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临床试验/NCT06505720
NCT06505720尚未招募不适用

Arthroscopic Versus Open Management of Acute Pediatric Septic Hip Infection: A Randomized Controlled Trial

Hesham Mohamed Elbaseet0 个研究点目标入组 62 人开始时间: 2024年8月13日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
62
主要终点
Modified Mckay's criteria

研究概览

简要总结

Acute septic hip infection in pediatric population is a true orthopedic surgical emergency that require early diagnosis and prompt management. Open surgical debridement and drainage of the hip through lateral approach is the gold standard method of treatment. Usage of hip arthroscopy in the treatment of such condition has been in clinical practice for more than 30 years. However, literature is still lacking in actual prospective comparison about the outcome of both methods.

详细描述

The study will divide the children presented with acute septic hip infection into two groups; the control group in which the child will undergo traditional open surgical debridement and drainage of the hip via lateral approach, and the intervention group in which arthroscopic drainage and debridement of the hip will be done. The outcomes of both methods will be recorded and compared. The research hypothesis is that arthroscopic management of acute pediatric septic hip infection is as effective as open surgery; with fewer complications and faster recovery.

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 (Outcomes Assessor)

入排标准

年龄范围
10 Months 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 10 months - 14 years _unilateral or bilateral acute septic hip arthritis

排除标准

  • Children with pre-existing other pathology of the affected hip, whether he / she has surgery for management of this pathology or not.
  • Patients whose parents refuse to participate in the study

结局指标

主要结局

Modified Mckay's criteria

时间窗: One Year Follow-up

Excellent: painless, stable hip; no limp; more than 15 degrees of internal rotation. Good: painless, stable hip; slight limb or decreased motion , negative Trendelenburg sign Fair: minimum pain; moderate stiffness, positive Trendelenburg sign Poor: significant pain.

次要结局

未报告次要终点

研究者

发起方
Hesham Mohamed Elbaseet
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hesham Mohamed Elbaseet

MD

Assiut University

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