human, prospective, multicenter, open-label study aims to assess the implant in symptomatic patients aged 21 to 65 years, focusing on areas with specific cartilage damage. The study is divided into two phases to test feasibility and outcomes in different lesion severities and sizes. Participants will receive the Hyalex Cartilage Knee Implant surgically, targeting cartilage and bone loss at the medial or lateral femoral condyles. Phase 1 involves patients with a single lesion, while phase 2 includes those with up to three treatable lesions. The study evaluates implant safety over 24 months and changes in knee function and pain scores over 12 months after implantation. Throughout the study, patients will be monitored for implant rejection, infection, and improvements in knee pain using the Knee Injury & Osteoarthritis Outcome Score KOOS. Assessments include clinical evaluations and imaging as needed. The trial spans up to two years post-implantation, with regular follow-ups to track safety and technical performance of the device.

The Hyalex First-in-Human Study