Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India: a Prospective Multi-Center Observational Study - INFINITI

AO Clinical Investigation and Documentation0 个研究点目标入组 1,000 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1) Men and women who are 18 years of age or older.
•2) Open or closed tibia fracture treated by internal fixation (plate or nail).
•3) Ability to understand the content of the subject information / informed consent form and to be willing to participate in the clinical investigation.
•4) Written informed consent.
•5) Subjects with bilateral fractures will be included. In these subjects, the most severe fracture will be the one included in the study.

•1) Subjects with fractures older than 14 days at the time of enrollment.
•2) Previous wound infection or osteomyelitis at the same limb (according to subject history).
•3) External fixation (before internal fixation or as main intervention).
•4) Previous fracture with retained hardware in injured extremity that will interfere with implant fixation.
•5) Immunological deficiency disease.
•6) Tumor related fractures.
•7) Any severe systemic disease: class V-VI of the American Society of Anesthesiologists (ASA) physical status classification (Appendix 5).
•8) Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment.
•9) Subject is a prisoner.
•10) Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study.

发起方

AO Clinical Investigation and Documentation