*Osseointegration Quality Registry Project

Walter Reed's Osseointegration Quality Registry represents a substantial and growing database of real-world clinical experience that collects detailed data on device use and both short- and long-term patient outcomes for osseoanchored devices implanted in various anatomical locations (e.g., transfemoral or transhumeral indications) from a broad range of clinical sites across the United States. The team will collaborate with Walter Reed and other stakeholders to establish a comprehensive registry specifically designed to leverage multidisciplinary real-world evidence for the systematic evaluation of osseoanchored devices across their entire product lifecycle. The project will focus on the following desired process and outcomes: (1) Identify and refine key data elements essential for comprehensive device evaluation (including clinical outcomes, patient-reported measures, device performance metrics, and adverse event tracking protocols). The data collection through the registry expansion will benefit stakeholders including patients, healthcare providers, device manufacturers and FDA, and will help promote both the safety and effectiveness of high-risk devices and broader device innovation. (2) Establish Stakeholder Data Governance. Engage stakeholders collaboratively to define the registry's purpose, scope, and decision-making authority. Convene a steering committee responsible for adjudicating disputes related to data access and policy changes. Develop and document comprehensive governance standards covering data quality, privacy compliance, data access protocols, and data lifecycle management.