Quality Analysis in Endoprosthetics

Challenge

Long-term implants in the human body are subject to constant stress, making their development and improvement a central goal in endoprosthetics. When introducing new products, studies are necessary to compare existing products with new models. The main focus is on achieving a less painful and potentially quicker recovery for patients, as well as determining whether the costs and benefits of new models differ from long-established products over the long term.

Approach

To validate the already completed and long-past long-term study, an ex post sample size calculation was conducted to contextualize the existing sample sizes. The subsequent data preparation involved merging multiple data sources (Case Report Forms, CRF) and assessing data quality, along with calculating various medical standard indices. Additionally, patient data were separately recorded for a survival analysis. The actual analysis included an extensive comparison of an older and a new endoprosthetic model, culminating in calculating the probability of revision.

Result

Compared to the older model, the new model significantly improved the physical well-being and resilience of patients more quickly. It also demonstrated a lower revision rate. The benefit of removing the old product from the market, which had already been decided by the medical community based on years of practical experience, was now statistically confirmed.