Change in Shoe Size and Forefoot Morphological Parameters After Scarf + P1 Osteotomy for Hallux Valgus: a Prospective Study Using Surface 3D Scanning
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Conditions studied: Hallux Valgus
In brief
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.
Key facts
- Study ID
- NCT07755488
- Run by
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- People needed
- 100
- Starts
- 2026-09-20
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-08-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Full record on ClinicalTrials.gov
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