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临床试验/NCT05744349
NCT05744349招募中不适用

Percutaneous Intramedullary K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures

Sohag University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年2月28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
20
试验地点
1
主要终点
Degree of supination and pronation

研究概览

简要总结

This study is to improving outcome of pediatric both bone forearm fractures using minimally invasive procedure by intramedullary K-wires.

详细描述

Most shaft injuries present no unusual challenges and require nothing more than skillful closed reduction and cast immobilization due to the unique property of the growth potential of the immature skeleton. There is a relatively high incidence of re-displacement, malunion and consequent limitation of movement. Perfect anatomical reduction is not always necessary since remodeling of malunion may correct any residual deformity. Angulation has been shown to affect the range of pronation and supination of the forearm.

The most common indications for surgery are failure of closed reduction, open fractures, and fracture instability. When operative intervention is indicated different techniques can be employed such as intramedullary nailing, osteosynthesis with plate and screws fixation and external fixators. Intramedullary nailing has been shown to produce excellent clinical results and in contrast to plate fixation is considered as a minimal invasive procedure.

Surgical technique of K-wires :

After administration of anesthesia, surgery will be performed with the patient supine on the operating table and fracture will be analyzed with an image intensifier. In radius, the wire will be inserted by surgical drilling through Lister's tubercle or the radial styloid while in ulna, the wire will be inserted through the tip of the olecranon.

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 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients who are younger than the age of 10 years old from both genders and suffering from displaced fractures of shaft both bone of the forearm;
  • Standard preoperative anteroposterior (AP) and lateral forearm radiographs;
  • Complete clinical and radiographic data.

排除标准

  • Poly-traumatized patients with other associated fractures;
  • Undisplaced fractures;
  • Open fractures;
  • Pathological fractures;
  • Malignancy;
  • Malnutrition;
  • Chronic diseases as renal, hepatic, cardiac patients;
  • Incomplete radiographic data.

结局指标

主要结局

Degree of supination and pronation

时间窗: 3 months

Union of fractures

时间窗: 1 month

Degree of flexion and extension at wrist joint

时间窗: 3 months

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

Mahmoud Hamdy Abdelmajeed

Resident at the department of Orthopedic surgery and Traumatology Sohag University Hospital

Sohag University

研究点 (1)

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