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

NCT07755488 | Not Yet Recruiting

• 1 other identifier: ID RCB/ 2026-A00408-43
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Hallux Valgus; Scarf Osteotomy; 3D Surface Scanner; Shoe Size; Forefoot Morphometry

Outcome Measures

Primary Outcomes (1)

• Change in Weight-Bearing 3D Surface Scan Shoe Size at 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 $\\ge 0.5$ Paris points will also be assessed.

  Baseline (preoperative) and 6 months postoperatively

Secondary Outcomes (4)

• Change in Self-Reported Shoe Size

  Baseline (preoperative) and 6 months postoperatively

• Forefoot Morphometric Changes Measured by 3D Surface Scanner

  Baseline (preoperative), 6 weeks, 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

Study Arms (1)

Hallux valgus

EXPERIMENTAL

patients consulting for hallux valgus

Procedure: Surgical correction of hallux valgus via osteotomy

Interventions

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: 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.

Hallux valgus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Hospitalier Diaconesses Croix Saint-Simon: lead

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Officials

• Antoine MOUTON

  Diaconesses Croix Saint Simon Hospital Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Younes KERROUMI, Clinical Research Physician

CONTACT

+33144643384; ykerroumi@hopital-dcss.org

Meriem BAKHTI, Clinical Research Technician

CONTACT

+33144641603; mbakhti@hopital-dcss.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): September 20, 2026
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share