NCT04174482已完成不适用
Pilot Study of Morphological and Functional Evaluation of Adult Flat Foot by Weight Bearing CT and Gait Analysis Before and After Corrective Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Weight bearing computed tomography parameter
研究概览
简要总结
Morphological weight bearing computed tomography parameters and gait analysis can implement the evaluation of the flat foot. Weight bearing CT is useful to verify the severity of the 3D deformities typical of flat foot, while kinematic and kinetic variables of gait is able to quantify the functional improvements of the foot after surgery.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with idiopathic flat foot with indication for corrective surgical treatment according to Grice (arthrodesis of the subtalar joint)
- •age between 18 and 65 years
- •BMI less than 40
- •signature of informed consent.
排除标准
- •patients with severe alterations or other pathologies affecting the foot and lower limb
- •severe vascular and neurological systemic diseases
- •systemic diseases that can compromise bone consolidation
结局指标
主要结局
Weight bearing computed tomography parameter
时间窗: change from baseline at 6-months
calcaneal pitch angle (degree)
Gait Analysis parameter
时间窗: change from baseline at 6-months
medial longitudinal arch
次要结局
- Pain clinical examination parameter(pre-operative phase and at a 6-months follow-up from the intervention)
- Function clinical examination parameter(pre-operative phase and at a 6-months follow-up from the intervention)
- Posture clinical examination parameter(pre-operative phase and at a 6-months follow-up from the intervention)
研究者
研究点 (2)
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