跳至主要内容
临床试验/NCT06747767
NCT06747767已完成不适用

Early Outcomes of Arthroscopic Versus Open Reduction for Developmental Dysplasia of the Hip in Children: A Randomized Controlled Trial

Hawler Medical University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2022年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
rate of hip redislocation documented clinically and radiographically at 6, 12, and 24 months postoperatively.

研究概览

简要总结

This study was designed to determine whether arthroscopic-assisted reduction offers better early surgical outcomes than open reduction for treating developmental dysplasia of the hip in children. By comparing these two approaches, the researchers sought to find out if using an arthroscopic-assisted method could lower redislocation rates, shorten operative time, reduce blood loss, maintain acceptable acetabular alignment, and potentially decrease the risk of complications such as avascular necrosis, thereby improving the quality of care and long-term hip function for affected children.

详细描述

This investigation evaluates two distinct surgical strategies for managing developmental dysplasia of the hip (DDH) in young children using a comparative, parallel-group design. The technical approach under consideration involves an arthroscopic-assisted procedure, which provides direct visualization of the hip joint structures through minimally invasive portals. By employing specialized instruments and an arthroscopic camera system, surgeons can assess ligamentous and capsular integrity, identify obstacles to proper femoral head positioning, and address intra-articular pathologies with potentially less disruption to the vascular supply and surrounding soft tissues than is typical in conventional open surgery. The surgical team implemented stringent measures to maintain uniformity in anesthesia protocols, operative setup, and postoperative immobilization strategies, ensuring that any observed differences would more likely be attributable to the surgical technique rather than confounding variables. Additionally, advanced imaging modalities, including fluoroscopic guidance where appropriate, were used intraoperatively to confirm adequate reduction and optimize acetabular coverage. The study's procedural protocols were developed in consultation with senior pediatric orthopedic surgeons experienced in both techniques and piloted to establish feasibility before patient enrollment commenced. In this manner, the investigation aims to refine the understanding of arthroscopic-assisted hip reconstruction in the pediatric population, providing insights that may influence future surgical guidelines, training curricula, and patient care pathways.

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 (Participant)

入排标准

年龄范围
1 Year 至 2 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children diagnosed with DDH (Tönnis grade II-IV)
  • •Age range: 12 to 24 months at the time of the first surgical reduction
  • •A documented failed attempt at conservative reduction (e.g., closed reduction) prior to enrollment

排除标准

  • •Presence of neuromuscular disorders
  • •Teratologic hip dislocation
  • •Prior surgical intervention on the affected hip
  • •Incomplete radiographic documentation (missing radiographs at any of the required assessment intervals)

研究组 & 干预措施

Arthroscopy

Experimental

Arthroscopic Reduction for Developmental Dysplasia of the Hip in Children

干预措施: Arthroscopy (Procedure)

Open Reduction

Experimental

Open Reduction for Developmental Dysplasia of the Hip in children

干预措施: Open reduction (Procedure)

结局指标

主要结局

rate of hip redislocation documented clinically and radiographically at 6, 12, and 24 months postoperatively.

时间窗: 2 years

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

Abdulkadr Muhammed S. Alany

University Faculty

Hawler Medical University

研究点 (1)

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