Study of OPRA Osseointegration Surgery for Adults with Transtibial Amputation Evaluating Safety, Function, and Quality of Life Compared to Traditional Prostheses

What this Trial Is About

Researchers are studying the OPRA osseointegrated prosthesis system in adults aged 22 to 65 with transtibial below-the-knee amputations. The study aims to measure and compare soft tissue complications and infections in patients treated with OPRA implants to those with transfemoral above-the-knee implants. It also evaluates improvements in physical function, quality of life, pain levels, physical performance, biomechanical loading, and bone quality over time, comparing OPRA users to traditional socket prosthesis users. Participants undergo two main surgical procedures to implant the OPRA device. In Stage I, the distal tibia is prepared and implanted with the fixture under imaging guidance. Stage II, performed 3 to 6 months later, involves attaching the abutment to the bone and creating a skin opening for prosthesis attachment. Follow-up visits are scheduled post-surgery at 2-3 weeks and then at 6, 12, 24, 36, 48, and 60 months to monitor healing and implant performance. Throughout the study, participants complete various assessments including questionnaires on function, pain, quality of life, and mobility tests such as the 6-Minute Walk Test, Timed Up and Go, and Dual-Energy X-ray Absorptiometry DEXA scans. Clinical exams, X-rays, and CT scans are performed regularly to monitor bone and soft tissue status. Data collection occurs at baseline and multiple follow-up points up to 60 months post Stage II surgery, ensuring comprehensive evaluation of safety, function, and patient-reported outcomes.

Transtibial Osseointegration