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

Localized cartilage injuries in the ankle occur when distinct areas of the cartilage in the ankle joint become damaged or worn down. This can lead to pain, swelling, reduced mobility and function, and an increased risk of osteoarthritis over time. The challenge with these injuries is that cartilage has a limited capacity for self-healing due to its lack of direct blood supply. Treatment options remain limited, as conventional methods such as physiotherapy or anti-inflammatory medications only address symptoms rather than the underlying damage. More invasive procedures, such as joint replacement or extensive reconstructive surgery, are associated with prolonged rehabilitation periods and variable success rates, particularly in younger, active patients. This highlights the need for precise, customized treatment solutions that can directly repair the damage and effectively restore joint function. A patient-specific implant has been designed to address focal cartilage injuries in joints, primarily in the knee but also in the ankle. The implant is based on advanced imaging and 3D modeling to adapt to the patient's unique joint anatomy and extent of injury. The method involves open surgery to replace the damaged cartilage and adjacent bone with a metal implant (cobalt-chromium) that mimics the patient's original joint surface. This facilitates targeted pain relief and improved joint function, offering a personalized treatment alternative for patients with localized cartilage defects. Compared to traditional ankle joint replacements or arthrodesis, the use of this implant is considered less invasive and associated with a shorter recovery period, reducing patient burden and allowing for a quicker return to daily activities. Additionally, the patient-specific design of the implant has the potential to minimize implant-related complications, such as implant wear and implant-related pain. Early clinical studies on this implant have shown promising results regarding pain relief, improved joint function, and patient satisfaction. However, only a limited number of reports exist to date, and further studies are needed to assess the long-term effects of the implant on pain, function, and quality of life.

The implant may represent a significant advancement in orthopedic surgery and has the potential to improve the quality of life for patients suffering from ankle joint injuries and osteochondral lesions.

In conjunction with the introduction of this method and implant, particularly in younger patients, the investigators aim to conduct a pilot study on the early outcomes of the first ten patients, focusing on safety, feasibility, and efficacy.

This project aims to evaluate the surgical outcomes in patients aged 20 to 60 years with challenging cartilage injuries in the ankle, two years postoperatively following implantation of a custom-made talus implant. The study focuses on safety, feasibility, and efficacy. Complications and adverse events will be recorded.

Clinical function will be assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score, a well-validated and reliable scoring system, while HRQoL will be assessed using the EQ-5D-5L score.