跳至主要内容
临床试验/CTRI/2021/05/033547
CTRI/2021/05/033547尚未招募不适用

A Prospective Randomized Control Study to compare TheFunctional Outcome Of Intramedullary Interlocking Nailing Versus Minimally Invasive Percutaneous Plate Osteosynthesis In Distal Third Extra-articular Fractures OF Tibia In Adult Population.

Dr DHANASEGARAN A1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年5月19日

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
48
试验地点
1
主要终点
FOOT FUNCTION INDEX SCORE

研究概览

简要总结

All patients with distal one third extra-articular tibial fractures presenting to the Hospital, are to be selected based on the inclusion and exclusion criteria. A detailed history including name, age, sex, mode of injury and existing co-morbidities will be obtained with due consideration to the exclusion criteria. Patient will be divided and randomized into two groups by simple randomization, assigning the two planned surgical modalities to patients on an alternate number basis wherein the odd numbered and even numbered patients will receive the Nailing and Plating type of Interventional modality and Selection of modality of treatment by the proposed implants for the patients will be done on comparative technique . All patients coming under the study will be explained regarding both the methods of intervention detailedly and about the tool used for assessing the functional outcome in their own understandable language. A detailed written and informed consent will be obtained from all patients prior to intervention. Autonomy of the patients will be preserved and maintained throughout the study. . A detailed consent in Helsinki declaration will be obtained.   Post operatively patient will be reviewed and assessed at 0, 3 and 6 and 12 weeks for Foot Function Index score , Olerud and Molander Score clinically and fracture union by plain radiography.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 95.00 Year(s)(—)
性别
All

入选标准

  • •Patients of both gender more than 18 years of age who sustain closed or Compound type1(Gustilo Anderson classification) distal one third extra-articular fractures of tibia with or without comminution.

排除标准

  • •Intra-articular fractures of tibia, tibial plafond fractures,
  • •Pathological fractures
  • •Patients with active infection, sepsis.
  • •Patients with skeletal immaturity.
  • •Patients with severe head injury.
  • •Patients who sustain compound fracture tibia of grade 2 and more of Gustilo Anderson classification.

结局指标

主要结局

FOOT FUNCTION INDEX SCORE

时间窗: AT 0,3,6 AND 12 WEEKS.

RADIOGRAPHICAL EVALUATION FOR FRACTURE UNION

时间窗: AT 0,3,6 AND 12 WEEKS.

次要结局

  • OLERUD AND MOLANDER SCORE(AT 0,3,6 AND 12 WEEKS)

研究者

发起方
Dr DHANASEGARAN A
申办方类型
Other [SELF FUNDING]

研究点 (1)

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