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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hallux Valgus
• Intervention / Treatment: Procedure: Surgical correction of hallux valgus via osteotomy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Younes KERROUMI, Clinical Research Physician; Phone Number: +33144643384; Email: ykerroumi@hopital-dcss.org
• Study Contact Backup: Name: Meriem BAKHTI, Clinical Research Technician; Phone Number: +33144641603; Email: mbakhti@hopital-dcss.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hallux valgus; patients consulting for hallux valgus

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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 at least 0.5 Paris points will also be assessed.	Baseline (preoperative) and 6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-Reported Shoe Size	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	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	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	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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon
• Investigators: Principal Investigator: Antoine MOUTON, Diaconesses Croix Saint Simon Hospital Group

Study record dates

Study Major Dates

• Study Start (Estimated): September 20, 2026
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 5, 2026
• First Submitted That Met QC Criteria: August 5, 2026
• First Posted (Actual): August 10, 2026

Study Record Updates

• Last Update Posted (Actual): August 26, 2026
• Last Update Submitted That Met QC Criteria: August 24, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Hallux Valgus; Scarf Osteotomy; 3D Surface Scanner; Shoe Size; Forefoot Morphometry
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Hallux Valgus
• Other Study ID Numbers: ID RCB/ 2026-A00408-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No