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临床试验/CTRI/2025/08/092867
CTRI/2025/08/092867尚未招募不适用

Rotational malalignment of tibia following intramedullary nail fixation

Aditya Dalvi1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Patient Satisfaction Gait Analysis Range of Motion

研究概览

简要总结

The study seeks to address critical questions regarding the incidence of rotational malalignment, the identification of potential risk factors contributing to malalignment, and the assessment of its impact on functional outcomes and patient satisfaction.

Despite the clinical significance of rotational malalignment, there is a noticeable gap in the literature regarding its prevalence and implications in the context of tibial fracture management. By shedding light on this aspect, our study aims to contribute valuable insights that could influence surgical decision-making and postoperative care. Understanding the factors that may contribute to rotational malalignment and its consequences is essential for optimizing surgical techniques, refining rehabilitation protocols, and ultimately improving patient outcomes.

This study adopts a prospective observational cohort design to systematically capture data from a diverse patient population undergoing either intramedullary nail fixation. By following patients longitudinally, we aim to delineate the trajectory of rotational malalignment postoperatively, identify potential risk factors, and assess the functional repercussions over time.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18 to 65 years and Undergoing intramedullary nail fixation for tibial fractures.

排除标准

  • Pre existing tibial malrotation Open fractures Conditions affecting rotational alignment.

结局指标

主要结局

Patient Satisfaction Gait Analysis Range of Motion

时间窗: Patient Satisfaction Gait Analysis Range of Motion

次要结局

  • To identify and analyze potential preoperative and intraoperative risk factors associated with the occurrence and severity of tibial malrotation(To identify and analyze potential preoperative and intraoperative risk factors associated with the occurrence and severity of tibial malrotation)

研究者

发起方
Aditya Dalvi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Aditya Dalvi

Datta Meghe Institute Of Medical Sciences Wardha

研究点 (1)

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