跳至主要内容
临床试验/NCT03545230
NCT03545230Unknown不适用

Four "Not" Technique in Delayed and Nonunion of Lateral Humeral Condyle Fracture in

Mahidol University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年6月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
the union rate

研究概览

简要总结

Fracture of lateral humeral condyle in children is not uncommon.The nonunion means no healing of the fracture after 3 months from the injury.Delayed union means no healing from 6 weels to less than 3 months after injury.

The treatment is difficult even surgery because of lack of blood supply of lateral condyle,unstability from muscle force and the articular fluid inhibition of union.

The author try to improve the healing of the fracture after surgery by "4 not techniques",

  1. the surgical approach should not enter posteriorly because the blood supply of lateral condyle enter posteriorly in order to avoid cut the vessels.
  2. The dissection should not too much especially the muscle around the condyle.
  3. It is not necessary to perfectly reduced the fracture after nonunion to avoid too much dissection the muscle and allow only healing of the fragment.
  4. Bone graft is not necessary. The author wants to know the results after perform "4 not technique" in delayed union and nonunion of lateral humeral condyle fracture

详细描述

All children with delayed union or nonunion fracture lateral humeral condyle fractures will be inclued in the study.

The children who received the previous surgery of the same elbow will be excluded.

After full explanation and discussion to the children and parents.The surgery in "4 not technique" will be performed.

  1. the lateral approach of the affected elbow and enter the fracture anteriorly. The approach should not enter posteriorly because the blood supply of lateral condyle enter posteriorly in order to avoid cut the vessels.
  2. The dissection should not too much especially the muscle around the condyle. The nonunon fragment will be cleaned,washed and made until the healthy bone surface of fracture appear in both side of fracture.
  3. It is not necessary to perfectly reduced the fracture after nonunion to avoid too much dissection the muscle and allow only healing of the fragment.The fixation by K-wires or screw in older children until the fragment is stable enough.
  4. Bone graft is not necessary but in valgus deformity the correctuve osteotomy should be performed to correct the valgus.

The skin is closed,the long arm cast is put and change in 2 weeks interval until bone union.

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • all children less than 18 years old with delayed union and nonunion of fracture lateral humeral condyle

排除标准

  • any previous surgery at the same elbow
  • refuse to participate the research

研究组 & 干预措施

children who recieved "Four Not Techniques" surgery

Experimental

:Four Not Techniques"

干预措施: :Four Not Techniques" (Procedure)

结局指标

主要结局

the union rate

时间窗: 1 year

the healing of the fracture in percentage

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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