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Change in Shoe Size and Forefoot Morphological Parameters After Scarf + P1 Osteotomy for Hallux Valgus: a Prospective Study Using Surface 3D Scanning (POINTURE-HV)

2026年8月24日 更新者：Groupe Hospitalier Diaconesses Croix Saint-Simon

Changes in Shoe Size and Forefoot Morphological Parameters After Scarf + P1 Osteotomy for Hallux Valgus: A Prospective Study Using Surface 3D Scanning

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：卫生服务研究
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Hallux valgus
patients consulting for hallux valgus
程序：Surgical correction of hallux valgus via osteotomy

A prospective, non-comparative, single-center interventional study involving human subjects and entailing minimal risk and burden (RIPH2).

The interventions introduced by the research consist of:

  1. Performing a mini-surface scan during the 6-week postoperative consultation.
  2. Scheduling the patient for a 6-month consultation.
  3. Performing a mini-surface scan during the 6-month postoperative consultation.
  4. Measuring shoe size using a foot-measuring device preoperatively, and tracking both reported and measured (using the device) shoe size postoperatively at 6 weeks and 6 months.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Weight-Bearing 3D Surface Scan Shoe Size at 6 Months Postoperatively
大体时间：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.
Baseline (preoperative) and 6 months postoperatively

次要结果测量

结果测量
措施说明
大体时间
Change in Self-Reported Shoe Size
大体时间：Baseline (preoperative) and 6 months postoperatively
Difference between the patient's self-reported shoe size at 6 months postoperatively compared to baseline (measured in Paris points).
Baseline (preoperative) and 6 months postoperatively
Correlation Coefficient Between Radiographic and 3D Surface Scanner Angular Measurements
大体时间：Baseline (preoperative) and 6 months postoperatively
Correlation coefficient evaluating the agreement between Hallux Valgus Angle (HVA) and Intermetatarsal Angle (M1-M2) measured on standing plain radiographs versus 3D surface scan reconstructions.
Baseline (preoperative) and 6 months postoperatively
Incidence of Surgical Complications
大体时间：Through 6 months postoperatively
Proportion of patients experiencing early or late postoperative complications, including deformity recurrence, hallux varus hypercorrection, transfer metatarsalgia, hardware intolerance/failure, delayed wound healing, surgical site infection, or dorsal collateral nerve sensory disorders.
Through 6 months postoperatively
Forefoot Morphometric Changes Measured by 3D Surface Scanner
大体时间：Baseline (preoperative), 6 weeks, and 6 months postoperatively
Changes in forefoot width (in mm), metatarsal perimeter (in mm), and global forefoot volume (in cm3) measured during weight-bearing 3D surface scanning.
Baseline (preoperative), 6 weeks, and 6 months postoperatively

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Groupe Hospitalier Diaconesses Croix Saint-Simon

调查人员

  • 首席研究员：Antoine MOUTON、Diaconesses Croix Saint Simon Hospital Group

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月20日

初级完成 (估计的)

2027年9月20日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2026年8月5日

首先提交符合 QC 标准的

2026年8月5日

首次发布 (实际的)

2026年8月10日

研究记录更新

最后更新发布 (实际的)

2026年8月26日

上次提交的符合 QC 标准的更新

2026年8月24日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ID RCB/ 2026-A00408-43

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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