跳至主要内容
临床试验/CTRI/2023/06/053602
CTRI/2023/06/053602招募中4 期

A non- randomized, prospective study to evaluate the Safety and Performance of Pelvic Plating System - PMCF-PPS

Auxein Medical Pvt. Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
招募中
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • ? Subject is willing and able to give informed consent for
  • participation in the study.
  • ? male and female above 18 years to 70 year skeletally mature
  • ? Subject diagnosed with fractures, fusions, and osteotomies of
  • acetabulum, sacrum, ilium and entire pelvic ring
  • ? Subjects need surgery for reconstruction of pelvic and

排除标准

  • ? patients with metabolic bone disease.
  • ? patients having inadequate tissue coverage over the operative
  • ? patients with skeletal immaturity. Systemic bone disease, neurological injuries of the lumbosacral plexus and urological injuries.
  • ? 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. Surgeon shall find out if the patient develops an
  • allergic reaction to the material of the implant (content of the
  • implant material is presented in IMPLANT MATERIAL).
  • ? severe lower back pain due to other causes such as lumbar
  • disc degeneration ,Lumbar disc herniation lumbar
  • spondylolisthesis, spinal stenosis , lumbar facet degeneration.
  • ? Spine surgery during the past 12 months
  • ? History of recent ( <1 year) fractures of the pelvis with
  • documented malunion , non union of sacrum, illium or any type
  • of internal fixation of the pelvic ring.
  • ? Previously diagnosed or suspected osteoporosis.
  • ? any condition or anatomy that makes treatment with the pelvic
  • plate 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

研究者

发起方
Auxein Medical Pvt. Ltd

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