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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

NCT07755488 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-08-10

No results posted yet for this study

Summary

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.

Conditions

  • Hallux Valgus

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Groupe Hospitalier Diaconesses Croix Saint-Simon

    lead OTHER

Principal Investigators

  • Antoine MOUTON · Diaconesses Croix Saint Simon Hospital Group

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-20
Primary Completion
2027-09-20
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07755488 on ClinicalTrials.gov