Orthopedic implants are long-term, often lifelong, interventions that require rigorous evidence demonstrating sustained safety and performance. Traditional RCTs with limited follow-up and narrow populations cannot fully capture the complex real-world environment, especially given the variability in surgical techniques, patient comorbidities, and health system factors. As payer and regulatory expectations evolve, RWE has become indispensable for demonstrating lifetime device value and supporting continuous improvement.
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