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

• Published in: Current controlled trials in cardiovascular medicine Vol. 23; no. 1; pp. 968 - 9
• Main Authors: Schoder, S., Lafuente, M., Alt, V.
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 01.12.2022; BioMed Central; BMC
• Subjects: Anti-Bacterial Agents; Antibacterial; Antibacterial agents; Antibiotics; Antimicrobial agents; Biocompatibility; Biofilms; Clinical trials; Coatings; Complications and side effects; Composition; Dosage and administration; Follow-Up Studies; Fracture; Fractures, Open; Health aspects; Humans; Infection control; Infections; Informed consent; Injuries; Internal fixation in fractures; Leg; Medical equipment; Methods; Orthopedic; Orthopedics; Patients; Prospective Studies; Randomized; Silver; Silver-coating; Study Protocol; Surgeons; Tibia; Tibia - surgery; Transplants & implants; Germany; Berlin Germany; Antimicrobial; Randomized; Tibia; Orthopedic; Silver-coating; Fracture; Antibacterial

Antimicrobial coatings of implants are of interest to reduce infection rate in orthopedic surgery. Demonstration of clinical effectiveness of such coated implants to obtain market approval is challenging. The objective of this article is to define a design for a randomized controlled trial to evalua...