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临床试验/NCT07289256
NCT07289256尚未招募不适用

Comparison of Hip Spica Duration (6 Weeks vs 12 Weeks) Following Open Reduction and Pelvic Osteotomy in Developmental Dysplasia of the Hip

Assiut University0 个研究点目标入组 40 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
Redislocation rate

研究概览

简要总结

The study aim is to compare clinical and radiological outcomes of 6-week versus 12-week hip spica immobilization following open reduction and pelvic osteotomy for DDH.

详细描述

Developmental dysplasia of the hip (DDH) is a common pediatric orthopedic disorder with a prevalence of 2% to 3% in neonates. Surgical intervention, including open reduction and pelvic osteotomy, is indicated when closed reduction fails or diagnosis is delayed. Traditionally, postoperative immobilization in a hip spica cast is recommended for 12 weeks to maintain stability. However, recent studies suggest that shorter durations (6 weeks) may provide equivalent stability with fewer complications such as joint stiffness, muscle atrophy, skin breakdown, and caregiver burden. some fractures occurs after the cast, according to Alassaf 2018 out of total of 128 patients (162 hips) 93 were in the double-leg spica group, and 69 were in the single-leg spica group three patients had a greenstick distal femur fracture after double-leg spica and one after single-leg spica. There is no international consensus on the optimal spica duration, and evidence is limited. Proving that 6 weeks immobilization is not inferior to 12 weeks immobilization could improve outcomes, reduce costs, and lessen morbidity.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children 18 months-6 years undergoing open reduction with pelvic osteotomy for DDH.

排除标准

  • • Infection
  • Paralytic hip dislocation

结局指标

主要结局

Redislocation rate

时间窗: 12 months post-surgery

Incidence of hip redislocation within the first 12 months after open reduction and hip spica immobilization.

次要结局

  • Radiological outcomes(3, 6, and 12 months post-surgery)
  • Functional outcomes(Within 6-12 months post-surgery)
  • Complications(During immobilization period and up to 3 months post-cast removal)

研究者

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

Makarious Medhat Mahfouz Ishak

resident doctor

Assiut University

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