Long-term Post-market Clinical Follow-up of the Safety and Performance of the OPRA Implant System for Transhumeral Amputees A Multicenter, Multinational Cohort Study

What this Trial Is About

Researchers are conducting a long-term, non-interventional clinical investigation to collect and evaluate data on the safety and performance of the OPRA Implant System used for transhumeral amputees. This study includes patients who have already received the implant and completed the second stage of surgery, focusing on outcomes over a period that may span from 6 months to over 20 years. Participants in this study have undergone treatment with the OPRA Implant System for unilateral or bilateral transhumeral amputation and have had at least six months of experience with the device before enrollment. The investigation is multicenter and multinational and involves no control group. Data collection includes retrospective review and prospective visits for device functionality and usage assessment. Patient-reported outcomes are gathered through questionnaires, which can be completed in person, by mail, email, electronically, or by phone. Functional tests of the prosthesis may be performed during follow-up visits or remotely via videoconference. Participants will attend visits where clinical data, device safety, and performance are evaluated. Medical records will document prosthesis function tests and patient responses to questionnaires. The primary outcome focuses on implant safety and effectiveness two years after surgery, with secondary outcomes assessing safety and effectiveness over periods up to more than ten years. The study emphasizes long-term follow-up and continuous monitoring of implant performance and patient experience.

A Multicenter, Multinational, Cohort Long-term Post-market Clinical Follow-up (PMCF) of the Safety and Efficacy of the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System When Used for Transhumeral Implantation in Amputee Patients