Post Market Clinical Follow-up (PMCF) study to evaluate the safety and performance of Tibia Plate System (PMCF - TIPS) - PMCF-TIPS

Kaulmed Pvt. Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年11月13日

试验速览

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•1. Subject is willing to give informed consent for participation in the study
•2. Skeletally mature patient
•3. Subject diagnosed as follows: Proximal, shaft & distal fractures of tibia/Articular fractures/ Osteotomies, Malalignment/ Non-Unions/Mal-unions

•1. Specific contraindication related to implant device
•2. 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.
•3. In case in subject has inadequate tissue coverage of the operative site. (Open fracture, Gustilo type IIIC)
•4. Subjects with substance abuse/alcohol issues.
•5. Subjects who are incarcerated or have pending incarceration.
•6. Female participant who is pregnant or planning pregnancy during the course of the study.
•7. Fracture that are not amenable to Tibia Plate osteosynthesis technique
•8. Morbid obesity (), (BMI (Kg/m2)) > 35

发起方

Kaulmed Pvt. Ltd.