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.
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)
