Hallux Valgus
Conditions
Keywords
Hallux Valgus, Scarf Osteotomy, 3D Surface Scanner, Shoe Size, Forefoot Morphometry
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.
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.
Interventions
PROCEDURESurgical 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
Groupe Hospitalier Diaconesses Croix Saint-Simon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight-Bearing 3D Surface Scan Shoe Size at 6 Months Postoperatively | Baseline (preoperative) and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Reported Shoe Size | Baseline (preoperative) and 6 months postoperatively | Difference between the patient's self-reported shoe size at 6 months postoperatively compared to baseline (measured in Paris points). |
| Forefoot Morphometric Changes Measured by 3D Surface Scanner | Baseline (preoperative), 6 weeks, and 6 months postoperatively | Changes in forefoot width (in mm), metatarsal perimeter (in mm), and global forefoot volume (in cm3) measured during weight-bearing 3D surface scanning. |
| Correlation Coefficient Between Radiographic and 3D Surface Scanner Angular Measurements | Baseline (preoperative) and 6 months postoperatively | 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. |
| Incidence of Surgical Complications | Through 6 months postoperatively | 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. |
Contacts
CONTACTYounes KERROUMI, Clinical Research Physician
CONTACTMeriem BAKHTI, Clinical Research Technician
PRINCIPAL_INVESTIGATORAntoine MOUTON
Diaconesses Croix Saint Simon Hospital Group
Outcome results
None listed