A Prospective, Single Arm, Post Market Clinical Follow-up (PMCF) Study to Evaluate the Safety and Performance of Foot Plate System - PMCF

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4月29日

研究概览

暂无简介。

•1. Patient diagnosed with foot fractures, metatarsals fractures, osteotomies, nonunions
•and complex fractures of the calcaneus.
•2. Both male and female above 18 (skeletally mature) to 75 years patients.
•3. Patient is willing and able to give informed consent for participation in the study.
•4. Patient willing and able to comply with post-operative study follow up.

•1. Any past or present evidence of infection of the treated joint.
•2. Signs of any local inflammation.
•3. Patient susceptibility to allergic reaction to the components of the alloy, the implant is
•manufactured from.
•4. Mental illness or schizophrenic, which may cause patients to ignore the limitations and
•precautions of the implanted material, leading to implants fracture and complication.
•5. Patients having inadequate tissue coverage over the operative site.
•6. 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.
•7. Patient who is pregnant or intends to become pregnant during
•8. Any patient unwilling to cooperate with the post ?operative
•instructions.
•9. Any condition or anatomy that makes treatment with the Foot plate system infeasible.

发起方

Auxein Medical Pvt Ltd