Clinical and Functional Study of Osteointegrated Implants for Adults with Transfemoral Amputation

What this Trial Is About

Limb amputation greatly reduces daily activity ability, mobility, and quality of life. In Italy, many people live with motor disabilities, and lower limb amputations mostly affect elderly individuals due to diabetes or vascular causes, as well as middle-aged adults from accidents and young people from traffic incidents. Traditional prostheses use sockets that often cause chronic skin problems and discomfort. To address these issues, research has developed osteointegrated prostheses, which connect the prosthesis directly to the bone, bypassing the socket and improving limb function. This study evaluates the use of osteointegrated implants in patients with transfemoral amputation. The implant involves surgically inserting a metal stem into the residual bone, allowing bone growth to secure the prosthesis. This method aims to improve load alignment, stability, comfort, and sensory feedback compared to conventional socket prostheses. The study focuses on adults aged 18 to 65 with unilateral transfemoral amputation from trauma, tumor, infection, or congenital defects who have difficulty using traditional sockets. Participants will undergo osteointegrated prosthesis surgery and be followed for at least 12 months. Researchers will assess quality of life and function using several tools, including the EQ-5D-5L, Q-TFA, and others. The study will monitor pain, functional ability, body image, and disability levels. Safety and cooperation will be evaluated, with regular assessments throughout the follow-up period. The study aims to understand the clinical and functional outcomes of this implant method in transfemoral amputees.

Clinical and Functional Assessment of Patients With Transfemoral Amputation Treated With Osteointegrated Implant