Post Marketing Clinical Follow-up Study, a single arm prospective case series to evaluate the safety and effectiveness of Intramedullary Tibia Nailing system intended for Tibia bone related fracture fixation (PMCF-INITIA NAIL) - PMCF-INITIA NAI

Kaulmed Pvt. Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年3月4日

研究概览

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•1. Subject is willing and able to give informed consent for participation in the study
•2. Male or Female, aged 18 years or above, skeletally mature patient.
•3. Subject is willing and able to complete required study visits or assessments.
•4. Subject diagnosed as per indications.

•1. Subjects with a disease entity or condition that could hindered bone healing and create unacceptable risk of fixation failure or complications such as known active cancer, neuromuscular disorder etc.
•2. In case in subject has inadequate tissue coverage of the operative site. (Open fracture, Gustilo type IIIC)
•3. Subjects unwilling to sign the Informed Consent document.
•4. Subjects who are incarcerated or have pending incarceration.
•5. Female participant who is pregnant or planning pregnancy during the course of the study.
•6. Fracture that are not amenable to intramedullary tibia nailing technique
•7. Morbid obesity (BMI (Kg/m2)) > 35

发起方

Kaulmed Pvt. Ltd.