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

•Male and female above 18 years to 70 year skeletally mature patients.
•-Subject with fractures/ malunion of distal humerus (intra/ extraarticular), olecranon/ proximal ulna.
•-Good joint function before the injury.

•-Patients with metabolic bone disease.
•-Patients having inadequate tissue coverage over the operative site.
•-Patients that have compromised vascularity that would inhibits adequate blood supply to the fracture or the operative site.
•-Suspected or documented allergy or intolerance to implant materials.
•-Patients with symptomatic arthritis.
•-Severely comminuted fractures in which bone fragments are too small or numerous to adequately fix or maintain a reduced position.
•-Previously suspected or diagnosed osteoporosis.
•-Any condition or anatomy that makes treatment with the elbow system infeasible.
•-Prominent neurological condition that would interfere with physical therapy.
•-Diagnosed psychiatric disease (E.g Schizophrenia, Major depression, personality disorder) that would interfere with study participation.
•-Pregnant women or planning pregnancy.

发起方

Auxein Medical Pvt Ltd