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临床试验/NCT06439147
NCT06439147已完成不适用

U-shaped Versus T-shaped Capsular Incision in Capsulorrhaphy During Surgery for Developmental Dysplasia of the Hip, A Randomized Controlled Trial

Assiut University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月1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
60
试验地点
2
主要终点
Modified Mackay's criteria as a clinical evaluation method

研究概览

简要总结

comparison of the outcome between using U-shaped incision and T-shaped incision for capsulorrhaphy in management of Developmental dysplasia of the hip

详细描述

Developmental dysplasia of the hip: Developmental dysplasia of the hip is a spectrum of abnormalities of the developing hip joint that ranges from shallowness of the acetabulum to capsular laxity and instability to frank dislocation . Developmental dysplasia of the hip is relatively common, occurring in 1 of 1000 live births.

When surgical intervention is decided, open reduction is needed to remove any obstacle that hinders hip reduction. Capsulorrhaphy is an essential step for minimizing instability of the hip after reduction The classic T-shaped capsular incision is done by two incisions: Vertical limb parallel to femoral neck axis and a transverse one parallel to the inguinal ligament resulting into two layers . Suturing them back is somewhat cumbersome after femoral head reduction. Therefore, the suggested technique utilizes a U-shaped incision to make re-suturing of the capsule easier with multiple stitches, and this study compares the outcome between using T-shaped incision and U-shaped incision for capsulorrhaphy after open reduction Femoral osteotomy or Pelvic osteotomy can be used in certain circumstances.

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 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients older than 1 year and younger than 4 years
  • Unilateral or bilateral cases

排除标准

  • Patients younger than 1 year and older than 4 years old
  • Secondary hip dislocation ,neuromuscular disorders (as cerebral palsy, myelodysplasia or arthrogryposis).

研究组 & 干预措施

U-shaped group

Active Comparator

Participants on which U shaped capsular incision will be used during capsulorrhaphy

干预措施: U shaped capsular incision during capsulorrhaphy (Procedure)

T-shaped group

Active Comparator

Participants on which T shaped incision will be used during capsulorrhaphy

干预措施: T-shaped capsular incision diuring capsulorraphy (Procedure)

结局指标

主要结局

Modified Mackay's criteria as a clinical evaluation method

时间窗: 1 year

Postoperative clinical evaluation Grade 1(Excellent):Painless,stable hip,no limp,more than 15 degrees of internal rotation Grade 2(Good):Painless,stable hip,slight limp or decreased motion;negative trendelenburg's sign Grade 3(Fair):Minimum pain,moderate stiffness;Positive trendelenburg sign Grade 4(Poor):Significant pain

次要结局

  • Operative time ofcapsulorrhaphy(1 year)
  • Number of stitches taken during capsulorrhaphy(1 year)
  • any complication detected(1 year)

研究者

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

Ahmed Mostafa Thabet Hussien

Orthopedic surgery resident

Assiut University

研究点 (2)

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