A Prospective, Single Arm, Post Market Clinical Follow-up (PMCF) Study to Evaluate the Safety and Performance of Humerus Nailing System intended for Fracture Fixation - NI

Auxein Medical Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

研究概览

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•Patients presenting to Orthopaedic emergency/ OPD with Humerus shaft fracture will be included in the study.

•1.Infection, local or Systemic Acute or Chronic Inflammation to the operative site.
•2.Subjects with a disease entity or condition that could hindered bone healing and create unacceptable risk of fixation failure complications such as known active cancer, neuromuscular disorder etc.
•3.In case subject has inadequate tissue coverage of the operative site.
•4.Subjects with Symptomatic Arthritis.
•5.Subjects with Suspected or documented metal allergy or intolerance.
•6.Subjects with substance abuse/alcohol issues.
•7.Subjects who are incarcerated or have pending incarceration.
•8.Female participant who is pregnant or planning pregnancy during the course of the study.
•9.Fracture that are not amenable to humerus nailing technique.
•10.Any patient unwilling to cooperate with the post-operative instructions.
•11.Compromised vascularity that would inhibit adequate blood supply to the fracture or the operative site.
•12.Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation of the devices.
•13. Implant utilization that would interfere with anatomical structures or physiological performance.

发起方

Auxein Medical Private Limited