Clinical Trial

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

Study acronym: POINTURE-HV
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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.
Trial Details
NCT Number NCT07755488
Lead Sponsor Groupe Hospitalier Diaconesses Croix Saint-Simon
Conditions Hallux Valgus
Enrollment 100 participants
Start Date 2026-09-20
Primary Completion 2027-09-20 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-10