Baropodometric Evaluation After Subtalar Arthroereisis for Pediatric Flexible Flatfoot: An Observational Cohort 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
- Step-Cycle Duration
研究概览
简要总结
Flexible flatfoot is common in children and adolescents. In some patients, the condition remains painful or limits activity despite non-surgical treatment. Subtalar arthroereisis is a minimally invasive operation in which an implant is placed in the sinus tarsi to limit excessive foot pronation while preserving joint movement.
This observational study follows children and adolescents who receive subtalar arthroereisis as part of their planned clinical care. Clinical status, standing foot radiographs, plantar-pressure distribution, and walking characteristics are assessed before surgery and six months after surgery. The study aims primarily to describe changes in dynamic plantar loading and walking parameters. Changes in clinical scores and radiographic alignment are assessed as secondary outcomes. No treatment is assigned for research purposes, and all surgical and postoperative decisions are made according to routine clinical indications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 是
入选标准
- •Scheduled for elective subtalar arthroereisis, with or without adjunctive surgical procedures.
- •Aged 10 to 18 years at the time of enrollment.
- •Male or female.
排除标准
- •Concomitant orthopedic or neurological conditions affecting walking ability.
- •Neurological or vestibular disorders affecting balance.
- •Contraindications to the medical devices used in the study.
- •Inability to understand and sign the informed consent form.
研究组 & 干预措施
Children and adolescents aged 10 to 18 years with symptomatic flexible flatfoot.
Children and adolescents aged 10 to 18 years with symptomatic flexible flatfoot and a clinical indication for elective subtalar arthroereisis. Participants receive the operation as part of routine clinical care and undergo clinical, radiographic, and dynamic baropodometric assessment before surgery and at six months after surgery.
干预措施: Subtalar Arthroereisis (Procedure)
结局指标
主要结局
Step-Cycle Duration
时间窗: Baseline and 6 months after surgery
Ground-Contact Duration
时间窗: Baseline and 6 months after surgery
Double-Support Duration
时间窗: Baseline and 6 months after surgery
Step Length
时间窗: Baseline and 6 months after surgery
Lateral Calcaneal Pitch Measured Using Synapse
时间窗: Baseline and 6 months after surgery
The lateral calcaneal pitch will be measured in degrees using the Synapse software on radiographic images. The measurement will be performed at baseline, before surgery (T0), and approximately 6 months after surgery (T1), in the operated foot. The change from baseline to 6 months after surgery will be evaluated.
Anteroposterior Talonavicular Coverage Angle Measured on Weight-Bearing Radiographs Using Synapse
时间窗: Baseline and 6 months after surgery
The anteroposterior talonavicular coverage angle will be measured in degrees using the Synapse software on radiographic images. The measurement will be performed at baseline, before surgery (T0), and approximately 6 months after surgery (T1), in the operated foot. The change from baseline to 6 months after surgery will be evaluated.
Anteroposterior Talocalcaneal Angle Measured Using Synapse
时间窗: Baseline and 6 months after surgery
The anteroposterior talocalcaneal angle will be measured in degrees using the Synapse software on radiographic images. The measurement will be performed at baseline, before surgery (T0), and approximately 6 months after surgery (T1), in the operated foot. The change from baseline to 6 months after surgery will be evaluated.
Lateral Meary's Angle Measured Using Synapse
时间窗: Baseline and 6 months after surgery
The lateral Meary's angle will be measured in degrees using the Synapse software on radiographic images. The measurement will be performed at baseline, before surgery (T0), and approximately 6 months after surgery (T1), in the operated foot. The change from baseline to 6 months after surgery will be evaluated.
次要结局
未报告次要终点
研究者
Luca Marin
Principal Investigator
University of Pavia