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临床试验/NCT05423561
NCT05423561已完成不适用

Sclerotic Bone Formation (Corticalisation) on the Intramedullar Nail Tip in Hypertrophic Non-union Developing After Femoral Transverse Diaphyseal Fractures

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization0 个研究点目标入组 12 人开始时间: 2010年1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
12
主要终点
Provide Bone Union

研究概览

简要总结

In 12 patients with corticalization and hypertrophic pseudarthrosis were present after dynamization, the old nail was removed and nail exchange was performed with a longer and larger diameter nail to pass the region formed in the cortex approximately 2-3cm inferior from the old nail.

详细描述

Corticalization is cortex-like sclerosis in the distal of the nail and it may indicate the early sign of dynamization treatment failure in hypertrophic nonunion after femoral transverse diaphyseal fractures. When corticalization is seen during follow-up after dynamization is performed because of non-union of a femoral transverse fracture, nail exchange should be performed without further delay. More rigid fixation should be applied with a longer and thicker nail crossing the area of corticalization.

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
28 Years 至 49 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subtrochanteric fractures
  • Nonunion with Pain

排除标准

  • Infection
  • Pathological Fracture (Tumor)

结局指标

主要结局

Provide Bone Union

时间窗: 6 months

Achievement of bone union with detecting callus formation on radiography after passing the region of corticalisation with a longer and thicker nail

Relieving pain in the nonunion area

时间窗: 6 weeks

Detection of reduction of pain scores in the nonunion area and enabling patients to load on the extremity in the early period postoperatively

次要结局

未报告次要终点

研究者

发起方
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Çağrı Tekin

Associated Professor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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