跳至主要内容
临床试验/NCT07400705
NCT07400705进行中(未招募)不适用

Short-term Outcomes of High Tibial Osteotomy Using a Plate Versus a Plate With an Interbody Fusion Cage in Adolescent Tibia Vara : a Comparative Study

Sohag University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年10月6日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
25
试验地点
1
主要终点
correction of tibia vara radiologically

研究概览

简要总结

Tibia vara is a progressive angular deformity of the lower limb centered at the proximal tibial physis, producing a characteristic bowing of the leg. The condition is believed to result from an abnormal distribution of biomechanical stresses combined with an underlying genetic predisposition. (1) Excessive mechanical loading on the medial portion of the proximal tibial growth plate leads to asymmetric physeal activity, ultimately causing a pathologic varus deformity of the tibia.(²)

详细描述

The adolescent tibia vara may affect one or both limbs and is typically identified during or shortly before the pubertal growth spurt. (1) It is more frequently reported among individuals of African descent and those with a body mass index (BMI) greater than 40. (2) The increased body weight in these patients accentuates compressive forces on the posteromedial aspect of the proximal tibial physis,(3) resulting in localized inhibition of growth according to the Heuter-Volkmann principle, and leading to progressive varus deformity.(4) In many cases, associated deformities may also be observed at the distal tibia or femur, presenting as either varus or valgus alignment abnormalities.(5) Given the mechanical and structural nature of this deformity, corrective high tibial osteotomy (HTO) remains the cornerstone of surgical management in adolescent tibia vara. Modern fixation methods particularly the use of plate fixation versus plate combined with interbody fusion cage are being explored to enhance alignment correction, stability, and long-term outcomes in this challenging age group.

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
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescents aged [10-18] years diagnosed with tibia vara.
  • Symptomatic varus deformity centered at the proximal tibia requiring surgical correction.
  • Both sexes included
  • Open or transitional growth plates are suitable for HTO.

排除标准

  • Prior tibial realignment surgery on the same side.
  • Ages below 10 years or above 18 years
  • Active infection, progressive metabolic disorder (e.g., rickets) or skeletal dysplasia, neuromuscular disorder, or systemic inflammatory arthritis.
  • Complex deformities need external fixation as the first-line treatment.
  • Patients with chronic comorbidities.
  • Associated with fractures in the same limb

研究组 & 干预措施

Group A: Corrective HTO with plate fixation only.

Active Comparator

干预措施: high tibial osteotomy using interbody fusion cage (Procedure)

Group B: Corrective HTO with plate fixation plus an interbody fusion cage.

Active Comparator

干预措施: high tibial osteotomy using interbody fusion cage (Procedure)

结局指标

主要结局

correction of tibia vara radiologically

时间窗: 6 months

Change in MPTA from baseline to 6 months, measured on radiographs by two blinded observers.

correction of tibia vara on radiographs

时间窗: 6 months

Change in MPTA from baseline to 6 months, measured on radiographs by two blinded observers.

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

Atef Ahmed Hafez

resident doctor in sohag orthopedic department

Sohag University

研究点 (1)

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