A prospective single arm post market clinical follow ?up study to evaluate the safety and performanceof radius system intended for radius fracture fixation. - Nil

Auxein Medical Pvt Ltd0 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

暂无简介。

•1 Subject or Subject legal Guardian or Parent willing and able to give informed consent for participation in the study
•2 Male or Female aged between 18 to 65 years
•3 Participant with confirmed diagnosis as per the indications

•1 Infection local or Systemic Acute or Chronic Inflammation to the operative site
•2 Severe osteopenia and or osteoporosis or in the presence of marked or rapid bone absorption metabolic bone disease cancer or any other tumor like condition of the bone which may compromise fixation Osteoporosis is a relative
•contraindication since this condition may limit the degree of obtainable correction the amount of mechanical fixation
•3 Insufficient skin tissue bone or neurovascular condition
•4 Subjects with high activity levels diabetes high bleeding from vascular Injury
•5 Blood circulation problems and blood supply impairment
•6 Subject with Suspected or documented metal allergy or in tolerance
•7 Psychologically or physiologically inadequate subjects
•8 Severe bow or gross distortion of the radius
•9 Female participant who is pregnant or planning pregnancy during the course of the study

发起方

Auxein Medical Pvt Ltd