Title {1}	Silver-coated versus uncoated locking plates in subjects with fractures of the distal tibia: a randomized, subject and observer-blinded, multi-center non-inferiority study
Trial registration {2a and 2b}	NCT05260463 [ClinicalTrials.gov] registered on 02.MAR.2022
Protocol version {3}	25.OCT.2021 Version 4.0
Funding {4}	This clinical evaluation is funded by aap Implantate AG and the German Federal Ministry of Education and Research (BMBF) as part of the program "Transferring medical solutions into patient care - Proving clinical evidence without delay" (funding codes: 13GW0313A, 13GW0313B, 13GW0449A and 13GW0449B). The BMBF has no role in designing the study, collection, analysis, or interpretation of the data.
Author details {5a}	Prof. Dr. Dr. Volker Alt: University Medical Centre Regensburg, Germany Dr. Stefan Schoder: aap Implantate AG, Berlin, Germany Michel Lafuente: aap Implantate AG, Berlin, Germany
Name and contact information for the trial sponsor {5b}	Dr. Stefan Schoder s.schoder@aap.de aap Implantate AG, Lorenzweg 5, 12099 Berlin, Germany
Role of sponsor {5c}	The sponsor is the manufacturer of the investigational device