Comparative Analysis of 3D Printed Reduction Splints vs Conventional Methods in Zygomaticomaxillary Complex Fractures: Assessing Anatomical Reduction and Clinical Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Precision of anatomical reduction assessed by radiographs, measuring orbital
研究概览
简要总结
“Comparative Analysis of 3D Printed Reduction Splints vs Conventional Methods in Zygomaticomaxillary Complex Fractures: Assessing Anatomical Reduction and Clinical Outcomes - A Pilot Randomised controlled trial is a double blinded clinical trial provisionally approved by Institute Ethics Committee, yet to start with recruiting participants. The primary objective of my study is “To compare the precision of anatomical reduction in Zygomaticomaxillary Complex fractures between patients treated with a 3D printed reduction splint and those treated with conventional reduction methods†for that will be utilizing the benefits of virtual surgical planning in the treatment planning and procedure of ZMC fractures for providing the best results for the patient. Assessing the effectiveness of this technology in zygomaticomaxillary complex fractures can contribute to advancing surgical techniques and patient care. Improved anatomical reduction and stability may lead to better clinical outcomes, including reduced complications, improved functionality, and enhanced aesthetic results. Positive outcomes from this study could influence and shape clinical guidelines, encouraging the adoption of 3D printing and virtual surgical planning in managing facial fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with unilateral Zygomaticomaxillary Complex (ZMC) fractures confirmed through clinical examination and imaging (CT scans).
- •Adults aged 15 to 65 years.
- •Willingness to provide informed consent for participation in the study.
- •Patients within 1 month from the occurrence of ZMC fracture v.
- •Absence of prior history of zygomaticomaxillary complex fractures.
排除标准
- •Patients with bilateral Zygomaticomaxillary Complex fractures.
- •Inability or unwillingness to complywith studyrequirements, including scheduled follow-up visits.
- •Pregnant individuals due to potential risks associated with imaging procedures and treatment iv.
- •Inability to understand or communicate effectively in the language used for study assessments.
- •Severe medical conditions that may impact the ability to undergo surgery or participate in the study.
- •Syndromes with malar involvement: Eg., Malar hypoplasia in Treacher-Collins Syndrome.
结局指标
主要结局
Precision of anatomical reduction assessed by radiographs, measuring orbital
时间窗: Preoperatively, Immediate post operatively, One week post operatively, One month post operatively and Three months post operatively
volume and linear dimensions.
时间窗: Preoperatively, Immediate post operatively, One week post operatively, One month post operatively and Three months post operatively
次要结局
- 1. Facialsymmetry and aesthetic outcomes assessed through clinical photography(in both frontal and supracranial oblique view.)
研究者
POOJALEKSHMI M B
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR