Study of a Custom Talus Implant for Ankle Cartilage Injuries in Adults Aged 20 to 60 with 2 Years Follow-Up

What this Trial Is About

Researchers are evaluating the safety, feasibility, and effectiveness of the Episurf Episeal talus implant in patients aged 20 to 60 years with symptomatic osteochondral lesions of the ankle. These cartilage injuries cause pain, swelling, and limited mobility, often leading to osteoarthritis. Conventional treatments may not fully heal the damage, especially in younger active patients, so this study explores a customized implant designed to restore joint function and improve quality of life over two years. The study involves a single group of ten patients receiving an open surgical procedure to implant a patient-specific cobalt-chromium talus prosthesis. This implant is tailored using advanced imaging and 3D modeling to match each patients ankle anatomy and damaged cartilage area. After surgery, patients will follow a standardized rehabilitation program with follow-up visits at 6 weeks, 6 months, 1 year, and 2 years to monitor recovery, complications, pain, and function. Participants will undergo clinical exams, X-rays, and MRI scans before surgery to assess their injury. Researchers will collect data on pain levels, ankle function using the AOFAS score, patient satisfaction, and quality of life with the EQ-5D-5L questionnaire throughout the two-year follow-up. The main outcome is the number of patients needing revision surgery. Safety and complications will also be recorded to understand the implants long-term impact on ankle cartilage injuries.

A Talus Implant in Patients Between 20-60 Years of Age Followed up for a Minimum of 2 Years After Surgery