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临床试验/CTRI/2025/07/090344
CTRI/2025/07/090344尚未招募不适用

ROMANOFF - Rotational Malalignment in Nailing of Femur Fractures - A Comparative Randomized Study between Supine and Lateral Position

Christian Medical College Vellore1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年7月18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
80
试验地点
1
主要终点
To compare post-operative rotational alignment of operative limb with CT scan axial images after surgery using 2 positions

研究概览

简要总结

Femur shaft fractures are among the most common orthopaedic injuries, and intramedullary nailing is the standard treatment of choice for these fractures. It aims to achieve alignment, length, and stabilization with minimal soft tissue dissection. The advantages of the nail include early weight-bearing and joint mobilization. There are many ways to perform fracture fixation, including variations in the entry point, implant choice, patient position, and operating table. Antegrade intramedullary nailing is the preferred choice for most femur shaft fractures, except for distal third shaft fractures, which are sometimes amenable to retrograde nailing.

Common positions used for antegrade nailing of femur fracture fixation are:

Supine position on a fracture table

Lateral decubitus position on a radiolucent table

The use of a fracture table with patient in supine position has become the preferred

treatment for most of these fractures. Literature shows that there can be rotational malalignment following antegrade intramedullary nailing of femur fractures. Malrotation mainly occurs because the traction table can easily overpower the patient’s resting muscle tension, as well as due to the surgeons manipulation when reducing the fracture during positioning. It has been hypothesized that the lateral position provides easier access to the entry point, facilitates fracture reduction, and allows for rapid implant positioning. Although rotational malalignment can occur in both positions, according to the literature, the lateral position provides better fracture reduction and control of fracture fragments. There are many ways to determine femoral rotation which includes clinical assessment, radiological measurement, Ultrasound and CT. Unlike when using radiography or ultrasound, the

position of the patient does not influence the accuracy of CT measurement of femoral rotation. Hence in this study we plan to use CT as a definitive tool to evaluate the impact of patient positioning on rotational alignment.

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
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Adult aged 18 years of age or older presenting to casualty or OPD Diaphyseal femur fractures A0 32 appropriate for antegrade nail fixation Ability to obtain perioperative imaging (CT scans) Provision of informed consent Enrolled within 3 weeks of femoral shaft fixation Open fractures Gustilo Anderson type 1, 2, 3A Bilateral femur fractures.

排除标准

  • Ipsilateral neck of femur fractures Distal femur shaft fractures amenable to retrograde nail fixation Ipsilateral tibia fractures Ipsilateral acetabular fractures Periprosthetic fractures Pathological fractures Open fractures Gustilo Anderson type 3B, 3C Inability to be positioned in lateral decubitus because of a concomitant injury Contraindications to CT imaging including impaired kidney/liver function, or lack of timely availability Pregnancy (due to decubitus positioning).

结局指标

主要结局

To compare post-operative rotational alignment of operative limb with CT scan axial images after surgery using 2 positions

时间窗: 1st postoperative day

次要结局

  • Pain score at 6 weeks, 3 months & 6 months using VAS score(Functional score by a LEFS (Lower Extremity Functional Scale) score at 6 weeks, 3 months & 6 months.)

研究者

发起方
Christian Medical College Vellore
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Gokulprasath S

Christian medical College vellore

研究点 (1)

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