[Minimum requirements in total knee replacement. Evidence report and model calculation of the healthcare situation].

This report assesses the volume-outcome relationship of total knee replacement and the effects of its application on medical care in Germany. Electronic bibliographic databases, the reference lists of relevant articles, and research-related resources of various health services were searched and selected studies were assessed. Additionally, the consequences of implementing a regulation based on volume-outcome relationship were calculated using different models. The results in the literature concerning defined outcome parameters are inconsistent, but in all but one publication a general correlation between high volume and low complication rate could be identified. Implementing a regulation based on volume-outcome relationship with cutoff points of 20/50/100 total knee replacements/year would lead to an exclusion of 242/502/709 hospitals, respectively, from medical care. This would result in a reallocation of 2358 (2.9%)/10752 (13.2%)/25482 (31.2%) patients/year, respectively (extrapolation). The application of a regulation based on volume-outcome considerations in the German healthcare system must be performed very carefully because significant effects are to be expected.