跳至主要内容
临床试验/NCT06500325
NCT06500325招募中不适用

Results of Retrograde Titanium Elastic Nails for Fixation of Proximal Third Tibial Shaft Fractures in Children.

Sohag University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Goniometry of knee and ankle joints range of motion (ROM)

研究概览

简要总结

Pediatric tibial shaft fracture is the third most common pediatric long bone fracture after fracture of femur and forearm, representing 15% of all pediatric fractures. Closed reduction and casting is the standard of care for stable and minimally displaced fracture of the tibia in pediatric age group. Treatment of pediatric fractures dramatically changed in 1982. The goals are to stabilize the fracture, control limb length, alignment, rotation, instability, promote bone healing, and minimize the morbidity and complications for the child and his/her family. Titanium elastic nails (TENs) fixation was originally meant as an ideal treatment method for femoral shaft fractures, but was gradually applied to other long bones diaphysial fractures in children, as it represents a compromise between conservative and surgical therapeutic approaches with satisfactory results and minimal complications.

Over the past 20 years, pediatric orthopedic surgeons have tried a variety of methods to treat pediatric lower limb fractures to avoid prolonged immobilization and complications. Each method has had its own complications: cast immobilization alone or following traction had resulted in limb-length discrepancy, angulations, rotational deformity, psychological and economic complications. External fixation had resulted in pin-tract infection, loss of knee range of motion, delayed union, non-union, and refracture after fixator removal. TENs work by balancing the forces between the two opposing flexible implants. To achieve this balance, the nail diameter should be 40% of the narrowest canal diameter or more. The nails should assume a double-C construct. They should have similar smooth curve and same level entry points.

Ligier et al and Flynn et al have reported that TENs can give rotational stability if good care is taken intra-operatively during nail insertion and postoperatively, especially for comminuted, spiral, and long oblique fractures.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria included children are patients presented with traumatic proximal shaft tibia fracture closed or open up to Gustillo grade II and patients between 4 and 12.

排除标准

  • Exclusion criteria excluded children presented with Gustillo grade III A, B & C open fractures and pathological fractures.

结局指标

主要结局

Goniometry of knee and ankle joints range of motion (ROM)

时间窗: 1 year

Goniometry involves using a goniometer, which is a specialized protractor-like device, to measure the angles of movement at joints such as the knee and ankle.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Youssery ahmed

Resident-Orthopedic surgery department-sohag hospital university

Sohag University

研究点 (1)

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