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
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
- 否
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.
干预措施: high tibial osteotomy using interbody fusion cage (Procedure)
Group B: Corrective HTO with plate fixation plus an interbody fusion cage.
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
Atef Ahmed Hafez
resident doctor in sohag orthopedic department
Sohag University
