NCT05880407招募中不适用
Pilot Study of Percutaneous Correction of Hallux Valgus: Clinical-functional Evaluation of Outcome Randomized Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Visual Analog Score
研究概览
简要总结
This is a pilot study with a randomized controlled design.
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
- 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 of both sexes with adult hallux valgus with indication for corrective surgical treatment
- •HVA (hallux valgus angle): 20°-40°
- •IMA (intermetatarsal angle): 10°-20°
排除标准
- •Patients with instability of the first metatarsophalangeal joint
- •Patients with severe morphostructural alterations or other pathologies in the foot and lower limb
- •patients requiring additional surgical procedures
- •patients with severe vascular and neurological systemic pathologies
- •systemic pathologies that may impair bone consolidation
研究组 & 干预措施
standard treatment
Active Comparator
SERI osteotomy
干预措施: SERI osteotomy (Procedure)
experimental treatment
Experimental
percutaneous osteotomy according to Chevron
干预措施: percutaneous osteotomy according to Chevron (Procedure)
结局指标
主要结局
Visual Analog Score
时间窗: 1 year
pain visual analog assessment
Visual Analog Score
时间窗: baseline
pain visual analog assessment
次要结局
- American Orhtopaedic Foot and Ankle Society forefoot score(baseline and aftef 1 year)
研究者
研究点 (2)
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