Changes in Shoe Size and Forefoot Morphological Parameters After Scarf + P1 Osteotomy for Hallux Valgus: A Prospective Study Using Surface 3D Scanning
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Change in Weight-Bearing 3D Surface Scan Shoe Size at 6 Months Postoperatively
研究概览
简要总结
Background and Rationale:
Surgical correction of Hallux Valgus via Scarf and P1 osteotomy aims to realign the first ray, modifying overall forefoot morphology. While radiological correction is well established, a discrepancy often exists between objective foot measurements and patient-perceived postoperative shoe fitting. Weight-bearing 3D surface scanning provides a non-irradiating, precise method to evaluate volumetric and dimensional changes without the biases of traditional foot-measuring gauges.
Objective and Hypothesis:
The primary objective is to measure changes in shoe size (in French/Paris points) using weight-bearing 3D surface scanning between baseline and 6 months postoperatively. The study hypothesis is that Scarf + P1 osteotomy induces a shoe size reduction of at least 0.5 Paris points at 6 months, correlated with forefoot width reduction, M1 shortening, and angular correction (HVA and M1-M2 angles).
Study Design:
Prospective, single-center, non-comparative interventional study with minimal risks and constraints (RIPH 2) involving 100 participants.
详细描述
Study Procedures and Follow-up Schedule: Preoperative Assessment: Clinical evaluation, standing plain radiographs (HVA and M1-M2 angles), baseline self-reported shoe size, foot-measuring device measurement, and weight-bearing 3D surface scan. Surgical Intervention: Hallux valgus correction via Scarf osteotomy of the first metatarsal combined with P1 phalanx osteotomy. Postoperative Follow-up Visits: 6-Week Visit: Routine clinical evaluation, 3D surface scan, foot-measuring device measurement, and self-reported shoe size assessment. 6-Month Visit: Final follow-up visit including standing radiographs, 3D surface scan, foot-measuring device measurement, self-reported shoe size assessment, and recording of surgical/mechanical complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient informed about the study and signed written consent obtained in duplicate
- •Male or female participant aged 18 years or older
- •Symptomatic hallux valgus without lateral ray involvement, requiring surgical correction by Scarf + P1 osteotomy
- •Primary surgery planned for the affected foot
- •Ability to understand study information, complete questionnaires, and comply with follow-up visits (6 weeks and 6 months)
排除标准
- •Previous bony surgery of the first ray or forefoot on the affected side (osteotomy, arthrodesis)
- •Surgical indication on lateral rays (claw toes, Weil osteotomy)
- •Severe lower-limb neurological or vascular disease altering gait or foot morphology (Charcot foot, critical limb ischemia, severe neuropathy)
- •Active inflammatory rheumatic disease (e.g., rheumatoid arthritis) with polyarticular foot involvement
- •Complex foot deformity requiring primary first metatarsophalangeal (MTP1) arthrodesis or procedure other than Scarf + P1 osteotomy
- •Pregnant or breastfeeding woman
- •Person under legal guardianship or unable to provide free and informed consent
- •Person deprived of liberty by judicial or administrative decision
- •Concurrent participation in another research study that could interfere with study endpoints
研究组 & 干预措施
Hallux valgus
patients consulting for hallux valgus
干预措施: Surgical correction of hallux valgus via osteotomy (Procedure)
结局指标
主要结局
Change in Weight-Bearing 3D Surface Scan Shoe Size at 6 Months Postoperatively
时间窗: Baseline (preoperative) and 6 months postoperatively
Mean change in shoe size (expressed in French size points / Paris points) measured objectively using a weight-bearing 3D surface scanner between baseline (preoperative) and 6 months postoperatively. The proportion of patients experiencing a clinically significant shoe size reduction of at least 0.5 Paris points will also be assessed.
次要结局
- Change in Self-Reported Shoe Size(Baseline (preoperative) and 6 months postoperatively)
- Correlation Coefficient Between Radiographic and 3D Surface Scanner Angular Measurements(Baseline (preoperative) and 6 months postoperatively)
- Incidence of Surgical Complications(Through 6 months postoperatively)
- Forefoot Morphometric Changes Measured by 3D Surface Scanner(Baseline (preoperative), 6 weeks, and 6 months postoperatively)