跳至主要内容
临床试验/CTRI/2024/07/070241
CTRI/2024/07/070241已完成Unknown

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

Auxein Medical Pvt Ltd1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
1 Bone healing and union

研究概览

简要总结

Assessing the functional and aesthetic outcomes of craniomaxillofacial reconstruction is essential for evaluating the success of treatment interventions. Outcome measures, such as patient-reported outcomes, quality of life assessments, and objective functional evaluations, provide valuable insights into the effectiveness of various surgical approaches and techniques. Long-term follow-up is necessary to monitor for potential complications, such as implant failures, infections, or late sequelae, and address them promptly. Craniomaxillofacial trauma requires a comprehensive and multidisciplinary approach for evaluation, management, and reconstruction. By collaborating among various specialists, leveraging technological advancements, and emphasizing long-term follow-up, healthcare professionals can optimize patient outcomes and minimize complications in craniomaxillofacial trauma. Present post marketing clinical follow up study aims to evaluate the safety and performance of craniomaxillofacial plates and screws manufactured by Auxein Medical Pvt Ltd.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Male or Female, aged
  • 75 years.
  • Patients presenting emergency/OPD requiring fixation of CMF fracture.

排除标准

  • Subjects with a disease entity or condition that could hinder bone healing and create unacceptable risk of fixation failure or complications such as known active cancer, neuromuscular disorder.
  • Subjects with metabolic bone disease.
  • Subject with inadequate tissue coverage of the operative site.
  • Subjects with substance abuse/alcoholics.
  • Subjects who are incarcerated or have pending incarceration.
  • Female participant who is pregnant or planning pregnancy during the study.
  • Morbid obesity.

结局指标

主要结局

1 Bone healing and union

时间窗: 6 week | 3 month | 6 month and 12 month

2 Improvement in QOL

时间窗: 6 week | 3 month | 6 month and 12 month

次要结局

  • Recording of AEs SAEs(6 week)

研究者

发起方
Auxein Medical Pvt Ltd
申办方类型
Other [Medical device manufacturer]
责任方
Principal Investigator
主要研究者

Dr Gursimrat Singh

Cheema Hospital and Trauma Center

研究点 (1)

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