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NCT Number: NCT07755488

Change 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.

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Key information

Conditions

Hallux Valgus Foot Deformities Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical correction of hallux valgus via osteotomy

Procedure

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:

  • Performing a mini-surface scan during the 6-week postoperative consultation.
  • Scheduling the patient for a 6-month consultation.
  • Performing a mini-surface scan during the 6-month postoperative consultation.
  • 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.

Primary outcomes

  1. Change in Weight-Bearing 3D Surface Scan Shoe Size at 6 Months Postoperatively

    Time frame: 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.

Secondary outcomes

  1. Change in Self-Reported Shoe Size

    Time frame: 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).

  2. Forefoot Morphometric Changes Measured by 3D Surface Scanner

    Time frame: 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.

  3. Correlation Coefficient Between Radiographic and 3D Surface Scanner Angular Measurements

    Time frame: 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.

  4. Incidence of Surgical Complications

    Time frame: 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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Other

Registry information

Official study title

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

Acronym: POINTURE-HV

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 10, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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