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临床试验/NCT06436365
NCT06436365已完成不适用

Is the Expert Nail With Poller Screws Superior to the Distal Tibial Locked Plate in the Management of Short Oblique Distal Tibial Fractures?

Kasr El Aini Hospital2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
2
主要终点
Olerud Molander Ankle Score (OMAS)

研究概览

简要总结

Distal tibial fracture management is difficult because of poor blood supply resulted from subcutaneous location. Therefore, the study aims to compare expert intramedullary nail (IMN) with poller screws to the distal tibial locked plate regarding operative and complications outcomes

详细描述

Stabilization of the fractured segments is the main goal in fracture fixation which will help to achieve proper healing, fasten early mobility, and get the full function of the injured limb. The fractures may be managed conservatively or by fixation whether internal or external .

Tibial fractures are the most common long bone fractures because of their subcutaneous location which makes them more liable to trauma. They are more common in young males as they are related to sports and traffic accidents. Elderly people come in second place of tibial fractures because they are more likely to occur from simple falls. Proper surgical management of displaced tibial fracture will help in increasing bone stability with the surrounding tissue and improving the bone alignment which in turn fastens the early movement, increases overall function, and prevents prolonged bedridden.

Distal tibia fractures represent from 7% to 10% of all lower limb fractures. Basically, there is controversy over the use of the term "distal tibial fractures" Some authors use the term to describe the distal metaphyseal fractures as defined by one Muller square as Giannoudis 2015 et al. Others use distal tibial fractures to refer to distal shaft fractures (meta-diaphyseal region) from 4 to 11 centimeters starting from the plafond as Polat 2015 et al . Others use the term for both regions, describing them as " two muller squares" as Mauffrey 2012 et al.

Management of distal tibial fracture management is difficult especially in old patients with mature skeletons and without involvement of knee joint because of a fracture near the position to the ankle joint with decreased blood flow resulting from the subcutaneous anatomical location [8]. There are common fixation techniques performed in distal tibial fracture management like open reduction with internal fixation, intramedullary nail insertion (IMN), minimally invasive percutaneous plate osteosynthesis, and external fixation with limited open reduction and internal fixation.

Despite these different management methods achieving success in proper reduction and enhancing the stability and union, they were associated with disadvantages that need to be considered during the management plan which makes no single method ideally preferred for all combined bone and soft tissue distal tibial traumas. Therefore, studies should address all advantages, disadvantages, and the proper application of each method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Skeletally mature (18-60 years) male and female patients presented with short oblique fractures which were defined by a fracture with an oblique fracture line its an inclination equal to or greater than 30° with respect to the perpendicular to the axis of the tibia .

排除标准

  • We excluded patients presented with other fracture patterns
  • intraarticular distal tibial fractures, old fractures, infected fractures, open fractures, and pathological fractures.

结局指标

主要结局

Olerud Molander Ankle Score (OMAS)

时间窗: 2 weeks

questionnaire assessing main nine aspects (daily life activity, pain, supports, swelling, jumping, stiffness, squatting, stair climbing, and running) with a maximum score of 100 indicated normal and minimal score of zero indicated totally impaired function. The score was graded by excellent (for scores between 91 to 100), good (scores between 61 to 90), fair (scores between 31 to 60), and poor (scores between 0 to 30)

次要结局

  • Complications(2 weeks and 6 months)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Omar Sabry

Dr.

Kasr El Aini Hospital

研究点 (2)

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