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临床试验/NCT03724630
NCT03724630Unknown不适用

The Results of Multiple Aspirations and Injections of Unicameral Bone Cyst by Methyl Prednisolone Acetate

Assiut University0 个研究点目标入组 15 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
主要终点
radiological healing of simple bone cyst

研究概览

简要总结

Evaluation of the efficacy of methyl prednisolone injection in treatment o f simple bone cyst to prevent all possible complications as pathological fractures and to avoid prolonged restriction of physical activity

详细描述

unicameral bone cysts (UBCs) are benign, fluid-filled cavities that develop in tubular and flat bones (eg,humerus, femur). These cysts tend to expand and weaken the local bone,but they are not true neoplasms. In 1876, Virchow1 first described these lesions as cystic structures caused by abnormalities in local circulation.

UBCs are also known as simple or solitary bone cysts. They occur almost exclusively in children and adolescents (up to 85% of cases), with a reported peak between ages 3 and14 years and the average age at diagnosis being 9 years.

These lesions represent approximately 3% of all bone tumors and occur more commonly in boys than in girls (2:1). Several treatment options exist for unicameral bone cysts (UBCs), including observation, steroid injection, bone marrow injection, and Surgical procedures have ranged from simple curettage with autologous bone graft or allograft to sub periosteal resection with internal fixation and grafting

.Treatment by multiple injection of steroids produce minimal surgical approach, no hospital stay, and very low morbidity. Three or four injections over a period of 12 month may be enough

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • age .: all children eighteen years of age or younger with unicameral bone cyst
  • Patient with previous fracture on top of unicameral bone cyst

排除标准

  • patient age more than 18 years old
  • patients with malignant tumors
  • patients on chronic steroid treatment
  • pregnancy

结局指标

主要结局

radiological healing of simple bone cyst

时间窗: one month after injection

1. Modified Neer classification 1. Healed cyst : Cyst filled by new bone, with or without small radiolucent area(s) \< 1 cm in size 2. Healing with defect: Radiolucent area(s) \< 50% of the diameter of bone, with enough cortical thickness to prevent fracture 3. Persistent cyst: Radiolucent area \> 50% of diameter of the bone and with a thin cortical rim. No increase in the size of the cyst. Continued restriction of activity or repeated treatment is required 4. Recurrent cyst: Cyst reappeared in a previously obliterated area, or a residual radiolucent area has increased in size 2. the cyst index which predict the risk of pathological fracture .The cyst index can be calculated as the area of the cyst divided by the square of the diaphysis diameter cyst index equal to or greater than 3.5 indicates a high fracture risk

次要结局

  • improvement of symptoms(one month after injection)

研究者

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

michael moured

principal investigator

Assiut University

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