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

ConditionHallux Valgus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGroupe Hospitalier Diaconesses Croix Saint-Simon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Surgical correction of hallux valgus via osteotomy

    Procedure/Surgery

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Hallux valgusExperimental treatment 1 intervention

Trial outcomes

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 at least 0.5 Paris points will also be assessed.

Time frame
Baseline (preoperative) and 6 months postoperatively

Secondary outcomes

1

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).

Time frame
Baseline (preoperative) and 6 months postoperatively
2

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.

Time frame
Baseline (preoperative), 6 weeks, and 6 months postoperatively
3

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.

Time frame
Baseline (preoperative) and 6 months postoperatively
4

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.

Time frame
Through 6 months postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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