Role of Rotational Guided Growth in Management of Increased Femoral Anteversion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Gait
研究概览
简要总结
Efficacy of guided growth in coronal plane deformity correction and limb length discrepancy has been well-established. Recently, studies have explored the validity of guided growth in correction of rotational deformity through a modified method of application.
This concept has been validated in animal studies, biomechanical studies and two limited human case series through different methods.
This study evaluates the efficacy of rotational guided growth in management of increased femoral anteversion using three different constructs.
详细描述
The purpose of this study is:
- Evaluate the efficacy of different constructs in correcting increased femoral anteversion clinically and radiographically.
- Asses possible complications of this new concept including LLD, undesired coronal, sagittal plane deformity and stiffness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with increased femoral anteversion causing in-toeing with decreased agility.
- •Aged 8 years and above with at least two years of bone growth remaining.
排除标准
- •Any patient who underwent previous femoral osteotomy.
- •Any patient with sick physis (skeletal dysplasias, post traumatic / post infective physeal damage, active rickets).
- •Cerebral Palsy (CP) patients
研究组 & 干预措施
Rotational Guided Growth
o On a radiolucent operating table with the child supine, a torniquet is applied. The limb is prepped and draped.
oA Kirschner wire is inserted in midsagittal plane of the distal femoral physis from medial to lateral under fluoroscopic guidance.
After the initial step, One of three Surgical techniques might be used according to surgeon preference and patient age:
- Plate technique
- Non-absorbable suture technique
- Cerclage wire technique
干预措施: Plate Technique (Device)
结局指标
主要结局
Gait
时间窗: 12 months
Foot Progression Angle 5-10 degrees by clinical gait assesment
次要结局
- Angular Deformities(12 months)
- Limb length discrepancy(12 months)