A Prospective, Post Market Clinical Follow-up (PMCF) Study to Evaluate the Safety and Performance of Craniomaxillofacial Plate System
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
Dr Gursimrat Singh
Cheema Hospital and Trauma Center
