A Non ?Randomized, Prospective, Post Market Clinical follow ?up study to evaluate the Safety and Performance of Humerus and Ulna System intended for fracture fixation. - PHEELOS

Auxein Medical Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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

•1. Infection, local to the operative site.
•2. Signs of local inflammation.
•3. Pregnancy.
•4. Severely comminuted fractures in which bone fragments are too small or numerous to adequately fix or maintain a reduced position
•5. Patient susceptibility to allergic reaction to the components of the alloy, the implant is manufactured from.
•6. Mental illness or schizophrenia, which may cause patients to ignore the limitations and precautions of the implanted material, leading to implants fracture and complication.
•7. Alcohol or drug addict
•8. 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.
•9. Symptomatic Arthritis
•10. Any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition.
•11. Any time implant utilization would interfere with anatomical structures or expected physiological performance.
•12. Any patient unwilling to cooperate with the post-operative instructions.

发起方

Auxein Medical Pvt Ltd