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临床试验/CTRI/2024/01/061496
CTRI/2024/01/061496已完成不适用

“EVALUATION OF FUNCTIONAL AND RADIOLOGICAL OUTCOMES OF OPEN TIBIA FRACTURE TREATED WITH SUPRACUTANEOUS PLATING VS EXTERNAL FIXATOR”- A PROSPECTIVE STUDY

AIIMS RAIPUR1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年1月19日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
1
主要终点
For open tibia fracture supracutaneous plating is expected to be superior to conventional external fixator in respect with

研究概览

简要总结

JUSTIFICATION:-External fixation plays a huge role  in the treatment of open fractures .this can be used as a temporary method of fixation andor stabilization of the bone until adequate soft tissue coverage is available for definitive management or they by themselves serve as a definitive method of union of the fracture however this external fixation have their own set of complications such as high rates of infection , higher chances of nonunion specially when bone loss is present in c/o open fractures, higher chances of progression to amputation in the future, pin tract infection, stiffness of the joints, difficulty in mobilization of the patient due to the bulky nature of the external fixator.In the background of the above mentioned complications this study aims at comparing the role of external fixator versus supracutaneous plating in open tibia fractures in Indian patients especially in the state of Chhattisgarh in our setup. This study helps us to compare whether supracutaneous plating is better or same or worse than external fixator in treating open tibia fracture in terms of functional and radiological outcomes.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All cases will be selected on basis of: Radiological findings confirming open tibia fracture according to Gustilo Anderson classification type 1,2,3(A,B,C) and Tscherne classification grade 1,2,3 Patients more than 18 years of age.

排除标准

  • Patients who are not willing for surgery H/o old surgery or fracture in the same limb.

结局指标

主要结局

For open tibia fracture supracutaneous plating is expected to be superior to conventional external fixator in respect with

时间窗: 2weeks,4weeks,6weeks,12weeks

Lesser chances of post operative infection

时间窗: 2weeks,4weeks,6weeks,12weeks

Better fracture reduction.

时间窗: 2weeks,4weeks,6weeks,12weeks

Higher chances of union.

时间窗: 2weeks,4weeks,6weeks,12weeks

Lesser incidence and lesser degree of ankle stiffness

时间窗: 2weeks,4weeks,6weeks,12weeks

Better LEFS and RUST scores.

时间窗: 2weeks,4weeks,6weeks,12weeks

次要结局

  • SECONDARY- To assess the intra & post op complications in these procedures(-To classify open fractures according to Gustilo Anderson & Tscherne classification)

研究者

发起方
AIIMS RAIPUR
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Mahendrakar Suhas

AIIMS Raipur

研究点 (1)

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